“Recognized for its strengths in product liability…”
— Chambers USA
Pharmaceutical and medical device manufacturers are subject to government review, complex regulations and vulnerable to product liability claims that can be devastating to your business, your finances, and your reputation.
Our pharmaceutical and medical device product liability attorneys understand the complex life sciences industry and we work with clients to ensure safe and effective products reach patients. When lawsuits do arise, we are well prepared to defend and try drug or medical device product liability cases. Our clients value our ability to simplify complex medical and scientific principles for judges and juries and control the issues at trial rather than allowing the plaintiff to dictate the presentation of evidence.
We draw from an established network of clinicians, research scientists, academicians, and consultants who help expose the weaknesses in the plaintiff’s medical and scientific case—such as use of junk science—and present good science to decide your case. Because preparation wins cases, nothing is left to chance in discovery, but we ensure discovery is focused and efficient. Winning for our clients (in and out of court) and protecting them from future claims is our fundamental priority.
We understand that not all cases implicate our clients’ business interests and that pre-trial resolution of meritorious cases is often the preferred outcome. We prepare each case with an eye towards trial while looking for opportunities for positive early resolution whenever possible.
How We Can Help
Preventive Services: Product Development Reviews
Legal review and input early in the product development process can avert or minimize future adverse legal action. We help clients:
- conduct company-wide document review and analysis of data and internal documents
- evaluate regulatory submissions including proposed product labels and label changes
- provide pre-publication review of abstracts and manuscripts
- identify academicians, clinicians, and other experts in various fields as potential litigation consultants
- review marketing materials for liability and regulatory concerns, such as off-label promotion activities
- analyze physician consulting and other third-party arrangements to ensure compliance with anti-kickback laws
- review company documents and electronically stored information (“ESI”)
- review clinical safety surveillance and adverse events reporting systems
Corrective Actions and Product Recalls
Because litigation often follows corrective actions and recalls, we assist clients in preparing their litigation defense before suit is filed by:
- identifying potential testifying experts in adverse health issues
- interviewing company witnesses involved in product design and testing
- assisting with “litigation hold” memoranda and paper document and ESI preservation efforts
- reviewing company documents and ESI to identify helpful and problematic (“hot”) documents
- assisting with press releases and public statements
- reviewing clinical safety surveillance and adverse events reporting systems
What Sets Us Apart
- We have industry and legal experience in many sectors, including intellectual property protection, healthcare services, health information technology, and venture capital, and we have an in-depth understanding of the unique business challenges and opportunities pharmaceutical and medical device businesses offer.
- We have experience related to compliance, enforcement, and reimbursement issues, representing federal agencies such as the National Institutes of Health (“NIH”), the Food and Drug Administration (“FDA”), the Centers for Medicare and Medicaid Services (“CMS”), the Department of Justice (“DOJ”), and the Office of the Inspector General (“OIG”).
- Antitrust Counseling & Litigation
- Appellate Litigation
- Business Litigation
- Class Action Defense
- Privacy Class Action Defense
- Delaware Corporate Litigation
- Mass Torts & Complex Disputes
- Product Liability
- Toxic Torts
- Professional Malpractice Defense
- Securities & Shareholder Litigation
- White Collar Defense & Investigations