Berwyn, Pennsylvania attorneys RM Law, P.C. filed a class action lawsuit against Acadia Pharmaceuticals. The suit was filed on behalf of “all persons or entities” that bought company stock between July 17, 2014 and July 3, 2018.
Berwyn, Pennsylvania attorneys RM Law, P.C. filed a class action lawsuit against Acadia Pharmaceuticals. The suit was filed on behalf of “all persons or entities” that bought company stock between July 17, 2014, and July 3, 2018.
The Southern Investigative Reporting Foundation on July 9, wrote, “San-Diego-based Acadia portrays itself as a pharmaceutical company but a Southern Investigative Reporting Foundation investigation has revealed that this is merely a clever facade. What lies below is a ruthless marketing entity whose pursuit of regulatory approval is best described as ‘loophole-centric.’”
The focus of the investigation and the lawsuit is on the company’s Nuplazid, its only commercial product, for episodic hallucinations and delusions associated with Parkinson’s disease psychosis. Back in April, CNN reported that during a Congressional budget hearing, FDA Commissioner Scott Gottlieb was asked about Nuplazid. This followed another CNN report citing an increasing number of patient deaths and adverse events related to the drug. Gottlieb promised the agency would take another look at the drug.
During the FDA’s original review of the drug, the lead physician, Paul Andreason, “warned that patients taking the drug during the company’s clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo. The company’s limited testing, he said, had not convinced him that the benefits outweighed the risks.”
But the committee voted 12 to 2 and recommended approval based on a six-week study of about 200 patients. Some of the committee members who voted to recommend the drug expressed concern, but felt that patients and family members would think the risk was worth it. The drug came on the market in June 2016.
However, soon after its release, “adverse events” reports grew, including deaths, life-threatening incidents, falls, insomnia, nausea and fatigue. Patients reported still having hallucinations while on the drug in more than 1,000 reports. It is still unclear if all of these are directly related to the drug, because they are often also associated with end-stage Parkinson’s disease.
In November 2017, nonprofit healthcare organization the Institute for Safe Medication Practices cited 244 deaths had been “reported to the FDA between the drug’s launch and March 2017.”
Since that report, FDA data indicates the number of reported deaths passed 700 (as of April 2018). The company argues that the benefits outweigh the risks and that the reason for the death reports is that Parkinson’s disease psychosis is seen most often in patients with the most advanced stages of the disease, who, as a result, are at a high risk of death.
Despite the reports, Acadia is working to get the drug approved for a larger patient population, those who have psychosis related to dementia, such as Alzheimer’s disease.
Stephanie Fox-Rawlings, a senior fellow at the National Center for Health Research, told CNN in their April story that “she understands how desperate families in these situations are, but she does not think Nuplazid is the answer based on her review of Acadia’s public research. She and Zuckerman said that, after previous studies didn’t show it was effective, the drugmaker changed the way the medication’s ability to improve psychosis was measured, which resulted in a positive outcome. Acadia said its studies have had different objectives and all of them have used ‘consistent, appropriate, and validated assessment methodology.’”
RM Law’s class action suit alleges that “throughout the Class Period, the defendants failed to disclose that: (1) adverse events and safety concerns related to Nuplazid threatened the drug’s initial and continuing FDA approval; (2) Acadia engaged in business practices likely to attract regulatory scrutiny; and (3) as a result of the foregoing, the defendants’ statements about Acadia’s business, operations, and prospects, were materially false and/or misleading and/or lacked a reasonable basis.”
The firm encourages members of the class to have the Court appoint you as a lead plaintiff of the class no later than September 17, 2018, with contact information enclosed in its press statement.
