On Monday a motion to dismiss was granted in an Eastern District of Tennessee lawsuit concerning failure to warn of potential side effects of Sientra Inc.’s breast implants.
The plaintiff, per the opinion, underwent breast reconstruction after a double-mastectomy. After the procedure, the patient experience swelling indicative of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and had to undergo removal and will need further testing and care related to the cancer.
The plaintiff claimed that defendant’s silicone gel breast implants caused her to develop BIA-ALCL, as they were defective, unreasonably dangerous, and/or adulterated, and were not manufactured in compliance with applicable laws, regulations, and/or standards.
All of the plaintiff’s claims were made under Tennessee state product liability law. The defendants moved to dismiss claiming that the state product liability laws were preempted by the Medical Device Amendments (MDA) to the Federal Food Drug, and Cosmetic Act.
The defendants argued and the court agreed that Congress had specifically intended that the MDA preempt state laws and set the standards by which medical devices would be evaluated and any mandatory warnings would be in compliance with the FDA standards, and not on a state by state basis.
The court also noted that while the plaintiff had pled broadly that there was a manufacturing defect in the implants, there was no specific statement as to a defect which could survive a motion to dismiss. While claims can and should be held as true during a motion to dismiss, there must be some indication of an actual defect from the evidence available to the plaintiffs in order for a claim to proceed and a generalized statement that the devices were made with texture and therefore were defective was not sufficient to meet this burden.
Plaintiffs were represented by Butler, Vines, and Babb. Defendants were represented by Kirkland & Ellis and Spears Moore Rebman & Williams.
