Pharmaceutical & Medical Device Litigation

Litigation of pharmaceutical and medical device matters requires trial experience and subject matter expertise – and we have both. Our group’s attorneys have tried more than 28 medical and products liability cases in the last six years, and are recognized routinely by ranking publications such as The Best Lawyers in America©, U.S. News & World Report and Best Lawyers® “Best Law Firms,” North Carolina Super Lawyers® and Benchmark Litigation. The ability to take a case to trial – and win – allows us to apply pressure throughout a matter, often resulting in favorable outcomes without the need for trial.

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Founded more than a century ago, Smith Anderson is located in North Carolina’s world-renowned Research Triangle Park region. For decades, our firm has combined its strong litigation reputation – and the relationships that go with it in the state and federal courts – with the resources available from the region’s scientific and medical communities to champion the interests of clients in the pharmaceutical, medical device and life science fields.

As part of a full-service business and litigation law firm, our lawyers have deep experience in pharmaceutical and medical device litigation and understanding of the specialized scientific issues and experts these cases often entail. We are well-equipped to serve as counsel in state or federal litigation regarding medical devices and drugs, as national trial or product coordinating counsel, or as North Carolina counsel in litigation. We bring to all of our work the experience and insight gained from successfully handling numerous jury trials, mediations and arbitrations.

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Services

• Advise and provide representation as to pre-litigation claims and demands for recovery
• Defend pharmaceutical companies and medical device manufacturers in litigation
• Advise and defend pharmaceutical clients in connection with the Food and Drug Administration (FDA) and various prosecutorial and governmental investigations
• Advise and provide representation for corporate clients and their employees when served with subpoenas or other requests for information during the course of litigation between unrelated parties

• Managed defense of a medical device company in a bet-the-company paraplegic injury lawsuit. The lawsuit alleged the paraplegia was the result of lower lumbar surgery involving lateral and contra-lateral access using a minimally invasive decompression medical device and micro-blade shaver system. The lawsuit was successfully resolved prior to trial.
• Defended a major pharmaceutical company in multiple pain pump lawsuits. The lawsuits claimed rotator cuff and shoulder joint deterioration from analgesic delivered in pain management infusion pumps following shoulder repair surgery. The cases were resolved through dismissal or transfer to MDL and ultimate settlement.
• Defended a surgical device manufacturer in a wrongful death action filed in the Middle District of North Carolina alleging that a tumor ablation device malfunctioned and caused the destruction of healthy tissue. Implementation of aggressive discovery and defense strategy resulted in dismissal of all claims that had been asserted against our client.
• Defended a global pharmaceutical company in litigation alleging that exposure to their pharmaceutical product caused Stevens Johnsons’ Syndrome and Toxic Epidermal Necrosis (SJS/TENS). The lawsuit was successfully resolved prior to trial.
• Defended a major pharmaceutical company in numerous consolidated personal injury lawsuits alleging that Thimerosal, the preservative used in many vaccines, caused autism in children. Following expert discovery and an evidentiary hearing, the court granted defendant's motion for summary judgment.

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• Defended a major latex glove manufacturer in a dozen latex allergy lawsuits in North Carolina as part of the national MDL. Cases were resolved through dispositive motions and favorable settlements.
• Defended multi-national consumer goods company in Rely tampon - toxic shock syndrome litigation nationwide. Member of the national lead counsel defense team. Specifically responsible for over 200 cases tried, dismissed or resolved in over twenty (20) states in federal and state trial and appellate systems.
• Defended the manufacturer of an oxygenator in a cardiopulmonary bypass machine that allegedly failed at the beginning of a cardiac bypass procedure. The plaintiff claimed he suffered permanent brain damage when the oxygenator did not adequately oxygenate his blood and had to be emergently replaced. Defendant’s motion for directed verdict based on a lack of qualified expert testimony was granted.
• Represented a major pharmaceutical manufacturer involving allegations that the menopause treatment drug Prempro caused cancer. The cases were ultimately transferred to a MDL in Arkansas where the claims were settled by the co-defendant/primary target. In re Prempro Products, 03-cv-015070-WRW, U.S. District Court, Eastern District of Arkansas (Little Rock).
• Obtained dismissal of products liability claims on behalf of a manufacturer of the generic form of vancomycin.  

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