09/06/24 | Federal Judge Certifies Class, Allowing Tracleer Lawsuit to Continue
In two Sept. 6, 2024, opinions, Chief United States District Judge George L. Russell III largely denied defendants’ motions to exclude the plaintiffs’ expert testimony and certified a class of hundreds of insurers and self-funded employers, and appointed Hagens Berman’s Tom Sobol as co-lead class counsel. The court also rejected Actelion's bid for summary judgment, in another win for plaintiffs. Read the opinion certifying the class »
Hagens Berman represents plaintiffs in this class-action lawsuit alleging that defendants engaged in a scheme to prolong their monopoly over Bosentan, a drug that they sell under the brand name Tracleer at an average cost of about $100,000 per patient per year.
Hagens Berman has filed a class-action lawsuit on behalf of Government Employees Health Association and a proposed class of drug purchasers against Swiss brand-name drug maker Actelion Pharmaceuticals Ltd. and its U.S. subsidiary, along with their affiliate Janssen Research & Development LLC. In the consolidated amended complaint, plaintiffs allege that these defendants engaged in a scheme to prolong their monopoly over Bosentan, a drug that they sell under the brand name Tracleer at an average cost of about $100,000 per patient per year.
ABOUT ACTELION'S ALLEGED TRACLEER MONOPOLY
Tracleer treats Pulmonary Arterial Hypertension (PAH), a disease affecting between 10,000 and 20,000 people in the U.S., most of them women. PAH is a progressive condition and usually fatal if not treated. As alleged, Tracleer is a highly profitable drug that earns billions for Actelion.
Bosentan is an important drug for PAH patients, but it also carries serious side effects. The drug is subject to a safety program put in place by the FDA to alert prescribers, pharmacists and patients to its risks and track patients’ usage. According to the complaint, Actelion took advantage of these safety precautions to accomplish its scheme.
Citing safety risks, Actelion allegedly refused to sell samples of Tracleer to generic companies that were seeking to file for FDA approval of generic Tracleer. According to the lawsuit, Actelion blocked its distributors from doing so and relied on the principle that companies are under no duty to do business with their competitors – denying that antitrust law imposes limits on that rule. Without samples, no generic drug company can demonstrate to the FDA that a generic product is bioequivalent to the brand drug, and they cannot even file an application for marketing approval, let alone get such approval.
The complaint states that the purpose and effect of Actelion’s scheme was to delay generic competition and maintain the Tracleer monopoly, with the result that no generic Tracleer was approved for sale until the spring of 2019, years after Actelion’s last patent had expired.
TRACLEER CASE STATUS
The case is pending in the U.S. District Court for the District of Maryland in Baltimore (Honorable George L. Russell III presiding). The case has been in active discovery since the Fourth Circuit U.S. Court of Appeals reversed the district court’s initial dismissal of the lawsuit. Expert discovery closes in May 2023, and class certification petitions will be filed thereafter. The Court has not yet set a date for trial.
TOP PHARMA LAW FIRM
Hagens Berman is one of the most successful litigation law firms in the U.S. taking on pharmaceutical companies and has achieved more than $320 billion in settlements against Big Pharma largest sellers and manufacturers for antitrust schemes, pay-for-delay, IP shams and other forms of wrongdoing that drive up the costs of prescription drugs for consumers and others.
CASE TIMELINE
On Jan. 23, 2019, the district court appointed Thomas M. Sobol as one of two co-lead class counsel for the prospective class of Tracleer purchasers, seeking to recover the amounts overpaid for Bosentan during the period that the generic alternatives were blocked from the market by Actelion’s scheme.
