Pharmaceutical and Medical Devices
The pharmaceutical and medical device industries are highly regulated, subject to intense government scrutiny, vulnerable to product liability lawsuits and often suffer negative or misleading media coverage. Faced with these challenges, U.S. and international drug and medical device companies, CROs and biotech businesses rely on Segal McCambridge to assert and defend their interests in and out of court and to provide them with comprehensive guidance on their day-to-day operations.
Our highly experienced Pharmaceutical & Medical Device Litigation Group represents prescription, OTC, generic and brand name drug manufacturers, as well as medical device manufacturers and distributors, CROs and biotech companies throughout their products’ lifecycle.
Segal McCambridge lawyers have served as lead defense counsel, national coordinating counsel and special counsel, defending drug and medical device cases throughout the country in state and federal courts at both the trial and appellate levels. From single-plaintiff product liability and personal injury lawsuits to consolidated proceedings, concurrent federal and state litigation, multidistrict litigation, class actions and mass-tort litigation, we have successfully resolved cases involving a broad array of branded and generic prescription drugs and medical devices. Particularly adept at litigating product liability defense matters, our lawyers have litigated cases involving a host of drugs and medical devices, including:
- Blood thinners
- Critical care devices
- Diet drugs
- Durable medical equipment (DME)
- Heart medications
- Hormone replacement therapy
- Human cadaver tissue
- Infusion pumps
- Implanted ports/catheters
- Intra-uterine pressure catheter
- Latex gloves allergy
- Pain medications
- Surgical equipment, instruments and implants
We have also defended companies against claims involving clinical trials and wrongful death allegations. With a national reputation as a top-tier product liability defense firm and a "real world" understanding of the business issues pharmaceutical and medical device companies face, few firms can match our record of success or our ability to strike the delicate balance required in litigation involving drug and device companies and their healthcare provider customers.
Beyond the courtroom, we also resolve matters through arbitration, mediation and negotiated settlement. Whether performing actual "hands-on" defense work or offering preventive counsel, we help our medical device and pharmaceutical clients avoid unfavorable results in and out of court.
Cost-Effective, Value-Added Service
We maintain a vast database of experts and employ state-of-the-art technologies to streamline litigation, contain costs, and keep our clients informed at all stages of litigation. With technical degrees in related fields and actual experience in the biomedical field, our team is comprised of highly experienced litigators and attorneys skilled as legal advisors and knowledgeable about regulatory compliance. We fully grasp the subtleties involved in such specialized litigation, enabling us to plan and carry out a well-informed, strategic defense.
Regulatory Guidance and Representation
With a deep understanding of food and drug laws and the evolving regulatory framework impacting pharmaceuticals and medical devices, we strategize with our clients, helping them assess and manage risks in the regulatory arena. We regularly advise clients on compliance with the various regulatory requirements applicable to their businesses. Additionally, our lawyers provide effective solutions regarding all aspects of federal and state government investigations, enforcement and compliance initiatives.
Strategic Business Advice
We advise on product development, warranties, product labeling, warnings and recalls, clinical trials, FDA clearances and approvals, drug advertising and crisis communications, among other matters. When issues arise, we work closely with each client to help determine the best course of action, effectively protecting the client’s reputation, containing costs and minimizing any negative impact on their future success.
- Segal McCambridge Attorneys Jeff Singer, Kim Kayiwa, and Mitch Morinec Gain Dismissal on Behalf of Generic Drug Manufacturer in High Damages Products Liability Case2.17.12
- Segal McCambridge Shareholder Walter "Pete" Swayze III To Speak at 2010 Drug Information Association Annual Meeting12.15.09
- Philadelphia Managing Shareholder, Walter "Pete" H. Swayze, III to Speak at Drug & Device Defense ForumPhiladelphia, 10.24.17
- Philadelphia Shareholder Megan Grossman Co-Chairs 4th Annual Drug & Device Defense Conference in PhiladelphiaPhiladelphia, PA, 10.24.17
- Pennsylvania Shareholder Megan Grossman to Speak at ACI's 4th Annual Women Leaders in Life Sciences Law ConferenceBoston, 7.19.17
- Philadelphia Shareholder Megan Grossman to Co-Chair HB Litigation Conferences' Drug & Device Defense Seminar for Third Consecutive YearPhiladelphia, PA, 12.13.16
- For the Defense: Litigation Across the Drug and Device SpecturmChicago Marriott Downtown, 5.19.16
- The Hub Cira Centre, 2929 Arch St, Philadelphia, PA, 10.20.15
- Segal McCambridge Shareholder Walter "Pete" Swayze III To Speak at Drug Information Association Conference5.26.11
Articles & Publications
- Drugs, Cosmetics, Medical Devices Also Now Clear of Some Federal Prosecutions for NoncomplianceFood Safety News, 2.13.18
- The Legal Intelligencer, 2.12.18
- Corporate Counsel, 1.29.15
- Corporate Counsel, 1.29.15
- What Every Compounding Pharmacy Should Know About Two Recent Initiatives: The Compounding Clarity Act and The Drug Quality and Security Act10.28.13