Hawaiʻi Court Penalizes Bristol-Myers Squibb and Others $834 Million Re Plavix Ineffectiveness
* Updated February 16, 10:06 AM
Hawai‘i Circuit Court Judge Dean E. Ochiai issued an $834 million state court order against Bristol-Myers Squibb Company and three US-based subsidiaries of French pharmaceutical company Sanofi for violating the State of Hawai‘i’s unfair and deceptive practices laws regarding the prescription drug Plavix.
“The substantial amount reflects the fact the Defendants earned enormous profits while engaged in deceptive conduct that spanned more than a decade,” according to a news release from the office of Hawaiʻi Attorney General Clare E. Connors.
The order arises out of the Defendants’ acts in developing, marketing and promoting Plavix, a prescription drug designed to reduce the risk of serious cardiovascular events such as heart attacks, strokes and blood clots.
According to evidence presented in court, the Defendants began marketing the drug to Hawai‘i physicians and consumers in 1998, “knowing that it was not effective for many patients, including Asian and Pacific Island patients,” according to the AG release.
According to the AG’s release, “Defendants only began warning Hawai‘i physicians and consumers about this issue in March 2010, when the US Food and Drug Administration required them to place a “black box” warning on the label accompanying the drug.”
After a four-week trial that ended in November, Hawai‘i Circuit Court Judge Ochiai concluded that the Defendants deliberately withheld vital information about Plavix’s efficacy from the FDA, the greater medical community and Hawai‘i consumers.
The Court found that between December 1998 and March 12, 2010—when the FDA required Defendants to disclose the warning—the Defendants sold 834,012 prescriptions, refills and non-retail units in Hawai‘i “without including important information about the large percentage of patients who received less benefit or no benefit from Plavix due to their race and genetic makeup.”
Based on this evidence, the Court determined the Defendants “knowingly placed Plavix patients at grave risk of serious injury or death in order to substantially increase their profits.”
The companies reached out to Maui Now in response to the ruling saying, “The Court’s ruling is unsupported by the law and at odds with the evidence at trial, and Bristol Myers Squibb and Sanofi will vigorously appeal the erroneous decision.”
The joint statement on behalf of both Bristol Myers Squibb and Sanofi continued: “The overwhelming body of scientific evidence demonstrates that Plavix is a safe and effective therapy, including for people of Asian descent. Plavix has helped millions of people with cardiovascular disease around the world for more than 20 years, and is endorsed as a first-line therapy by leading treatment guidelines across the globe.”
According to Bristol Myers Squibb, “The penalties awarded by the Court are wholly unsupported, particularly given that the State of Hawaiʻi provided no evidence that even a single person has been harmed by Plavix. Additionally, as every Hawaiʻi doctor at trial testified, the Hawaiʻi medical community recognizes the medical benefits of Plavix and continues to recommend it without restrictions based on racial, ethnic or genetic status.”
The company maintains its stance saying, “We remain confident in the merits of our case and our likelihood of success on appeal.”
According to the Hawaiʻi Attorney General, the Court further found that the Defendants engaged in “immoral, unethical, oppressive or unscrupulous” acts, by choosing not to warn about the risks and benefits of Plavix and instead “buried their heads in the sand.”
Finally, the Court found that Defendants’ acts deprived consumers of the right to make informed choices about the use of Plavix, and found that each distribution of Plavix with its “misleading package label: constituted a violation of Hawai‘i law. Noting that the Defendants’ acts were “unfair and deceptive,” the Court imposed a penalty of $1,000 per violation, for a total of $834,012,000 awarded as penalties.
“Today’s order vindicates seven long years of work by this Department and its attorneys to ensure that companies marketing and selling their products in Hawaiʻi keep the safety and welfare our people at the forefront of their business decisions,” Attorney General Connors said. “The order entered by the Court today puts the pharmaceutical industry on notice that it will be held accountable for conduct that deceives the public and places profit above safety.”
The Attorney General’s Office states that the court’s order highlights Defendants’ “seemingly blind refusal to accept the reality of Plavix’s limitations.” The Court further determined that “[t]hose limitations could potentially contribute to very significant harm, including death, to large groups of patients unable to bioactivate it, or only able to activate it partially.”
*Note: This story has been updated to reflect comments from Bristol Myers Squibb.