Cliff Katz represents generic pharmaceutical companies in complex commercial litigation. His litigation practice includes pharmaceutical pricing, antitrust, breach of contract, federal and state false claims acts, consumer protection laws, fraud, class actions, products liability, opioid-related claims, and Hatch-Waxman patent litigation. In addition, he has extensive experience counseling pharmaceutical clients on transactions with partners, customers and vendors, Medicaid and Medicare issues, pricing and antitrust policies, and opioid-related obligations and liabilities.
Cliff is thorough when it comes to case evaluation and defense strategy development. His meticulous attention to detail has allowed him to manage and contain costs during the discovery phase, prepare and defend his witnesses for depositions and trial, effectively cross-examine witnesses, and consequently, build a record that puts his clients in a position to prevail.
Pro Bono Counsel for A Foundation Building Strength for Nemaline Myopathy
Fraud / False Claims Acts / Consumer Protection Acts
Representing multinational pharmaceutical manufacturers in numerous federal and state actions across the country, concerning alleged violations of federal and state false claims acts, state consumer protection and deceptive trade practices acts, false advertising acts, and common law fraud in connection with the Medicaid and Medicare programs and health plans. These actions have included qui tam litigation, class action litigation, as well as cases brought by the United States Department of Justice and state attorneys general. In these actions, Cliff has taken and defended more than 75 depositions of qui tam relators, federal Medicare and Medicaid officials, state agency officials from more than a dozen states, present and former pharmaceutical company employees, wholesalers, pharmacies, pharmacy associations, pharmaceutical industry publishers, Medicaid fiscal agents and industry consultants.
Represented eligible telecommunications carriers (ETCs) in investigations by the Office of Inspector General (OIG) of the Federal Communications Commission (FCC) with respect to the federal Lifeline program.
Member of the team that prosecuted claims for approximately $1.2 billion on behalf of JPMorgan Chase Bank, against 11 insurance companies over surety bonds written in connection with transactions that the bank entered into with Enron Corp. A favorable settlement was achieved after closing arguments following a month-long trial.
Antitrust and Pricing
Representing a generic pharmaceutical company in the multidistrict antitrust litigation, In re Generic Pharmaceuticals Pricing Antitrust Litigation
. This MDL includes actions brought by private class action plaintiffs and state attorneys general.
Represented a generic pharmaceutical company in an action concerning the enforcement of a Hatch-Waxman settlement agreement.
Represented a generic pharmaceutical company in a “pay-for-delay” antitrust investigation.
Counseling generic pharmaceutical companies on the setting of published prices and contract prices.
Counseling generic pharmaceutical companies on pricing and antitrust policies.
Representing generic pharmaceutical company in breach of contract action relating to acquisition of company.
Represented generic pharmaceutical companies in breach of contract actions involving the manufacturing, supply and marketing of drugs.
Represented generic pharmaceutical company in breach of contract action involving the development of a drug.
Represented generic pharmaceutical company in breach of contract action involving alleged force majeure issues.
Represented generic pharmaceutical company in breach of contract action involving the supply of a medical device.
Representing generic pharmaceutical companies in the negotiation of contracts with wholesalers, pharmacies, group purchasing organizations, suppliers and other customers and vendors.
Representing generic pharmaceutical company in negotiating co-development agreements.
Assisted in successfully defending a major alarm service company in actions seeking damages for losses sustained as the result of the alarm company’s alleged gross negligence and breach of contract.
Represented a national life insurance company in a variety of actions alleging fraud, breach of contract and negligence.
Represented a life insurance trade association as amicus curiae in the Delaware Supreme Court. Assisted life insurance companies in obtaining a decision by the Delaware Supreme Court holding stranger-originated life insurance (STOLI) illegal and against public policy, and permitting life insurance companies to challenge STOLI policies as void ab initio after the expiration of the two-year statutory contestability period.
Products Liability and Opioids
Obtained a dismissal of all claims against a generic pharmaceutical company in the multidistrict litigation, In re: Zantac (Ranitidine) Products Liability and Opioids Litigation
Representing a generic pharmaceutical company in the multidistrict litigation, In re: National Prescription Opiate Litigation
Counseling generic pharmaceutical companies on insurance coverage for opioid-related claims.
Counseling generic pharmaceutical company on policies relating to controlled substances.
Representing multinational generic pharmaceutical manufacturers in Hatch-Waxman patent litigation, trials and appeals, including:
- Forest Laboratories, LLC v. Breckenridge Pharmaceutical, Inc., Civil Action No. 14-1504-SLR (D. Del.), and Appeal No. 2017-2369 (Fed. Cir.) (asenapine maleate)
- Novartis Pharm. Corp. v. Natco Pharma Ltd., Civil Action No. 1:15-cv-00987-LPS (D. Del.) (imatinib)
- Eli Lilly & Co. v. Lupin Ltd., Civil Action No. 1:15-cv-673 (S.D. Ind.) (prasugrel)
- Daiichi Sankyo Company, Ltd. v. Accord Healthcare Inc., USA, IPR201501881, IPR201501882 (PTAB), and Appeal No. 171052 (Fed. Cir.) (prasugrel)
- Endo Pharmaceuticals Solutions Inc. v. Paddock Laboratories, LLC, Civil Action No. 14-1422-SLR (D. Del.) (testosterone undecanoate)
- AstraZeneca AB et al. v. Lupin Limited, Civil Action No. 3:15-cv-6092 (D.N.J.) (esomeprazole)
- Forest Laboratories, LLC v. Lupin Limited, Civil Action No. 1:14-cv-01058-LPS (D. Del.) (memantine XR)
- Otsuka Pharmaceutical Co., Ltd. v. Lupin Atlantic Holdings SA, Civil Action No. 1:14-cv-07105-JBS-KMW (D.N.J.) (aripiprazole)
- G.D. Searle LLC v. Lupin Pharmaceuticals Inc., Civil Action No. 13-CV-121 (E.D.Va.) and Appeal No. 2014-1476 (celecoxib)
- Sciele Pharma, Inc. v. Lupin Pharmaceuticals, Civil Action No. 09-CV-0937 (D. Del.) and Appeal No. 2012-1228 (Fed. Cir.) (metformin ER)
- Orexo AB v. Mylan Pharmaceuticals Inc., Civil Action No. 11-CV-03788 (D.N.J.) (zolpidem)
Representing a media company in actions involving ad insertion technology.
Represented a national testing laboratory in actions concerning patent infringement and breach of contract.
Represented disabled children and parents in actions against the New York City Department of Education under the Individuals with Disabilities Education Improvement Act.