Michigan Strikes Back . . . In Pennsylvania

by Reed Smith
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A (relatively) long time ago in a state not so far away, the Michigan Legislature enacted the Michigan Product Liability Act.  It contained a provision providing the manufacturers of FDA-approved drugs with immunity from product liability absent the application of two narrow exceptions.  A challenge to the constitutionality of the provision soon followed and the Michigan Supreme Court, in Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003), basically said the legislature can enact a law like that and the immunity on drug manufacturers was as broad as it seemed.  (This guest post provides a nice history.)  Other decisions followed, like Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), and Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008), coming down on opposite sides of the issue of whether the first exception—the defendant “before the event that allegedly caused the injury . . . intentionally withholds from or misrepresents to [FDA] information concerning the drug that is required to be submitted” under the FDCA that would have prevented original or continued approval—runs into Buckman preemption.  What also followed was that Michiganders who wanted to sue over alleged drug started to go elsewhere.  (Not to galaxies several parsecs—a unit of distance, not time—away, but just to other states.)  They did so because they hoped that the immunity in § 600.2946(5) would not follow them.

We have called this phenomenon the Michigan diaspora, and, while the dispersal of the Michigan litigation tourists is merely temporary, their cases do keep popping up in some likely spots.  Just last month, we discussed how West Virginia state courts have applied Michigan law to the claims of Michiganders hoping to find more plaintiff-friendly law.  We have also discussed how the claims of Michiganians claiming gynecomastia from Risperdal have fared in the Philadelphia Court of Common Pleas, a jurisdiction that has seen plenty of action in that particular litigation.  We praised the court’s application of the Michigan statute to bar the claims.  The plaintiffs in that case appealed to the Superior Court of Pennsylvania, which has reversed more than a few defense rulings we have liked.  Instead In re Risperdal Litig., __ A.3d __, 2017 WL 5712521 (Pa. Super. Nov. 28, 2017), respected the force of the Michigan Legislature’s clear enactment and affirmed.

On appeal, the plaintiffs agreed that Michigan law applied, but argued that the statute provided no protection where the use was off-label.  When the plaintiffs (actually all but one of them) were prescribed the drug it had been approved but did not yet have an indication for use in juveniles, which they were at the time.  The statute, however, hinged on whether “the drug was approved for safety and efficacy,” not whether the particular indication had been approved.  Federal courts had followed “the plain language of the statute” and found off-label use was irrelevant to the application of immunity as long as the drug was approved.  2017 WL 5712521, **5-6.  “Thus, we conclude that as long s a drug has received approval, and its label is compliant with FDA regulations, the MPLA applies to bar any product liability claim, despite the drug’s indicated uses.” Id. at *6.

Next, plaintiffs argued that they had enough evidence to raise a genuine issue as to the statutory exception based on a fraud on the FDA.  Defendants claimed that any attempt to meet the exception would be preempted because the FDA had never found such a fraud.  The Superior Court did not take the opportunity to add to either side of the preemption ledger because plaintiffs did not have the evidence they needed anyway. Id. at *7.  The statute did not just require any fraud on FDA, but a withholding of information such that its proper submission would have meant “the drug would not have been approved” or FDA “would have withdrawn approval for the drug.”  Plaintiffs argued that their evidence of purported fraud was relevant to the approval of the additional indication for juvenile use, but they never contended that the drug would not have been approved or would have been withdrawn.  “[T]he proof of fraud a plaintiff is required to present in order to receive the benefit of the fraud exception must relate to the initial FDA approval.” Id. at *8.  Given that FDA had denied a citizen’s petition in 2014 that requested the drug be withdrawn, it was clear that any purported fraud related to the application to add the juvenile use indication almost a decade earlier was insufficient to trigger the exception. Id. We all know Yoda famously said “Do or do not.  There is no try.”  Here, plaintiffs tried and tried again, but they did not get around the statutory immunity despite their sojourn to Pennsylvania.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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