Texas Attorney General Ken Paxton filed a lawsuit Thursday on behalf of the state that takes aim at “false, misleading, and deceptive” marketing practices that Sanofi and Bristol Myers Squibb allegedly engaged in to sell blood thinner Plavix.
Plavix was first approved by the FDA in 1997. In 2010, the regulator added a boxed warning to the antiplatelet med’s label, noting that some patients may not be able to receive its full benefits; those “poor metabolizers” make up between 2% and 14% of the population, per the FDA, and studies have shown that people who are Black, East Asian or Pacific Islander are disproportionately impacted.
A handful of states have filed suit against Sanofi and BMS over their alleged sales and marketing tactics for the then-blockbuster before the warning was added, including Hawaii and New Mexico, among others, and now Texas.
The petition (PDF) claims that the two drugmakers “knew or should have known” since early 1998 that Plavix “has diminished effect on a considerable percentage of patient-consumers, specifically Minority Patients,” but allegedly chose not to disclose that information to protect their bottom line.
Even after the scientific community began to become aware of the potential inefficacies, according to the state, the companies allegedly began to market Plavix as more effective than aspirin and “falsely, misleadingly, and deceptively suppressed and minimized clinical trial data and other information showing that Plavix was in many cases less effective than aspirin in treating patients, and that Plavix has a higher chance of other complications.”
“At bottom, Defendants prioritized profits even if that meant putting patients’ lives at risk,” the complaint claims.
In a joint statement sent to Fierce Pharma Marketing, the Big Pharmas said, “Bristol Myers Squibb and Sanofi will vigorously defend against the Texas Attorney General’s lawsuit concerning Plavix. The overwhelming body of scientific evidence demonstrates that Plavix is a safe and effective therapy, regardless of a patient’s race or genetics. Plavix has helped millions of patients with cardiovascular disease around the world for more than 25 years, is endorsed as a first-line therapy by leading treatment guidelines across the globe and remains the standard of care.”
According to the state, those alleged practices violate both the Texas Deceptive Trade Practices-Consumer Protection Act (DTPA) and the Texas Health Care Program Fraud Prevention Act (THFPA).
It has therefore requested a jury trial to decide the case and is seeking civil damages to the tune of up to $10,000 for each violation of the DTPA. Under the THFPA, it’s asking not only for repayment of all payments or benefits provided by state healthcare programs as a result of the “unlawful acts,” but also civil penalties for those actions, as well as “an additional two times the value of payment(s) and/or benefit(s) unlawfully received by Defendants.”
In Hawaii, for one, the companies were ultimately ordered last year to pay a combined $916 million to the state over similar complaints.
“It’s despicable how Big Pharma puts lives at risk by refusing to be honest with patients,” Paxton said in a release Thursday. “We are going to make Sanofi and Bristol-Myers Squibb pay a heavy cost for their utter lack of regard or concern for Americans and the company’s clear violations of Texas law. Every healthcare and pharmaceutical company should be put on notice that anyone who endangers the health of Americans absolutely will be held accountable.”
The Texas AG has long made a habit of taking legal aim at major drugmakers. Since August, Paxton has filed lawsuits accusing Eli Lilly of “incentivizing” providers to prescribe its drugs and Kenvue of “deceptively” marketing Tylenol to pregnant mothers, citing the dubious claims that purport to link the active ingredient acetaminophen to autism.
And just this week, Pfizer and manufacturer Tris Pharma inked a $41.5 million deal to settle a case brought by Paxton in 2023, accusing them of knowingly providing “adulterated” ADHD med Quillivant XR to children through Texas’ Medicaid program.