Litigation Support and Expert Witness
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.
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Expert knowledge of FDA regulations that helps you strategically grow your business
I am truly impressed… Marc understands the workings of the regulatory agencies and this allows him to very effectively achieve the results that his customers want without creating an environment of confrontation. Beyond that, he has insight into the laws governing foods, supplements, and medicine that goes beyond that of the federal officials involved in these regulatory areas. This allows him to open avenues of compromise and agreement that would not have existed before he was brought to bear on the difficulty. Even as he produces compromise and agreement, it is clear that he holds his customer's interest at heart.
I have never found a more powerful and effective counsel.
Steven Frank CEO
Nature's Rite Remedies
We retained Marc to answer some extremely time-sensitive and complex questions regarding COVID-19 and FDA regulations. Despite being overloaded with clients, Marc was very responsive and was able to provide us with the comprehensive answers we needed within 24 hours. This enabled us to respond quickly and effectively to the changing regulatory landscape. I strongly recommend using Marc and look forward to working together again in the future.
Marc Sanchez has provided our company with expert advice and letters that have saved us time and money in dealing with the FDA. We have worked with many FDA attorneys and consultants in the past and they can't hold a candle to the knowledge and expertise that we have found with Marc.
Jeff Maier (VP Sales & Marketing)
Marc is incredibly intelligent, poised and able to make reasonable, timely recommendations about risk. Additionally, he is extremely organized, has a calm demeanor and has provided insightful counsel to me on many regulatory issues. I strongly recommend him.