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Plaintiffs claiming they were injured by steroid injections are not entitled to summary judgment on their state or federal prescription-law claims, the Court of Appeals of Indiana has ruled.
Over a decade ago, several patients in St. Joseph and Elkhart counties were injured, and some died, after being given injections of preservative-free methylprednisolone acetate, or MPA, a steroid purchased from New England Compounding Pharmacy.
Over a hundred people affected filed a lawsuit. In 2016, the appellate court ruled that the plaintiffs’ claims against an anonymous clinic and the defendants were subject to provisions of the Indiana Medical Malpractice Act.
Then in 2018, the plaintiffs moved for preliminary determination/partial summary judgment on their prescription-law claims before the St. Joseph and Elkhart Superior Courts. Both trial courts denied the partial summary judgment motions and found the cases first had to be presented to medical-review panels.
The MPRs led to the filing of a motion for preliminary determination by ASC Surgical Ventures LLC in Elkhart County and a joint motion in St. Joseph County.
The trial courts reached different conclusions.
In St. Joseph County, the judge found the plaintiffs’ claims of prescription-drug-law violations by the anonymous clinic should be presented to the MRPs in each case and rejected its preemption argument.
Conversely, the Elkhart County judge denied the plaintiffs’ motion for partial summary judgment and found that they were asserting fraud on the Food and Drug Administration, which was preempted by the federal Food, Drug, and Cosmetic Act. It also found that the plaintiffs’ negligence per se claims based on ASC’s violations of Indiana’s Food, Drug, and Cosmetic Act were preempted.
The St. Joseph County court found Sherrow v. GYN, Ltd., 745 N.E.2d 880 (Ind. Ct. App. 2001), did not preclude the parties from discussing the prescription-drug-laws in their MRP submissions. However, the Elkhart County court ruled the opposite.
On appeal, the COA affirmed the judgment of the Elkhart County court in its entirety but reversed the St. Joseph County court.
“Because Plaintiffs cannot establish that Defendants’ alleged statutory violations caused their injuries or, indeed, that Defendants have violated any federal or state prescription-drugs law whatsoever, any questions regarding negligence per se and preemption are moot,” Judge Cale Bradford wrote. “Even if we were to assume that an MMA plaintiff could discuss allegations of statutory violations in the MRP under certain circumstances (a question we leave for another day), Plaintiffs certainly cannot continue to press those claims in this case.”
The COA first addressed ASC’s argument that the plaintiffs failed to establish that any alleged violations of federal or state law caused their injuries.
“While we conclude that Plaintiffs cannot establish any causal connection between Defendants’ alleged statutory violations and Plaintiffs’ injuries, we nonetheless elect to address their specific allegations,” Bradford wrote.
Turning next to the federal law claims, the appellate court determined the plaintiffs “failed to establish any violations of FDCA labeling provisions.”
“Any suggestion that the FDCA required Defendants to provide additional information to (the New England Compounding Center) in connection with its MPA orders or to the patients to whom it was administered is entirely unsupported by any FDCA provision,” Bradford wrote.
Finally, as to the state-law argument, the COA noted, “It is undisputed … that NECC never distributed any MPA to any patients, only to medical providers like Defendants.”
“While it is true that Defendants would have had to issue a prescription to NECC in order for NECC to deliver or administer MPA to a patient, that has nothing to do with this case because all agree that NECC never delivered or administered MPA to any Plaintiff, Defendants did,” Bradford wrote.
The case was remanded in St. Joseph County was instructions to enter summary judgment in favor of the defendants on the plaintiffs’ federal and state prescription-law claims.
“This opinion has no effect on Plaintiffs’ ability to proceed with their MMA claims as they see fit; they may not, however, continue to pursue their allegations of statutory violations or mention them in the MRPs,” Bradford concluded.
The case is Joe Alcozar, et al. v. Orthopedic & Sports Medicine Center of Northern Indiana, et al., 22A-CT-909.
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