Lawsuit alleges defects and fraudulent misrepresentation of Vivitrol/Naltrexone Led to overdose death of 26-year-old Clayton Stafford after two years of Vivitrol use
February 4, 2020—(LOS ANGELES)—Lieff Cabraser has filed a wrongful death lawsuit against biopharmaceutical manufacturer Alkermes, Inc. on behalf of the family of California resident Clayton Stafford relating to Clayton’s mandated prescription use of Vivitrol that led to a tragic and preventable opioid overdose in February 2018. The lawsuit alleges that Clayton, his parents, his rehabilitation counselors, and healthcare providers were misled into believing that Vivitrol would be an appropriate solution for the treatment of his opioid addiction, and that if defendants properly marketed and warned about the limitations of Vivitrol, Clayton would not have used the drug that led to his death.
“Clayton Stafford’s tragic death could have been avoided,” notes Lieff Cabraser partner Fabrice N. Vincent, who filed the lawsuit on behalf of the Stafford family. “The well-reported defects in Vivitrol made Clayton’s overdose a near-foregone conclusion, and had the Staffords received accurate information about Vivitrol’s risks and effective deficiencies from Alkermes, they would never had consented to its use by Clayton.”
Plaintiffs bring their lawsuit for wrongful death and a survivor’s action for the pain and despair suffered by Clayton and themselves as a direct and proximate result of defendants’ negligent and wrongful misconduct in connection with the design, development, manufacture, testing, packaging, promotion, advertising, marketing, distribution, labeling, and sale of the naltrexone drug known as Vivitrol.
Vivitrol is an injectable release-version of Alkermes’ prescription drug naltrexone, marketed and sold to patients in need of drug addiction rehabilitation and therapy. The complaint alleges that defendants have known for years that naltrexone is an ineffective drug for the use treating opioid dependence; although the drug temporarily blocks the ability to feel the euphoric effects of opioid drugs, unlike longstanding and proven methods for treating addiction like methadone and buprenorphine, naltrexone does nothing to treat the patients’ continued addiction and powerful opioid cravings.
As the complaint notes, because Vivitrol only blocks the brain’s opioid receptors without treating the brain’s needs, patients’ cravings for opioids remain, so patients are not weaned off their drug addiction. “At the end of a Vivitrol cycle, a patient’s opioid tolerance is highly diminished, which leads to a greatly heightened chance of overdose. Further, because Vivitrol blocks the body’s natural endorphins from attaching to the brain’s receptors, the patient remains in a mentally deficient state and more likely to seek external drugs for relief. Because the patient’s addiction is not adequately treated, the patient requires indefinite Vivitrol use to merely block the euphoric effects and keep the patient from seeking opiates. Patients therefore remain highly likely to relapse despite indefinite use of Vivitrol.”
The complaint further alleges that undeterred by the lack of evidence for Vivitrol’s efficacy, defendants engaged in a highly aggressive marketing campaign to raise awareness about Vivitrol and promote policies to permeate the product as widely into the marketplace as possible. This effort included significant lobbying to influence legislators, judges and government officials to incorporate Vivitrol into the criminal justice system. Defendants also engaged in a campaign to persuade addiction rehabilitation centers to use Vivitrol rather than the other more proven treatment methods. Defendants further disseminated widespread marketing to the public to encourage as many people as possible to use Vivitrol.
Patients who take the older and more established methadone and buprenorphine treatments are not required to endure a tormenting process of detoxing before beginning treatment, which means they can immediately begin treatment once they receive a prescription. Unlike Vivitrol, methadone and buprenorphine enable their users to control cravings, withdrawal symptoms, and the feeling of physical dependency to opioids. For these reasons, methadone and buprenorphine have long-standing reputations as the gold-standard treatment options among the medical community for treating opioid dependence.
Indeed, as the complaint goes on to argue, in their own economic self-interest — and despite the lack of evidence — defendants 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, defendants knew that Vivitrol’s lack of effectiveness could have highly destructive effects on patients but failed to adequately inform the public of these dangers.
“This lawsuit is brought by and on behalf of Clayton Stafford’s surviving family, but the justice it seeks goes far beyond the pain and suffering of a single family,” notes Lieff Cabraser partner Wendy R. Fleishman, who also represents the Staffords. “Alkermes’ marketing of Vivitrol led to sales exceeding $200 million by as far back as 2016, profits that should not matter more than putting the lives of thousands upon thousands of Americans in peril due to Vivitrol’s manifest dangers and defects.”
The complaint notes that prior to marketing Vivitrol, Alkermes had not conducted a single study comparing the effectiveness of Vivitrol to methadone or buprenorphine. In addition, no independent studies were ever conducted comparing these treatments during this time period. Despite lacking any scientific basis for promoting Vivitrol over methadone and buprenorphine, defendants engaged in a calculated campaign to mislead the policymaker community, including drug courts, legislators, and law enforcement, into believing that Vivitrol was more effective than the other treatments because it contains no opioids.
The lawsuit was filed in the Superior Court of California in the County of Los Angeles stating claims for wrongful death, design defects, negligence, strict liability, failure to warn, and fraud and deceit, among other claims, and seeks wrongful death damages, survival damages, economic damages, and punitive damages, along with such other relief as the court may deem just and proper.
Fabrice N. Vincent
Lieff Cabraser Heimann & Bernstein, LLP