IN RE ZYPREXA PRODUCTS LIABILITY LITIGATION Nos. 04-MD-1596, 06-CV-1729.
489 F.Supp.2d 230 (2007)
In re ZYPREXA PRODUCTS LIABILITY LITIGATION. Monty Souther, Robert Cusella, Judith New, Beverly Pearson, Donna Worthington, Plaintiffs, v. Eli Lilly & Company, Defendant.
United States District Court, E.D. New York.
June 11, 2007.
Lawrence J. Myers, Smith Moore, Atlanta, GA, Samuel J. Abate, Jr., Pepper Hamilton LLP, New York, NY, for Defendant.
MEMORANDUM, ORDER, & JUDGMENT
WEINSTEIN, Senior District Judge.
TABLE OF CONTENTS I. Introduction .....................................................................236 A. History of Litigation ........................................................236 B. Some General Considerations ..................................................238 1. Preemption ...............................................................240 2. Benefits and Roles of Others Reducing Damages ............................241 3. Protections Available to Plaintiffs Through Sources Such as Available Experts' Information and Treating Physicians ...........................244 4. Appropriate Recoveries and Payments ......................................245 C. Motions for Summary Judgment .................................................247 II. Facts ............................................................................248 A. Nature of Zyprexa ............................................................248 B. FDA Labeling .................................................................248 1. September 2003 Label Change ..............................................248 2. Consensus Statement of American Diabetes Association and Other Learned Groups .........................................................249 3. FDA March 2007 Letter ....................................................250
C. International Zyprexa Labeling ...............................................250 1. Japan ....................................................................250 2. European Union, Australia, and Canada.....................................250 D. Lilly's Promotion of Zyprexa..................................................250 1. Pre-September 2003 Label..................................................250 2. Post-September 2003 Label.................................................251 E. Plaintiffs ...................................................................253 1. Robert Cusella ...........................................................253 a) Patient History ......................................................253 b) Prescribing Physician's State of Knowledge ...........................253 c) Representations Made by Lilly Salespeople ............................255 2. Judith New ...............................................................256 a) Patient History ......................................................256 b) Prescribing Physician's State of Knowledge ...........................256 c) Representations Made by Lilly Salespeople ............................257 3. Monty Souther ............................................................259 a) Patient History ......................................................259 b) Prescribing Physicians' State of Knowledge ...........................259 c) Representations Made by Lilly Salespeople ............................261 4. Donna Worthington ........................................................261 a) Patient History ......................................................261 b) Prescribing Physician's State of Knowledge ...........................261 c) Representations Made by Lilly Salespeople ............................262 III. Summary Judgment .................................................................262 A. Law ..........................................................................262 1. Summary Judgment Standard ................................................262 a) Generally ............................................................262 b) Right to a jury ......................................................263 2. Choice of Law ............................................................264 a) Substance ............................................................264 b) Statute of Limitations ...............................................264 3. Florida Law ..............................................................265 a) The Learned Intermediary Doctrine ....................................265 b) Adequacy of Warning ..................................................266 c) Statute of Limitations ...............................................266 4. Pennsylvania Law .........................................................267 a) The Learned Intermediary Doctrine ....................................267 b) Adequacy of Warning ..................................................268 c) Statute of Limitations ...............................................268 5. North Carolina Law .......................................................269 a) The Learned Intermediary Doctrine ....................................269 b) Adequacy of Warning ..................................................269 c) Statute of Limitations ...............................................269 6. Application of Federal Law ...............................................270 a) Preemption ...........................................................270 i) FDA Preamble ...................................................270 ii) FDA Regulation of Prescription Drug Warning Labels .............271 iii) Deference Due FDA's Interpretation .............................272 iv) FDCA Preemption of State Law Causes of Action ..................272 b) Preemption of State Failure to Warn Claims ...........................273 i) The Preamble Does Not Control the Question of Preemption .......273 ii) State Law Failure to Warn Claims are Not Preempted ..............275 7. Damages Issues ...........................................................278 B. Application of Law to Facts ..................................................278 1. Robert Cusella ...........................................................278 a) Choice of Law ........................................................278 b) Statute of Limitations ...............................................278 c) Adequacy of Warning Post-September 2003 Label Change .................278 d) Deposition of Treating Physician .....................................279 e) Summary Judgment Decision ............................................279 2. Judith New ...............................................................279 a) Choice of Law ........................................................279 b) Statute of Limitations ...............................................279 c) Adequacy of Warning Post-September 2003 Label Change .................279 d) Deposition of Treating Physician .....................................279 e) Summary Judgment Decision ............................................279 3. Monty Souther ............................................................279 a) Choice of Law ........................................................279 b) Statute of Limitations ...............................................279 c) Adequacy of Warning Post-September 2003 Label Change .................279 d) Deposition of Treating Physician .....................................279 e) Summary Judgment Decision ............................................279 4. Donna Worthington ........................................................280 a) Choice of Law ........................................................280 b) Statute of Limitations ...............................................280 c) Adequacy of Warning Post-September 2003 Label Change .................280 d) Deposition of Treating Physician .....................................280 e) Summary Judgment Decision ............................................280 5. Adequacy of September 2003 Warning Label .................................280 IV. Admissibility of Expert Opinions at Trial ........................................281 A. Motions Regarding Admissibility of Expert Reports ............................281 B. Rules 702 and 703 of the Federal Rules of Evidence ...........................281 C. Qualifications of Expert Witnesses ...........................................282 D. Helpfulness and Relevance ....................................................282 E. Reliability ..................................................................283 F. Individual Experts' Reports ..................................................285 1. Challenges to Plaintiffs' Experts ........................................285 a) Dr. Carol Levy, M.D ..................................................285 b) Dr. Stefan P. Kruszewski, M.D ........................................286 c) Dr. Arvin P. Shroff, Ph.D ............................................288 2. Challenges to Defendant's Expert Dr. Robert R. Henry, M.D ................289 V. Conclusion .......................................................................291 A. Cusella ......................................................................291 B. New ..........................................................................291 C. Souther ......................................................................291 D. Worthington ..................................................................291
A. History of Litigation
Some 30,000 cases have been brought against Eli Lilly & Company ("Lilly") by plaintiffs suffering from serious psychiatric problems who were treated with the Lilly antipsychotic drug Zyprexa. They allege that Zyprexa caused deleterious side effects of excessive weight gain, hyperglycemia, and diabetes; that Lilly misled them and their physicians about the likelihood of these side effects; and that, had they or their attending physicians been aware of the risk, they would not have taken Zyprexa.
Litigation against Lilly for injuries allegedly caused by Zyprexa was initiated in this court in March 2004. See Benjamin v. Eli Lily & Co., Docket No. 04-CV-00893. Thousands of cases were then transferred here from federal district courts throughout the United States pursuant to an order of the Judicial Panel on Multidistrict Litigation. See Letter from Multidistrict Litigation Panel to Clerk of the Eastern District of New York, No. 04-MD-1596
The litigation has been administered as a quasi-class action. See In re Zyprexa Prods. Liab. Litig.,
Cooperation between federal and state courts has been encouraged at all stages of the Zyprexa litigation. See, e.g., In re Zyprexa Prods. Liab. Litig.,
An attorneys' fee structure for many cases has been ordered, capping fees at 20% of recovery in smaller, lump-sum claims, and at 35% of recovery in other claims. See In re Zyprexa Prods. Liab. Litig.,
A national system for resolving Medicare and Medicaid liens has been approved. See In re Zyprexa Prods. Liab. Litig.,
After discovery and negotiations, overseen in part by a court-appointed special discovery master and four special settlement masters, in November 2005 the defendant, without conceding liability, entered
Following an influx of thousands of new cases, in January of 2007 the parties announced another round of settlements. Approximately 1,000 claims remain unresolved in the MDL cases. Four of those cases are slated to be tried beginning July 9, 2007; a number of the cases originally scheduled for trial on that date have been settled or withdrawn. Lilly has moved for summary judgment in these four cases, which are the subject of this memorandum.
A separate motion for summary judgment has been filed by Lilly against plaintiff Rickie Dickerson, who alleges that he developed acute pancreatitis as a result of his ingestion of Zyprexa. That motion will be dealt with in a separate memorandum and order.
B. Some General Considerations
Discussed in this section I.B. are developing general issues of liability and damages that may substantially reduce any recovery for plaintiffs should they obtain judgments in their favor. All the states whose substantive law is operative incorporate these general considerations in their laws.
Suits alleging injury resulting from the ingestion of pharmaceuticals designed for huge populations present more complicated liability and damages issues than traditional one-on-one tort suits such as those resulting from people stepping into potholes. The medical and scientific communities — and necessarily tort law — accept the reality that there can usually be no benefit without some cost in possible side effects in use of prescription drugs. Unlike the classic tort pothole situation, elimination of all risk is almost impossible in medicine. Health improvements, especially in the area of pharmaceuticals, have benefits and risks. Treatment, especially of the kind of serious debilitating mental diseases suffered by present plaintiffs, often necessitates a choice between imperfect options.
Developers of medicines are under social and economic pressure to put their products on the market quickly and spread their uses as widely as benefits allow. They may not rely on fraud. But they and the public are entitled to some guidance and limitations from other controlling entities.
Modern American jurisprudence suggests that a jury will have to consider a number of legal-equitable causal vectors, apart from those involving the named defendant and plaintiff, in determining whether liability of defendant has been proven, and, if so, what damages should be assessed against a pharmaceutical designer-manufacturer of a drug intended to alleviate serious psychiatric and physical problems.
As one commentator has put the matter:
Alan Calnon, Justice and Tort Law, 4 (1997). "[T]he fault system as it operates today, with comparative responsibility, is a very different system than the generally all-or-nothing regime that [Guido Calabresi] criticized in The Costs of Accidents ." Donald G. Gifford, Forward, Calabresi's The Costs of Accidents: A Generation of Impact on Law and Scholarship, 64 Md. L.Rev. 1, 11 (2005); see also, e.g., Keith N. Hylton, Calabresi and the Intellectual History of Law and Economics, 64 Md. L.Rev. 85, 110 (2005) ("an evolutionary path of comparative causation in tort law"); id. at 112 (history of comparative causation); id. at 129 ("comparative causation is a more `precise' term than comparative fault"); id. at 135 (comparative causation rules approximate a "social optimum").
What has been said about latent diseases by one distinguished commentator applies as well to a case such as the instant one dealing with causation and pharmaceuticals:
Donald G. Gifford, The Peculiar Challenges Posed by Latent Diseases Resulting from Mass Products, 64 Md. L.Rev. 613, 617-18, (2005); see also id. at 667-68, 672, 674, 689 (situations where best "cost avoider" may be liable as in tobacco, lead, and guns); Guido Calabresi & Jeffrey 0. Cooper, New Directions in Tort Law, 30 Valparaiso U. L Rev. 859, 883 (1996) ("Given the advent of splitting rules, it would not take much of a doctrinal leap for splitting to spread into some . . . new areas.").
In making its determination of fault and damages the trier will need to consider in the larger legal and factual context the contribution to damage resulting from failures in a variety of systems designed to protect users of pharmaceuticals. They include: lack of adequate federal Food and Drug Administration ("FDA") supervision of the pharmaceutical industry; lack of sufficient testing by the manufacturer and failure to reveal risks in a timely manner, as well as circulating misleading information, see Restatement of the Law, Second, § 310, Conscious Misrepresentation Involving Risk of Physical Harm; id. § 311, Negligent Misrepresentation Involving Risk of Physical Harm; lack of sufficient information on risks and benefits of the drug and competing drugs available to the medical field because the usual medical publications and scientific sources other than the manufacturer or the FDA have not published necessary studies; failures of treating doctors to adequately inform themselves, to discuss risk and benefits with patients, and to exercise sound medical
A reasonable national public policy — in the absence of fraud — would give a pharmaceutical manufacturer protection against tort liability for failure to warn when the FDA had approved the accused warnings. See generally Part III.6.a, infra. Were that the law, Lilly would be liable at most for injuries caused by its failure to warn up to the time of either the first FDA-approved warning label ordered in October 1996, or the time of the new warning label ordered on September 11, 2003, or the distribution of "Dear Doctor" letters in March 2004 giving widespread notice of the September 2003 warnings. Preemption is best instituted by Congress, since it should provide national uniformity of liability and responsibility of the manufacturer, the doctor, other screeners, and the patient, and define the scope of state and federal substantive law protecting consumers of pharmaceuticals.
Here the law on preemption is ambiguous. Under such circumstances, a federal court should take the law's default position, honoring the traditional state control of tort law. See generally John C.P. Goldberg & Benjamin C. Zipursky, Accidents of the Great Society, 64 Md. L.Rev. 364 (2005).
Were the courts in a position to rely on the adequacy and candor of representations to the FDA and of robustness of inquiry and decisions of the FDA, a desirable result would be to apply preemption, excluding the state tort law relied upon by present plaintiffs. It is apparent, however, that the FDA's own research is limited and that it relies heavily on self-motivated representations and studies by the pharmaceutical industry. The FDA's attempts to keep abreast of and inform the public about dangerous side effects discovered only after a drug has been approved have been decried by many in the medical community as inadequate. See, e.g., Editorial, Rosiglitazone and Cardiovascular Risk, 356 New Eng. J. Med ____ (2007) ("The FDA frequently requires phase 4 trials to address some of the unanswered efficacy or safety questions at the time of approval. But [manufacturers] propose the designs, which sometimes compare their products with inferior treatments or doses. During the period from 1998 through 2003, only about a quarter of the required phase 4 trials were completed . . . This desultory approach to postmarketing studies necessarily
The divergence among the risk-benefit conclusions about Zyprexa and other drugs between, on the one hand, the FDA and the pharmaceutical industry, and, on the other, independent associations of scientists such as the American Diabetes Association, as well as alleged misleading by salespersons of Lilly arguably provides a murky mix of inadequate information and misinformation to doctors. While the much stronger Zyprexa labeling requirements in Japan and the European Union are not decisive, they do suggest the controversial nature of FDA supervision of drug warning labels. See Part II.C, infra; see, e.g., Gardiner Harris, Potentially Incompatible Goals at F.D.A.: Critics Say a Push to Approve Drugs is Compromising Safety, N.Y. Times, June 11, 2007, at A14; Gardiner Harris, F.D.A. Remains Unsettled in Wake of New Questions, N.Y. Times, May 31, 2007, at A14 (discussing pervasive criticism of FDA's handling of pharmaceutical safety concerns).
The work of the medical staffs, particularly psychiatrists, who prescribed Zyprexa for the current plaintiffs was in general extraordinarily good. The label warnings were meant for doctors. But even fine doctors have to rely on, and could have been misled by, the incomplete and possibly misleading information available to them as a result of lack of adequate warnings on the label and Lilly's overselling. Cf. Richard Horton, Book Review, What's Wrong With Doctors, The New York Review, 16 (May 31, 2007) (Review of "How Doctors Think" by Jerome Groopman) ("there can never be a purely rational or exact mathematical solution to a patient's predicament").
Given the high quality of treatment by plaintiffs' physicians and aides, their general knowledge, and their candid discussions with patients regarding risks and dangers, the summary judgment decision in all these cases is a close one. The experts for both sides are excellent and come to different conclusions on the key issues of adequacy of warning and causation.
State tort laws that are applicable provide substantial reliance on the protective nature of the treating physicians through the "learned intermediary" rule. See, e.g., Part III.A.3.a, infra. Given the alleged inadequacy of the warnings provided by Lilly to doctors, for most of the cases the learned intermediate defense is not sufficient to entirely block a judgment of liability.
2. Benefits and Roles of Others Reducing Damages
In the case of at least some of its users who were leading dismal, hazardous and burdensome lives as a result of their mental problems, Zyprexa provided a greatly improved quality of life. The trier may choose to weight the cost to the plaintiff in increase weight and diabetes against the gain in quality of life with Zyprexa; this consideration would be expected to reduce any damage awards.
Supporting reduction of damages when an injured plaintiff gained substantial benefit from the allegedly harmful activity of the defendant is a strong legal substratum upholding proportionality in damages and punishment based upon Benthamite pragmatic balancing of benefits and harms to society as well as to the parties. The law is cognizant of the real world complexity of causation with many "causes" for each
Developing tort law is based on consideration of economic theory, such as who can best bear the cost of harms, see e.g., Guido Calabresi, The Costs of Accidents: A Legal and Economic Analysis (1970); English development of the writ system and American legal history, see e.g., 1 Fowler Harper and Fleming James, Jr., The Law of Torts xxvii-xliv (1956); Julius Goebel, Jr., Cases and Materials on the Development of Legal Institutions 139ff. (1946); Oliver Wendell Holmes, Jr., The Common Law (1881); and classical theory, see, e.g., John C.P. Goldberg & Benjamin C. Zipursky, Accidents of the Great Society, 64 Md. L.Rev. 364 (2005). But it also incorporates considerations of fairness as among the injured and others as well as an understanding of the myriad causes of harm to individuals in a complex modern society that has had to development of rules of proportionality. See Customs & Excise v. Barclays Bank, 4 All E.R. 256, ¶ 82 (House of Lords 2006) (Lord Mance) ("The conceptual basis on which courts decide whether a duty of care exists in particular circumstances has been repeatedly examined. Three broad approaches have been suggested, involving consideration (a) whether there has been an assumption of responsibility, (b) whether a three-fold test of foreseeability, proximity and `fairness, justice and reasonableness' has been satisfied or (c) whether the alleged duty would be `incremental' to previous cases. . . . All three approaches operate at a high level of abstraction. What matters is how and by reference to what lower-level factors they are interpreted in practice.") (citation omitted).
As the Supreme Court has noted in a punitive damages opinion:
Cooper Industries, Inc. v. Leatherman Tool Group, Inc.,
There is a need for a jury instruction that will restrict the jury's discretion in these polycentric multiple "blame-causation" pharmaceutical cases by providing a standard of "justice." Excessive flexibility in applying views of individual jurors of "the" just result can reduce necessary predictability and uniformity required by the rule of law. As Professor Warren A. Seavey put it in his Mr. Justice Cardozo and the Law of Torts, 48 Yale L.J. 390, 401 (1938) (footnote omitted):
Articulation of the appropriate controlling charge to the jury can await the trial of the instant cases. That charge will take account of some aspect of the need for proportionality in liability, damages or both.
Society's current sense of justice has required modification of ancient all-or-nothing liability-damages principles. In tort law, contributory negligence which once blocked all damages has been replaced by comparative fault and apportionment of liability. See, e.g., ALI Restatement of the Law Third, Economic Torts and Related Wrongs Prel. Draft No. 3 (April 12, 2007), § 16, Contributory Negligence and Proportionate Responsibility (not yet adopted by ALI); id. § 8, Factors for Assigning Shares of Responsibility; id. § 26, Apportionment of Liability When Damages Can be Divided by Causation; id. § 18, Liability of Multiple Tortfeasors for Individual Harm; Restatement of the Law, Torts, Apportionment of Liability, § 7, comment a (comparative responsibility "replaces the rule of contributory negligence as an absolute bar to a plaintiff's recovery . . ."). In capital crimes, the cruel 18th century all-encompassing felony-death rule has been replaced by one considering mitigating factors. See 18 U.S.C. § 3592 (mitigating and aggravating factors to be considered in determining whether a death sentence is justified). The rule that there can be no recovery for emotional harm is now often negated when the harm is serious and there are other confounding circumstances. See Restatement of the Law Third Torts: Liability for Physical and Emotional Harm, Tent. Draft No. 5, April 4, 2007, Reporters Note p. 4ff (not yet adopted by ALI). "An actor may be absolved from liability for harm forseeably resulting from the actor's negligence when the liability would be unfairly disproportionate to the actor's fault and compensation." Restatement of the Law Third of Economic Torts and Related Wrongs, Prel. Draft No. 3 (April 12, 2007) p. 17 (not yet adopted by ALI); id. at p. 78, § 18 Damages ("Responsibility is apportioned for that part of the damages the claimant could have [reasonably] avoided without undue risk or burden"); id. at p. 112 ("estoppel will lie only if necessary to avoid injustice and only when it does not stultify the policies of the law"). Sentencing increasingly considers restorative needs of the criminal and victim rather than rigid "just desserts." See Model Penal Code Sentencing, Tent. Draft No. 1 (April 9, 2007) (not yet adopted by ALI), p. 27 ("The goal of proportionality in punishment is ubiquitous. . . ."). In the area of unjust enrichment, the availability of a remedy is qualified to avoid unfair hardship. See Restatement of the Law Third Restitution and Unjust Enrichment Tent. Draft No. 5 (March 12, 2007) (not yet adopted by ALI), p. 117, id. p. 119 ("the remedial spectrum"). The good samaritan's responsibility for negligence in rescue may be forgiven or minimized because of good intentions. See, e.g., Dan B. Dobbs, The Law of Torts 663 (2001); N.Y. Education Law § 6527(2) (good samaritan immunity for licensed physicians). The "measure of a recipient's unjust enrichment may depend on the recipient's degree of fault." ALI Draft Restitution and Unjust Enrichment § 49(3), Measures of Enrichment; Classes of Recipient. In protection of civilians under the laws of war, proportionality is central. See In re Agent Orange Prod. Liab. Litig.,
The present cases, of course, do not involve a good samaritan. But the example illustrates why current law reflects a sense of multiple causes, shared responsibility, intention, and proportionality in finding liability and in assessing damages. The governing tort law in each of the instant cases includes the learned intermediary defense — an aspect of proportionality that shifts at least some of the burden of protecting patients from pharmaceutical manufacturers to treating physicians See, e.g., Part III.A.3.a, infra. In a case such as the present one the learned intermediary rule cannot be viewed as an all-or-nothing regulation that absolves the manufacturer, shifting the onus entirely to the treating physician, but its force in ameliorating liability for damages of the manufacturers cannot be ignored.
3. Protections Available to Plaintiffs Through Sources Such as Available Experts' Information and Treating Physicians
The conclusions of specialized medical and scientific panels, selected on as unbiased a basis as practicable, is particularly important in evaluating relevant studies and gaps in data and such documents as peer-reviewed articles. These panels often are not capable of, or interested in, declaring — in a form equivalent to civil litigation's "more probable than not" standard — a statistically-based probability of the adverse side affects or the benefits of pharmaceuticals and toxic substances with respect to general causation, specific causation, or other relevant legal issues. Such panels can, however, by meta-analysis of extant studies and other information, provide the best available estimates on such factors as risks and benefits to a doctor, a patient, or a jury. Daubert v. Merrell Dow Pharms.,
Epidemiologists and other scientists will be called to testify at the trial. The trained judgments of such scientists may
Despite the many drug safety and efficacy screens in this country — the manufacturers' own revealed tests, medical scientists and their peer-reviewed studies, the FDA, the competitive marketplace, self-interest of the patient, the general body of medical knowledge available to the public and to physicians, checks by managed care and insurance institutions, and the deterrent threat of tort law — ultimately it is the treating physician that we rely upon as the guardian of individual health.
Where summary judgment motions are pending in the instant individual cases, a reasonable juror could find that by the time a reasonably informed treating physician should have been aware of the label warning required by FDA, each plaintiffs treating physician already knew that Zyprexa was associated with weight gain and diabetes, and believed that the benefits of the particular seriously ill patient being treated warranted assuming the risks and benefits of Zyprexa as against the risks and benefits of other drugs and modes of treatment.
In each of the instant claims, the treating physician made a judgment, after balancing the potential benefits and risks of other drugs and methods of treatment, that Zyprexa should be prescribed for the patient at the time it was administered. See Parts II.E.1.b, 2.b, 3.b, 4.b, infra; Appendices A, B, C, and D, infra. Despite possible overselling by some Lilly salespeople, the evidence is strong that, for the most part, the individual physicians and physicians aides here were in a position to knowingly exercise their obligation to their patients and that they were sufficiently aware of Zyprexa's relative dangers. A jury could find that the latest date beyond which it was unreasonable for the doctor not to have been aware was when Dear Doctor letters were sent on March 1, 2004, at the FDA's direction, many months after the new warnings were published. Because, however, of the claim, that has some support, that Lilly salespeople might have been misleading at least some treating medical staff, the issue of a cutoff date is best left for the jury except in one case. See Part III.B.1.e, infra.
4. Appropriate Recoveries and Payments
In a mass pharmaceutical injury case such as this one — as well as in toxic tort cases exemplified by asbestos, breast implants and Agent Orange — it is important that all those who are entitled to damages, as a result of the facts and law, have an opportunity to file timely claims and have them prosecuted by competent lawyers. A powerful plaintiffs' bar is available to prospective claimants, utilizing advertising, references of cases from originating attorneys to specialists, contingency fee arrangements and substantial capital to investigate claims, retain suitable experts, and conduct complex discovery, motion practice, settlement negotiations and, when needed, trials.
Despite this effective civil prosecution network, there are usually a substantial number of potential harmed plaintiffs who never press their claims. There also are usually a substantial number of claims that are marginal or unfounded, but hyped and prosecuted using a variety of questionable techniques.
Even for a defendant, such as Lilly, which has decided to settle and pay reasonable Zyprexa user claims, the problem of totally disposing of a massive potential litigation, so that its main business can be conducted with emphasis on research and production of useful medicines rather than on costly litigation distractions, remains difficult. There is to be expected a massive
Faced with small elements of the legal community which may appear rapacious, industry looks to the courts to separate the worthy from the unworthy claims. Yet, the normal tools for excluding non-meritorious claims — summary judgment, trials and appeals — remain expansive and consuming of executive energy and capital availability while the litigation drags on.
In the present litigation, the first eight thousand or so claims were settled using a discovery master, magistrate judge, and efficient national assembly of documents collected by a Plaintiffs' Steering Committee; fees were controlled; liens were compromised on a national basis; and four special masters, using a matrix, passed on the validity of the claims, assigning appropriate values to each of them.
In the second phase involving many thousand of subsequent individual claims, settlements were made individually, without any check of fairness by the court or its designees. The present four summary judgment motions are examples of those cases.
Whatever the advantages to available court procedures limiting the "piling on" phenomena in mass tort cases, the process involves substantial transactional costs. The substitute opted for by most attorneys is settlement — the acceptance of proportionality and reasonableness in demands for compensation.
The danger of "piling on" in the instant litigation is exacerbated by the substantial Medicare and Medicaid liens of the states and federal government, which lead to pressure for higher settlement so that the plaintiffs — and their attorneys — can gain some compensation for their alleged suffering. In addition, some states are now claiming reimbursement directly from Lilly for their purchases of Zyprexa. And private unions, insurers and the like are seeking third-party reimbursement for their purchases of Zyprexa on behalf of those they were insuring. Shareholder suits based on alleged misleading of investors about Zyprexa are also pending. While somewhat different from the catastrophic costly litigation that led to so many bankruptcies in the asbestos and breast implant industries, all of the actual and potential Zyprexa-based claims increase the stakes for both plaintiffs and defendants, and place added pressure on the legal system to provide rational and affordable compensation schemes.
In almost every conglomerate litigation — including class actions and quasi-class actions such as the instant one — the claimants with the best claims receive somewhat less than they would have obtained in individual suits, while the less worthy claimants receive somewhat more. The advantages to all plaintiffs and defendants in predictability and reduced transaction costs usually more than offsets the disadvantages of these disparities. In the present settlement phase of the user-Zyprexa cases, in addition to the good sense and bona fides of plaintiffs' attorneys, some counsel have retained neutral advisors to ensure a proper division of damages among their clients. For ethical as well as tort law conceptualizations, substantial efforts to provide a reasonable and proportionate division of payments between defendant and plaintiffs, and among plaintiffs, is necessary and justified.
C. Motions for Summary Judgment
Lilly has moved for summary judgment in the four cases discussed in this memorandum, primarily on the theory that the prescribing physician was aware, or should have been aware, of the risks of weight gain and diabetes associated with Zyprexa. In September of 2003, a new warning about the risks of which plaintiffs complain was directed by the FDA to be placed on Zyprexa package inserts. Lilly argues that, as a matter of law, knowledge of these possible side effects was attributable to plaintiffs' prescribing physicians on or after that date. The applicable state laws provide that FDA approval does not automatically make a prescription drug warning adequate as a matter of law, and most federal courts have refused to hold that the federal Food Drug and Cosmetic Act ("FDCA") preempts state law failure to warn claims in cases where the pharmaceutical warning label is approved by the FDA. See Part III.A.6, infra.
Lilly's contention that these four plaintiffs' prescribing physicians were as a matter of fact aware of the risks of weight gain and diabetes posed by Zyprexa before the September 2003 label change is based on the particular facts of each of these four cases. Lilly has attempted to demonstrate that the four prescribing physicians' knowledge of the risks of weight gain and diabetes is indisputable. While the facts relating to the four physicians' state of knowledge supports Lilly's claim, plaintiffs have barely — but sufficiently under summary judgment standards — demonstrated that reasonable minds may differ on this point.
The strong constitutional right to a jury precludes a pretrial finding that no reasonable juror could find for any plaintiff except when a reasonable treating physician must have been fully aware of Zyprexa's dangers and those of competing drugs. Genuine issues exist as to material facts regarding the prescribing physicians' state of knowledge about the risks of diabetes and excessive weight gain associated with Zyprexa in three of the cases defendant moves to dismiss.
As to plaintiff Robert Cusella the record shows he was fully advised of Zyprexa's dangers, discussed the matter repeatedly with his doctor, and developed diabetes in close conjunction with the taking of Zyprexa. The state statute of limitations ran before he commenced his suit. See Appendix A; Part II.E.1, III.B.1, infra.
The following chart summarizes the conclusions described in more detail in Part III.B, infra.
------------------------------------------------------------------------------------------- Plaintiff Date of First Use Date of Last Use Result ------------------------------------------------------------------------------------------- Robert Cusella May 1997 April 2005
Case dismissed.Case was commenced more than two years after plaintiff learned he had diabetes and was aware that Zyprexa was a potential cause of his diabetes. Judith New April 2003 July 2005 Summary judgment denied.Monty Souther June 1997 May 2005 Summary judgment denied.Donna Worthington Aug 2003 Dec 2003 Summary judgment denied.-------------------------------------------------------------------------------------------
A. Nature of Zyprexa
Zyprexa's active ingredient is olanzapine, one of a class of medications known as "atypical" or "second generation" anti-psychotics. It was approved for use in treating schizophrenia and acute manic episodes associated with bipolar disorder by the FDA in 1996. In 2004, the FDA also approved Zyprexa for the treatment of bipolar disorder.
B. FDA Labeling
1. September 2003 Label Change
In May of 2000, the FDA undertook an analysis of the incidence of diabetes and hyperglycemia in patients using atypical antipsychotics. The director of the FDA's Division of Neuropharmalogical Drug Products ("DNDP") wrote to Lilly requesting additional safety information about Zyprexa. In its letter, the FDA cited post-marketing reports of diabetes-related adverse events associated with Zyprexa use. In response, Lilly provided the FDA with clinical studies, data analysis, and case report reviews. The parties disagree about whether the information given by Lilly to the FDA was complete and accurate.
On September 11, 2003, the FDA required a warning about risks of hyperglycemia and diabetes mellitus and treating precautions to appear in the package insert of all atypical antipsychotics, including Zyprexa. Designed fox prescribing doctors, the label noted that epidemiological studies and other information indicated the relationship between the drug and hyperglycemia and diabetes were not yet fully understood. It reads:
Curiously, the label did not mention weight gain or diabetes in the "warning to patients" section.
Lilly added the FDA required language to the Zyprexa label on September 16, 2003. It issued a press release announcing the label change on September 17, 2003. At the FDA's request, on March 1, 2004, Lilly sent a "Dear Doctor" letter to physicians in the United States informing them of the 2003 label change.
2. Consensus Statement of American Diabetes Association and Other Learned Groups
In November of 2003, the American Diabetes Association, American Psychiatric Association, American College of Clinical Endocrinologists, and the North American Association for the Study of Obesity convened a consensus development conference (the "ADA consensus conference") on the subject of the association between antipsychotic drugs and diabetes. An eight member panel heard presentations from 14 experts drawn from the fields of psychiatry, obesity, and diabetes; FDA representatives; and atypical antipsychotic drug manufacturers. The panel reviewed most of the relevant peer-reviewed English language scientific articles.
The ADA consensus conference concluded that Zyprexa and Clozaril posed an increased risk of diabetes as compared to other atypical antipsychotic drugs The consensus statement declared that these relative risks as well as advantages of the individual drugs for individual patients in a heterogeneous population "should . . . influence drug choice." In part its report concluded:
3. FDA March, 2007 Letter
On March 28, 2007, the FDA raised concerns about the adequacy of Zyprexa's warning label in a letter to Lilly.
C. International Zyprexa Labeling
Lilly began marketing Zyprexa in Japan in 2001. In April of 2002, after reports of 9 serious cases of hyperglycemia and diabetic ketoacidosis among Zyprexa users in Japan, the Japanese Ministry of Health Labor and Welfare required Lilly to issue to physicians an "Emergency Safety Information" letter about Zyprexa's risks. The Japanese agency further required that Zyprexa's warning be adjusted to include a contraindication against use of Zyprexa by diabetics and instructions to monitor patients' blood glucose with an initial fasting blood glucose test and periodic tests thereafter while they were using Zyprexa.
2. European Union, Australia, and Canada
Before the September 2003 change, Zyprexa's label contained more strongly-asserted warnings about the risk of developing diabetes in the European Union, Australia, and Canada than in the United States. The European Union's Agency for the Evaluation of Medicinal Products required Lilly to discuss the risks of hyperglycemia and diabetes in Zyprexa's label in 1999. Unlike the American label, the European Union label contained an explicit warning regarding diabetes, and the Australian and Canadian labels contained explicit precautions regarding diabetes.
D. Lilly's Promotion of Zyprexa
1. Pre-September 2003 Label
Lilly sales representatives marketed and promoted Zyprexa directly to physicians.
In response to that suggestion, a senior executive within the medical group stated the following: "I do have concerns regarding making any connections between olanzapine [Zyprexa]-induced weight gain and hyperglycemia. Therefore, in my opinion, I would not include your following statement: `Patients who gain weight may develop insulin resistance which may lead to hyperglycemia and diabetes.'"
Zyprexa was approved by the FDA for treating schizophrenia and bipolar disorder, two conditions usually managed by psychiatrists. In late 2000, however, Lilly decided to begin directing its Zyprexa marketing efforts towards primary care physicians ("PCPs"). This strategy was outlined by the company as follows:
2. Post-September 2003 Label
After the September 2003 label change, see supra Part III.B.1, and the ADA Consensus Conference, see supra Part III.B.2, Lilly sales representatives remained reluctant to discuss the risk of diabetes with physicians. An internal Lilly presentation about Zyprexa and diabetes to sales representatives instructed: "This is a highly competitive driven issue. Therefore, we will NOT proactively address the diabetes
Lilly salespeople apparently still continue to deny to physicians that Zyprexa "causes" weight gain and diabetes. For example, Lilly sales representative Susan Kay Schuler gave the following deposition testimony on this subject in February of 2007:
Schuler Deposition, 13-62 (February 1, 2007).
Lilly salespeople generally do not admit that other atypical antipsychotic drugs may provide lesser risk of diabetes than Zyprexa. The Schuler deposition continued:
This response is contrary to the conclusion of the ADA Consensus Conference. See Part II.B.2, supra.
1. Robert Cusella
a) Patient History
Cusella is a fifty-six year old Pennsylvania resident who was diagnosed with schizophrenia in 1973. Def. Statement of Undisputed Material Facts for Robert Cusella, Ex. 1, 2 (hereinafter "Def. Stat. Cusella"); Id., Ex. 2, 20-21. Zyprexa was first prescribed for him in May of 1997. Id., Ex. 2, 57-58.
He was diagnosed with Type 2 non-insulin-dependent diabetes mellitus in or around September of 1996, before he first took Zyprexa. Id., Ex. 8, 12. He began to be treated with insulin in August of 1999. Id., Ex. 6, CUSELLAR_NFP_0066. Cusella alleges that Zyprexa caused a worsening in his condition so that he went from having non-insulin-dependent diabetes mellitus to having insulin-dependent diabetes mellitus. Id., Ex. 1, 12. He stopped taking Zyprexa in April of 2005. Id., Ex. 2, 121.
This plaintiff commenced an action against Lilly on April 12, 2006, in the Eastern District of New York.
b) Prescribing Physician's State of Knowledge
Cusella's psychiatrist, Dr. Peter Ganime, prescribed Zyprexa. Pl.'s Opp'n to Def.'s Mot. for Summ. J. Cusella, Ex. 51, 57-58 (hereinafter "Pl. Opp. Cusella"). Dr. Ganime has practiced psychiatry for forty years and is a Clinical Assistant Professor of Psychiatry at Robert Wood Johnson University of Medicine. See Appendix A, infra.
In September of 2002 Dr. Ganime raised with Cusella "recent controversies about Zyprexa and blood sugar elevation." Id., Ex. 51, 89-93. Dr. Ganime describes his conversation with Cusella as follows:
In a subsequent deposition, Dr. Ganime elaborated on the information in his possession concerning the link between Zyprexa and weight gain and diabetes during the time he was treating Cusella:
Id. Ex. 52, 21-23.
This treating psychiatrist was deposed at length. His deposition reflects an experienced physician knowledgeable about available medicines, sensitive to the needs of the patient, and committed to fully discussing relative benefits, risks and dangers with the patient. See Exhibit A, infra.
c) Representations Made by Lilly Salespeople to Dr. Ganime
Dina Bray was the Lilly sales representative assigned to Dr. Ganime. Neither Dr. Gamine nor Bray appear to remember any specific conversation between them. Bray has described generally the information she possessed and conveyed to doctors regarding Zyprexa's risks and side effects. She denied Zyprexa causes diabetes. Her deposition in part is as follows:
* * *
Bray is currently employed by Lilly as a senior sales representative. Id. at 10. Her work had little if any effect on Dr. Ganime's treatment of Cusella.
2. Judith New
a) Patient History
Plaintiff Judith New is a forty-nine year old Florida resident who was diagnosed with schizophrenia around 2000 and 2001. Def. Statement of Undisputed Material Facts for Judith New, Ex. 3, 79 (hereinafter "Def. Stat. New"). Zyprexa was first prescribed for her in April of 2003. Id., Ex. 10, 23-25. She was diagnosed with type 2 diabetes mellitus in September of 2004, though her physician was unsure whether New then suffered from diabetes mellitus or impaired glucose tolerance, which is a precursor to diabetes mellitus. Id., Ex. 9, 29-30, 38.
New stopped taking Zyprexa in July of 2005. Id., Ex. 2, JN-04-000055. She subsequently resumed treatment with Zyprexa in October of 2005. Id., Ex. 6, 23-24. She finally discontinued use of Zyprexa in August of 2006. Pl.'s Opp'n to Def.'s Mot. for Summ. J. New, Ex. 55, NEWJ_ACI_0015.
This plaintiff commenced an action against Lilly on April 12, 2006, in the Eastern District of New York.
b) Prescribing Physician's State of Knowledge
No evidence has been presented regarding the doctor who first prescribed Zyprexa for New in April 2003. She began seeing the psychiatrist Dr. Nunez-Hinestrosa ("Dr. Nunez") in January of 2004. He continued her Zyprexa treatment. See Def. Stat. New, Ex. 6, 22. Dr. Nunez described his familiarity with Zyprexa's side effects and decision to continue Ms. New on the medication, partly because the patient did not wish to stay on an alternate drug he tried:
Id. at 21-25 (quotation marks omitted).
Dr. Nunez was aware of the risks and benefits of Zyprexa. He believed the benefits to this patient outweighed the risks, as indicated by his deposition testimony.
Id. at 25. For further parts of the Nunez and other treating physicians' depositions, see Appendix B, infra.
c). Representations Made by Lilly Salespeople
Ronnie Taylor was the Lilly sales representative assigned to promote Zyprexa to Dr. Nunez between 2000 and 2003. Taylor insisted to all the doctors he spoke to that the risks of weight gain and diabetes were comparable across all atypical antipsychotics:
Deposition of R. Taylor (Dec. 26, 2006), 64-65, 87-88, 95-97, 173.
Taylor continues to believe that Zyprexa does not cause diabetes.
Id. at 89.
Taylor left his position at Lilly on December 31, 2005.
From 2004 onwards, Michael Bolinder was the Lilly sales representative assigned to Dr. Nunez. He does not believe there is a causal relationship between Zyprexa and diabetes:
Deposition of Michael Bolinder (Dec. 15, 2006), 83-89.
3. Monty Souther
a) Patient History
Plaintiff Monty Souther is a 50-year old resident of North Carolina who suffers from bipolar disorder, among other psychiatric illnesses. Def. Statement of Undisputed Material Facts for Monty Souther, Ex. 9, 6, 11 (hereinafter "Def. Stat. Souther"). Zyprexa was prescribed for him in June of 1997. Id., Ex. 9, 17.
Souther contends that he was diagnosed with diabetes in May of 2003. His physician's memory of the precise diagnosis is hazy:
Id., Ex. 8, 30-31.
Souther stopped taking Zyprexa around May of 2005. Id., Ex. 1; Pl.'s Opp'n to Def.'s Mot. for Summ. J. Souther, Ex. 50, 128 (hereinafter "Pl. Opp. Souther"). He commenced an action against Lilly on April 12, 2006, in the Eastern District of New York.
b) Prescribing Physicians' State of Knowledge
Souther was first prescribed Zyprexa by Dr. Thaddeus Kostrubala in July of 1997. Pl. Opp. Souther, Ex. 51, 17. Dr. Kostrubala has described his knowledge of Zyprexa's risks, and discussion of those risks with Souther, as follows:
Id., Ex. 51, 24-29.
In November 1998, Souther began seeing Dr. Lynda Weston, a psychiatrist, who continued to treat him with Zyprexa. Dr. Weston does not recall specifically the knowledge she had of the risks of weight gain, hyperglycemia, and diabetes posed by Zyprexa during the period between 1998 and 2002, the time she treated Souther. Id., Ex. 52, 18-20, 24. She described what she does remember as follows:
Id., Ex. 53, 46, 51.
From September 2002 until May 2005, Souther was treated by Dr. Michael Nunn, a psychiatrist, who continued to prescribe Zyprexa. See Appendix D, infra.
c) Representations Made by Lilly Salespeople
Susan Kay Schuler was the Lilly sales representative assigned to Dr. Nunn. Schuler's deposition testimony is referred to in Part ILD.2, supra.
4. Donna Worthington
a) Patient History
Plaintiff Donna Worthington is a fifty-seven year old North Carolina resident who was diagnosed with bipolar disorder in October of 2001. See Def. Statement of Undisputed Material Facts for Donna Worthington, Ex. 1, 1 (hereinafter "Def. Stat. Worthington"); Id., Ex. 6, WORTHINGTOND_DGHI_0003. She was first prescribed Zyprexa to treat her bipolar disorder in on August 5, 2003. Id., Ex. 7, WORTHINGTOND_OBHH_0013.
In December 2003, Worthington's glucose level was tested and found to be above the normal range. In light of the high level, and potential association between Zyprexa and diabetes, Worthington's physician discontinued her Zyprexa treatment. Pl.'s Opp'n to Def.'s Mot. for Summ. J. Worthington, Ex. 53, 27-29 (hereinafter "Pl. Opp. Worthington") ("Given the risk of elevated gluclose with Zyprexa, we decided to discontinue this medication."); Worthington was diagnosed with diabetes on April 13, 2004. Id., Ex. 9, WORTHINGTOND_POWELLL-0008.
Worthington commenced this action against Lilly on April 12, 2006, in the Eastern District of New York.
b) Prescribing Physician's State of Knowledge
Worthington was first prescribed Zyprexa by Dr. Deborah Ross in August of 2003. Dr. Ross has testified that she was not aware of a connection between Zyprexa and diabetes at that time:
Pl. Opp. Worthington, Ex. 51, 63-64. See Appendix E, infra.
c) Representations Made by Lilly Salespeople
It can be assumed for purposes of this motion that representations were made by Lilly's salespeople to Dr. Ross, similar to those described in Part II.D.2, supra.
1. Summary Judgment Standard
Summary judgment is appropriate only if "there is no genuine issue as to any material fact . . . [in which case] the moving party is entitled to a judgment as a matter of law." Anderson v. Liberty Lobby, Inc.,
The burden rests on the moving party to demonstrate the absence of a genuine issue of material fact. Goenaga v. March of Dimes Birth Defects Fund.,
Peripheral factual disputes will not defeat an otherwise properly supported motion for summary judgment. Anderson, 477 U.S. at 247, 106 S.Ct. 2505. "[O]nly disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment. Factual disputes that are irrelevant or unnecessary will not be counted." Id. at 248, 106 S.Ct. 2505.
In deciding the motion, all inferences from, and ambiguities in, the underlying facts are to be resolved in favor of the party opposing summary judgment. Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,
"In considering the motion, the court's responsibility is not to resolve disputed issues of fact but to assess whether there are factual issues to be tried." Knight v. U.S. Fire Ins. Co.,
Curry v. City of Syracuse,
b) Right to a Jury
The Seventh Amendment of the Constitution protects the right to a jury trial. It reads: "In suits at common law, where the value in controversy shall exceed twenty Dollars, the right of trial by jury shall be preserved, and no fact tried by a jury shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law." U.S. Const. amend. VII.
The Seventh Amendment "was designed to preserve the basic institution of jury trial in only its most fundamental elements, not the great mass of procedural forms and details, varying even then so widely among common-law jurisdictions." See Galloway v. United States,
Yet, the jury has had some of its fact-finding authority attenuated indirectly through various evolving "procedural devices." Fed.R.Evid. 104(a) (judicial discretion to bar evidence that fails conditional relevancy); Fed.R.Evid. 403 (judicial discretion to bar cumulative, irrelevant, prejudicial information); Edward J. Imwinkelried, Trial Judges — Gatekeepers or Usurpers? Can the Trial Judge Critically Assess the Admissibility of Expert Testimony Without Invading the Jury's Province to Evaluate The Credibility and Weight of the Testimony?, 84 Marg. L.Rev. 1, 7 (2000) (Daubert may limit jury's fact finding role); Lisa S. Meyer, Taking the "Complexity" Out of Complex Litigation: Preserving the Constitutional Right to a Civil Jury Trial, 28 Val. U.L.Rev. 337 (1993) (juries replaced by bench trials in complex cases). The increasing use of bench trials, Daubert hearings, summary judgments, and directed verdicts — as authorized by rules of practice and appellate courts — to limit jury fact finding and set aside verdicts poses a threat to the continued viability of the Seventh Amendment jury trial. See Suja A. Thomas, Why Summary Judgment is Unconstitutional, 93 Va. L.Rev. 139 (2007); Adam Liptak, Cases Keep Flowing In, But the Jury Pool is Idle, N.Y. Times, April 30, 2007, at A14 ("Jury trials may be expensive and time-consuming, but the jury, local and populist, is a counterweight to central authority and is as important an element in the constitutional balance as the two houses of Congress, the three branches of government and the federal system itself.").
Prematurely disposing of a case before the jury can pass on it generally favors defendants, who do not have the burden of proof on most issues, leading not only to a violation of the Constitution, but a tilting of the scales of justice away from injured
2. Choice of Law
A number of states' laws as well as general American rules are discussed below to provide context, and because of the other pending cases, even though the precedents are not controlling in the four cases before the court on summary judgment motions.
Federal courts sitting in diversity jurisdiction apply the forum state's choice of substantive law rules. Klaxon Co. v. Stentor Elec. Mfg. Co.,
b) Statute of Limitations
A court sitting in diversity applies the statute of limitations of the state in which it sits. "Where a cause of action accrues outside New York in favor of a nonresident, the foreign statute of limitations is borrowed." Besser v. E.R. Squibb & Sons, Inc.,
3. Florida Law
a) The Learned Intermediary Doctrine
The learned intermediary doctrine is discussed under the law of each state whose law is applicable. As in Florida, it is one recognized generally throughout the county. See, e.g., J.D. Lee and Barry A. Lindahl, Modern Tort Law § 27:45 (2d ed.2002). Prosser and Keeton put the special problems of pharmaceuticals and treating physicians as follows:
Prosser and Keeton on the Law of Torts, 688 (5th ed.1984) (footnote omitted).
The doctor has the obligation to be informed about the risks and benefits of the drugs prescribed and must inform the patient of known risks and benefits. See Foister v. Purdue Pharma, LP,
Dan B. Dobbs, The Law of Torts, 659 (2001). The list is not exclusive.
Under Florida law, the manufacturer of a product has a general duty to warn users of any dangers inherent in or associated with its use. See Zanzuri v. G.D. Searle & Co.,
A prescribing physician who has been adequately warned about the drugs' risks breaks "the causal link between the manufacturer and the plaintiff, thereby insulating the manufacturer from tort liability for harm caused by the drug." Zanzuri, 748 F.Supp. at 1515. Florida courts base this rule on the following rationale: "the prescribing physician, acting as a `learned intermediary' between the manufacturer and the consumer, weighs the potential benefits against the dangers in deciding whether to recommend the drug to meet the patient's needs." Felix v. Hoffmann-LaRoche, Inc.,
An adequate prescription drug label warning to physicians is sufficient to break the causal link between the patient and drug manufacturer. "Whether the physician in fact reads the warning, or passes its contents along to the recipient of the drug is irrelevant." E.R. Squibb & Sons, Inc. v. Farnes,
b) Adequacy of Warning
The question of whether a prescription drug warning adequately informs prescribing physicians of the risks inherent in the drug is one of fact, ordinarily determined by a jury. See Upjohn, 562 So.2d at 683 ("the adequacy or inadequacy of the warning to inform a physician must, except in the more obvious situations, be proved by expert testimony"); Felix, 540 So.2d at 105 ("whether a warning is adequate is usually a jury question"). Where the warning is "accurate, clear, and unambiguous," its adequacy becomes a question of law. See Felix, 540 So.2d at 105 ("While in many instances the adequacy of warnings concerning drugs is a question of fact, we hold that it can become a question of law where the warning is accurate, clear, and unambiguous.").
c) Statute of Limitations
Florida allows a plaintiff with a cause of action, such as the one here, founded in negligence, four years to commence suit. See Fla. Stat. Ann. § 95.11(3). Under Florida law, the "delayed discovery doctrine" postpones the accrual date of a cause of action "until the plaintiff knows or reasonably should know of the tortious act giving rise to the cause of action." Hearndon v. Graham,
In Florida, there is a statutory basis for application of the delayed discovery doctrine.
4. Pennsylvania Law
a) The Learned Intermediary Doctrine
Pennsylvania "imposes strict liability on the seller of any product `in a defective condition unreasonably dangerous to the user or consumer."' Incollingo v. Ewing,
"It is clear that the manufacturer of a prescription drug known to be dangerous for its intended use, has a duty to exercise reasonable care to inform those for whose use the article was supplied of the facts which make the product likely to be dangerous." Makripodis v. Merrell-Dow Pharm., Inc.,
Makripodis, 523 A.2d at 378; see also Leibowitz v. Ortho Pharm. Corp.,
A prescribing physician is "expected to make an independent medical
b) Adequacy of Warning
"Whether a product is defective because of a failure to give an adequate warning is initially a question of law to be decided by the trial court." Fletcher v. Raymond Corp.,
In the case of prescription thugs, expert medical testimony is often relied upon "to determine whether the drug manufacturer's warning to the medical community is adequate because prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect." Demmler, 671 A.2d at 1154.
Pennsylvania has "recognized a cause of action against drug manufacturers for the overpromotion of a drug that nullify [sic] otherwise adequate warnings." Baldino v. Castagna,
c) Statute of Limitations
Pennsylvania imposes a two year statute of limitations on negligence claims. See 42 Pa.C.S.A. § 5524(7). That statute begins running "as soon as the right to institute and maintain a suit arises; lack of knowledge, mistake or misunderstanding do not toll the running of the statute of limitations." Pocono Int'l Raceway v. Pocono Produce, Inc.,
Pennsylvania recognizes a "discovery rule" exception to its two-year statute of limitations for negligence actions. Under the discovery rule, where a plaintiff is unable, despite exercising due diligence, to discover her injury or its cause, the statute of limitations is tolled. See Fine v. Checcio, 582 Pa. 253,
5. North Carolina Law
a) The Learned Intermediary Doctrine
Products liability claims in North Carolina are governed by section 99B of the North Carolina General Statutes, which provides that "no manufacturer or seller of a product shall be held liable in any product liability action for a claim based upon inadequate warning or instruction unless the claimant proves that the manufacturer or seller acted unreasonably in failing to provide such warning or instruction. . . ." N.C. Gen.Stat. § 99B-5(a); see also Part III.A.3.a, supra. In the case of prescription drugs, manufacturers have a duty to warn the prescribing physician, rather than the patient, about the risks associated with the particular drug. See Salmon v. Parke, Davis & Co.,
Under the learned intermediary doctrine, patients of an adequately warned prescribing physician cannot maintain a products liability action against a drug manufacturer because "a manufacturer or seller of a prescription drug has no legal duty to warn a patient of the dangerous tendencies of its drug, as long as sufficient warnings are provided to the prescribing physician." Dellinger v. Pfizer, Inc., No. 5:03CV95, 2006 WL 2057654, *6 (W.D.N.C. July 19, 2006). This common law doctrine has been codified by the state legislature:
N.C. Gen.Stat. § 99B-5(c).
b) Adequacy of Warning
A seller or manufacturer must act unreasonably to be held liable for failure to provide adequate warning under North Carolina law. See N.C. Gen.Stat. § 995(a). "No manufacturer or seller of a product shall be held liable in any product liability action for failing to warn about an open and obvious risk or a risk that is a matter of common knowledge." See id. § 99B-5(b). Where the evidence that the prescribing physician was adequately warned is not contradicted, the drug manufacturer has satisfied its duty to warn the learned intermediary and summary judgment may be granted. See Baraukas v. Danek Medical, Inc., No. 6:97cv00613, 2000 WL 223508, *4 (M.D.N.C. Jan.13, 2000); Foyle, 674 F.Supp. at 536.
c) Statute of Limitations
In North Carolina, "where bodily injury or a defect in property is an `essential
6. Application of Federal Law
i) FDA Preamble
On January 24, 2006, the FDA issued a final rule governing the "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products." 71 Fed.Reg. 3922 (Jan. 24, 2006) (hereinafter "Final Rule"). The Final Rule adds new labeling requirements meant to "make it easier for health care professionals to access, read, and use information in prescription drug labeling" and "enhance the safe and effective use of prescription drug products and reduce the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information." 71 Fed.Reg. at 3922. The Final Rule became effective on June 30, 2006. Id.
In the Preamble to the Final Rule (the "Preamble"), the FDA expressed great concern over the recent spate of products liability actions against prescription drug manufacturers and the impact of those cases on its own regulation of prescription drugs:
Id. at 3935. In view of these concerns, the FDA declared in the Preamble that state law causes of action based upon a theory of inadequate warning where the warning has
Nearly every court to have considered the issue of federal preemption before the Preamble was issued has rejected the FDA's current position. The agency maintains that this results from a "misunderstanding of the act encouraged by State law actions . . . that FDA labeling requirements represent a minimum safety standard." Id. at 3934. According to the FDA, the Federal Food, Drug, and Cosmetic Act of 1938 ("FDCA"), 21 U.S.C. § 301 et seq., establishes both a floor and ceiling as to the adequacy of warning labels.
Lilly argues that, irrespective of the factual merits of plaintiffs' state law claims, it is entitled to summary judgment as a matter of law on the theory that the Final Rule and accompanying Preamble preempt any and all state law causes of action based upon failure to adequately warn, where the warning label has been approved or directed by the FDA, as is the case with Zyprexa. Lilly maintains that allowing states to impose liability for failure to warn despite FDA approval of the warning label would force drug manufacturers to add language to their warning labels that could expose them to liability for misbranding under the FDCA. See 21 U.S.C. § 352.
ii) FDA Regulation of Prescription Drug Warning Labels
Pursuant to the FDCA, the FDA is charged with the obligation to "promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner." 21 U.S.C. § 393(b)(1). Encompassed within such products are prescription drugs intended for human consumption. Id. § 393(b)(2)(B). The powers to (1) approve proposed warning labels to ensure that drugs are safe and effective, see id. § 355, and (2) institute enforcement actions against manufacturers for issuing false or misleading labels, see id. § 352, are included within the FDA's delegated authority.
FDA regulations require that prescription drug manufacturers meet a series of stringent labeling requirements. See 21 C.F.R. §§ 201.56 to 201.57. The manufacturer must indicate among other things warnings and precautions, contraindications, dosage information, adverse reactions, and interactions with other prescription drugs., Id. § 201.56. When new information regarding the risks associated with a drug is available to the manufacturer, the drug's labeling must be changed, regardless of whether a causal link between the drug and a newly-discovered risk has been definitively proved. See id. § 201.57(c)(6)(i) ("the labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.").
Once a label has been approved, the FDA permits two types of labeling changes. Major changes require the prior approval of the FDA. Id. §§ 314.70(b), 601.12(f)(1). Manufacturers are permitted to unilaterally change warning labels in a "minor" way without prior approval, so long as the agency is notified of the changes. Such changes are specifically defined to include strengthening language regarding warnings, contraindications, precautions,
iii) Deference Due FDA's Interpretation
An administrative agency's interpretations of the statutory scheme it administers are entitled to substantial deference, unless Congress has directly spoken on the issue. See Chevron USA, Inc. v. Nat'l Res. Def. Council, Inc.,
If an agency interpretation lacks the "power to control" — because it was not promulgated in the exercise of congressionally-delegated authority under Chevron, or does not resolve an ambiguity in a previously issued regulation under Auer — it serves as guidance for litigants, but will only be respected by the court to the extent that it has the "power to persuade":
Skidmore v. Swift & Co.,
iv) FDCA Preemption of State Law Causes of Action
In fields traditionally occupied by the states, such as health and safety regulation, there is a strong presumption against federal preemption. See Medtronic, Inc. v. Lohr,
"[A]n agency cannot supply, on Congress's behalf, the clear legislative statement of intent required to overcome the presumption against preemption." Desiano v. Warner-Lambert & Co., 467 F.3d 85, 97 n. 9 (2d Cir.2006) (citations omitted). See also Bates v. Dow Agrosciences LLC,
b) Preemption of State Failure to Warn Claims
i) The Preamble Does Not Control the Question of Preemption
The Preamble accompanying the Final Rule is not entitled to deference under Chevron or Auer, and controls this court only insofar as it has the "power to persuade." The FDA lacks the authority to supply the legislative intent required to overcome the presumption against preemption in this case, removing it from those agency interpretations that receive deference under Chevron. See Bates, 544 U.S. at 449, 125 S.Ct. 1788; Medtronic, 518 U.S. at 487, 116 S.Ct. 2240; Desiano, 467 F.3d at 97 n. 9.
The Preamble's assertion of preemption is not persuasive. First, prior interpretations of the FDCA by the FDA contradict the current view adopted by the agency. In a 2000 Proposal of the same amendments at issue in this case, see 65 Fed.Reg. 81082 (Dec. 22, 2000), the FDA explicitly stated that it "ha[d] determined that this proposed rule does not contain policies that have federalism implications or that preempt State law." Id. at 81103. Similarly, in a 1998 Final Rule relating to the provision of labeling directly to patients for certain prescription drugs and other biological products, the FDA noted:
63 Fed.Reg. 66378, 66383-84 (Dec. 1, 1998). There is a lack of harmonization between the 1998-2000 interpretation and the 2006 Preamble. Even those courts persuaded by the FDA's current position have noted that the prior interpretations are "difficult to reconcile [with] the FDA's current position." Colacicco v. Apotex, Inc.,
Courts have generally rejected the argument that the FDA labeling approval process somehow preempts state law adequacy of warning claims. See, e.g., Desiano, 467 F.3d at 97 & n. 9; Tobin v. Astra Pharm. Prods., Inc.,
A majority of courts have held that the FDA's labeling requirements represent only minimum safety standards and do not absolve prescription drug manufacturers of liability. See, e.g., Hill, 884 F.2d at 1068 ("FDA approval is not a shield to liability."); Wells v. Ortho Pharm. Corp.,
FDA regulations themselves militate against deferring to the Preamble's statement of the Final Rule's preemptive effect. The 2006 Preamble is, by regulation, an advisory opinion, binding only on the agency and changeable at any time without notice and comment. See 21 C.F.R. § 10.85(d)(1), (e), (g). The Supreme Court has ruled that internal agency guidelines which are not promulgated subject to notice and comment procedures are entitled only to "some deference." See Reno v. Koray,
ii) State Law Failure to Warn Claims are Not Preempted
The regulation of public health is an area traditionally occupied by the states, supporting a presumption against preemption in this case. See Travelers, 514 U.S. at 654-55, 115 S.Ct. 1671. That presumption has not been overcome in this case. Plaintiffs' state-law adequacy of warning claims are not preempted.
The required clear statement of legislative intent to preempt is lacking. Bates, 544 U.S. at 449, 125 S.Ct. 1788; Medtronic, 518 U.S. at 487, 116 S.Ct. 2240; Desiano, 467 F.3d at 97 n. 9. Despite repeated urging by Lilly to dismiss the Second Circuit Court of Appeals' discussion of the Preamble in Desiano as obiter dictum, the reasoning in that case remains persuasive. In Desiano, the Court of Appeals addressed a Michigan law that immunizes drug manufacturers from liability for drugs approved by the FDA, but excepts them from that immunity if they make misrepresentations to or withhold information from the agency. See Mich. Comp. Laws § 2946(5); Desiano, 467 F.3d at 87-88. Defendant Warner-Lambert & Co., manufacturer of Rezulin (a diabetes drug linked to liver damage that has been withdrawn from the United States market), claimed that portions of the FDCA and Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. ("MDA"), preempted the fraud exception to Michigan's immunity statute. Plaintiffs maintained that their state-law tort claims remained viable. Id. at 88-89. The court rejected preemption, noting that "[t]he Michigan legislature's desire to rein in state-based tort liability falls squarely within its prerogative to regulate matters of health and safety, which is a sphere in which the presumption against preemption applies, indeed, stands at its strongest." Id. at 94 (internal citations and quotation marks omitted). Although not relied upon by the defendant in Desiano, the appellate court nonetheless took notice of the Preamble at issue here, and expressed doubt over its preemptive force:
Id. at 97 n. 9. The need for a "clear statement from Congress" is imperative where, as in this case, a finding of preemption "will foreclose a remedy that was traditionally available and for which federal law provides no substitute." Perry, 456 F.Supp.2d at 684. See also Bates, 544 U.S. at 449-50, 125 S.Ct. 1788. The FDA cannot be allowed to usher in such a sweeping change in substantive law through the back door. Cf. Jackson v. Pfizer, Inc.,
Where Congress has preempted the states' traditional regulation of public health, it has done so explicitly. Two federal statutes passed in this area contain express preemption provisions, in clear contrast to the FDCA. The Medical Device Amendments to the FDCA, passed to regulate
Congress has not spoken on the issue of preemption as related to prescription drugs, and this silence is telling. While a direct statement of legislative intent is not essential for preemption, it would be odd for Congress to include express preemption provisions in amendments to the FDCA regarding state-law tort claims in certain contexts (i.e. for medical devices) if it intended all FDCA claims to be preempted.
There is no actual conflict between plaintiffs' claims and federal law. FDA labeling regulations and state law adequacy of warning claims have existed harmoniously from the time the FDCA was first enacted. Where a state law requirement necessitated violation of the FDCA, a direct conflict would exist and the state law could be preempted under the theory of conflict preemption. For example, if a state, by positive law, required a drug manufacturer to include a warning within the labeling for its product that the FDA had previously rejected as scientifically unsubstantiated, that inclusion could expose the manufacturer to liability for misbranding, see 21 U.S.C. § 352. A direct conflict would then result between state and federal law, something impermissible under the FDCA or any other act of Congress. See Perry, 456 F.Supp.2d at 685-86 ("Where, however, the FDA has made a conclusive determination, positive or negative, as to the existence of a link between the drug at issue and some adverse health consequence, state law cannot mandate that a manufacturer include additional warning beyond those that the FDA has determine to be appropriate to the risk."). See also Bates, 544 U.S. at 453-54, 125 S.Ct. 1788 (discussing whether Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. § 136 et seq., preempts state-law adequacy of warning claims against herbicide manufacturer) ("For example, were the Court of Appeals to determine that the element of falsity in Texas' common-law definition of fraud imposed a broader obligation than FIFRA's requirement that labels not contain false or misleading statements, that state-law cause of action would be preempted. . . . ").
By contrast, a jury verdict finding Lilly negligent for failure to warn of Zyprexa's risks would not compel the company to do anything. Cf. Bates, 544 U.S. at 444, 125 S.Ct. 1788
Jury verdicts and adequacy of warning claims serve an important regulatory role in the tort system. State law adequacy of warning claims may alert the FDA to potential inadequacies in product labeling. The current litigation against Lilly may be a testament to that fact. See Letter from FDA to Eli Lilly & Co. (Mar. 28, 2007).
In any event, the type of failure to warn claim at issue here may not even fall within the Preamble's ambit of purportedly preempted claims. Of the six categories of preempted state-law listed in the Preamble, the one pertinent here includes "claims that a drug sponsor breached an obligation to warn by failing to include a statement in labeling or in advertising, the substance of which had been proposed to FDA for inclusion in labeling, if that statement was not required by FDA at the time plaintiff claims the sponsor had an obligation to warn." 71 Fed.Reg. at 3934 (emphasis supplied). This language suggests that the FDA would consider preempted only those state-law adequacy of warning claims which seek to impose liability for failure to include labeling language already rejected by the FDA. See Perry, 456 F.Supp.2d at 684. Lilly has not proposed statements for inclusion in labeling relating to the increased risks of hyperglycemia and diabetes associated with Zyprexa. Lilly, and other manufacturers of atypical antipsychotics, were compelled by the FDA to include such statements by the September 2003 labeling directive. Even if the Preamble had preemptive force, plaintiffs' failure to warn claims are arguably not the type contemplated by the FDA as preempted.
The lesson of prescription drug tort litigation cautions against permitting the FDA to sweepingly remove adequacy of warning claims from the prescription drug regulatory landscape:
Jonathan V. O'Steen & Van O'Steen, The FDA Defense: Vioxx and the Argument Against Federal Preemption of State Claims for Injuries Resulting from Defective Drugs, 48 Ariz. L.Rev. 67, 94 (2006). As the Supreme Court has noted, "labels
7. Damages Issues
It is contemplated that the normal charges on damages from failure to warn of dangers of a product either negligently or deliberately will be given to the jury. They will be modified by explaining the role of the jury in applying the rules of proportionality. See Part I.B.2 and I.B.3, supra.
Epidemiological and other relevant scientific factors are subject to good faith differing conclusions. See Part IV, infra. Under these circumstances, punitive damages appear not to be available. This issue has not been briefed and may be raised by motion before the trial begins.
B. Application of Law to Facts
1. Robert Cusella
a) Choice of Law
Cusella, a Pennsylvania resident, was diagnosed with Type 2 non-insulin dependent diabetes mellitus in September 1996. Afflicted with mental heath problems for the majority of his adult life, Cusella was prescribed Zyprexa by Dr. Ganime, a well-qualified Pennsylvania psychiatrist. The plaintiff had been hospitalized for acute paranoia, delusions, and psychosis in May 1997. See Def. Stat. Cusella, 2-11, 34. Cusella developed insulin-dependent diabetes in August of 1999, and alleges that this worsening of his condition was a direct result of his Zyprexa use. Id. 1135. Because Pennsylvania has the most significant contacts with Cusella's claims, the law of that state controls Lilly's motion for summary judgment on those claims. See Auten, 308 N.Y. at 160, 124 N.E.2d 99.
b) Statute of Limitations
Diabetes developed and Zyprexa was prescribed years before the September 2003 label change. At least from the date of March 2004 Dear Doctor letter, the causal connection between Zyprexa and diabetes was known to Dr. Ganime, Cusella's treating physician. Since Lilly's duty to warn ran to Dr. Gamine rather than Cusella, it became Dr. Ganime's duty from that point onwards to disclose to Cusella that Zyprexa might exacerbate his diabetes, and that it may have been the impetus behind Cusella's insulin-dependancy in the first place.
Dr. Ganime's medical records and deposition testimony, see Ex. A, show that Cusella was warned numerous times about the link between Zyprexa and diabetes. While the pre-label change warnings Dr. Ganime received from Lilly may not have been adequate to absolve Lilly of liability to Cusella, those warnings Cusella received from Dr. Ganime following the label change placed him on notice that use of Zyprexa might have worsened his diabetes and caused him to become insulin-dependent.
Measured either against the date Cusella developed diabetes — August 1999 — or the latest possible date Dr. Gamine was aware of the potential causal connection between Zyprexa and diabetes — March 2004 — Pennsylvania's two year statute of limitations had run on Cusella's claim before he filed this suit in April of 2006. Cusella's suit is time barred.
c) Adequacy of Warning Post-September 2003 Label Change
For a full discussion of whether Mr. Cusella's physician was adequately warned
d) Deposition of Treating Physician.
See Appendix A, infra.
e) Summary Judgment Decision
The motion for summary judgment against Robert Cusella is granted.
2. Judith New
a) Choice of Law
Judith New was prescribed Zyprexa and developed diabetes in Florida. See Def. Stat. New ¶¶ 24, 39. Because the state of Florida has the most significant contacts with New's claims, Florida tort law governs her product liability action against Lilly. See Auten, 308 N.Y. at 160, 124 N.E.2d 99.
b) Statute of Limitations
New was diagnosed with diabetes in September 2004. She commenced this action against Lilly on April 12, 2006, well within Florida's four-year limitations period for negligence claims. See Part III. A.3.c., supra. New's claim is not time-barred.
c) Adequacy of Warning Post-September 2003 Label Change
For a discussion of whether Ms. New's physician was adequately warned of the diabetes and weight gain risks posed by Zyprexa upon reading the language of the new September 2003 label, see Part II. E.2.b, supra; Part III.B.5, and Appendix B, infra.
d) Deposition of Treating Physician
See Appendix B, infra.
e) Summary Judgment Decision
Summary judgment is denied. Disputed material questions of fact exist concerning the issue of whether the warning provided by Lilly to New's physician was adequate, particularly when viewed in light of the position its salespeople were taking, to convey the risks of weight gain, hyperglycemia, and diabetes.
3. Monty Souther
a) Choice of Law
Monty Souther's diagnosis with bipolar disorder and other psychiatric illnesses, his treatment for those illnesses with Zyprexa, and his development and diagnosis of diabetes all occurred in North Carolina. See Pl's Ex. 60, Aff. of Monty Souther, at ¶¶ 2-6. Because North Carolina has the most significant contacts with Souther's claims, the law of that state controls Lilly's motion for summary judgment on those claims. Auten, 308 N.Y. at 160, 124 N.E.2d 99.
b) Statute of Limitations
Souther began taking Zyprexa in 1997. He was diagnosed with diabetes on in May of 2003, see Def. Stat. Souther, Ex. 8. He commenced this action against Lilly on April 12, 2006, before North Carolina's three-year statute of limitations for negligence actions had run. See Part III.A.5.c, supra. Souther's claim is not time-barred.
c) Adequacy of Warning Post-September 2003 Label Change
For a full discussion of whether Souther's physician was adequately warned of the diabetes and weight gain risks posed by Zyprexa upon reading the language of the new September 2003 label, see Part II.E.3.d, supra; Part III.B.5, and Appendix C, infra.
d) Deposition of Treating Physician.
See Appendix C, infra.
e) Summary Judgment Decision
Summary judgment is denied. Disputed material questions of fact exist
4. Donna Worthington
a) Choice of Law
Donna Worthington's treatment with Zyprexa and diagnosis with diabetes both occurred in North Carolina. See Def. Stat. Worthington ¶¶ 11, 18. Since North Carolina has the most significant contacts with Worthington's claims, the law of that state controls Lilly's motion for summary judgment as to Worthington. See Auten, 308 N.Y. at 160, 124 N.E.2d 99
b) Statute of Limitations
Worthington was diagnosed with diabetes on April 13, 2004, see Def. Stet. Worthington ¶ 11. She commenced this action against Lilly on April 12, 2006, before North Carolina's three-year statute of limitations for negligence actions had run. See Part III.A.5.c, supra. Worthington's claim is not time-barred.
c) Adequacy of Warning Post-September 2003 Label Change
For a full discussion of whether Ms. Worthington's physician was adequately warned of the diabetes and weight gain risks posed by Zyprexa upon reading the language of the new September 2003 label, see Part II.E.4.d supra; Part III.B.5, and Appendix D, infra.
d) Deposition of Treating Physician.
See Appendix D, infra.
e) Summary Judgment Decision
Summary judgment is denied. Disputed material questions of fact exist concern the issue of whether the warning provided by Lilly to Worthington's physician was adequate, particularly when viewed in light of the position its salespeople were taking, to convey the risks of weight gain, hyperglycemia, and diabetes.
5. Adequacy of the September 2003 Label
The adequacy of the Zyprexa warning label approved by the FDA in September of 2003 is a question of fact for the jury. See, e.g., Felix v. Hoffmann-LaRoche, Inc.,
In evaluating the adequacy of the September 2003 warning label, the jury may be guided by the parties' experts as well as the more neutral expert opinion of the FDA, which approved the warning. See, e.g., Upjohn Co. v. MacMurdo,
A. Motions Regarding Admissibility of Expert Reports
Each side has opposed the admissibility of some of the opponent's expert opinions on Daubert grounds. None of these challenges has merit.
B. Rules 702 and 703 of the Federal Rules of Evidence
The key provisions are rules 702 and 703 of the Federal Rules of Evidence, embodying the basic principles of Daubert v. Merrell Dow Pharms.,
In some instances the experts arc also fact witnesses, requiring satisfaction of Rule 701 of the Federal Rules of Evidence covering opinions of non-experts. See, e.g., Asplundh Mfg. Div. v. Benton Harbor Eng.,
While a detailed analysis for such in limine matters is not required, a gatekeeping function is conferred upon the district court by the Rules of Evidence. Daubert, and the guidelines set forth in Rule 104(a) governing decisions on witness qualifications and admissibility of evidence, suggest a preliminary determination that the testimony of experts expected to testify is or is not helpful to the tier of fact, reliable from an evidentiary standpoint, and relevant to the issues in the case. The method for determining the reliability of such testimony is within the discretion of the district court. See Kumho Tire Co. v. Carmichael,
C. Qualifications of Expert Witnesses
Witnesses may be qualified as experts if they possess specialized knowledge, skill, experience, or education. See Fed.R.Evid. 702. In keeping with the "liberal thrust" of the Federal Rules and their "general approach of relaxing the traditional barriers to `opinion' testimony," Daubert, 509 U.S. at 588-89, 113 S.Ct. 2786, the standard for qualifying expert witnesses is liberal. Assertions that the witness lacks particular educational or other experiential background, "go to the weight, not the admissibility, of [the] testimony." McCullock v. H.B. Fuller Co.,
D. Helpfulness and Relevance
In deciding whether to allow the witness to give expert testimony the primary issue is whether the expertise provides the witness with the ability to assist the finder of
In inquiring into the potential helpfulness of the proffered expert testimony, the court decides whether it concerns matters requiring assistance to the kind of people expected to sit on the jury. See United States v. Mulder,
Expert testimony should not merely reiterate arguments based on inferences that can be drawn by laypersons; those can properly be advanced by the parties in their summations. Neither should it include conclusory testimony that "undertakes to tell the jury what result to reach . . . [or] attempts to substitute the expert's judgment for the jury's." United States v. Duncan,
After determining that the requirements of general helpfulness and specific "fit" are met, the court engages "in a balancing . . . to determine whether the probative value of the proffered evidence substantially outweighs its danger of unfair prejudice." United States v. Jakobetz,
The most challenging and controversial gatekeeping role, as set out in Daubert and elaborated in Kumho, is that of ascertaining the reliability of proffered testimony, or "whether the reasoning or methodology underlying the testimony is scientifically valid." Daubert, 509 U.S. at 592, 113 S.Ct. 2786. This is partly because "[u]nlike an ordinary witness [governed by Rule 701], an expert is permitted wide latitude to offer opinions,
The Daubert court supplied the following nonexhaustive guidelines for analysis of the reliability of expert testimony: (1) "whether it can be (and has been) tested"; (2) "whether the theory or technique has been subjected to peer review and publication"; (3) "the known or potential rate of error"; and (4) "general acceptance" within the scientific community. Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786. These guidelines are not to be construed as a "definitive checklist." Id. at 593, 113 S.Ct. 2786. The applicability of any one factor will depend "upon the particular circumstances of the particular case at issue." Kumho, 526 U.S. at 137, 119 S.Ct. 1167.
While, preferably, the content of the expert's testimony will grow "naturally and directly out of research [the or others have] conducted independent of the litigation," Daubert v. Merrell Dow Pharmaceuticals,
Of primary importance in determining reliability of expert testimony is the methodological soundness of the expert's study. See Liriano v. Hobart Corp.,
To be considered is whether there is "a sufficiently rigorous analytical connection between [the expert's] methodology and the expert's conclusions," Nimely, 414 F.3d at 397, and whether the scientific principles and methods have been reliably applied by the expert to the facts of the case. Unfounded extrapolations not supported by, or sufficiently related to, scientific data or expertise should be rejected; opinion that "is connected to existing data only by the ipse dixit of the expert" need not be admitted. General Elec. Co. v. Joiner,
Subjective methodology, as well as testimony that is insufficiently connected to the facts of the case, have been relied upon by appellate courts as grounds for rejection of expert testimony. See, e.g., O'Conner v. Commonwealth Edison Co.,
The mere fact that an expert's testimony conflicts with the testimony of another expert or scientific study does not control admissibility. See Fed.R.Evid. 702 advisory committee note (2000) ("When a trial court, applying this amendment, rules that an expert's testimony is reliable, this does not necessarily mean that contradictory expert testimony is unreliable."). If two contradictory expert opinions meet the requisite threshold of reliability, it is the function of the factfinder, utilizing the "conventional devices" of "cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof," to determine which is the more trustworthy and credible. Daubert, 509 U.S. at 596, 113 S.Ct. 2786. It is worth noting in this respect that defendants' experts have a less demanding task, since they have no burden to produce models or methods of their own; they need only attack those of plaintiffs' experts. Contradiction is to be expected and is often unresolvable without trial.
When considering reliability factors under Rule 702 and Daubert, it is important to recall the Supreme Court's caution that the analytical focus should be on principles and methodology. See Liriano, 949 F.Supp. at 177. Expert testimony should not be rejected simply because the conclusions reached by the witness seem subjectively improbable. See Daubert, 509 U.S. at 594, 113 S.Ct. 2786.
It is critical that "doubts about whether an expert's testimony will be useful should generally be resolved in favor of admissibility unless there are strong factors such as time or surprise favoring exclusions." Jakobetz, 955 F.2d at 797. Any more rigorous approach would deny the jury's constitutional role.
F. Individual Experts' Reports
1. Challenges to Plaintiffs' Experts
Each of plaintiffs' proposed experts is highly qualified. Each can present testimony that meets requirements for admissibility described in Parts IV.B., C, D, and E, supra.
a) Dr. Carol Levy, M.D.
Dr. Carol Levy is a practicing endocrinologist. Eminent experts on both sides of this litigation acknowledge the difficulty of pinpointing the specific cause of diabetes in any individual. Dr. Levy opines that she can do so. It is defendant's position that Dr. Levy overlooks parts of the medical records as follows:
Id. at 5-6.
While the predicates for Dr. Levy's proposed specific causation testimony may appear to be weak, her distinguished background and clinical experience warrant permitting her to testify. Her credibility will be subject to attack by both cross-examination and the contrary testimony of other experts. The jury may well find it useful on appropriate scientific grounds. Her professional background includes the following: She is presently an assistant Professor of Medicine at Weill Medical College, a consulting physician at Cole-Goldwater Hospital, a Lecturer at Cornell Medical School, an Attending Physician at the Endocrine Clinic, Obstetrics Clinic and Endocrine Consult Service at. New York Presbyterian Hospital, part of the Endocrine Fellowship interviewing/evaluation team and the Internal Medicine Residency interviewing team, and co-director of the Endocrine Fellowship Program at Weill Medical College. Dr. Levy is a member of the American Diabetes Association, the American College of Physicians and the Endocrine Society, and board certified in Internal Medicine, Endocrinology, Diabetes and Metabolism. Dr. Levy has treated patients who have ingested Zyprexa and have diabetes. Report of Dr. Carol Levy, M.D., 1-2 (hereinafter "Levy Report").
This expert's written opinion indicates a thorough understanding of diabetes. Id. passim. She also has read widely in relevant fields. Id., Index to Zyprexa Literature (attached to Levy Report). Her opinion will be admitted.
b) Dr. Stefan P. Kruszewski, M.D.
Lilly moves to exclude the opinions offered by plaintiffs' proposed expert witness Stefan P. Kruszewski, M.D. on the ground that they are factually flawed and include matters on which he is not qualified to testify. Dr. Kruszewski's testimony is inadmissible, according to Lilly, for the following reasons:
Def. Mot. to Exclude Testimony of Stefan Kruszewski, 1-2 (May 29, 2007).
Dr. Kruszewski is offered to, testify to two main opinions:
Dr. Kruszewski will not be permitted to testify to the fact that some Zyprexa studies included work of researchers sanctioned or indicted. This information is likely to inflame the jury and is not useful
This distinguished expert's analysis of the relevant literature may be useful to the jury. Dr. Kruszewski's experience provides an adequate basis for his opinion and proposed testimony. His curriculum vitae includes the following: He has 28 years of clinical practice (including internship and residency) in which he treated several thousand patients with a wide variety of psychiatric and neuropsychiatric conditions to whom he prescribed numerous drugs for psychiatric and neuropsychiatric indications. He witnessed the side effects of drugs that predispose an individual to neuropsychiatric complications. During this time and with this population, he monitored the effects of various antipsychotics, including Zyprexa.
Dr. Kruszewski has expertise in psychopharmacology, including education in medical school, internship, residency, postgraduate work and continuous reading and updating through Continuing Medical Education (CME) work. He has been an educator regarding basic and applied psychiatric and neuropsychiatric psychopharmacology, including metabolic dysfunction, at several institutions, including Harvard Medical School (1974-77), (specifically, the epidemiology of obesity), UMDNJ-Rutgers Medical School/Robert Wood Johnson for several years as a member of their residency program and faculty (1980-83) and University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic (1988-1991), Allegheny General Hospital and related Medical Schools, (1991-92), University of North Texas Medical School (1992-93) and, as a member of the Clinical Faculty of Penn State College of Medicine-Hershey Medical School (1999-2004). As part of those academic teaching appointments, he lectured on epidemiology, psychiatry, neuropsychiatry and related-fields, including factors that affect and illness of individuals and populations to identify risk factors for disease and to determine optimal treatment approaches to clinical practice. His work has been published as solo and primary author in peer-reviewed journals, including the BMJ (previously titled, British Medical Journal), American Journal of Psychiatry, Neurology, Journal of the American Medical Association, the New England Journal of Medicine, Annals of Clinical Psychiatry, Journal of Clinical Psychiatry (as of Spring 2007) and others. Those publications have covered a wide spectrum of issues pertaining to drugs (including antipsychotics), side-effects, conflicts of interest and the validity and consistency of research.
This expert is on the Board or Directors of the Alliance for Human Research Protection. In that capacity, he reviews and analyzes information from national and international peer-reviewed and edited sources related to clinical research on issues pertaining to drugs and device side-effects. That work includes his ongoing study of effects and side-effects of anticonvulsants, antidepressants, antipsychotics, stimulants, sedatives, drugs of abuse and mood-stabilizing drugs. In 2001-2003, he provided psychiatric expertise regarding behavioral access to care for a white paper designed for the NCQA (National Committee on Quality Assurance, Washington D.C.) and to be used a guide for nationwide behavioral health programs. He participated in the design and implementation of drug trials, including Zyprexa. He performed extensive research of peer- and non-peer-reviewed scientific literature, including an in-progress review of Zyprexa New Drug Application (NDA) documents concerning the mechanism of action, efficacy and safety features of olanzapine. Report
c) Dr. Arvin P. Shroff, Ph.D.
Plaintiffs' FDA regulatory expert Arvin P. Shroff, Ph.D. proposes to testify that Lilly (1) failed to provide sufficient safety information to the FDA, including information required by its post-marketing adverse event reporting obligations; (2) failed to make appropriate and timely labeling changes; (3) delayed communicating the September 2003 labeling change; and (4) failed to warn physicians and patients about weight gain, hyperglycemia, and diabetes.
In addition, Dr. Shroff proposes to offer general opinions to the effect that the FDA's review of prescription medications is limited by the information provided by the sponsor; that the performance goals of the Prescription Drug User Free Act limit the FDA's review of prescription drugs; that the FDA lacks the authority to dictate product labeling; and that Lilly had an obligation to distribute medical literature to physicians.
Lilly points out that although he purports to be an FDA regulatory expert, Dr. Shroff has only two years of experience in product labeling, gained more than thirty years ago. Lilly asserts that this proposed expert has neither looked at any key data nor conducted any independent analysis of the issues on which he testifies. For example, Lilly claims:
Def. Mot. to Exclude Testimony of Arvin Shroff, 1-2 (May 29, 2007).
Dr. Shroff has a good general knowledge of how the FDA operates. He can testify as to this. He may not testify as to the specifics of how Zyprexa regulatory issues were processed by the FDA; he has no specific knowledge of this matter.
As to general knowledge, Dr. Shroff's background qualifies him to be helpful to the jury. It includes the following: He is the President of Arvin Shroff Associates, LLC, a consulting film specializing in FDA regulatory, enforcement and compliance issues including submissions of various types of applications and documents to FDA. The firm provides advice to pharmaceutical manufacturers, biotechnology companies, medical device firms, biological industry,
He began his career with the FDA in 1974 at the Center for Drug Evaluation and Research ("CDER") in the Office of New Drug Evaluation as a Review Chemist. His main responsibilities included reviewing Investigational New Drug Applications (INDs), New Drug Applications (DMFs), as well as supplements and amendments associated with these applications. He also reviewed Abbreviated New Drug Applications (ANDA) and Abbreviated Antibiotic Drug Applications (AADAs) on occasion. During his tenure in this position, he reviewed and evaluated numerous different types of drug products. He was a member of many FDA technical committees the prepared guidance documents for the regulated industry in various drug-related subject areas such as Stability, Packaging, Chemistry and Manufacturing Controls. He was also an FDA liaison with the United States Pharmacopoeia, a scientific standard-setting organization, recognized in the Food, Drug and Cosmetic Act (Act).
In 1976, he was promoted to Chief, Product Surveillance Branch, Division of Drug product Quality, Office of Compliance, CDER, with primary responsibilities to help determine the quality of imported and domestic drugs distributed in the United States. In 1981, he was promoted to Director, Division of Field Science, Office of Regulatory Affairs ("ORA"). In that role, he directed and managed the scientific efforts and methods development research for ORA laboratories (there were 19 laboratories and 7 Research Centers in ORA at that time) for all program areas (food, drugs, devices, biologics and veterinary medicine). In 1985, he became the Deputy Director, Office of Regional Operations, ORA. He supervised and coordinated FDA's regulatory activities, such as inspections, imports, surveillance and emergency operations, as well as recall activities dealing with district and regional offices. These activities involved all FDA program areas, including drugs and biologics. In 1992, he became Deputy Director, Office of Enforcement, ORA. In that role he evaluated and coordinated proposed legal actions to ascertain compliance with regulatory policy and enforcement objectives, including GMP issues, recalls and other enforcement and compliance issues. The recall unit was transferred from Office of Regional Operations to the Office of Enforcement, where he oversaw hundreds of recalls each year in all program areas.
Prior to working at the FDA, this expert was employed as a Group Leader and Senior Research Chemist at Ortho Pharmaceutical Corporation, a Johnson & Johnson subsidiary, where he was involved in both synthetic organic chemistry and analytical chemistry. He received his Ph.D. in Pharmaceutical Chemistry from the School of Pharmacy, University of Maryland in 1962. Report of Alvin Shroff, Ph.D., 1-3 (March 25, 2007). He has authored a considerable number of publications on FDA practice. Id. at appendix III.
2. Challenges to Defendant's Expert Dr. Robert R. Henry, M.D.
Plaintiffs challenge the report and proposed testimony of Dr. Robert R. Henry on the grounds that:
Pl. Mot. to Exclude Testimony of Dr. Robert R. Henry (May 29, 2007).
None of these objections warrant Daubert exclusion, particularly in view of the expert's distinguished career which fully qualifies him to give his proposed opinions that available scientific data do not establish a causal relationship between Zyprexa and type 2 diabetes. The opinion may be helpful to the jury.
His background includes the following: He holds an M.D. from the University of Manitoba Medical School, and is board certified by the American Boards of Internal Medicine and Endocrinology and Metabolism. Currently he is employed as Professor of Medicine at the University of California, San Diego, and Chief of the Section of Endocrinology, Metabolism and Diabetes and the Special Diagnostic and Treatment Unit at the Veterans Administration Medical Center, San Diego. The Special Diagnostic and Treatment Unit functions primarily as a clinical center of research in diabetes and obesity. He is also Director of the Center for Metabolic Research, which administers all aspects of the clinical research conducted at the Special Diagnostic and Treatment Unit. At the University of California, San Diego, he regularly teach courses in endocrinology and diabetes, and he supervises the education and clinical training of medical students, residents and fellows in the treatment of diabetes and other endocrinologic and metabolic disorders. In his clinical practice at the VA Medical Center, San Diego, he treats patients with metabolic disorders. About 80% of his patients have diabetes. They include people who have serious mental disorders, including patients with schizophrenia and bipolar disorders, who are being treated with atypical antipsychotics.
This expert's research focuses on abnormalities of glucose and fat metabolism in patients with obesity, as well as those with type 1 and type 2 diabetes and those who are prediabetic. A focus of his research involves studies directed at understanding the interaction between obesity and type 2 diabetes. He regularly designs, conducts, and evaluates mechanistic studies of glucose and fat metabolism, including vivo studies such as glucose clamp technique and in vitro studies of human fat and muscle tissues. This research includes studies directed at elucidating the mechanisms by which atypical antipsychotics, including Zyprexa, may influence glucose and fat metabolism. He has also been an investigator in a number of national diabetes-related research studies, including the Diabetes Prevention Program and the VA Co-Operative Studies Program diabetes trial of glycemic control and complications in diabetes mellitus type 2. His activities include service to the American Diabetes Association. In the past five years, he served on the ADA's Board of Directors, Research Policy Committee (chair), and National Legal Advocacy Subcommittee, and also served as a Meeting Abstract Reviewer for the ADA National Meeting. He is a reviewer of manuscripts for many of the leading endocrinology and medical journals and of grant applications submitted to many organizations, including the ADA, the Veterans Administration, and the National Institute of Health. Report of Robert R. Henry, 1-2 (May 9, 2007).
In view of the extensive briefing, oral submissions, and clarity of the law and facts, no further argument is required.
A. Robert Cusella
Summary judgment against Robert Cusella is granted with costs and disbursements. Either party may submit a judgment.
B. Judith New
Summary judgment against Judith New is denied.
C. Monty Souther
Summary judgment against Monty Souther is denied.
D. Donna Worthington
Summary judgment against Donna Worthington is denied.
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