Mark S Brown

Representative Experience

Litigation and Enforcement Matters

• As part of the firm’s team as national coordinating and trial counsel for GlaxoSmithKline (“GSK”) in the Paxil products liability litigation, Mr. Brown represented GSK on all FDA-related issues, including federal preemption.  In January 2008, he won a summary judgment motion on federal preemption grounds for GSK in a Paxil case in O’Neal v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline, No. Civ. S-06-1063 (Jan. 30, 2008).  The ruling in O’Neal is believed to the first case in which a court has fully considered the legal issue of implied conflict preemption and rendered an opinion in a pediatric suicide case brought against an antidepressant manufacturer alleging a failure-to-warn of an increased risk of suicidality.
  
  
• During 2005 to 2008, Mr. Brown served as lead counsel and negotiator for three (3) of the world’s largest medical device manufacturers, including Baxter Healthcare, The General Electric Company, and Medtronic.  He negotiated consent decrees of permanent injunction with FDA and the U.S. Department of Justice relating to quality systems and manufacturing practices successfully resolving enforcement proceedings.  None of these clients were required to pay any monetary penalty or recall products as part of these agreements.
  
  
• In 2002, Mr. Brown represented GSK in federal court and helped successfully defeat a preliminary injunction motion seeking to enjoin GSK from making claims in direct-to-consumer television advertisements for Paxil in a case that received substantial publicity within the pharmaceutical industry.
  
  
• From 1995 to 2001, Mr. Brown served as part of 3M’s National Trial Team in the Silicone Gel-Filled Breast Implant Litigation.  In that capacity, he was responsible for virtually all FDA issues and activities associated with breast implants.  He had primary responsibility for preparation and handling of defense expert witnesses and cross-examination of adverse witnesses on FDA issues.
  
  
• In 1999, on behalf of SmithKline Beecham (‘SB”) and its outside patent counsel, he helped win one of the few successful motions to compel FDA to provide deposition testimony by research scientists in FDA’s Center for Biologics, which proved critical in enabling SB to win a hotly contested patent dispute with Connaught Laboratories relating to a purified form of pertactin, a component of the pertussis vaccine.  Connaught Laboratories v. SmithKline Beecham P.L.C., 7 F.Supp. 2d 477 (D. Del. 1998), appeal dismissed, 165 F. 3d 1368 (1999).
  
  
• Mr. Brown 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.  He successfully negotiated a favorable settlement on behalf if Next Nutrition by obtaining a consent decree of permanent injunction and a damage award in Next Nutrition, Inc. v. SportPharma USA, Inc., No. 97-CV-1898J (1997).
  
  
• He represented a pharmaceutical manufacturer in a grand jury investigation regarding alleged irregularities in regulatory submissions to FDA.  The U.S. Department of Justice Office of Consumer Litigation declined to seek indictment of either the company or any individuals under investigation.
  
  
• Represented pharmaceutical company in a grand jury investigation conducted by the United States Attorney’s Office, for the Eastern District of Pennsylvania concerning alleged cGMP violations which the government ultimately declined prosecution.

Regulatory and Compliance Matters:

• Mr. Brown has conducted internal investigations into the sales and marketing practices of multiple international pharmaceutical and biopharmaceutical companies, including conducting interviews of sales and marketing representatives, directors, and management, reviewing company policies, procedures, and other key documents to develop a risk profile and recommendations for reducing potential liability and risk exposure.
  
  
• Conducted proactive risk assessments for a Top 10 pharmaceutical company’s blockbuster investigational drug to identify potential medical, scientific, regulatory and products liability risk areas in advance of product launch.
  
  
• He 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.
  
  
• Mr. Brown and his colleagues prepared and presented comprehensive, two-day training program for a major pharmaceutical manufacturer related to current enforcement trends with respect to medical, scientific, and health economic activities and communications.  Training was attended by over 350 company employees and has become part of the company’s standard training material.
  
  
• He has conducted internal investigations for several 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.
  
  
• Mr. Brown has represented a variety of pharmaceutical manufacturers concerning drug 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.
  
  
• He 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 obtained PMA 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.
  
  
• Mr. Brown represented a device manufacturer and coordinated an extensive product investigation into reported failures of an implantable device featuring sophisticated failure analyses and clinical assessments.
  
  
• He has conducted extensive training on FDA regulatory, IRB, and protocol requirements for clinical investigators participating in the study of implantable devices.
  
  
• Mr. Brown has assisted numerous companies in preparing for FDA inspections, developing responses to FDA investigational 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 and centers for drugs and devices.
  
  
• At the request of a large pharmaceutical manufacturer. Mr. Brown conducted a comprehensive assessment of the company’s compliance with FDA’s IND and NDA reporting requirements for numerous clinical trials.
  
  
• Represented a large pharmaceutical manufacturer in responding to a wide ranging request from FDA to provide documents and information relating to promotional activities involving one of its best-selling drug products.
  
  
• Assisted a biotechnology company in securing Food and Drug Administration (FDA) release from a safety-related “clinical hold” imposed on gene therapy trials using retroviral vectors, and provided advice on a variety of other issues related to clinical investigations.
  
  
• Conducted a nationwide audit of clinical studies for a medical device client and prepared a report detailing deficiencies and recommending corrective actions.  Assisted in the preparation of procedures for the conduct and monitoring of clinical studies.