FDA Enforcement Actions
Our attorneys have a wealth of experience in designing and carrying out plans to address potential FDA enforcement actions. We regularly advise clients on enforcement matters ranging from advisory actions such as FDA Warning Letters to formal actions such as withdrawals of product approvals, product seizures, injunctions and consent decrees, recalls, import alerts, denial of export certificates, civil money penalty hearings, clinical investigator disqualification hearings, and criminal prosecutions.
We are frequently engaged to protect the interests of our clients by bringing legal actions directly against the FDA and other federal and state government agencies. In many cases, these legal actions involve complex scientific and legal challenges to government decisions that can impact our clients’ business or their products. These situations also entail strategic decisions about timing and access to the administrative records that govern federal agency determinations.
Here are some representative examples of our FDA enforcement and litigation experience:
- Represented a leading medical device manufacturer in regard to an FDA inspection of one of its manufacturing facilities and have been advising the company on its interactions with regulatory authorities around the world relating to issues arising out of the inspection and subsequent product recalls.
- Represented a medical device manufacturer in connection with FDA compounding regulations involving one of its drugs resulting in the FDA issuing a letter in support of the company’s position. Following the FDA letter, we filed an amicus brief on behalf of the client in a pending lawsuit challenging the FDA’s position.
- Represented a medical device manufacturer in responding to an FDA Warning Letter alleging violations of the QSR.
- We represent numerous pharmaceutical and medical device clients in responding to FDA inspection reports (“483s”) and Warning Letters alleging violations of GMPs, adverse event reporting requirements for drugs and medical devices, and other FDA rules.
- Represented a health provider in an FDA criminal investigation associated with distribution of counterfeit medical devices.
- We were part of a team that successfully persuaded the California Supreme Court that the requirements of the state labeling initiative, known as Proposition 65, are pre-empted when applied to our client's products.
- We represent clients in challenges under the Hatch-Waxman Amendments involving denial by the FDA of citizen petitions that formally request the agency to take particular actions based on the science surrounding a particular pharmaceutical product.
- We worked closely with a pharmaceutical client’s copyright litigation counsel in successfully protecting intellectual property rights that were created from the patient assistance materials that were developed when the client’s products were switched from prescription to OTC status.