Pharmaceuticals & Medical Devices

Overview

“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”).

Experience

  • Served as national litigation counsel in two MDLs and two state coordinated procedures for manufacturers of alendronate sodium in litigation related to allegations of failure to warn.
  • Served as national trial and litigation counsel for manufacturer of prosthetic knee device.  
  • Served as national coordinating counsel for a distributor of the drug paroxetine in mass tort cases consolidated in Pennsylvania’s First Judicial District, and elsewhere in the United States. 
  • Served as national coordinating counsel for a manufacturer of a medical device in the “Pain Pump” mass tort cases, which involve allegations related to an off-label promotion of a mixed medical-pharmaceutical device.
  • Fashioned comprehensive multi-billion-dollar nationwide resolutions supported by multi-billion-dollar insurance recovery efforts, and also resolved claims by governmental entities and health insurers for two of the major defendants in the silicone-gel breast implant litigation.
  • Negotiated two nationwide class settlements resolving personal injury claims involving Hepatitis C and HIV for a major supplier of blood products.
  • Successfully pursued insurance coverage for hundreds of products liability claims throughout the United States and assisted the client and defense counsel with developing a comprehensive resolution strategy of all the product-related claims for a manufacturer of latex gloves.
  • Served as coordinating counsel for a manufacturer of Allopurinol in cases related to claims of failure to warn where the plaintiffs alleged they developed Severe Cutaneous Adverse Reactions (“SCAR”) or Stevens–Johnson Syndrome (“SJS”). 
  • Served as national coordinating and trial counsel for a major, branded pharmaceutical company in thimerosal-containing childhood vaccine litigation.
  • Obtained a dismissal of a $6 billion qui tam lawsuit under the federal False Claims Act regarding patents and licensing programs relating to the Nobel Prize-winning polymerase chain reaction (“PCR”) process for amplifying DNA for the world’s leading molecular diagnostics company.
  • Served as counsel for a branded pharmaceutical company in a national product liability litigation involving prescription diet medications.
  • Represented a publicly traded medical device manufacturer in complex criminal, civil, and administrative proceedings involving off-label promotion.
  • Served as counsel for a medical device manufacturer against claims that a Class III device failed during a multi-study-center, FDA-approved clinical trial.
  • Successfully defended the manufacturer of a robotically assisted, minimally invasive surgical system in a case involving claims of design defect.
  • Successfully defended the manufacturer of an orthopedic implant against claims of improper labeling.
  • Successfully defended a heparin manufacturer in a case involving claims that the product did not have adequate warnings.