Beginning in 2012, patients around the country began suffering meningitis after being injected with preservative-free methylprednisolone acetate ("MPA"), a steroid purchased from New England Compounding Pharmacy, Inc., a/k/a the New England Compounding Center ("NECC"). It was soon discovered that some lots of MPA had become contaminated with fungus. This consolidated appeal concerns claims brought by injured patients (or those suing on their behalf) (collectively, "the Plaintiffs") against Anonymous Clinic in St. Joseph County and Orthopedic and Sports Medicine Center of Northern Indiana ("OSMC") and affiliated entities in Elkhart County (collectively, "the Defendants"). Plaintiffs contend that the Defendants were negligent in choosing to administer preservative-free MPA and in failing to properly evaluate NECC before using it as a supplier. Some of the Plaintiffs brought suit without using the procedures laid out in the Indiana Medical Malpractice Act ("the MMA"), and Defendants moved either for dismissal or summary judgment on the basis that Plaintiffs' claims were claims of medical malpractice.
Stephen W. Robertson, acting in his capacity as Commissioner of Indiana Department of Insurance, which administers the Indiana Patient's Compensation Fund ("the PCF") intervened, arguing that Plaintiffs' claims were of general negligence and therefore not subject to the provisions of the MMA. The trial courts ultimately agreed with Defendants and Plaintiffs (who had reversed their initial position) that Plaintiffs' claims were governed by the MMA. In this consolidated appeal, the PCF contends that the trial courts erred in concluding that Plaintiffs' claims are claims of medical malpractice. Plaintiffs, Defendants, and Amici Curiae (health-care providers facing similar claims in other cases), contend that Plaintiffs' claims are subject to the MMA as they involve actions informed by the exercise of professional medical judgment. Because we conclude that Plaintiffs' claims are subject to the MMA, we affirm the judgments of the trial courts and remand for further proceedings consistent with this opinion.
Facts and Procedural History
I. St. Joseph County Litigation
The St. Joseph Superior Court set forth the facts underlying the claims filed in St. Joseph County in its order dismissing Plaintiffs' claims:
Appellant's App. pp. 93-97 (record citations omitted).
A total of six claims against Anonymous Clinic were consolidated to address the threshold legal issue of whether the claims are claims of general negligence or are subject to the MMA. On May 15, 2015, in the consolidated action captioned In re Steroid Litigation, Anonymous Clinic filed a motion to dismiss all of the Plaintiffs' claims for lack of subject matter jurisdiction on that basis that MMA requirements had not been met.
On June 26, 2015, the PCF filed a response to the motion to dismiss, opposing it on the ground that the MMA did not apply to Plaintiffs' claims. Also on June 26, 2015, Plaintiffs reversed their earlier position and filed a response urging the trial court to conclude that their claims were covered by the MMA. On August 27, 2015, the St. Joseph Superior Court heard oral argument on Anonymous Clinic's motion to dismiss.
On October 12, 2015, the St. Joseph Superior Court granted Anonymous Clinic's motion to dismiss in part, concluding that Plaintiffs' claims were governed by the MMA. The St. Joseph Superior Court stayed proceedings until compliance with MMA procedures could be accomplished. On November 12, 2015, the PCF moved the St. Joseph Superior Court to certify the case for interlocutory appeal, which motion was granted on November 16. This court accepted jurisdiction.
II. Elkhart County
The Elkhart Superior Court set forth the facts underlying the claims filed in Elkhart County in its order entering summary judgment in favor of OSMC:
FINDINGS OF FACT
Appellant's App. pp. 116-31.
Beginning on October 27, 2014, several Plaintiffs sued OSMC to recover for injuries allegedly suffered because of the injection of defective MPA.
III. Appellate Procedure
On February 17, 2016, Plaintiffs moved this court to consolidate the St. Joseph appeal with the Elkhart appeal, a motion the PCF did not oppose. On March 7, 2016, this court granted the motion to consolidate the appeals, consolidating appellate cause numbers 20A03-1512-CT-2148 and 71A03-1512-CT-2199 under the latter cause number.
Discussion and Decision
All agree that the only issue in this appeal is whether Plaintiffs' allegations against Anonymous Clinic and OSMC are claims of general negligence or are covered by the provisions of the MMA. The parties also agree that the issue, as ultimately one of jurisdiction, is to be reviewed de novo by this court. See Kondamuri v. Kondamuri, 799 N.E.2d 1153, 1156 (Ind.Ct.App.2003) ("A court's jurisdiction either exists or does not, and the question of a court's jurisdiction is therefore a question of law that is not entrusted to the trial court's discretion but rather is reviewed de novo"), trans. denied.
I. Background — The MMA
Plaintiffs, Defendants, and Amici Curiae argue that Plaintiffs' claims are covered by the MMA while the PCF argues that they are not.
Ellenwine v. Fairley, 846 N.E.2d 657, 660 (Ind.2006).
In re Stephens, 867 N.E.2d 148, 150 (Ind. 2007).
At the heart of both the Elkhart and St. Joseph Superior Courts' decisions is their conclusion that the MMA governs Plaintiffs' claims against Defendants. Defendants and Amici Curiae, who are also health care providers under the MMA, wish to have this court declare Plaintiffs' claims subject to the MMA. Plaintiffs, despite the fact that they would face the additional procedural burdens of compliance with the MMA as well as the limitations on recovery, take the same position. The PCF contends that Plaintiffs' claims are claims of general negligence, not governed by the MMA.
II. The Arguments
Pursuant to Indiana Code section 34-18-2-13, "`Health care' means an act or treatment performed or furnished, or that should have been performed or furnished, by a health care provider for, to, or on behalf of a patient during the patient's medical care, treatment, or confinement." The question is whether the negligence alleged against Defendants qualifies as "health care." If so, Plaintiffs' claims are subject to the MMA; if not, they are claims of general negligence.
In the brief in support of the PCF's summary judgment motion filed in Elkhart Superior Court, it characterized Plaintiffs' arguments as follows:
Appellant's App. p. 277.
In the PCF's motion in St. Joseph Superior Court, it characterizes the Plaintiffs' claims as follows:
Appellant's App. pp. 996-97. So, the question is whether deciding to use preservative-free MPA and deciding to purchase it from NECC constitute "health care" under the MMA. If so, the alleged negligence in those areas would be subject to the MMA. If not, such claims would be claims of general negligence.
A. Legal Arguments
The PCF contends that the general procurement of products that will eventually be used in the course of treatment does not qualify as "health care" under the MMA. The OSMC and Anonymous Clinic argue that Plaintiffs' allegations are covered by the MMA. Amici point out that the U.S. District Court for the District of Massachusetts, which is hearing hundreds of similar cases in federal multidistrict litigation ("the MDT Court"), has determined similar claims to be claims of professional negligence, and urges this court to do the same.
"The [MMA] is not all-inclusive as to claims against medical providers, and a claim against a medical provider sounding in general negligence or premises liability rather than medical malpractice is outside the [MMA]." Peters v. Cummins Mental Health, Inc., 790 N.E.2d 572, 576 (Ind.Ct.App.2003), trans. denied.
Terry v. Cmty. Health Network, Inc., 17 N.E.3d 389, 393 (Ind.Ct.App.2014).
Howard Reg'l Health Sys. v. Gordon, 952 N.E.2d 182, 185-86 (Ind.2011).
Harts and Pluard
The PCF relies primarily on two Indiana cases to support its argument that alleged negligence in this case is not governed by the MMA. The first of these cases is Harts v. Caylor-Nickel Hosp., Inc., 553 N.E.2d 874 (Ind.Ct.App.1990), trans. denied, in which the elderly plaintiff was injured when the railing allegedly collapsed on his hospital bed, causing him to fall out. Id. at 875-76. Harts argued, and the court agreed, that his claim against the hospital was not subject to the MMA. Id. at 879. In so doing, the Harts court relied on our earlier decision in Winona Memorial Found. of Indianapolis v. Lomax, 465 N.E.2d 731 (Ind.Ct.App.1984):
Harts, 553 N.E.2d at 879-80 (quoting Lomax, 465 N.E.2d at 740) (emphasis in Harts, first ellipsis added).
Noting that Harts's allegations were limited to a claim that the hospital's employees failed to properly restrain or secure the guardrail on his bed, we concluded that
Harts, 553 N.E.2d at 879.
The PCF also relies on our decision in Pluard ex rel. Pluard v. Patients Compensation Fund, 705 N.E.2d 1035 (Ind.Ct.App.1999), trans. denied. Infant Pluard was injured when a surgical lamp detached from a wall and fell on him, striking him in the head. Id. at 1036. After settling with the hospital, Pluard sought to recover excess damages from the PCF, which countered that the tort that caused Pluard's injuries was not governed by the MMA. Id. We ruled in favor of the PCF, concluding that
Id. at 1038.
The PCF contends that the court's focus in Harts and Pluard was on whether the product was defective or misused during treatment. Specifically, the PCF asserts that the decisions stand for the proposition that if the product is defective, the claim falls outside the MMA, and, if the product is misused, the claims are governed by the MMA. It would follow, then, that because there have been no allegations that the Defendants misused the MPA, Plaintiffs' claims fall outside the MMA. We are not persuaded, however, that the PCF's position is a reasonable reading of Harts and Pluard.
A fair reading of both decisions indicates that the court's true focus in both cases was on whether the issues were capable of resolution without referring to the medical standard of care; if so, the claims would not be subject to the MMA. The Harts court stated that "[w]hen ... the matters at issue are within the common knowledge and experience of the jury, expert testimony regarding the exercise of reasonable care is improper and should be excluded." Harts, 553 N.E.2d at 879 (quoting Lomax, 465 N.E.2d at 740). The Pluard court also based its conclusion on this distinction, determining that the case involved "issues capable of resolution without application of the standard of care prevalent in the local medical community, and thus, is outside the purview of the Act, which requires convening a panel of medical experts for the purpose of judging a
With this in mind, we turn to Plaintiffs' specific allegations. Plaintiffs have alleged that Defendants negligently decided to purchase preservative-free MPA from NECC and also negligently failed to properly investigate and evaluate NECC's manufacturing procedures. The PCF asserts that these allegations are not covered by the MMA. We have little trouble concluding that the selection of preservative-free MPA — in particular, preservative-free MPA made by NECC — in favor of MPA with preservatives from other suppliers, were actions that involved the exercise of professional medical skill and judgment, i.e., they qualify as the practice of medicine.
We have observed that "[t]he practice of medicine may be said to consist in three things: First, in judging the nature, character, and symptoms of the disease; second, in determining the proper remedy for the disease; third, in giving or prescribing the application of the remedy to the disease." Fowler v. Norways Sanitorium, 112 Ind.App. 347, 42 N.E.2d 415, 420 (Ind.Ct.App.1942) (quoting Underwood v. Scott, 43 Kan. 714, 23 P. 942, 943 (1890)) (superseded by statute on other grounds as recognized by Sloan v. Metro. Health Council of Indpls., Inc., 516 N.E.2d 1104, 1106 (Ind.Ct.App.1987)). We conclude that the allegations in this case clearly fall under the second aspect of the practice of medicine — selection of the proper remedy.
As mentioned, MPA is injected into the lumbar spinal region of patients to relieve lower back pain. In Anonymous Clinic's case, the decision to administer preservative-free MPA was made by a physician, Dr. Kathryn Park, on the basis that preservatives can be neurotoxic. In OSMC's case, the decision to purchase preservative-free MPA from NECC was made by its medical board, which consisted of Dr. Gene Grove and other physicians on OSMC's board. Physicians at SMC determined that the preservatives in question could cause arachnoiditis and damage the spinal cord. Selection of preservative-free MPA clearly involved the practice of medicine.
We also conclude that the decision to purchase preservative-free MPA from NECC was an integral part of the remedy-selection process. For Anonymous Clinic, the decision to purchase from NECC was made by Dr. Park because NECC was, as far as she knew, the only supplier of preservative-free MPA; Anonymous Clinic had used other NECC products for years without problems; and NECC had a good reputation among other physicians. Put another way, Anonymous Clinic's medical decision to administer preservative-free MPA necessarily involved an evaluation of NECC's suitability as a supplier because it represented the only source known to the clinic. It is reasonable to assume that Dr. Park evaluated NECC's suitability in light of Anonymous Clinic's long-standing relationship with NECC and its reputation.
In the case of OSMC, the decision to source the MPA from NECC was also the result of a long-standing relationship. In 2005, OSMC began purchasing betamethasone and hyaluronidase from NECC after Elkhart General Hospital began ordering compounded pharmaceuticals from NECC. As it happens, in addition to being on the medical board of OSMC, Dr. Grove was chairman of the pharmacy and therapeutics board at Elkhart General and had become aware that the Elkhart General medical staff had authorized NECC as a supplier. The record reflects that OSMC's
2. Lack of Causal Connection
The PCF also contends that there is no causal connection shown in this case between the treatment of any individual patient and the exercise of medical judgment by any Defendants. The PCF's argument is apparently that the decisions by Defendants to purchase preservative-free MPA from NECC, even if they did involve the exercise of medical judgment, occurred years before any of Plaintiffs received their treatments and were therefore made outside the provider-patient relationship. This position would seem to be based on the proposition that only decisions made by providers with specific patients in mind can be subject to the MMA. The language of the MMA is not so restrictive. "`Health care' means an act or treatment performed or furnished, or that should have been performed or furnished, by a health care provider for, to, or on behalf of a patient during the patient's medical care, treatment, or confinement." Ind.Code § 34-18-2-13. Nothing in the
B. Policy Arguments
The PCF points out that, pursuant to the MMA, the total recovery in any malpractice action is $1,250,000 per injury or death. Ind.Code § 34-18-14-3(a)(3). Moreover, the MMA caps the health care provider's malpractice liability at $250,000 per occurrence. Ind.Code § 34-18-14-3(b). Amounts in excess of this are payable from the PCF upon petition. Ind. Code §§ 34-18-14-3(c), -15-3. Also, subject to certain terms and conditions,
Ind.Code § 34-18-6-6(a).
The PCF notes that OSMC faces approximately 100 individual claims while Anonymous Clinic faces approximately twelve individual claims. Assuming that Defendants are found liable for negligence following trial in all or many of these cases, the potential exposure could be significant. The PCF asserts that the General Assembly did not contemplate making the PCF the insurer of the safety of practically all products used in health care and suggests that a decision against it would subject it to strict liability in this and similar cases. The PCF further argues, essentially, that the allegedly increased potential liability it would face due to cases such as this would result in increased surcharges from healthcare providers to fund the PCF and jeopardize their ability to obtain affordable medical malpractice insurance.
Defendants counter that a determination that this case is governed by the MMA does not thwart but, rather, furthers the legislative intent. Defendants argue that the MMA was designed as a comprehensive medical liability insurance arrangement that struck a balance between ensuring both that (1) the patients injured by professional negligence receive at least some compensation and (2) health care providers can continue to provide affordable health care. Anonymous Clinic also argues that the PCF mischaracterizes Plaintiffs' claims as product liability and that the PCF would not be subject to strict liability for defective products used in medical care. OSMC also points out that a statutory mechanism, i.e., Indiana Code section 34-18-5-4, already exists for increasing the surcharge on health care provides to maintain the PCF's liquidity in the event of large payouts. In a nutshell, Defendants argue that even if the claims at issue in this case were to drain the PCF entirely, it is not this court's place to ensure the PCF's liquidity; this court's only job is to decide if the claims before it are governed by the MMA. To the extent that
The Defendants and Plaintiffs have the much more defensible position here, namely that ensuring the PCF's continued liquidity is not this court's job. If, pursuant to the MMA's plain language and under current precedent, the Plaintiff's claims should be governed by the MMA, we should rule as such, whatever the consequences. See, e.g., Ind. Dep't of Envtl. Mgmt. v. Chem. Waste Mgmt., Inc., 643 N.E.2d 331, 338 (Ind.1994) ("The General Assembly has decided to concentrate the State's energies on regulating commercial waste disposal facilities and it is not our job to second guess such decisions."). Even if we assume that the claims in this case will result in payouts sufficient to threaten the viability of the PCF (which is by no means a foregone conclusion), we are not free to ignore the law in an attempt to save it.
There is really only one issue before the court in this case, whether alleged negligence by a medical provider in selecting a certain drug from a particular supplier are claims subject to the MMA or sound in general negligence. Indiana law stands for the proposition that if allegations cannot be understood by laypersons without resort to expert testimony, the claims are governed by the MMA. We conclude the claims in this case, i.e., that Defendants were allegedly negligent in choosing to purchase and administer preservative-free MPA and in choosing NECC without proper vetting, are allegations that claim negligence in decisions that were made using professional expertise. Because we conclude that Plaintiffs' claims are governed by the provisions of the MMA, we affirm the judgment of the trial courts and remand for further proceedings consistent with this opinion.
We affirm and remand for further proceedings.
PYLE, J., and ALTICE, J., concur.
Amici, who are health care providers and defendants in several cases involving defective MPA, note that the U.S. District Court for the District of Massachusetts ("the MDL Court") is currently overseeing multi-district litigation ("MDL") from jurisdictions nationwide involving steroids made by NECC in In re: New England Compounding Pharmacy, Inc., Products Liability Litigation, No. 1:13-md-02419 (D.Mass.). The MDL Court has dismissed claims regarding defective MPA under other states' laws. As with Casko and Dove, however, the plaintiffs' claims in those cases are all claims of products liability, unlike the negligence claims brought in this case. Consequently, the MDL Court's reasoning is no more helpful in this case than the courts' reasoning in Casko and Dove.
Finally, the Amici have compiled a table of cases in their brief from other jurisdictions addressing the question of whether the delivery of a product in the context of medical treatment can support a products liability claim or whether the claim is one of medical malpractice. The Amici note that twenty-three of twenty-five jurisdictions to consider the question have determined the claim before it to be one of medical malpractice and not products liability. Suffice it to say that, as with Casko, Dove, and the decisions rendered by the MDL Court, all of the holdings rely on the concept that medical treatment is primarily a service and not a sale of products and do not address negligence theories of the type brought in this case.