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Eastern District of PA Dismisses Liability & Warranty Claims for Medical Device, Predicating Decision on State Lower Court Opinions

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In its recent decision, Terrell v. Davol, Inc., et al., the Eastern District of Pennsylvania dismissed both a strict liability claim based on a manufacturing defect and a claim alleging a breach of the implied warranty of merchantability for a medical device.  In doing so, the Court reaffirmed state court extensions of protections for prescription drugs to medical devices. 

The plaintiff in this matter underwent bilateral ventral hernia repair surgery using Marlex Mesh in 1996.  Following her surgery, the plaintiff experienced years of abdominal complications that physicians did not link to the mesh until 2011.  Finally, during an exploratory surgery, her surgeons discovered that the mesh had adhered to her abdominal wall.  Surgeons removed the plaintiff’s appendix and resected part of her bowel in order to remove as much of the mesh as possible.  Parts of the mesh had adhesed so densely with the patient’s abdomen that not all of it could be removed. 

After learning the root of her medical issues, the plaintiff sued the manufacturers in federal court, alleging that the mesh was “unreasonably susceptible to shrinkage and contraction inside the body” and that prolonged tension allowed the mesh to become deformed.  Defendants maintained that despite its risks, Marlex mesh was both safe and reliable.  The plaintiff’s complaint included, among others, counts for strict liability based on manufacturing defect and a breach of the implied warranty of merchantability.  The Court held that Pennsylvania law bars both these claims. 

Although the state Supreme Court and the Federal Court do not always see eye to eye in product liability cases, U.S. District Judge Joel Slomsky relied on the Pennsylvania Supreme Court’s 2014 ruling in Lance v. Wyeth, which declined to extend strict liability to the prescription drug arena to avoid stifling “the incentive to produce new products.”  Lance thus propagated the Supreme Court’s original holding in Hahn v. Richer, which originally established this strict liability ban based on the Restatement (Second) of Torts.  The Pennsylvania Supreme Court has not yet explicitly ruled whether this prohibition includes medical devices; however, Judge Slomsky noted that the state Superior Court held in 2006 that it does.  In turning to the Western District of Pennsylvania, Judge Slomsky quoted the 2004 case Parkinson v. Guidant Corp., which discussed the caveats contained in comment K of Section 402A of the Restatement concerning unavoidably unsafe products.  In Parkinson, the Western District held, “the Pennsylvania Supreme Court has ruled that §402A strict liability is precluded entirely for prescription drugs, and, by extension, prescription medical devices.”  Judge Slomsky similarly permitted this extension for medical devices and dismissed plaintiff’s strict liability claim.

Likewise, Judge Slomsky pointed to several cases to hold that Pennsylvania law also bars claims based on the implied warranty of merchantability.  Generally, purchased goods include an implied warranty that the goods will be fit for their intended use.  Judge Slomsky noted that the Pennsylvania Supreme Court had also not yet ruled whether this implied warranty extended to medical devices, but that federal courts had followed an approach set forth in Makripodis v. Merrell-Dow.  The 1987 Pennsylvania Superior Court ruling in Makripodis held that prescription drugs should be exempt from the implied warranty of merchantability for the same reasons they were exempt from strict liability claims.  Judge Slomsky looked to the progeny of Makripodis and its treatment in federal courts to predict, “the Supreme Court of Pennsylvania would come to the same conclusion with respect to medical devices.” 

Despite having two of her claims dismissed, Judge Slomsky allowed the plaintiff’s claims for negligent manufacturing and negligent failure to warn as they were sufficiently pled.


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