FDA Litigation Adviser

FDA Litigation Adviser

FDA litigation can involve numerous complex regulatory questions. For example, a product liability suit involving the injury from a drug or medical device could raise questions of FDA approval, classification, off-label use, and investigations into FDA sources indicating when problems were first reported. A FDA litigation adviser can help answer these and other questions for the litigation team. The guidance provided on compliance sheds light on culpability and duty of care. This is commonly the case in product liability litigation and class action lawsuits. Plaintiff’s counsel is typically challenged by overcoming the presumption of safety associated with a device or drug approval. Understanding how the product was approved and how the company complied with post-market responsibilities can prove pivotl in building a winning strategy.

FDA litigation advisers can also serve as expert witnesses. Testimony or opinions can be given on a wide range of topics for trademark or patent litigation, product liability, securities and other litigation. The competition in food, beverage, and supplements is immense. It is not uncommon for similar names or concepts to emerge and engage in litigation. Here questions of claims compliance, misbranding, classification and related topics can prove key to these cases.

FDA litigation advisers are also needed to examine documents in securities and acquisitions litigation. The due diligence involves understanding what disclosures were made and whether the information is adequate for the purpose.

The FDA Atty firm offers a litigation support in any FDA matter. Our attorneys can serve as FDA litigation advisers, expert witnesses, or manage FDA document production and FOIA requests.