CA Firm Files Wrongful Death Lawsuit Over Opioid Dependence Drug

March 03, 2020 - Law firm Lieff Cabraser, Heimann & Bernstein recently filed a wrongful death lawsuit against biopharmaceutical manufacturer Alkermes, for its alleged misrepresentation of an opioid dependence drug, Vivitrol. 

The lawsuit was filed on behalf of the family of Clayton Stafford and alleges that Clayton, his family, his rehabilitation counselors, and healthcare providers were misled into believing his prescription use of Vivitrol would be the correct treatment for his opioid addiction. 

However, the drug led to a preventable opioid overdose in February 2018. 

“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,” said Wendy Fleishman, who represents the Staffords.

Fabrice Vincent, a Lieff Cabraser partner who filed the lawsuit on behalf of the Stafford family, stressed that Clayton Stafford’s death could have been avoided if the defendants were truthful and warned about the limitations of Vivitrol.

READ MORE: Insys’ John Kapoor Sentenced to 66 Months for Opioid Scheme

“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 have never consented to its use by Clayton,” he said.

Aside from wrongful death, the lawsuit also accused the biopharmaceutical manufacturer of design defects, negligence, strict liability, failure to warn, and fraud and deceit, among other claims. 

Vivitrol is an injectable version of Alkermes’ prescription drug naltrexone which targets patients in need of drug addiction rehabilitation. The lawsuit alleges that the defendants “have known for years” that naltrexone is not effective for opioid use treatment although it blocks the effects of the drug temporarily. 

“At the end of a Vivitrol cycle, a patient’s opioid tolerance is highly diminished, which leads to a greatly heightened chance of overdose,” the law firm explained. 

Vivitrol also blocks the body’s natural endorphins from attaching to the brain’s receptors so the patient is more likely to seek other drugs for relief and are likely to relapse due to the lack of effect from the treatment. 

READ MORE: Esperion Earns FDA Approval for Cholesterol Lowering Drug Nexletol

The lawsuit argues that Alkermes was aware that Vivitrol’s lack of effectiveness could have a highly destructive effect on patients, but failed to inform the public of the dangers. It further claims that despite having no scientific basis for promoting Vivitrol, Alkermes misled drug courts, legislators, and law enforcement into believing the drug was more effective than other treatments because it contained no opioids. 

Additionally, Alkermes participated in a campaign to persuade addiction rehabilitation centers to use Vivitrol in place of other proven treatments and marketed to the public to encourage as many people as possible to use Vivitrol. 

“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,” Fleishman said.

Methadone and buprenorphine are long-standing as effective drugs because they do not require a prior detoxing process before beginning treatment, unlike Vivitrol, which does not enable patients to control cravings, withdrawal symptoms, and physical dependence to opioids.  

“For these reasons, methadone and buprenorphine have reputations as the gold-standard treatment options among the medical community for treating opioid dependence,” the law firm stated.

READ MORE: CA Proposes Single Market for Drug Pricing, Manufacturing Hub

The Lieff Cabraser lawsuit is the latest legal action by patents impacted by the opioid crisis against a major pharmaceutical company. Just last month, John Kapoor, Insys Therapeutics founder and former CEO, was sentenced to 66 months in federal prison for his role in an alleged opioid kickback scheme.

Insys faced a $225 million sentencing order last summer over kickbacks in the marketing of Subsys. The government suggested 15 years for Kapoor’s sentencing. 

“This was a landmark of prosecution that successfully held accountable a pharmaceutical company’s top executives for their roles in the illicit marketing and prescribing of opioids,” said US Attorney Andrew E. Lelling, at the time. 

According to the lawsuit, Insys executives from John Kapoor on down, bribed doctors to prescribe the addictive drug to individuals who did not need it.  “These defendants, led by Kapoor, ploughed ahead, setting weekly quotas for doctors on their payroll, urging them to prescribe Subsys in higher and higher doses, all so they could make millions of dollars at patients’ expense.” 

AARP said that nearly 8,000 people died taking Sybsys as a result of Insy's persuasion.