A federal judge in the Middle District of Pennsylvania has joined a counterpart in the Eastern District in opening a window for plaintiffs to make a claim for strict liability against prescription drugmakers on a manufacturing defect theory.
Despite developing case law in the opposite direction, U.S. District Judge Malachy Mannion of the Middle District of Pennsylvania ruled that Ryan Bergstresser could bring a strict liability manufacturing-defect claim against Bristol-Myers Squibb over its antipsychotic drug, Abilify.
However, Mannion also held that Bergstresser hadn’t pled with sufficient factual specificity to meet the standard set in Ashcroft v.Iqbal and Bell Atlantic v.Twombly.
Bergstresser will be allowed to file an amended complaint, the judge said. He alleges that he suffered from dystonia, which is characterized by involuntary muscle contractions, after his psychiatrist increased his dosage of Abilify, according to the opinion.
"Any strict liability claim brought by the plaintiff for failure to warn or design defect are barred by Hahn and its progeny," Mannion said, referring to the Pennsylvania Supreme Court’s 1996 opinion in Hahn v. Richter, which closed off the option for plaintiffs to pursue strict liability for failure to warn against prescription drugmakers.
Clarifying the Hahn ruling, the Pennsylvania Superior Court issued an opinion in 2010 explaining that the Supreme Court’s precedent would similarly foreclose plaintiffs’ ability to make design defect claims in strict liability. That opinion was captioned Lance v. Wyeth.
However, that still leaves the third type of defect that Pennsylvania law recognizes as giving rise to a strict liability claim — manufacturing defect.
"To the extent that the plaintiff attempts to bring a strict liability claim based upon a manufacturing defect, this claim would not be barred," Mannion ruled in Bergstresser v. Bristol-Myers Squibb.
He read the courts’ silence on manufacturing defect claims as leaving them open for plaintiffs to bring, as did U.S. District Judge William H. Yohn of the Eastern District of Pennsylvania in Doughtery v. C.R. Bard last year.
"Although Pennsylvania law does not recognize a strict liability claim based on a design defect or a failure to warn as a viable cause of action against a manufacturer of prescription drugs or devices, Pennsylvania law does not preclude a strict liability claim based on a manufacturing defect," Yohn said in his July 2012 opinion.
Mannion noted that several state and federal courts in Pennsylvania have interpreted the Hahn ruling as broadly barring all non-negligence-based claims brought against prescription drugmakers, but he read previous courts’ rulings differently and held similarly to Yohn.
Tagging along with the design defect claim was a cause of action for breach of implied warranty.
Mannion quoted the Doughtery opinion, explaining, "The theories of strict liability and breach of the implied warranty of merchantability are parallel theories of recovery, one in contract and the other in tort."
So, Mannion said, "any claim by the plaintiff under a theory of breach of the implied warranty of merchantability or breach of the implied warranty of fitness for a particular purpose would be barred under Pennsylvania law to the extent that they are based on a design defect or failure to warn, but would be allowed if based on a manufacturing defect."
But, as was the case with the earlier claim, Mannion ruled that Bergstresser hadn’t sufficiently pled the case.
Michelle Hart Yeary, a defense attorney in products liability and mass torts in Dechert’s Princeton, N.J., office, summed up Mannion’s recent contribution to the thrust of strict liability in manufacturing defect for prescription drugmakers this way: There is significant precedent going in the opposite direction, but there are now two federal judges who are chipping away at courts’ across-the-board reading of Hahn‘s restriction on strict liability claims. Yeary isn’t involved in the Bergstresser case.
Edwin Abrahamsen Jr. of Abrahamsen Conaboy & Abrahamsen in Scranton, who is representing the plaintiff, couldn’t be reached for comment.
Daniel Pariser of Arnold & Porter in Washington, D.C., who is representing Bristol-Myers Squibb, referred questions to Jennifer Mauer, a spokeswoman for the pharmaceutical company. Mauer declined to comment.
(Copies of the 14-page opinion in Bergstresser v. Bristol-Myers Squibb, PICS No. 13-1027, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •