On December 9, 2021 Judge Troy L. Nunley of the U.S. District Court for the Eastern District of California temporarily blocked implementation of California’s California Assembly Bill 824, legislation that imposes restrictions on “pay for delay” settlements in pharmaceutical litigation, including the greater of $20 million or three times the affected commerce.
On December 17, 2021, U.S. District Court for the District of New Jersey largely denied the motions to dismiss from Johnson & Johnson pharmaceutical unit and affiliates from a patent attorney’s False Claims Act lawsuit over the prostate cancer treatment Zytiga, finding that the complaint adequately alleged that the company obtained a patent under false pretenses, before the eventual invalidation of the patent. The lawsuit alleged Janssen obtained the patent after several failed attempts patent regulators by misrepresenting Zytiga’s market share and then trying to delay generic competition with sham infringement litigation.
The U.S. House of Representatives’ Committee on Oversight and Reform released a staff report detailing the results of their multiyear investigation into U.S. drug pricing. The report found numerous drug companies raising prices “with abandon, especially when they succeed in delaying or blocking competition”. The report included internal documents revealing that manufacturers have raised prices specifically to meet ever-increasing revenue targets, which were often tied to higher executive bonuses, and efforts to shut down competition from the generic-drug industry by using anti-competitive strategies.
On December 10, 2021, Blue Cross and Blue Shield of Minnesota (“BCBS Minnesota”), on behalf of a putative class of health care end payors, announced a settlement in principle with Vyera Pharmaceuticals, LLC (“Vyera”) and two of its executives, including Martin Shkreli, over their alleged anticompetitive conduct to protect exorbitant price increases for Daraprim.
The Court found that, while an antitrust defendants’ share of the relevant market is typically used as evidence of monopoly power, this is not necessary in the highly-regulated market for pharmaceuticals. The allegations provided sufficient evidence to create a genuine dispute of material fact as to whether Ranbaxy maintained monopoly power due to its first-filer status and the resulting exclusionary periods. This would give Ranbaxy the ability to reduce or destroy competition in the relevant market.
On November 17, 2021, the U.S. District Court for the District of Kansas granted final approval of a $345 million settlement by Pfizer with a class of purchasers of EpiPen. The purchaser class alleged that Pfizer and Mylan schemed to inflate the price of the EpiPen, an emergency injectable allergy treatment.
On November 4, 2021 the end-payor class in antitrust litigation alleging anticompetitive conduct in the market for combination antiretroviral therapy (“cART”) drugs announced a $10 million settlement with Defendants Bristol-Myers Squibb Company and E.R. Squibb & Sons, L.L.C. (“BMS”).
Two U.S. subsidiaries of Indian pharmaceutical company Sun Pharma announced preliminary settlements with a putative class of direct purchasers in the generic price-fixing multidistrict litigation pending in the U.S. District Court for the Eastern District of Pennsylvania. Taro Pharmaceuticals USA Inc. and Sun Pharmaceutical Industries Inc. will pay a total of $85 million to resolve the direct purchaser claims.
The U.S. Securities and Exchange Commission (SEC) finished fiscal year 2021 with record breaking rewards, paying a combined $564 million. The SEC also reached a new high for total whistleblower award recipients at 108 individuals.
The SEC whistleblower reward program is a program authorized by Congress to reward individuals who bring forward information about security fraud or other wrongdoing resulting in SEC sanctions and recoveries. After the SEC secures a sanction or verdict, whistleblowers can receive a portion of the sanction. This program is intended to entice those with knowledge of wrongdoing to step forward and reveal information to government agencies.
Residents of assisted living facilities operated by Aegis Senior Communities LLC (Aegis) will share in a settlement fund of $16.25 million awarded as part of a class action settlement approved by the United States District Court for the Northern District of California on August 23, 2021.