Products Liability Law Daily Wrap Up, PREEMPTION—MEDICAL DEVICES—D. S.C.: Suit alleging defective injectable gel dermal fillers dismissed because parallel claim was deficiently plead, (Jan 14, 2014)

By John W. Strzelecki, J.D.

A product liability parallel claim for defective injectable gel dermal fillers did not identify the federal requirement applicable to the devices with which it allegedly failed to comply and did not explain how that violation caused the injury; consequently, the claim was dismissed by a U.S. District Court in South Carolina. (Wells v. Allergan USA Inc., January 13, 2014, Cain, T).

Background. Suzy Wells (Wells) filed a product liability suit in state court, alleging that Allergan USA Inc. and Medicis Aesthetics, Inc. (Allergan) manufactured, distributed, and sold medical devices that were defective, unreasonably dangerous, and failed to contain adequate warnings when, after using the defendants’ products, she suffered an immune system reaction that produced lesions in her lips and Lyme-disease-like symptoms. The products were injectable gel dermal fillers.

Allergan removed the suit to federal court and moved to dismiss on the grounds that the claim was preempted by federal law and that, even if not preempted, Wells failed to state a claim properly. Wells amended the complaint and Allergan again moved to dismiss on the same grounds as before.

Preemption. The Court noted that generally the Food and Drug Administration (FDA) retains exclusive enforcement authority over the manufacturers pursuant to the applicable law involved which was the Federal Drug & Cosmetic Act (FDCA). While individuals may report wrongdoing and petition the FDA to take action, Congress has made clear that there is no private right of action under the FDCA and that all actions to enforce the statute must be brought by the government.

Parallel claims. However, according to the court, there is one narrow exception to the general rule. Plaintiffs may bring claims directly against device manufacturers if the state law claims parallel federal law, i.e., do not impose requirements that are different from, or in addition to, those already imposed on the manufacturers by federal law. The court pointed out that a well-pleaded parallel claim must at least (1) identify the federal requirement applicable to the device with which it allegedly failed to comply and (2) explain how that violation of a federal requirement caused the plaintiff’s injury. Since Wells failed to meet this standard in the pleading, the case was dismissed (without prejudice). The court also refused to lower the standard and allow the case to move to discovery.

The case number is 6:12-3509-TMC.

Attorneys: William Ashley Jordan (William A. Jordan Law Office) for Suzy Wells. Marvin Quattlebaum, Jr. (Nelson Mullins Riley and Scarborough) for Allergan USA, Inc. Jay P Lefkowitz (Kirkland and Ellis) for Medicis Aesthetics Inc.

Companies: Allergan USA, Inc.; Medicis Aesthetics, Inc.

Cases: CourtDecisions PreemptionNews MedicalDevicesNews SouthCarolinaNews