PENNSYLVANIA RECORD

A federal judge in Philadelphia has refused to dismiss Johnson & Johnson as a defendant

from a lawsuit initiated by a woman who claims she sustained injuries due to an allegedly defective surgical mesh product.

U.S. District Jan DuBois, of the Eastern District of Pennsylvania, disagreed with J&J’s claim that it should be dismissed from litigation filed against it and Ethicon Inc. by Ramona Shelley because, as J&J asserted, the defendant is merely a holding company that doesn’t “design, develop, manufacture, market, promote or sell any product.”

Johnson & Johnson had argued that it did not manufacture the Prolene TM soft mesh device that allegedly caused the plaintiff complications, and that it therefore owed no duty of care to Shelley.

The company sought to have all claims against it dismissed. Additionally, J&J cited a declaration by company secretary Douglas K. Chia that sought to convert certain portions of the dismissal motion into a motion for summary judgment.

DuBois viewed things differently.

“The Court rejects defendants’ argument with respect to Johnson & Johnson,” the judge wrote in his July 9 memorandum and order. “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 ruled that making factual determinations at this point in the litigation would be inappropriate.

The plaintiff did, in fact, state a plausible claim for liability on the part of Johnson & Johnson in her complaint, the judge wrote.

The defendants had also sought to dismiss the remainder of the complaint’s non-negligence claims for failure to state a claim upon which relief can be granted under Pennsylvania law.

The additional counts in the lawsuit were for strict liability–product defect, strict liability–failure to warn, breach of express and implied warranties, and fraudulent misrepresentation.

Addressing the claims one by one, DuBois agreed with the defense’s argument that the two strict liability counts should be dismissed, citing a Pennsylvania Supreme Court ruling that determined state law does not recognize a strict liability claim based on a design defect or failure to warn as a “viable cause of action against a manufacturer of prescription drugs or devices …”

The state’s high court had previously determined that “where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturers’ negligence, is the only recognized basis of liability,” according to the federal court memorandum.

Accordingly, DuBois dismissed both strict liability claims with prejudice.

The judge, however, allowed the breach of express warranty claim to move forward, writing that such a claim is permitted under Pennsylvania law.

DuBois did side with the defense in its bid to have the breach of implied warranty claim tossed, although the judge did so without prejudice.

The complaint doesn’t specify whether there was a claim of breach of the implied warranty for merchantability or a breach of the implied warranty of fitness for a particular purpose, the memorandum states, but regardless of this fact, both claims are not cognizable under Pennsylvania law to the extent that they are based on a design defective or failure to warn.

They are, however, permissible if based on a manufacturing defect or any other theory, DuBois noted.

In the Shelley case, the judge stated, the breach of warranty claim appears to be based on a claim of design defect, since the lawsuit asserts that the mesh product was unsafe for its intended use because it had “very dangerous propensities” when put to its intended use and once implanted inside a person’s body would cause “serious injuries to the user.”

DuBois dismissed this claim without prejudice, which enables the plaintiff to file an amended complaint containing more specific allegations.

Lastly, DuBois denied the defendant’s motion to dismiss the fraudulent misrepresentation claim, which J&J said should be tossed because it isn’t based on a theory of negligence.

The courts have found fraud claims concerning prescription medical devices cognizable if they contain allegations of “overt acts,” such as affirmative misrepresentations, “that go beyond a mere failure to warn,” DuBois wrote.

“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,” he stated. “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.”