State awarded more than $900M against pharma companies that failed to disclose efficacy for a blood thinner drug

The state of Hawai‘i was awarded $916,012,000 against pharmaceutical companies that violated the state’s laws against unfair and deceptive practices for failing to disclose the efficacy and safety profile of the drug Plavix.

Companies involved in the payout include Bristol-Myers Squibb Company and three U.S.-based subsidiaries of French pharmaceutical company Sanofi.

“Once actually received by the state general fund, I anticipate that this award will provide greater health care services to the people of Hawai‘i. The state has many needs and these funds will help us improve delivery of expanded health care to our residents,” said Gov. Josh Green.

Plavix is an oral antiplatelet medication (a form of blood thinner) in tablet form and is a “prodrug.” Unlike most other medications, which are active when ingested, a prodrug is activated by enzymes in the patient’s liver.

Following a trial, First Circuit Court Judge James Ashford found that from the launch of Plavix in 1998, the defendant pharmaceutical companies knew “that there was a risk that about thirty percent of patients might have a diminished response to Plavix,” particularly in members of non-Caucasian races, “but they did not update their label.”

Ashford concluded that the defendants’ “unfair acts or practices were deliberate and pervasive, and they slowed and negatively affected the development of science related to Plavix for over a decade,” and “[b]y suppressing research, Defendants created an environment where Hawaiʻi prescribing physicians practiced for more than a decade without the necessary information needed to evaluate the serious limitations of this heart medication.”

Ashford found that the defendants “deliberately turned a blind eye toward the diminished response problem because of Defendants’ concern that addressing that problem might adversely affect Plavix sales and Defendants’ profits.” In enforcing Hawaiʻi consumer protection statute, the court concluded that Hawaiʻi had a heightened interest in this case because “the omission of warning information raises a serious risk of harm to all consumers, but a particularly high risk to patients of East Asian and Pacific Island descent, who represent a significant portion of Hawaiʻi’s population.”

The Court in its order awarded the state $458,006,000 from Bristol-Myers Squibb Company and $458,006,000 from the three Sanofi subsidiaries, for a total of $916,012,000.

“This case was originally filed in 2014 by Attorney General David Louie, and I applaud him for his foresight and courage in pursuing this matter,” said Attorney General Anne Lopez. “As Judge Ashford found following a trial, these pharmaceutical defendants acted in bad faith and marketed a product that could potentially have devastating effects on Hawaiʻi patients, when they knew that the medicine would lack efficacy for a substantial portion of the population. The Department of the Attorney General stands for the right of people of Hawaiʻi to be informed of the facts before choosing a path to take with respect to their own medical care.”

“After over 10 years, two trials, and a split Hawaiʻi Supreme Court decision, it is a great day for Hawaiʻi consumers,” said Special Deputy Attorney General Rick Fried, of the Honolulu law firm Cronin, Fried, Sekiya, Kekina & Fairbanks. “Plavix must be, unlike aspirin, activated by the liver and a high number of Asian and Pacific Islanders have a liver that does not activate Plavix. The drug companies knew this from the time the drug was first sold in 1998, and they hid this information until the Food and Drug Administration required a black box warning in 2010. This drug is used to treat prior heart attack, stroke, or peripheral artery disease. If the drug is not metabolized it is effectively providing no protection. The black box warning remains to this day.”

The case is State of Hawaiʻi ex. rel. Anne E. Lopez, Attorney General v. Briston-Myers Squibb Company et al., Civil No. 1CC141000708. A copy of the Findings of Fact, Conclusions of Law, and Order can be found here.