INGE PRYTZ JOHNSON, District Judge.
Pending before the court is the defendant's motion for summary judgment and exhibits in support of said motion as to (1) the adequacy of the July 1, 2009, label, and (2) the running of the statutes of limitations
This is a multidistrict product liability action concerning the drug Chantix,
According to the plaintiffs, Chantix causes depression and other psychiatric disorders, some so severe that reports of suicide and attempted suicide from Chantix use have been made. Master Consolidated Complaint, ¶ 32. The plaintiffs allege defendant either knew or should have known about such side effects, but for defendant's intentional failure to design studies which were reflective of their targeted population. Master Consolidated Complaint, ¶¶ 27-31, 33-38. The defendant denies there is any merit to such allegations, and asserts that numerous studies show the side effects of Chantix to be in line with those of other nicotine replacement therapies (NRTs), such as nicotine patches.
Because of reports of suicidal thoughts and acts, as well as other neuropsychiatric disorders, the labeling of Chantix since May 2006 has been changed to strengthen the warnings on the package inserts, culminating in a "black box warning" being placed on the package insert in July 2009. See defendant ex. 1 (doc. 590-1). In November 2007 the "adverse reactions" section of the label was updated to reflect post-marketing reports of depression, agitation, changes in behavior, suicidal ideation and suicide in patients taking Chantix.
In addition to the black box warning added in July 2009, a "Medication Guide" was added to the package inserts at the same time, to inform patients that "[s]ome people have had changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions while using CHANTIX ..." and that if "you [or] your family" notice such symptoms or changes in behavior, "stop taking CHANTIX and call your healthcare provider right away..." Defendant ex. 5 (doc. 590-5), at 1. The "black box warning" and the Medication Guide have remained unchanged since July 2009.
In October 2011 the FDA released a Safety Announcement which reported that the FDA reviewed two FDA-sponsored studies evaluating the risk of neuropsychiatric injury from Chantix. Defendant ex. 6 (doc. 590-6). That Announcement states
Id., at 1. That Announcement further states that "[o]verall, FDA has determined that the current warnings in the Chantix drug label, based on post-marketing surveillance reports, remain appropriate." Id., at 2.
The defendant asserts the July 2009 label change is sufficient as a matter of law, and thus should trigger the statute of limitations to run on all plaintiffs' failure to warn claims based on neuropsychiatric injury. The plaintiffs disagree, asserting that the court cannot find the July 2009 warning sufficient as a matter of law.
SUMMARY JUDGMENT STANDARD
A moving party is entitled to summary judgment if there is no genuine issue of material fact, leaving final judgment to be decided as a matter of law. See Federal Rule of Civil Procedure 56; Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 1355-56, 89 L.Ed.2d 538 (1986); Reeves v. C.H. Robinson Worldwide, Inc., 525 F.3d 1139, 1143 (11th Cir.2008). The facts, and any reasonable inferences therefrom, are to be viewed in the light most favorable to the non-moving party, with any doubt resolved in the non-movant's favor. See Adickes v. S.H. Kress & Co., 398 U.S. 144, 158, 90 S.Ct. 1598, 1609, 26 L.Ed.2d 142 (1970). All "reasonable doubts" about the facts and all justifiable inferences are resolved in favor of the non-movant. Fitzpatrick v. City of Atlanta, 2 F.3d 1112, 1115 (11th Cir.1993). However, all "doubts" need not be so resolved. Barnes v. Southwest Forest Industries, Inc., 814 F.2d 607, 609 (11th Cir.1987). Once met by the moving party, the burden shifts to the non-moving party to come forward with evidence to establish each element essential to that party's case sufficient to sustain a jury verdict. See Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986); Earley v. Champion Int'l Corp., 907 F.2d 1077, 1080 (11th Cir. 1990).
"The mere existence of some factual dispute will not defeat summary judgment unless that factual dispute is material to an issue affecting the outcome of the case.... A genuine issue of material fact does not exist unless there is sufficient evidence favoring the nonmoving party for a reasonable jury to return a verdict in its favor." Chapman v. AI Transport, 229 F.3d 1012, 1023 (11th Cir.2000), quoting Haves v. City of Miami, 52 F.3d 918, 921 (11th Cir.1995). A factual dispute regarding a non-material issue will not preclude the defendant from succeeding on a motion for summary judgment. Brown v. American Honda Motor Co., 939 F.2d 946, 953 (11th Cir.1991).
A. Adequacy of 2009 Boxed Warning
While the elements of a failure to warn claim vary from state to state, the requirements of a such a claim generally include that "where the manufacturer ... of a product has actual or constructive knowledge of danger to users, the ... manufacturer has a duty to give warning of such dangers." See e.g., PLIVA, Inc. v. Mensing, ___ U.S. ___, 131 S.Ct. 2567, 2573, 180 L.Ed.2d 580 (2011), citing Frey v. Montgomery Ward & Co., 258 N.W.2d 782, 788 (Minn.1977). See also Stupak v. Hoffman-La Roche, Inc., 326 Fed.Appx. 553, 557-558 (11th Cir.2009) (discussing Wisconsin law and noting that "under both negligence and strict liability failure to warn claims, the duty to warn arises from the foreseeability of the harm encountered by the user. Hence, in order to maintain an action against a manufacturer for harm arising from the manufacturer's failure to warn of a danger ... the plaintiff must prove that the manufacturer knew or should have known of the danger which caused the harm at issue").
Although such claims arise under the various laws of the fifty states, the content of the drug label itself is regulated by federal law. "Under the 1962 Drug Amendments to the Federal Food, Drug, and Cosmetic Act, 76 Stat. 780, 21 U.S.C. § 301 et seq., a manufacturer seeking federal approval to market a new drug must prove that it is safe and effective and that the proposed label is accurate and adequate." PLIVA, 131 S.Ct. at 2574, citing 21 U.S.C. §§ 355(b)(1), (d); Wyeth v. Levine, 555 U.S. 555, 567, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). Thereafter, a manufacturer bears responsibility for the content of its label at all times. "It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market." Wyeth v. Levine, 555 U.S. at 570-571, 129 S.Ct. 1187 (citing 21 CFR § 201.80(e) (requiring a manufacturer to revise its label "to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug");
The label at issue here has, since July 2009, included the warning that
Defendant ex. 1, at 1 (emphasis in original).
The plaintiffs rely on the testimony and expert report of Joseph Glenmullen, M.D., for evidence that the current label on Chantix is insufficient. See plaintiffs' brief in opposition, at 4-8. In his expert report, Dr. Glenmullen states that "on July 1, 2009 the FDA's Chantix warnings culminated in a black box, the highest level warning possible, prominently displayed at the beginning if a drug's official prescribing information." Report of Glenmullen, at 38, submitted as plaintiff ex. 016178. After setting forth the warning and the list of possible psychiatric side effects, Dr. Glenmullen states that this list "underscores the severity of Chantix's side effects." Id., at 39. Dr. Glenmullen adds that defendant resisted these FDA required changes as early as 2007 and that defendant resisted the addition of the black box warning, delaying its implementation by eight months. Id., at 40-41. Later in his report, Dr. Glenmullen discusses other medications which impact dopamine levels or uptake in regard to FDA required warnings, the conclusion being that dopamine-altering medications tend to have neuropsychiatric
Conspicuously absent from Dr. Glenmullen's report is any discussion of the adequacy of the 2009 black box warning. Hence plaintiffs' arguments otherwise, based on Dr. Glenmullen's expert report, are unpersuasive. Perhaps recognizing this shortcoming, the plaintiffs rely instead on Dr. Glenmullen's deposition testimony, where he suggests that the Chantix label should reflect the Veteran's Administration prescribing guidelines. See e.g., plaintiffs' brief in response at 7-8.
While plaintiffs suggest that the Chantix label should include a warning to prescribing doctors not to use Chantix as a first line treatment to assist in smoking cessation, in accordance with the Veteran's Administration (VA) guidelines, such a suggestion is not relevant to the issue of the sufficiency of the current label for purposes of a failure to warn claim. The issue for a failure to warn claim is whether the warning given was sufficient to alert to the possibility of the harm actually suffered.
Relevant to these arguments is whether the label sufficiently alerted medical professionals that their patients could suffer neuropsychiatric injuries from taking Chantix as prescribed. The parties agree that the vast majority of states apply the "learned intermediary doctrine" to failure to warn claims concerning prescription medications.
With this backdrop, the court has considered the plaintiffs' new proposition on label inadequacy — that a warning not to use Chantix as a first-line treatment should have been included.
See expert report of Blume (submitted as plaintiff ex. 016164), at 39-40 (emphasis added).
To survive a motion for summary judgment, a party must do more than make conclusory allegations. The Eleventh Circuit has "consistently held that conclusory allegations without specific supporting facts have no probative value.... One who resists summary judgment must meet the movant's affidavits with opposing affidavits setting forth specific facts to show why there is an issue for trial." Leigh v. Warner Bros., Inc., 212 F.3d 1210, 1217 (11th Cir.2000) (internal citation omitted). Similarly, the district court has no obligation to parse a summary judgment record to search out facts or evidence not brought to the court's attention." Atlanta Gas Light Co. v. UGI Utilities, Inc., 463 F.3d 1201, 1208 n. 11 (11th Cir.2006). Dr. Glenmullen provides no assistance to the plaintiffs in this regard.
Dr. J. Wesley Boyd, M.D., another of plaintiffs' experts, does state that in his opinion, Chantix should not be used as a first line treatment. Expert report of Boyd, submitted as plaintiff ex. 016165, at 17. However, at no time did he opine that the 2009 warning contained in the Chantix label was inadequate. The plaintiffs attempt to dodge this problem by arguing, "[a]s with other aspects of the VA guidelines, noted above, this opinion of Dr. Boyd — that Chantix is not a first line therapy — is not contained in the July 2009 label."
The plaintiffs next argue that in an article co-authored by Dr. Glenmullen and Dr. Carl Furberg, another of plaintiffs' experts, the suggestion is made that "the FDA should consider revising the suicidal behavior and depression language in the Boxed Warning and Highlights of Prescribing Information to state clearly that the risks of suicidal behavior and depression are higher with varenicline than with other smoking cessation treatments." Plaintiffs' ex. 016092, plaintiffs' brief in opposition at 9-10. This statement is really indistinguishable from plaintiffs' argument that Chantix is so dangerous, it should not be used as a first-line treatment, as discussed above. However, the plaintiffs again do not suggest that the failure to include this language renders the warnings inadequate. Nowhere in their complaint do they suggest either this, or that the warnings should have stated that varenicline should not be used as a first line treatment, rendered the 2009 label changes insufficient.
Rather, as other courts have recognized, it is the responsibility of the physician as a learned intermediary to assess the risks and benefits of a particular course of treatment. Caveny v. CIBA-GEIGY Corp., 818 F.Supp. 1404, 1406 (D.Colo.1992); Ferrara v. Berlex Laboratories, Inc., 732 F.Supp. 552 (E.D.Pa.1990); Wooten v. Johnson & Johnson, Products, Inc., 635 F.Supp. 799 (N.D.Ill.1986).
The Restatement (Third) of Torts: Products Liability § 6(d) (1998), comment b. Similarly, as recognized by other courts, whether physicians choose to follow the warnings is a matter of medical judgment. See e.g., Estate of LaMontagne v. Bristol-Myers Squibb, 127 Wn.App. 335, 111 P.3d 857 (2005), citing Adams v. Synthes Spine Co., 298 F.3d 1114 (9th Cir.2002).
Unlike the majority cases reviewed by this court, the plaintiffs seek to pursue their failure to warn claims post the 2009 black box warning, not for failing to warn of possible complications from Chantix, but for failing to tell physicians when to prescribe it.
Additionally, plaintiffs argue both that "hundreds of serious psychiatric adverse event reports that had been originated by Pfizer as far back as 2006 had not been properly submitted to the FDA," and that "many of the aforementioned adverse events occurred before July 2009 ..." Plaintiffs' brief in opposition, at 10. In no way does this assist plaintiffs' argument that the July 2009 label contained an inadequate warning. Thus, plaintiffs' next statement that "this is another respect in which expert testimony
For the foregoing reasons, the court finds the 2009 black box warning adequate as a matter of law on the issue of sufficiency of warnings for purposes of neuropsychiatric injuries. The court shall grant the pending motion on the same.
B. Statute of Limitations
Based on the foregoing, the defendant seeks to have this court rule that the statute of limitations started running on all neuropsychiatric claims on July 1, 2009. The plaintiffs respond that even if the July 2009 label is found adequate as a matter of law, such an ruling cannot be tantamount to a blanket summary judgment ruling on the statute of limitations in neuropsychiatric cases. Plaintiffs' brief in opposition, at 14. The court agrees. The issue of the running and/or expiration of the statute of limitations must be considered on a case by case basis, even given that the court has determined the July 2009 label adequate as a warning as a matter of law.
Rather than the method suggested by the defendant, namely that plaintiffs whose prescriptions were filled after July 1, 2009, should be free to present arguments opposing summary judgment, the court believes the proper course of action is to allow defendant leave to file motions for summary judgment in individual cases alleging neuropsychiatric injury, wherein the individual plaintiffs had prescriptions filled for the first time after the July 1, 2009, FDA mandated strengthening of the warnings for Chantix.
In consideration of the foregoing, the court shall rule by separate order that the July 1, 2009, black box warning is adequate as a matter of law to warn of the risk of neuropsychiatric complications in patients taking Chantix, and the court shall grant the defendant's motion for summary judgment (doc. 590) to this extent. For the reasons set out herein, the court shall also rule by separate order that
21 CFR § 201.80(e).
In fact, one court ruled that if a warning label clearly and unambiguously states the particular ailment suffered by the plaintiff, summary judgment on a failure-to-warn claim is appropriate despite the prescribing physician's testimony that the warning did not adequately inform him of the risk involved. Calhoun v. Hoffman-La Roche, Inc., 98-2770, (La.App. 1 Cir.2000), 768 So.2d 57, 62.