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From Health Law Daily, July 11, 2013

Product liability claims to proceed against surgical mesh manufacturer for design defect

By Michelle L. Oxman, JD, LLM

Ethicon, Inc., maker of the Prolene surgical mesh (Prolene), must defend claims for negligence, breach of express warranty, and fraudulent misrepresentation concerning the design of its device (Shelley v Ethicon, Inc., July 9, 2013, DuBois, J). However, the court dismissed claims for strict liability and breach of implied warranties because state law does not recognize strict liability for design defect claims.

Claims against Johnson & Johnson. Shelley sued both Ethicon, Inc. and Johnson & Johnson, its parent company. Johnson & Johnson moved to dismiss the claims against it on the ground that it was a holding company and was not involved in the design, manufacture, or marketing of the device. It submitted an affidavit of a corporate officer and asked that the court grant it summary judgment. However, the court denied the motion because the parties had not engaged in discovery, so no factual record had been developed.

Strict liability claims. Plaintiff alleged claims for breach of the implied warranty of fitness and for strict liability based on the defective design and failure to warn of the dangers of the Prolene product. The courts of Pennsylvania have followed the Restatement (Second) of Torts, which requires proof of negligence in design defect claims. Therefore, the court dismissed these claims. However, the court noted that the Pennsylvania Supreme Court had announced that it would consider adoption of the strict liability theories under the Restatement (Third). Therefore, the court would reconsider the motion if the parties believed the result would be different under the Restatement (Third) analysis.

Breach of warranty and fraud claims. Shelley’s complaint alleged breach of express warranties and fraudulent misrepresentation in addition to negligence and strict liability. The allegations stated a claim under Pennsylvania law; therefore, the motion to dismiss was denied.

Negligence claims. The plaintiff alleged that she was injured because of the negligent design and insufficient warnings of the dangers of the surgical mesh and that the manufacturers made false representations as to the safety of the product. The court ruled that the allegations were sufficient to state claims under Pennsylvania for negligent design and negligent misrepresentation.

The case number is 12-6862.

Attorneys: David F. Abernethy (Drinker Biddle & Reath LLP) for Ethicon, Inc. and Johnson & Johnson.

Companies: Ethicon, Inc.; Johnson & Johnson

MainStory: TopStory PLDeviceNews MDeviceNews PennsylvaniaNews

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