Hernia Patient Can Go After Johnson & Johnson

(CN) - Johnson & Johnson and Ethicon must face claims that their Prolene surgical mesh injured a woman being treated for hernia, a federal judge ruled.

Ramona Shelley filed suit in the Eastern District of Pennsylvania, seeking relief for injuries allegedly caused by an implanted surgical Prolene TM mesh manufactured and distributed by Johnson & Johnson and its Somerville, N.J.-based subsidiary, Ethicon, for use in repairing ventral hernias.

The complaint asserts claims for negligence, strict liability for product defect and failure to warn, breach of express and implied warranty, and negligent and fraudulent misrepresentation.

Johnson & Johnson and Ethicon moved to dismiss certain claims for failure to state a claim, but U.S. District Judge Jan DuBois preserved many last week.

In a declaration to the court, Johnson & Johnson secretary Douglas Chia said his Fortune 500 employer is merely "a holding company that does not design, develop, manufacture, market, promote or sell any product."

DuBois brushed aside the argument, noting that it "requires conversion of certain portions of defendants' motion to one for summary judgment."

"The parties have not conducted any discovery, and as such, treatment of the instant motion as one for summary judgment would be inappropriate at this stage in the litigation," DuBois wrote. "Accordingly, the court does not consider the declaration submitted by defendants. Further, 'at this early stage, factual determinations [as to corporate status] are not appropriate.'" (Brackets in original.)

Shelley cannot pursue strict liability claims, however, with DuBois noting that the Pennsylvania Supreme Court's 1996 ruling in Hahn v. Richter holds that "the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer's negligence, is the only recognized basis of liability."

"Hahn has been broadly applied to both prescription drugs as well as prescription medical devices," DuBois wrote. "Thus, '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.'"

Shelley's implied warranty claim for defective design is additionally not cognizable for relief under Pennsylvania law, DuBoid found, citing the 2012 decision in Tatum v. Takeda Pharmaceuticals N. Am. Inc.

"Count V appears to be based on a claim of design defect," DuBois wrote. "It avers that the Prolene TM soft mesh were 'unsafe for their intended use ... in that they had very dangerous propensities when put to their intended use and implanted into the patient's body and would cause serious injuries to the user.' Accordingly, defendants' motion on this ground is granted, and Count V is dismissed without prejudice to plaintiff's right to file an amended complaint consistent with this order if warranted by the facts."

Shelley's claims for breach of express warranty and fraudulent misrepresentation will advance.

"In this case, plaintiff avers that defendants made affirmative misrepresentations concerning the testing of Prolene TM soft mesh, the history of their use, and the risks and benefits of their use," DuBois wrote. "By alleging such affirmative misrepresentations on the part of defendants, plaintiff has stated a claim for fraud and defendants' motion on this ground is denied."

Johnson & Johnson's revenue reportedly totaled more than $65 billion in 2012.

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