Healthcare: Enforcement, Litigation, Investigations, and Audits

Healthcare False Claims Act (FCA) Litigation

• Defended a Medicare Advantage organization in a DOJ intervened FCA qui tam civil litigation in the Northern District of California
• Defended a Medicare Advantage organization in a direct DOJ civil FCA litigation in the Southern District of New York
• Defended a national pharmacy benefits entity in state agency litigation enforcing new Pharmacy Benefit Manager legislation

Healthcare Antitrust Litigation

• Defended a pharmaceutical company against a multi-billion-dollar class action (MDL) antitrust "reverse payments" claim in the U.S. District Court for Massachusetts. Obtained a unanimous defense jury verdict after a seven-week trial, in the first "reverse payment" antitrust trial after the U.S. Supreme Court's landmark decision in FTC v. Actavis
• Defended a pharmaceutical manufacturer in a long-running action alleging antitrust claims arising from the settlement of patent litigation. Defeated motions for certification of both direct purchaser and end-payor classes. Obtained a precedential opinion on class certification from the Third Circuit
• Defended a pharmaceutical company in antitrust class action litigation related to allegations arising from patent litigation brought by direct purchasers, end payors, and retailers of an opioid pain medication 
• Defended a pharmaceutical company as trial counsel against a class action and individual antitrust claims arising from settlement of patent litigation. Obtained favorable settlements after a multi-week trial 

Health HIPAA and Privacy Litigation

• Represented a medical data management company in a significant data security incident pertaining to international and domestic data
• Represented a national clinical laboratory before the OCR following allegations of improper access to medical records; the regulatory inquiry closed without enforcement

Healthcare Investigations

• Representing a telehealth company in an internal investigation into whistleblower allegations related to device sales and licensure
• Conducted an internal investigation into whistleblower allegations related to a national Medicare Advantage organization's compliance with Medicare Advantage regulations
• Represented a major health insurance company in an investigation regarding billing and reimbursement practices and procedures
• Defended a national Medicare Advantage organization in an investigation into Affordable Care Act commercial risk adjustment practices
• Represented the chief marketing officer of a pharmaceutical company in a DOJ investigation of alleged off-label promotions, potential violation of FCA, and violations of the anti-kickback statute in promoting a branded drug, resulting in termination of the investigation without charges against the client
• Defended a physician group in a DOJ FCA civil investigative demand premised on a Management Service Organization (MSO) lab referral kickback theory

Healthcare Commercial Litigation

• Defended a large pharmaceutical manufacturer in an arbitration over a $2 million breach of contract claim, defeating the claim and recovering $4.35 million on counterclaim
• Led a team that conducted shareholder litigation against three former officers of Tampa-based WellCare Health Plans, Inc., following a Zapata investigation into claims on behalf of an independent director of WellCare

Healthcare Insurance Litigation

• Served as lead trial counsel for numerous ambulatory surgical treatment centers and medical practice groups in numerous cases seeking millions in damages for unpaid claims against a major health insurance company. Following multiple trials, recovered $40+ million for clients, plus pre- and post-judgment interest
• Successfully argued an appeal in the Illinois Supreme Court reversing a trial court's decision to dismiss a podiatric practice group's multi-count complaint against a major health insurer for breaching their provider agreement, resulting in the client recovering millions in unpaid claims at trial (Chatham Foot Specialists, P.C. v. HCSC, 216 Ill. 2d 366, 837 N.E. 2d 48, Ill. 2005)
• Successfully appealed a trial court decision to dismiss an out-of-network provider's complaint alleging promissory estoppel, resulting in a multi-million-dollar recovery at trial and pre- and post-judgment interest (Chatham Surgicore v. HCSC, 356 Ill. App. 3d 795, 826 N.E. 2d 970, 1st Dist. 2005)
• Defended a global health insurance provider in multidistrict shareholder litigation against antitrust, Racketeer Influenced and Corrupt Organizations Act (RICO), and Employee Retirement Income Security Act (ERISA) claims filed because of government investigations into broker compensation practices, resulting in a settlement for the client

Healthcare Labor and Employment Litigation

• As first-chair trial counsel, successfully defended two healthcare system officers against a retaliatory discharge claim during a five-day jury trial in the U.S. District Court for the Eastern District of New York
• Attained summary judgment dismissal of national origin discrimination claims and a retaliatory failure to re-hire claim against a large hospital employer (Saji. v. Nassau University Medical Center, 2:13-cv-03866, E.D.N.Y. 2017); successfully argued and defeated plaintiff's appeal of the dismissal order before the U.S. Court of Appeals for the Second Circuit (Case No. 17-878, 2d Cir. Jan. 30, 2018)
• Won a defense verdict in a $10 million breach of contract case brought by a medical practice group against a hospital
• Represented a large food and beverage company in federal ERISA litigation

Healthcare Pharmaceuticals Litigation

• Represented a pharmaceutical manufacturing company in a civil investigation concerning allegations of Current Good Manufacturing Practice (CGMP) violations and conduct involving the Federal Food Drug and Cosmetic Act (FFDCA)
• Defended a pharmaceutical company and secured a dismissal of a "failure to warn" claim against the client
• Defending a pharmaceutical company as a non-party to California state court litigation
• As co-counsel, negotiated with the FDA to obtain qualified health claims for several nutrient-disease relationships
• Negotiated with the FTC and avoided the issuance of a civil investigative demand, on behalf of a national client that manufactures and distributes homeopathic preparations

Healthcare Product Liability and Mass Torts Litigation

• Served as national counsel in litigation related to a shingles vaccine. Obtained dismissals in nearly 1,200 MDL cases in which the plaintiffs failed to comply with a Lone Pine order requiring plaintiffs to produce laboratory results confirming that the vaccine caused plaintiff's injury. In addition, expert witness challenges led to summary judgment in all 13 bellwether cases
• Served as national counsel to a pharmaceutical company in the defense of an anti-epileptic medication in nationwide litigation over alleged birth defects. Developed, deposed, and defended numerous expert witnesses; prepared and defended several company witnesses; prepared cases for trial; and tried multiple cases to jury verdicts 
• Serve as national counsel for litigation related to a prescription asthma and allergy medication in more than 300 lawsuits in courts throughout the United States. Earned summary judgment in two of the federal cases, and have obtained more than 130 dismissals with prejudice in various jurisdictions
• Serve as co-national counsel for a manufacturer of proton-pump inhibitor medications in more than 6,000 cases in multi-district and state court litigations with allegations of kidney injuries

Healthcare Real Estate Litigation

• Represented a Maryland hospital and prevailed in a Certificate of Need proceeding before the Maryland Health Care Commission, in which the hospital objected to a project in which a competitor sought to relocate its facilities from an urban site to a suburban location. An extended hearing was held on numerous issues relating to the relocation. After the hearing officer issued a proposed decision, finding that the project was not financially feasible, the competing hospital withdrew the application

Healthcare Securities Litigation

• Represented a former board member of a publicly traded pharmaceutical company in a Securities and Exchange Commission investigation regarding a proposed merger
• Represented a leading pharmaceutical company in nationwide litigation against state and local governments

Healthcare Prosecutions (Pre-Venable)

• Prosecuted healthcare fraud claims against a medical practice on behalf of a large New York-based healthcare insurance company
• Led the prosecution of a medical doctor and two nurses for running a healthcare fraud scheme that defrauded Medicare of approximately $9 million