The following guest post about a couple of recent generic preemption opinions is written by Dylan Carson & Avril Love, of Tucker Ellis & West (a firm headed by Bexis' old Bone Screw compatriot Bob Tucker). They get all the credit and or blame as the case may be for what follows
The start of the pro football season reminds us of the old adage, attributed to Vince Lombardi, that the best defense is a good offense. (Especially when watching Tom Brady and our beloved Patriots put up video game numbers on offense while the defense does its best to allow the same pinball numbers by the other side).
That adage comes to mind in two recent rulings out of the Northern District of Georgia, which dismissed an eight-count products liability complaint against two generic pharmaceutical manufacturers based on the one-two punch of TwIqbal and Mensing. See Henderson v. Sun Pharmaceuticals Indus., Ltd., No. 4:11-cv-00060-HLM, 2011 WL 4024656 (N.D.Ga. Jun. 9, 2011); Henderson v. Sun Pharmaceuticals Indus., Ltd., No. 4:11-cv-00060-HLM, 2011 WL 4015658 (N.D.Ga. Aug. 22, 2011). Yes, that’s more scores for the TwIqbal Cheat Sheet and Post-Mensing Generic Drug Preemption Scorecard.
In Henderson, Plaintiff alleged that he took several generic anticonvulsant medications (phenytoin and fosphenytoin) manufactured or distributed by the various defendants and that, as a result, he sustained severe skin reaction, Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Plaintiff brought claims for (1) failure-to-warn, (2) strict liability, (3) fraud, (4) breach of warranties, (5) negligence, (6) gross negligence, (7) joint and several liability, and (8) punitive damages. Boiled to its essence, this was a failure-to-warn case about generic medication.
Confronted with the complaint, the defendants went on the offensive. One generic manufacturer, Caraco, threw long, taking aim at every cause of action. The other generic, Mylan, looked only for a short gain, moving to dismiss only the fraud and breach of warranties claims.
In his first order, Judge Murphy winnowed down the allegations in the complaint, dismissing without prejudice all but the failure to warn and joint and several liability claims. On the warnings claim, the court found a plausible claim that the defendants failed to warn plaintiff’s doctors of a risk of SJS/TEN from the medications. Fair enough, but plausibility stopped there. The court TwIqballed the claims for strict liability, negligence, and punitive damages. Plaintiff had not alleged: "any specific design or manufacturing defect"; "a specific list of injuries"; whether the defendants were manufacturers, distributors, suppliers or sellers of the product at issue; whether any specific product caused his injuries or contained a defect; or "the causal connection between the breaches [of duty] and Plaintiff's injuries.”
Particularly useful for those of us who see boilerplate complaints with scant facts about a plaintiff's injuries is the court's note that “the Complaint lists every possible side effect of phenytoin and alleges that Plaintiff 'suffered serious bodily injury including, but not limited to' those side effects.” 2011 WL 4024656 at *8. "Such general, conclusory allegations, devoid of any specific, factual content to support the legal conclusions, are plainly insufficient under Iqbal." Id. at *5. The court also held that Plaintiff's "general, conclusory allegations" regarding punitive damages - basically a recitation of the elements - were insufficient without "any factual support for those allegations." Id. at *8.
The court picked off the fraud claim for failure to plead with particularity, relying on the Eleventh Circuit's requirement to "plead the who, what, when, where, and how of the allegedly false statements." Id. at *6. In so doing, the court distinguished a contrary ruling in a similar phenytoin SJS/TEN case, which involved only one defendant – Mylan (Gainer v. Mylan Bertek Pharmaceuticals, Inc., Civil No. 09-690 (JNE/JSM), 2010 WL 2519988 (D. Minn. June 15, 2010). In Gainer, that district court had found sufficient fraud allegations in a one-defendant case, but the Henderson court required more specificity when multiple defendants and multiple products were involved. (Flagged for too many men on the field?)
The court also disposed of the breach of warranties claim based on Georgia's requirement for privity between the parties. Because Plaintiff alleged to have purchased medications from retailing pharmacies, not the pharmaceutical defendants, there was no privity. Some states have a food and drug exception to the privity requirement when warranties are involved; Georgia is not one of them.
With two counts surviving the initial blitz, the court dismissed the remaining claims without prejudice, allowing Plaintiff to draw up a new offensive strategy, er, complaint. Two weeks after the court’s first order, however, the Supreme Court decided the Super Bowl, Pliva, Inc. v. Mensing. It is hard to score points against generics with a failure-to-warn game plan in a post-Mensing world.
Within days of the Mensing decision, Caraco’s parent, Sun Pharmaceuticals, moved to dismiss the remaining failure-to-warn and joint and several liability claims on preemption grounds. Plaintiff moved for leave to file an amended complaint with just four counts: (1) strict liability, (2) negligence, (3) joint and several liability, and (4) punitive damages. The amended complaint dropped the failure-to-warn claim and Plaintiff opposed the new motion to dismiss, arguing that the amended complaint would make it moot. The defendants responded that the amended complaint did not address the failures of the original, and that amendment would be futile. The court agreed.
The court first evaluated Plaintiff's motion to amend, finding that, although it contained “some more detailed allegations,” it failed to state a claim and that amendment would thus be futile. Plaintiff had added allegations about regulatory action suggesting product failures and manufacturing compliance problems, but these allegations were not specific to a phenytoin or fosphenytoin product, nor did they “provide a causal link between any manufacturing or design defect and SJS....” 2011 WL 4015658 at *4. This failure to allege a causal link was a fatal short-coming in the strict liability and negligence claims, so Plaintiff's proposed derivative claims for punitive damages and joint and several liability were insufficient as well. Id. at *5.
Because the court found that amendment would be futile (and denied Plaintiff's motion for leave to amend), the original complaint's two surviving claims remained. Thus, the court evaluated the new motion to dismiss and found that Mensing barred the remaining failure-to-warn claim against all the generic defendants. Because Plaintiff was arguing that the labeling was inadequate under state tort law, not that the label was inconsistent with the branded product’s warnings, the claim was preempted. “[T]his is exactly the type of state tort failure to warn claim that the Mensing Court found was preempted...” Id. at *7.
After Plaintiff turned it over on downs, the court will still allow a future Hail Mary. Despite Mensing and a tough uphill battle attacking the defective design of an FDA-approved medication, the court dismissed without prejudice, noting that it could not “find that it would be impossible for Plaintiff to state a claim against any Defendant.” Id. at 7 n.7. So in the end, as Vince Lombardi might say, Plaintiff didn’t lose the game; he just ran out of time.