Mark S.
Brown

Phillip Morris USA v. FDA, 202 F.Supp. 3d (D.D.C. 2016). Represented one of the plaintiffs in a successful legal challenge to an FDA guidance governing the Substantial Equivalence Review process for tobacco products.

United States v. Franck's Lab, 2011 WL 4031102 (M.D. Fla., Sept. 12, 2011). Lead counsel in successful defense of FDA enforcement action against pharmacy compounder of veterinary drugs.

During his 30-year career, he has served as lead counsel and negotiator for numerous consent decrees of injunction, both during his tenure with FDA (1990–1994), and since 1994 in private practice. For example, he has negotiated consent decrees some of the world's largest device manufacturers, including Medtronic (2008 and 2015), The General Electric Company (2007) and Baxter Healthcare (2006).

Since 2002, served on the national counsel team for GlaxoSmithKline in the Paxil Products Liability Litigation. Represented GSK on all FDA-related issues, including federal preemption. Argued and won a summary judgment motion on federal preemption grounds in O'Neal v. SmithKline Beecham (E.D. Cal 2008). In 2002, represented GSK in successfully defending an injunction seeking to enjoin GSK from making claims in direct-to-consumer television advertising for Paxil.

From 1995 to 2001, served on 3M's National Trial Team in the Silicone Gel-Filled Breast Implant Litigation. Responsible for virtually all FDA issues and had primary responsibility for preparation and handling of defense expert witnesses, and cross-examination of adverse witnesses on FDA issues.

Connaught Laboratories v. SmithKline Beecham, 7 F.Supp. 2d 477 (D.Del. 1998), appeal dismissed, 165 F.3d 1368 (1999). Represented SmithKline Beecham in winning one of the few successful motions to compel FDA to provide testimony by its research scientists in patent litigation relating to purified form of pertactin, a component of the pertussis vaccine.

Next Nutrition, Inc. v. SportPharma USA, Inc., No. 97-CV-1898J (1997). Served as lead counsel to a dietary supplement company that brought an action under the Lanham Act alleging false and misleading comparative advertising relating to competing products. Successfully negotiated a favorable settlement by obtaining a consent decree of permanent injunction and a damage award.

Represented pharmaceutical manufacturers in grand jury investigations regarding data integrity concerns in regulatory submissions to FDA, and alleged cGMP violations. In both cases, the U.S. Department of Justice declined to prosecute the company and individuals under investigation.

Conducted internal investigations into the sales and marketing practices of multiple international pharmaceutical and biotech companies to develop a risk profile and recommendations for reducing potential liability and risk exposure.

Conducted comprehensive prelaunch risk assessments for a Top 10 pharmaceutical company’s blockbuster drug to identify potential medical, scientific, regulatory and products liability risk areas.

Conducted a risk assessment for a top tier biotechnology company’s drug safety system to identify areas for possible improvement in pharmacovigilence planning, postmarket signal detection and investigation, and business decision-making.

Led numerous internal investigations for biotechnology, pharmaceutical and medical device manufacturers into allegations made by current and former employees regarding product integrity issues, sales and marketing activities, and manufacturing quality issues.

Represented several drug and device manufacturers concerning product approvals, and in responding to FDA requests for information relating to promotion and advertising, manufacturing practices, field alerts, recalls and numerous post-market issues.

Represented one of the nation’s foremost cardiovascular institutes and some of the leading interventional cardiologists in responding to deficiencies identified during FDA inspections and developing appropriate corrective action to avoid further FDA regulatory enforcement.

Represented a device manufacturer in obtaining expedited PMA review and approval in 90 days for a first-of-a-kind device to treat aneurysms in the renal vascular arteries. Successfully obtained approval for a major PMA supplement for the same product.

Represented a device manufacturer and coordinated an extensive product investigation into reported failures of an implantable device featuring sophisticated failure analyses and clinical assessments.

Conducted extensive training on FDA regulatory, IRB and protocol requirements for clinical investigators participating in the study of implantable devices.

Assisted numerous companies in preparing for FDA inspections, developing responses to FDA observations (FDA-483 forms) and warning letters related to manufacturing practices, quality systems, adverse event reporting, deviations from approved drug master files and manufacturing processes, and a variety of other regulatory matters. Assisted these companies in preparing for meetings with FDA compliance officials in District Offices, centers for drugs and devices, and the Office of Chief Counsel.