Products Liability Law Daily Wrap Up, PREEMPTION—MEDICAL DEVICES—C.D. Cal.: Patients’ claims against manufacturer of breast implants preempted by federal law, (Sep 3, 2019)

By Elena Eyber, J.D.

Dismissal of negligence, failure to warn, and manufacturing defect claims was based on preemption under the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act.

A federal district court in California dismissed the state law claims by a number of patients against the manufacturer of breast implants, finding that the claims were preempted by federal law. Additionally, the court held that the manufacturer’s removal was timely and proper based on new information; and that an alleged manufacturer of a defective component of the breast implants was fraudulently joined in the action (Billetts v. Mentor Worldwide, LLC., August 27, 2019, Birotte Jr., A.; Sewell v. Mentor Worldwide, LLC., August 27, 2019, Birotte Jr., A.).

Procedural history. Patients who suffered injuries after receiving surgical breast implants filed complaints in state court against the manufacturer of breast implants and the suppliers of silicone used in the implants, asserting causes of action for (1) negligence/negligence per se; (2) failure to warn; and (3) manufacturing defect. The manufacturer filed a notice of removal to federal court and then filed a motion to dismiss the patients’ actions. The patients filed a motion to remand.

Subject matter jurisdiction. The patients argued that the manufacturer’s notice of removal was untimely and improper because it was not based on new grounds or new information. The court held that the manufacturers’ successive removal was timely and proper. A member of a silicone supply company testified that the company was a holding company and that it had not been involved in the manufacturing of the implants at issue. The member’s statements provided further clarity regarding the status of the company and its lack of involvement in the production of the silicone used in the manufacturer’s breast implants. Thus, the court held that after the member’s deposition, the manufacturer timely removed based on the new information.

In their complaints, the patients claimed that the silicone supplier manufactured a defective component of the breast implants. The manufacturer contended that the silicone supplier was fraudulently joined in the action. Based on the member’s deposition, the court held that the silicone supplier did not manufacture silicone and was not involved in the development of the breast implants. Therefore, because there was no possibility that the patients could recover under a theory of product liability against the silicone supplier, the silicone supplier was not a proper defendant in the actions at bar.

Motion to dismiss. In support of the manufacturer’s motion to dismiss, the manufacturer argued that the patients’ state-law claims were expressly and impliedly preempted by the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act (FDC Act). The court agreed that the patients’ claims against the manufacturer were preempted by the MDA and granted the manufacturer’s motion to dismiss. The court found that there was no presumption against preemption that was applicable. Also, the patients did not assert a parallel claim that survived preemption. Furthermore, the patients failed to sufficiently plead that the manufacturers failed to report adverse events regarding the implant. The court also held that the patients’ manufacturing defect claims were preempted. Finally, the court denied leave to amend because the patients did not explain how further amendment could cure the pleading deficiencies in their complaints.

The cases are No. ED CV 19-01026-AB (PLAx) and No. SA CV 19-01126-AB (PLAx).

Attorneys: Jennifer A. Lenze (Lenze Lawyers, PLC) for Mary Sewell. Amanda Deanne McGee (Lenze Lawyers, PLC) for Brittany Billetts. Monee Takla Hanna (Tucker Ellis LLP) for Mentor Worldwide, LLC. Melissa J. Fassett (Price Postel & Parma, LLP) for NuSil, LLC and NuSil Technology, LLC.

Companies: Mentor Worldwide, LLC; NuSil, LLC; NuSil Technology, LLC

Cases: CourtDecisions PreemptionNews JurisdictionNews MedicalDevicesNews SCLIssuesNews CaliforniaNews