Beth P. Weinman
Counsel
Beth Weinman is a member of the firm’s life sciences and FDA regulatory practice group, and focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices and dietary supplements. Beth provides counseling on issues related to off-label promotion and other marketing practices, good manufacturing practices, good clinical practices, compounding, and product recalls and withdrawals. In addition to regulatory counseling, Beth represents clients on False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations, and other enforcement actions before state and federal regulators.
Prior to joining Ropes & Gray, Beth spent nearly eight years as Associate Chief Counsel for Enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with FDA’s Office of Criminal Investigations, the Department of Justice and other government agencies to investigate and, when appropriate, prosecute alleged violations of the FDCA and related crimes under Title 18 (including, e.g., mail fraud, wire fraud, healthcare fraud, and conspiracies to defraud). She also worked on numerous parallel and independent FCA investigations involving FDA regulated drugs and devices and has significant experience in opioid related investigations.
Before starting at FDA, Beth spent more than seven years as an associate in the litigation department of a large New York law firm, where, among other matters, she represented a number of pharmaceutical companies in government investigations and securities class action lawsuits.
Experience
Representative matters Beth worked on prior to joining Ropes & Gray include:
- Investigated major national pharmaceutical wholesaler in connection with the repackaging of millions of vials of sterile oncology supportive care drugs into pre-filled syringes by a subsidiary that purported to be a state-regulated pharmacy in compliance with state pharmacy laws. The parallel FDCA and FCA investigation resulted in a corporate plea to the distribution of misbranded drugs, a more than $250 million criminal fine and forfeiture, and payment of $625 million in civil penalties.
- Investigated, indicted and served on trial team that prosecuted former executives of a medical device manufacturer in connection with marketing of the company’s medical device for unapproved use in a multi-week trial in the District of Massachusetts. The trial resulted in convictions on ten misdemeanor adulteration and misbranding counts. Also involved in parallel civil FCA investigation that led to $18 million settlement.
- Investigated, indicted and served on trial team that prosecuted medical device manufacturer and its CEO in connection with the distribution of its FDA cleared medical device for unapproved uses in a multi-week trial in the Western District of Texas. Also involved with parallel civil FCA investigation that led to an approximately $500,000 settlement.
- Involved in multiple criminal FDCA and civil FCA investigations examining the marketing and reporting practices and cGMP compliance of pharmaceutical and medical device manufacturers that led to public global resolutions involving criminal pleas and payment of FCA penalties by pharmaceutical and medical device manufacturers and, at times, their executives.
- Investigated NJ based drug repackager and compounding pharmacy in connection with its repackaging and compounding of sterile injectable drugs in non-aseptic conditions and distribution of contaminated drug product. Served on the prosecution team that indicted the CEO and chief pharmacist on various FDCA and fraud charges, resulting in pleas to wire fraud conspiracy.
- Resolved three civil actions that DOJ filed in multiple federal courts in connection with the seizure and destruction of dietary supplements containing unsafe food additive DMAA in the warehouses of a major dietary supplement retailer. Also worked on parallel negotiated destruction of identical product administratively detained by FDA at the product manufacturer’s warehouse.
- Counseled OCI and DOJ in connection with various parallel FDA and FDCA investigations involving marketing practices with respect to FDA approved opioid drug products, including oxymorphone, oxycodone and fentanyl products.
- Provided advice to multiple federal agency law enforcement agents and DOJ regarding enforcement theories.
- Worked with DOJ and OCI in connection with the prosecution of various individuals in the shadow cosmetics industry related to the administration of illicit silicone injections for body contouring purposes.
- Defended pharmaceutical company in connection with parallel FDCA and FCA investigation into drug marketing practices.
- Defended pharmaceutical company in connection with class action stock drop law suit involving a line extension of one of its drug products.
- Defended pharmaceutical company in connection with securities class action involving failure to disclose allegedly material information about a clinical trial.
Publications
- Co-author, “FDA Draft Guidance On Medical Device Inspections Is Limited,” Law360 (May 10, 2019)
- Co-author, “2018 FDA Enforcement Review: Drugs, Biologics And Devices,” Law360 (January 28, 2019)
- Profiled, “Fresh From US FDA’s Chief Counsel Office, Beth Weinman Talks Qui Tam and Compliance,” Medtech Insight (November 13, 2018)
- Profiled, “Ropes & Gray Adds Ex-FDA Enforcement Pro In DC,” Law360 (October 26, 2018)