HONOLULU — A Hawai‘i Circuit Court judge awarded the state $916 million on Tuesday in a decade-old case alleging unfair and deceptive practices against the makers of a blockbuster blood thinner drug.
Gov. Josh Green said it was a record litigation award for the state stemming from an immense legal effort to protect public safety from companies that wanted to protect profits.
The case, filed in 2014 with the help of two private law firms, alleged that the makers of the drug Plavix, Bristol-Myers Squibb and Sanofi, failed to disclose that their drug was less effective in patients with certain liver-enzyme mutations more prevalent in people of Asian and Pacific Islander descent representing up to 30 percent of people who took the drug in Hawai‘i.
“We feel that companies have a duty to warn patients and doctors that the medication is not going to work properly, which is why we took up this fight,” Green, a medical doctor, said at a news conference in his office. “Ultimately, the court found that the pharmaceutical companies deliberately turned a blind eye on this problem to save profits.”
State Attorney General Anne Lopez added, “The court found that the pharmaceutical companies acted in bad faith.”
The judgement, however, might not be the final outcome in the case, which has had one prior award appealed and appears headed for another appeal.
Bristol Myers Squibb and Sanofi said in a statement that they strongly disagree with the court’s penalty award and that they intend to appeal the decision.
“The unprecedented penalties awarded in this case are unwarranted and out of proportion,” the companies said. “The overwhelming body of scientific evidence demonstrates that Plavix is a safe and effective therapy, regardless of a patient’s race or genetics.”
Bristol Myers Squibb and Sanofi also said that Plavix cases in other states all had been resolved earlier and involved “successful defense” by the companies.
Pat McTernan, an attorney with Cronin Fried Sekiya Kekina & Fairbanks who helped pursue the Hawaii case, said no other cases involved the same issue or scope as Hawai‘i’s case.
The two companies began selling Plavix in 1998 as a better and more expensive alternative to aspirin for reducing heart attacks, strokes, blood clots and vascular death.
In 2010, Bristol Myers Squibb and Sanofi were required by the U.S. Food and Drug Administration to add a “black box” warning on the label about diminished effectiveness for poor metabolizers of the drug with certain genes.
The disclosure prompted the state’s lawsuit, which was filed in 2014 with assistance from Honolulu-based Cronin Fried Sekiya Kekina & Fairbanks along with Dallas-based law firm Baron & Budd.
A trial that lasted over a month took place in 2020 in state Circuit Court and was characterized later by the Hawai‘i Supreme Court as a “battle royale of testifying pharmacology experts, regulatory experts, and medical doctors.”
Rick Fried, an attorney who helped argue the case for the state, said 12 million documents were produced in discovery, including internal emails that shed light on what the companies knew before the warning label was added.
The case did not identify, and was not filed on behalf of, patients who took the drug and were among poor metabolizers.
In early 2021, Circuit Judge Dean Ochiai ruled that the drugmakers engaged in deceptive and unfair acts and practices. He awarded the state $834 million.
The award represented a $1,000 fine for each of 834,012 Plavix prescriptions filled or refilled in Hawai‘i before the warning label was added in 2010.
The two companies appealed on a variety of grounds, and the Hawai‘i Supreme Court ruled in March 2023 that the companies had not been allowed to present a full defense on deceptiveness claims that could affect the penalty award, which was vacated.
A partial retrial in Circuit Court was held from Sept. 25 to Oct. 16, and Circuit Judge James Ashford on Wednesday awarded $834 million over deceptiveness and $82 million over unfairness.
Ashford’s ruling said in part that a significant number of Plavix patients in Hawai‘i were unnecessarily exposed to the risk of an adverse event, including serious physical injury or death.
“This day has been a long time coming,” Fried said at the news conference. “They knew this in ’98, when the drug came out, that it didn’t work particularly well in those ethnic groups, and they kept that secret.”
The court’s award is subject to 10 percent interest if appealed and upheld. The private law firms that assisted the state are to receive 20 percent of the award, or $183 million.
Proceeds received by the state are to be deposited into the general fund, though Green said he would like that revenue to be used to improve Hawai‘i’s health care system.
