Explosive Accusations: HMO Claims BMS Engaged in Patent Fraud to Preserve Pomalyst Monopoly

Legal Fireworks: Blue Cross and Blue Shield of Louisiana Drops a Bombshell Lawsuit on Bristol Myers Squibb Over Pomalyst

In a stunning legal showdown, Blue Cross and Blue Shield of Louisiana has unleashed a class action lawsuit against pharmaceutical giant Bristol Myers Squibb (BMS), accusing the company of a high-stakes scheme to unlawfully prolong its market dominance of the multiple myeloma wonder drug, Pomalyst (pomalidomide).

Joining the fray is HMO Louisiana, a subsidiary of Blue Cross and Blue Shield of Louisiana, and together they represent a proposed class of entities across the U.S. and its territories who footed the bill for Pomalyst from October 2020 onwards.

The explosive 151-page legal dossier lays bare the not-for-profit health insurance company’s allegations. BMS, along with its subsidiary Celgene, is accused of orchestrating patent fraud by allegedly concealing and misrepresenting vital data about Pomalyst that was already public knowledge.

But that’s not all—the legal complaint delivers a second punch, claiming that BMS and Celgene manipulated the federal judicial system by launching what it calls a barrage of “sham lawsuits” against generic drug companies attempting to enter the U.S. pomalidomide market. The lawsuit asserts that BMS and Celgene went further, engaging in anti-competitive practices by allegedly paying off several competitors to withdraw their legal challenges to pomalidomide patents, thus delaying their entry into the U.S. market.

Among the generic competitors named in the lawsuit are Teva, Aurobindo, Eugia, and Natco. The lawsuit alleges that these deals, shrouded in secrecy, involved payments in the nine figures—far exceeding the potential revenues these generic companies could have earned, even if they had won their patent litigation battles.

As a result of these alleged machinations, the plaintiffs and other Pomalyst purchasers contend that they have collectively overpaid by potentially hundreds of millions, if not billions, of dollars. Seeking both monetary restitution and injunctive relief, the plaintiffs emphasize that the alleged violations are ongoing.

Pomalyst, an immunomodulatory antineoplastic agent, is no stranger to controversy. It suppresses the growth of hematopoietic cancer cells and triggers their programmed cell death, all while enhancing the function of T-cells and natural killer cells. However, the drug comes with a serious boxed warning regarding embryo-fetal toxicity and venous and arterial thromboembolism.

Originally developed by Celgene, Pomalyst gained its first FDA approval in February 2013 for multiple myeloma. In May 2020, it secured another indication for AIDS-related and HIV-negative Kaposi Sarcoma. BMS entered the picture in 2019, acquiring Celgene in a monumental $74 billion deal.

Pomalyst has since become one of BMS’ shining stars, raking in nearly $3.5 billion in 2022—an impressive 5% boost from its 2021 sales.

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