What looked like a promising drug to cure Hepatitis C is no longer in the pipeline. With one dead and eight hospitalized, including a woman needing a heart transplant, the future of the drug is unknown. Research on a similar drug by Idenix Pharmaceuticals has been placed on "clinical hold."
A lawsuit filed last week by a 60-year old Texas woman alleges drugmaker Bristol-Myers Squibb "proceeded with conscious indifference"(1) in a clinical trial of a new Hepatitis C drug.
"Defendants pushed ahead despite clear signs of heart malfunction or damage for those enrolled in the trials" according to the complaint filed by Robert Hilliard of the Texas-based law firm Hilliard Munoz Gonzales L.L.P., who with Stephen Sheller of Philadelphia's Sheller, P.C. is representing the plaintiff and other clients including the family of the patient that died.
"The complaint states that the company had a duty to exercise reasonable care and breached that duty by failing to warn trial participants of the dangers of the defective drug" says Sheller. "The plaintiff claims that in the company's quest to be first, to grab a portion of the $20 billion a year market, they rushed clinical trials without fully evaluating the risks and benefits of the drug."
The suit alleges that the drug company could have suspended the clinical trial at several junctures when tests revealed patient cardiac problems, but chose not to do so.
In a press release, Bristol-Myers Squibb acknowledges that "the initial case of heart failure, which was the basis for halting the study, subsequently resulted in one death" (2). To date, eight of the trial participants have been hospitalized. According to court documents, after just four weeks of taking the drug plaintiff Janet Vella experienced heart and liver failure.
According to a Wall Street Journal report, earlier this year Bristol Myers Squibb bought drug company Inhibitex for $2.5 billion based on the promise that one of its investigational drugs could safely treat Hepatitis C (3). The drug BMS-986094 is an oral pill-based regimen designed to treat the virus. Hepatitis C affects 170 million people worldwide and is the leading cause of liver transplants in the United States.
Another investigational drug trial for the treatment of Hepatitis C by Idenix Pharmaceuticals has been placed on "clinical hold" by the FDA until data from additional cardiac testing of patients becomes available in coming weeks (4).
Bristol-Myers Squibb and Idenix say they are working with the FDA to monitor the health of trial participants (2,4).
The case is Janet Schaefer Vella et al v. Bristol-Myers Squibb, Inhibitex, Inc., and Alamo Medical Research, Cause No. 2012-CCV-61640-4, Nueces County, TX.
About Sheller. P.C.
Sheller, P.C. represents plaintiffs injured by drugs and whistleblowers reporting pharmaceutical industry wrongdoing. The firm's defective drug attorneys are currently litigating mass tort cases for children harmed by the Johnson & Johnson/Janssen Pharmaceuticals antipsychotic Risperdal (5,6). In practice since 1977, Sheller, P.C. has challenged some of the largest corporations in the country including tobacco, auto, and drug and medical device manufacturers. The firm has been counsel in more than $4.2 billion in whistleblower recoveries for the U.S. government, three of the largest in U.S. history (7,8,9). Led by the Sheller whistleblower leadership team, the firm continues to represent whistleblowers in other cases across the country.
(1) Janet Schaefer Vella et al v. Bristol-Myers Squibb, Inhibitex, Inc., and Alamo Medical Research, Cause No. 2012-CCV-61640-4, Nueces County, TX
(2) Bristol-Myers Squibb Press Release "Bristol-Myers Squibb Discontinues Development of BMS-986094, an Investigational NS5B Nucleotide for the Treatment of Hepatitis C"
(3) Wall Street Journal "Bristol Halts Test Drug for Hepatitis"
(4) MarketWatch by Dow Jones Newswire "FDA places clinical hold on Idenix hepatitis drug"
(5) In re Risperdal Litigation, March Term 2010, No. 296 (Philadelphia County Court of Common Pleas)
(6) In re Risperdal/Seroquel/Zyprexa Litigation, Case No. 274 (Superior Court, Middlesex County, N.J.)
(7) United States, ex. rel. James Wetta, et al. v. AstraZeneca Corp., No. 04-0379
(8) United States, ex. rel. Ronald Rainero, et al. v. Pfizer, Inc., No. 07-11728
(9) United States, ex. rel. Robert Rudolph, et al. v. Eli Lilly and Company, No. 03-943