Frederick (Rick) Ball focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies.
Mr. Ball helps generic pharmaceutical companies, biologics manufacturers, medical device manufacturers, food companies, pharmacies, long term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries including complying with current Good Manufacturing Practices, price reporting, the Foreign Corrupt Practices Act, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements.
Mr. Ball also assists generic manufacturers bring product to market through patent analysis and Hatch-Waxman litigation. Mr. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation.
Finally, Mr. Ball helps companies maintain their trade secrets and competitive advantage through trade secrets litigation and enforcement of restrictive covenants. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal.
- Represented a generic pharmaceutical manufacturer in Inter Partes Review litigation related to a prescription drug resulting in an agreement to settle with a license date prior to expiration of patents.
- Obtained a voluntary no-pay dismissal for a pharmaceutical distributor after filing a summary judgment motion establishing that our client’s over-the-counter talcum powder was not contaminated with asbestos and that the plaintiffs’ personal injury claims were preempted by the Federal Food, Drug and Cosmetics Act.
- Obtained on behalf of Novel Laboratories Inc. a settlement of a patent litigation matter, which will allow Novel to begin marketing its generic form of a medication well prior to the expiration of the patents.
- Represented Wockhardt in Paragraph IV litigation involving Otsuka’s oral Abilify. Negotiated a settlement and license agreement permitting entry into the market prior to the expiration of the Orange Book Patents.
- Obtained a settlement for Wockhardt, a global pharmaceutical and biotechnology company, with Abbott and Alkermes regarding the drug Tricor.
- Represented generic pharmaceutical manufacturer Wockhardt in Paragraph IV and Hatch-Waxman litigation, obtaining settlement allowing entry into the market prior to patent expiration.
Education : Cornell Law School, J.D., 1996
- U.S. Court of Appeals for the Seventh Circuit
- U.S. Court of Appeals for the Eighth Circuit
- High Mowing School , – Board of Trustees, 2016
- Illinois State Bar Association
- Food and Drug Law Institute, – Executive Committee, 2016
Rate : $$$