LIFE SCIENCES PRODUCT LIABILITY

Life sciences companies face a wide range of potential product liability lawsuits, including cases that allege failure to warn/duty to warn, design defect, manufacturing defect or preemption type matters. No matter the claim, life sciences product liability actions are all rooted in the regulatory scheme, which allows these products to be tested, enter the market and be used by consumers/patients.

Life sciences companies, regardless of whether they produce drugs or food or animal health products, face product liability not only when a suit is filed but when products are tainted, subject to a recall or the company receives a warning letter. Recalls often lead to threats of litigation or the actual filing of claims. The process of the recall, the corrective action the company takes and the position of the company during the recall to the consumer is critical in establishing a products liability strategy. Regardless of whether the recall is voluntary or involuntary, written processes and plans, record-keeping and public notices can set the tone for subsequent product and consumer litigation.

Life science companies facing products liability litigation benefit the most by not only having a team of experienced litigators but having one with regulatory experience because of the highly regulated nature of the industry and its products. Thompson Coburn has regulatory-savvy litigators in place to best defend life sciences companies in product liability litigation. For example, in any given case, our litigators can quickly:

• Understand what needs to be contained on product labels and how marketing claims or Internet descriptions can be seen as part of the labeling process and how they can create liability
• Understand the tracing/tracking requirements for medical device companies and how they affect product identification in products cases
• Understand the difference in types of claims that dietary supplement clients can make (what required preapproval and what did not will affect litigation strategy)
• Understand food labeling and health claims, including the use of terms such as organic and natural and the liability the misuse of such terms can create
• Efficiently assess claims (threatened or actual) and devise a litigation strategy that takes into account the business needs of our clients
• Draft corrective action plans, manage recalls and assist clients in drafting effective recall notices