Connecticut et al. v. Teva Pharmaceuticals USA, Inc. et al., No. 2:19-cv-02407, (E.D. Pa. filed in MDL 05/30/2019)
44 plaintiff states filed suit against Teva Pharmaceuticals and 19 of the nation’s largest generic drug manufacturers alleging a broad conspiracy to artificially inflate and manipulate prices, reduce competition and unreasonably restrain trade for more than 100 different generic drugs. The lawsuit was originally Connecticut, was transferred to the MDL court in Pennsylvania. The lawsuit…
Connecticut, et al. v. Sandoz, et al., Case No. 20-cv-3539 (E.D. Pa. June 10, 2020), MDL 2724 (E.D. Pa.)
Plaintiff states filed a third lawsuit stemming from the ongoing antitrust investigation into a widespread conspiracy by generic drug manufacturers to artificially inflate and manipulate prices, reduce competition, and unreasonably restrain trade for generic drugs sold across the United States. The complaint focuses on 80 topical generic drugs and names 26 corporate Defendants and 10…
In the Matter of Investigation of Emergent BioSolutions, Inc.. Assurance No. 19-156 Dec. 31, 2019)
New York reached an agreement with Emergent BioSolutions, manufacturers of the opioid overdose reversal nasal spray NARCAN, to allow additional companies to gain access to the nasal spray delivery devices developed by Emergent. In February 2016, Adapt Pharma, Inc. launched a naloxone nasal spray, branded as NARCAN, in the United States. Naloxone has been used…
Alabama et al. v. Endo International, No. 3:19-cv-04157 (N.D. Cal. July 19, 2019)
Eighteen states reached a settlement with Endo Pharmaceuticals Inc. under which Endo paid $2.3 million to settle allegations it entered into a reverse-payment agreement to obstruct generic competition to Lidoderm, a pain relief patch frequently used to treat shingles. According to the complaint, Endo had an agreement with Watson Laboratories Inc. ensuring Endo would not face…
FTC et al. v. Vyera Pharmaceuticals, No. 1:20-cv-00706 (S.D.N.Y. Apr. 19, 2020)
The FTC, New York and six other states filed suit against Vyera Pharmaceuticals, its parent company, Phoenixus and its former officers, Kevin Mulleady and Martin Shkreli, alleging anticompetivie conduct in connection with Daraprim, the only FDA approved drug for the treatment of the life-threatening parasitic disease toxoplasmosis. The suit alleges that Vyera purchases the unpatented…
Florida v. Abbott Laboratories and Geneva Pharmaceuticals, Inc.
The brand name maker of the prescription drug Hytrin, Abbott, entered into an agreement with Geneva to keep Geneva’s generic version of Hytrin off the market. Geneva was paid a substantial amount of money by Abbott while Abbott continued to collect monopoly profits on its name brand drug. Because of federal regulatory system for new generic entry, Geneva effectively blocked the entry of other generic drug makers. The matter settled in conjunction with MDL litigation.
State of California v. Teva Pharmaceutical Industries, Ltd. et al., No. 2:19-cv-03281 (E.D. Pa. 2019)
California agreed to four settlement agreements with pharmaceutical companies to resolve claims that they entered into collusive “pay-for-delay agreements.â€
The state argued that Teva delayed entry of generic competition through four pay-for-delay agreements that illegally maintained its monopoly over Provigil sales between 2006 and 2012. This resulted in artificially high costs of Provigil for consumers. The state secured $69 million for California and a 10-year injunction prohibiting Teva from entering into pay-for-delay agreements. As part of the $69 million settlement, a $25,250,000 consumer fund will be created for California residents who purchased Provigil, Nuvigil or Modafinil during this time.
The state also argued that Teva, Endo Pharmaceuticals, and Teikoku entered into pay-for-delay agreements regarding Lidoderm, a medical patch to relieve shingles pain. In June 2019, the state settled with Endo Pharmaceuticals, securing an eight-year injunction against further pay-for delay agreements and payment of $760,000. The settlement also included a 20-year injunction against Teikoku, a partner in the production of Lidoderm with Endo.
California et al. v. Teikoku Seikayu Co.(Lidoderm), No. 3:18-cv-00675 (N.D. Cal. 01/31/18)
Plaintiff states alleged that defendant, the producer of Lidoderm (pain medication), paid or incentivized generic drug makers to delay entry into market to protect its monopoly on Lidoderm. (“pay for delay”) The settlement agreement, which expires in twenty years, prohibits Teikoku from entering into agreements that restrict generic drug manufacturers from researching, manufacturing, marketing, or selling products for a period of time and requires Teikoku to cooperate in an ongoing investigation into similarly anticompetitive conduct by other drug manufacturers, among other things.
State of California ex rel. Becerra v. Watson Laboratories, Inc., No. 17-cv-00562 (N.D. Cal. Feb. 3, 2017)
Plaintiff state filed complaint alleging violations of the Sherman Act and California’s Cartwright Act. the complaint alleged an anticompetitive pay-for-delay agreement with respect to the Lidoderm pain relief patch. According to the complaint, Watson Pharmaceuticals Inc. colluded with its competitors and fixed the price of the generic version of the drug.
Watson, which subsequently was acquired by Teva Pharmaceutical Industries Ltd., allegedly agreed to settle a patent infringement suit with its competitor Endo Pharmaceuticals Inc., which was the only producer of the name-brand pain relief patch. Pursuant to the agreement, Endo agreed to allow Watson to sell branded Lidoderm at no cost, if Watson agreed to hold off on its release of a generic version of the drug. Then, when Watson released its generic version, Endo did not release its own generic version for nearly eight months, the suit claims.
According to the complaint, “The threat of generic entry to Lidoderm posed significant financial risks for the company,â€ and “Endo knew that generic competition would decimate its Lidoderm sales and that any delay in generic competition would be highly profitable for Endo, but very costly for consumers.â€
California settled with Endo for a $760,000 payment (not characterized as attorneys’ fees or civil penalties) and an eight-year injunction preventing future pay-for-delay conduct.
FTC and Plaintiff States v. Mallilnckrodt Ard Inc. (formerly Questcor), No. 1:17-cv-00120 (D.D.C. Jan. 18, 2017)
Four states and the FTC reached a $100 million settlement with Mallinckrodt plc and its US subsidiary, formerly known as Questcor Pharmaceuticals, Inc. resolving a lawsuit accusing Questcor of monopolizing the market for Achthar, the only adrenocorticotropic hormone (ACTH) based therapeutic drug sold in the United States. ACTH is used as a last resort to treat infantile spasms and multiple sclerosis. Questcor allegedly blocked competition for Acthar by disrupting the bidding process and acquiring the U.S. rights for Synacthen Depot, the only other ACTH based drug sold in the world. In 2001, Questcor bought the rights to Acthar and increased the price of it by 85,000 percent, charging over $34,000 for a vial of the drug that used to cost $40 per vial. In 2012, Novartis Pharma A.G sold the U.S. rights of Synacthen, Achthar’s only competitor. The complaint alleges that three other companies had all conducted due diligence and submitted formal offers for Synacthen with plans to develop and launch Synacthen in the United States in direct competition with Questcor. However, perceiving the threat to its U.S. monopoly if a rival drug company purchased the assets, Questcor stepped in to outbid the three other companies, offering Novartis $135 million in guaranteed payments with only vague plans for Synacthen and after very limited due diligence. Through the acquisition, Questcor sought to extinguish the most likely challenges to its Acthar monopoly. According to the complaint, this allowed Questcor to continue charging over $34,000 per vial for H.P. Acthar Gel. In addition to paying $100 million in disgorgement, Under the settlement, Mallinckrodt will pay $100 million. The company will also be required to license a competitor to the rights it acquired from Novartis to commercialize and develop Synacthen in the United States, including the Synacthen trademark, along with clinical trial data and certain intellectual property related to manufacturing and formulation. Mallinckrodt is also prohibited from taking actions that would interfere with clinical trials or clinical plans for Synacthen.