Industries: Health Care

Litigation

Medical Devices

We regularly advise clients on navigating the intricate maze of federal regulations governing the design, testing, manufacture, and sale of medical devices. We also have extensive experience in defending medical device manufacturers’ products in litigation.

Some of the medical device products we have defended include:

  • catheters
  • continuous feeding tube devices
  • implantable medical devices
  • intrauterine contraceptive device
  • natural rubber latex medical devices
  • nebulizers
  • orthopedic fixation devices
  • orthopedic replacement joints
  • orthopedic surgical instruments
  • raw material used in medical devices
  • surgical closure devices
  • ventilators

Drugs and Pharmaceuticals

Our services to the drug and pharmaceutical industries include advising clients on product risk management, defending manufacturers and sellers in products liability litigation involving drugs and pharmaceutical products, counseling clients on strategies to comply with regulations governing the pre- and post-market life of a drug, establishing internal programs for compliance with adverse event reporting obligations, representing clients before the Food and Drug Administration (FDA) on pre-market clearances, post-market reporting and surveillance, and other pre-market regulatory compliance, and developing strategies for reimbursement from third-party payers for drug or device-related therapy.

Some of the drugs we have experience with include:

  • benzodiazepine drugs
  • diethylstilbestrol
  • anesthesia drugs
  • fen-phen
  • ophthalmic solutions
  • generic drugs
  • tetracycline
  • topical non-steroidal anti-inflammatory drugs

Risk Management

We advise clients on compliance programs, risk management issues, defense against allegations of medical malpractice, personnel training requirements, operations analysis, incident investigations, National Practitioner Data Bank issues, peer review issues, Health Care Quality Improvement Act (HCQIA) requirements, patients’ rights and ethics, internal audits, and educational in-services.

White Collar Crime

We have considerable experience with federal and state white collar crime statutes, particularly as they pertain to investigation and prosecution of health care institutions and individuals. We conduct internal investigations on behalf of boards of directors and advise management regarding the establishment of compliance programs, with emphasis on DOJ internal guidelines on corporate prosecutions and federal sentencing guidelines.

Fraud and Abuse

We assist clients in preventing federal and state fraud and abuse violations, including anti-kickback laws, self-referral restrictions, and false claims prohibitions. We counsel health care providers who are under investigation for fraud and abuse violations, and defend clients in fraud and abuse litigation.

Antitrust

We have experience defending against antitrust actions, as well as developing business strategies to avoid antitrust problems.