The parents of a 26-year-old California man who died of an opioid overdose have sued the Waltham manufacturer of Vivitrol, the medication he took to treat his addiction, in a case that highlights the controversies surrounding the response to the nation’s opioid crisis.
The wrongful-death suit alleges Alkermes failed to warn of the high risk of overdose when patients stop taking Vivitrol and then relapse into opioid use. It also claims Vivitrol is ineffective and deceptively marketed.
The company said in a statement that it stands by "the efficacy and safety of Vivitrol and will vigorously defend the matter.”
Adam H. Weintraub, one of plaintiffs’ attorneys, said that as far as he knows this suit, filed in Superior Court in Los Angeles Jan. 31, is the first personal-injury lawsuit involving Vivitrol, the newest of three medications to treat opioid addiction.
The legal action brings an ironic twist to the debate over the role of pharmaceutical companies in the opioid crisis, said Leo Beletsky, a Northeastern University professor of law and health sciences. Multiple lawsuits have blamed the explosion of opioid-related deaths on the marketing practices of painkiller manufacturers such as Purdue Pharma. “Meanwhile,” Beletsky said, “some of the same practices are happening on the treatment side.”
The suit against Alkermes goes to the heart of longstanding complaints about Vivitrol’s marketing, which critics say plays into biases and misconceptions about the other two anti-addiction drugs, methadone and buprenorphine (often referred to by the trade name Suboxone).
“Alkermes has been disparaging the efficacy of methadone and Suboxone,” said Wendy R. Fleishman, a lawyer with Lieff Cabraser Heimann & Bernstein, the firm that sued on behalf of Thomas Mark Stafford and Mary Stafford, parents of the man who died. “We know they work. They’re the gold standard for treatment . . . You can’t disparage the gold standard in order to try to sell your drug.”
In December, the Food and Drug Administration accused Alkermes of “misbranding” Vivitrol by omitting warnings, in a journal advertisement, about the risk of overdose.
Vivitrol, a once-a-month injection, blocks the effects of opioids in the brain. Unlike with the other medications, patients must first clear all opioids from their system, an often painful process that takes seven to 10 days. If they miss the monthly Vivitrol shot and relapse, they are at risk of overdosing because their tolerance for opioids has been reduced.
That’s what happened to Clayton Stafford two years ago, according to the lawsuit.
Stafford suffered from body dysmorphia disorder, a mental illness in which patients focus on perceived flaws in their appearance. Born in New Orleans, he moved with his mother, Mary Stafford, to Los Angeles to seek treatment. Meanwhile, he turned to opioids to cope with the stress of his illness, the suit states. (It does not specify which drugs.)
Seeking help for her son, ’s addiction, Mary Stafford saw “advertising for Vivitrol that touted its effectiveness and superiority in comparison to the other addiction therapy drugs on the market,” according to the complaint.
“She thought she had found a wonder drug,” said Weintraub, who is with Weintraub Law in New Orleans.
In 2016, Stafford found a physician who prescribed Vivitrol for Clayton. The next year, he relapsed on an opioid and entered treatment at a clinic that required him to detoxify and resume Vivitrol (the Camden Center in Santa Monica, Calif., also named as a defendant).
Vivitrol prevented him from getting high, but didn’t take away his craving for opioids, according to the suit. When he missed a monthly dose, he relapsed and died of an overdose on Feb. 4, 2018.
Alkermes, the suit alleges, “intended to mislead the public into believing that Vivitrol was superior to methadone and buprenorphine and to stigmatize those safer and more effective methods of treatment. Meanwhile, [Alkermes] knew that Vivitrol’s lack of effectiveness could have highly destructive effects on patients but failed to adequately inform the public of these dangers."
The Staffords are seeking unspecified compensatory and punitive damages, including for pain and suffering and medical costs.
Vivitrol is a extended-release version of naltrexone, an older drug originally used to treat alcohol addiction. Administered by a shot into the buttocks, Vivitrol blockades the brain’s opioid receptors, preventing the feeling of being high, for about 28 days.
Methadone and buprenorphine work in different ways. They are both opioids that activate receptors in the brain that quiet cravings without producing a high. If the patient stops taking these medications and resumes opioid use, overdoses can occur, but they’re less likely to be lethal, because tolerance has been maintained.
Vivitrol was approved as a treatment for opioid addiction in 2010, but doctors and patients were slow to adopt it. So Alkermes marketed Vivitrol directly to drug court judges and correctional institutions, selling it as a nonaddictive and non-opioid treatment.
Addiction specialists say that such terminology exploits the false belief that taking methadone or buprenorphine amounts to “trading one addiction for another.”
Others object to selling Vivitrol to criminal justice officials, who have little medical knowledge.
“A lot of patients don’t like this drug,” Beletsky said. “And so the solution has been to force it on people . . . In Massachusetts, [some] people are required as a condition of their parole or probation to take Vivitrol.”
Prisons and jails in Massachusetts have for years offered one Vivitrol shot to departing inmates with opioid addiction, obtaining free samples from Alkermes. But it took an act of the Legislature to get a few correctional facilities to start offering buprenorphine and methadone.
Alkermes’ marketing has apparently worked. Vivitrol sales have grown steadily, reaching $335.4 million in 2019, up 11 percent from the previous year.
Although the lawsuit alleges that Vivitrol is ineffective and dangerous, addiction treatment providers consider it helpful for a minority of patients, provided the decision to take it is made between doctor and patient.
“We’ve had some highly motivated patients do well on this medication,” said Dr. Kevin P. Hill, director of addiction psychiatry at Beth Israel Deaconess Medical Center. But his clinic prescribes far more buprenorphine, he said in an e-mail.
Dr. Sarah Wakeman, medical director of Massachusetts General Hospital’s Substance Use Disorders Initiative, said she considers Vivitrol “a good but second option for patients who are able to and want to withdraw from opioids.”
A study published in 2017 compared the effectiveness of buprenorphine with Vivitrol. A significant number of patients in the Vivitrol group were unable to start the drug because they could not complete the necessary detox, and many of them relapsed. But among those who succeeded in starting Vivitrol, relapse rates were similar to those taking buprenorphine.
A more recent study by Wakeman found that people on Vivitrol were just as likely to overdose or need emergency room care for their addiction as people who had received no treatment. But the number of people taking Vivitrol was so small that Wakeman said the results may not be definitive.
The suit claims people on Vivitrol continue to crave opioids even though they can’t experience the high. Wakeman said some people do find that Vivitrol reduces craving, often because over time they stop thinking about it as much. “That’s a highly motivated person,” she said.
When Vivitrol is prescribed for patients who continue to have a strong urge to take opioids, they sometimes wait till the shot starts to wear off and then resume drug use. “That’s where we get the risk of fatal overdose,” she said.