Medical Device Litigation

  • Represented the manufacturer of an obesity medical device in scores of cases, including a lawsuit filed in Indiana. Plaintiff alleged that the implanted medical device had eroded into her stomach and small bowel, and sued the manufacturer in state court for defective design, manufacturing defect and failure to warn. We removed the case to federal court and immediately filed a motion to dismiss based on failure to state a claim under Rule 12(b)(6). The device in question had received pre-market approval (PMA) from the FDA, and we argued that the claims asserted were preempted by the express preemption provision of the Medical Device Amendments of 1976 (MDA). Our legal brief explained the United States Supreme Court case Riegel v. Medtronic and distinguished the 7th Circuit's decision in Bausch v. Stryker Corp. Plaintiff voluntarily dismissed the Complaint in response to our filing.

  • Represented a component part manufacturer from the Far East whose part was utilized in a surgical device made in the United States. Our defense included a refusal to answer given improper service under the Hague Convention as well as lack of personal jurisdiction in New Jersey state court. This approach was successful in staying within a limited legal budget for this self-insured company.

  • Represented the manufacturer of silicone gel-filled breast implants sued in federal court in Iowa after an implant ruptured. Silicone gel migrated beyond the breast cavity into other parts of Plaintiff's body, necessitating additional surgical procedures. Plaintiff alleged a host of ailments (including fibromyalgia) resulted from this silicone leak. We secured from the federal court a dismissal for our client on two separate legal bases without any payment to Plaintiff.

  • Obtained summary judgment in Maryland for our medical device manufacturer client based on federal preemption. Plaintiff had the manufacturer's saline-filled breast implant surgically placed after undergoing a modified radical mastectomy. A later infection in the breast pocket required removal of the implant. Plaintiff subsequently suffered a pulmonary embolism and other ailments. She sued the manufacturer and her surgeon. Allegations against the device manufacturer included manufacturing defects and defective warnings. Our early motion for summary judgment based on federal preemption prior to any significant discovery was granted, saving our client the expense of years of discovery and litigation costs.

  • Obtained early dismissal in Morris County, New Jersey for our client, an international manufacturer of medical devices, sued after Plaintiff's saline-filled breast implant deflated. Our Frivolous Litigation letter demand resulted in Plaintiff's counsel dismissing the suit prior to Answer.
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