On the eve of trial, January 3, 2020, Allergan, the parent company of Warner Chilcott and Watson Pharmaceuticals, agreed to a settlement with the Third-Party Payor Class Plaintiffs with respect to Loestrin 24 FE (“Loestrin”), a top-selling birth control drug, for a total $62.5 million, rather than face trial over antitrust claims that the company colluded with would-be generic manufacturers, Watson and Lupin Pharmaceuticals, to delay lower-priced generic versions of Loestrin. The settlement was preliminarily approved by Judge William E. Smith for the United States District Court of Rhode Island on March 23, 2020. The End-Payors previously settled with Lupin Pharmaceuticals for $1 million, which settlement received preliminary approval on December 21, 2019.  The final approval hearing for both settlements is currently scheduled for August 27, 2020.

Cohen Milstein serves as Co-Lead Counsel to the certified class of Third-Party-Payors.

Case Background

Filed on October 3, 2013 the lawsuit alleges that Warner entered into agreements with Lupin and Watson to delay the market entry of a generic version. Through these settlements, Warner sought to delay competition in order to artificially inflate its prices.  The district court initially dismissed plaintiffs’ claims, on the grounds that the alleged payment at issue was not in the form of cash, based on its assessment of the Supreme Court’s ruling in FTC v. Actavis, a similar pay-for-delay lawsuit.

In February 2016 the U.S. Court of Appeals for the First Circuit found that the lower court’s assessment of the U.S. Supreme Court’s ruling of FTC v. Actavis was too strict, and that non-cash reverse payments, potentially including licensing deals and agreements, should also be assessed. This appellate ruling enabled Loestrin purchasers to file amended complaints in the district court in May 2016.

On remand, the District Court denied Defendants’ motion to dismiss.  In addition to plaintiffs’ pay-for-delay allegations, Judge Smith’s August 2017 ruling allowed the plaintiffs’ claim that there was so-called Walker Process fraud in how Warner secured the patent that allowed it to keep its branded exclusivity. The suits claim that, among other things, Warner withheld from the U.S. Patent and Trademark Office a study that either wasn’t sufficient or would have proved the drug had been in public use for a year, meaning it was not patent eligible.

Judge Smith also allowed plaintiffs “product hopping” antitrust claims, which allege that Warner took a successful drug off the market to replace it with a reformulated version, forcing patients to switch to the new formulation in order to avoid competition as to its previous formulation of the drug.

On September 17, 2019, Judge Smith granted Plaintiffs’ Motion for Class Certification of a class of Third-Payor Payors. The motion was hotly contested following the First Circuit’s decision reversing certification in a similar pay-for-delay case involving end-payors and the drug Asacol.

On December 21, 2019 Judge Smith granted preliminary approval of a $1 million settlement between Lupin Pharmaceuticals Inc. and End-Payors. Trial against the remaining defendant, Warner Chilcott, was scheduled for January 2020 before the parties reached an eve-of-trial settlement agreement.

The case name is: In re Loestrin 24 FE Antitrust Litigation, Case No. 1:13-md-02472, U.S. District Court, District of Rhode Island.