Pharmaceutical and Medical Device Product Liability Defense

Our Representative Experience

• Mass Tort & Class Action Defense: Represented a Fortune 500 company in complex mass tort product liability cases, including defending against class certification hearings involving major pharmaceutical product manufacturers.
• Wrongful Death & Traumatic Injury: Successfully defended pharmaceutical clients in high-stakes lawsuits alleging traumatic injury and wrongful death, utilizing expert medical testimony to challenge causation and limit liability.
• International Manufacturer Defense: Served on the trial team for a large international product manufacturer, managing cross-border discovery issues and coordinating a unified defense strategy for a global brand.
• Defeating Defect & Failure to Warn Claims: Defended product manufacturers against multi-faceted claims of manufacturing defects, design defects, and failure to adequately warn. Our strategies often involve leveraging federal preemption defenses for FDA-approved devices to secure dismissals or favorable rulings.
• Strategic Settlement Negotiation: Assisted clients in obtaining favorable settlements early in large, multi-defendant cases to minimize litigation costs and reputational exposure before trial.
• Establishing the “Daubert” Standard in Oklahoma: A member of our team served as appellate counsel in the landmark case Christian v. Gray, persuading the Oklahoma Supreme Court to adopt the federal Daubert standard for expert witness admissibility. This victory fundamentally changed civil litigation in the state, providing manufacturers with a critical defense tool to challenge and exclude “junk science” and unreliable expert testimony.

Consult with Our Product Liability Defense Team

Our Product Liability Defense team combines litigation skill with scientific and regulatory knowledge, making us uniquely qualified to handle urgent, high-stakes situations.

If the enterprise is currently facing claims related to:

• Alleged injuries or serious adverse events tied to a branded or generic drug that may escalate into pharmaceutical product liability defense and mass tort exposure.
• Malfunctions or failures of implants or equipment (e.g., orthopedic implants, cardiac devices, surgical mesh, pumps, diagnostic devices) requiring coordinated medical device product liability defense.
• Claims of failure to warn, inadequate labeling, or off-label promotion that are spreading across jurisdictions or forming the basis for mass torts or multidistrict litigation.
• Clinical trial data, pharmacovigilance reports, or post-market surveillance are being used to argue your company “knew or should have known” of a product risk.
• Product recalls, safety alerts, or “Dear Doctor” letters have triggered follow-on lawsuits and heightened regulatory scrutiny.
• Parallel FDA or other regulatory investigations arising at the same time as civil suits, demanding a coordinated product liability defense team to manage litigation and regulatory risk together.

In these scenarios, engaging an experienced product liability attorney early is critical. Our team can step in immediately to conduct internal investigations, preserve crucial evidence, manage expert and e-discovery strategy, and develop a coordinated defense plan that protects both your litigation position and your business.

Challenges in Pharmaceutical and Medical Device Defense

Pharmaceutical and medical device product liability defense involves a set of high-stakes, highly technical challenges that require sophisticated litigation strategies, scientific expertise, and regulatory knowledge, including:

• Medical Causation Complexity is the core challenge in proving whether a drug or device actually caused the alleged injury, given other risk factors and competing explanations. A plaintiff may, for example, claim that a blood thinner caused a stroke despite significant pre-existing risks such as hypertension, diabetes, and smoking history. Our pharmaceutical product liability defense team builds a rigorous, expert-driven record to challenge plaintiffs’ causation theories, present alternative causes, and exclude unreliable expert testimony under Daubert where appropriate.
• Mass Tort and MDL exposure occurs when a single product issue leads to numerous similar lawsuits, which are consolidated to improve efficiency and coordinate litigation strategies. For example, a commonly used pain medication might be accused of causing unexpected cardiac events, resulting in hundreds of filings across the country and consolidation into a federal Multidistrict Litigation (MDL). We understand the significant logistical and financial challenges of multi-party claims, and our product liability attorneys are ready to develop national strategies to ensure consistency across jurisdictions, manage costs, and safeguard the company’s long-term litigation position.
• The FDA Preemption Defense involves arguing that federal regulatory approval and oversight preempt certain state-law claims, which limits or prevents plaintiffs from second-guessing FDA-approved warnings, designs, or labeling. For example, a plaintiff might sue over an alleged failure to warn about a side effect that had already been reviewed and included in an FDA-approved label, thereby providing a strong preemption argument for a branded prescription drug. In some cases, a well-structured preemption defense can lead to early dismissal of claims or a significant narrowing of issues, and our attorneys are experienced in utilizing FDA compliance, approval history, and regulatory correspondence to assert preemption and reduce exposure in pharmaceutical and medical device litigation.
• Risk to regulatory status refers to the threat that civil lawsuits and public allegations could lead to regulatory actions affecting approvals, labeling, or the ongoing marketing of a product. For instance, a series of lawsuits claiming undisclosed neurological side effects from a medical device might cause the FDA to initiate its own review, request additional post-market studies, or even consider a recall. In these situations, the courtroom is just one element of a broader effort to protect the product’s viability. We help clients manage this dual threat by defending in litigation and advising on communications with regulators, remediation strategies, and compliance improvements to sustain market access and minimize regulatory disruptions.