Pennsylvania’s bar on strict liability claims for prescription drugs shaved two claims from a woman’s case against a mesh manufacturer in federal court.
U.S. District Judge Joel Slomsky of the Eastern District of Pennsylvania looked to both state and federal courts’ treatment of that standard—which have not always ruled in concert—in deciding that it would extend to Gayle Terrell’s claims for strict liability based on an alleged manufacturing defect and for breach of implied warranty of merchantability of the Marlex mesh that was surgically implanted to treat a hernia and had to be removed almost 20 years later after years of medical complications.
Referring to the applicable section of the Restatement (Second) of Torts and the 1996 Pennsylvania Supreme Court case—Hahn v. Richter—that established the bar on strict liability claims for prescription drugs, Slomsky said, “In this case, to overcome the Section 402A bar on strict liability claims for prescription medical devices, plaintiff contends that Hahn does not prevent strict liability claims based on manufacturing defects. This court does not agree. Although federal courts are currently split on this issue of whether Section 402A applies to medical devices, and some allow strict liability claims to proceed when a manufacturing defect is alleged, the decisions of these courts predate Lance.”
That case, Lance v. Wyeth, was decided by the Pennsylvania Supreme Court in January and made clear that the court wouldn’t allow strict liability claims based on a defective prescription drug, Slomsky said.
While the state’s high court hasn’t ruled specifically on whether the bar to strict liability for prescription drugs applies equally to medical devices, the Pennsylvania Superior Court ruled in its 2006 opinion in Creazzo v. Medtronic that it does.
“In accordance with Pennsylvania law, federal district courts have held that in the case of prescription drugs and devices, strict liability claims based on all three defective conditions, including manufacturing defects, are barred in Pennsylvania,” Slomsky said. He cited to half-a-dozen opinions from various district courts in a footnote.
The judge leaned especially on a 2004 opinion from the Western District of Pennsylvania, which referred to the comment included in the restatement that addresses the inherent danger in some products, particularly prescription drugs. That opinion, in a case called Parkinson v. Guidant, said, “While comment K precludes strict liability, it does contain the following two caveats for unavoidably unsafe products: ‘Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.’ However, the Pennsylvania Supreme Court has ruled that Section 402A strict liability is precluded entirely for prescription drugs, and, presumably by extension, prescription medical devices. Instead, the caveats in comment K are to be evaluated under negligence not strict liability principles.”
Looking again to the state Supreme Court’s Lance opinion from January, Slomsky said the court “reiterated the principle that a strict liability claim based on a defective prescription drug is barred.”
“In explaining this principle, the court did not exempt from this bar a claim based on a manufacturing defect. Based on the above, this court predicts that the Supreme Court of Pennsylvania would come to the same conclusion with respect to defective medical devices,” the judge said.
Slomsky’s treatment of the breach of implied warranty of merchantability claim took a similar route.
“This court recognizes that just as federal district courts are split regarding strict liability claims based on defects in the manufacture of prescription drugs, there is also a split in authority on the applicability of breach of implied warranty of merchantability claims based on defects in the manufacture of medical devices,” he said.
“Needless to say, plaintiff would have this court hold that the breach of an implied warranty of merchantability claim is a viable cause of action under Pennsylvania law, ‘to the extent [that it is] based on a manufacturing defect,’” Slomsky said. “Once again, this court does not agree with plaintiff’s position.”
He cited the Pennsylvania Superior Court’s 1987 opinion in Makripodis v. Merrell-Dow, which ruled that claims for breach of implied warranty regarding prescription drugs should be handled the same way as claims for strict liability.
“Although the Pennsylvania Supreme Court has yet to rule on the viability of a breach of implied warranty of merchantability claim for prescription drugs or medical devices, many federal courts have followed the approach in Makripodis and dismissed breach of implied warranty of merchantability claims for much the same reason that strict liability claims are precluded,” Slomsky said.
The judge remarked on the uncertain status of products liability law in Pennsylvania in a footnote, explaining that the U.S. Court of Appeals for the Third Circuit has several times predicted that the state Supreme Court would adopt the Restatement (Third) of Torts, although that court has yet to do so. It heard arguments on that issue last fall in a case called Tincher v. Omega Flex, but it hasn’t yet issued an opinion.
“In the event that the Pennsylvania Supreme Court adopts the strict liability analysis of the Restatement (Third) of Torts, this court will entertain a motion for reconsideration if either party concludes that the result would be different,” Slomsky said in the footnote.
Michael Anthony Bowman of Bowman & Partners in Philadelphia represented Terrell and said, “We don’t agree that Pennsylvania is where the court says it is,” but he wants to move ahead with the two negligence claims that survived.
Amy M. Vanni of Reed Smith represented C.R. Bard Inc., the manufacturer of the mesh, and couldn’t be reached for comment.
(Copies of the 18-page opinion in Terrell v. C.R. Bard, PICS No. 14-1196, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •