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Lawsuits Filed Over Hepatitis C Clinical Trials

Author Stephanie Dube

Once hailed as a potential breakthrough in Hepatitis C treatment, the drug known only as BMS-986094 soon revealed a dark side: heart and kidney damage, sometimes requiring transplants and at least once, resulting in death. The unexpected side effects were so severe that Bristol-Myers Squibb dropped development of the drug after investing almost $2 billion in acquiring it less than a year earlier, Reuters reported.

Now, people who participated in the clinical trials for this drug are coming forward, revealing the severity of the fallout. Many of these cases are currently being filed or reviewed by Thomas J. Henry.

"We have already interviewed a number of injury victims from the Hepatitis C trials," Thomas J. Henry said. "More calls are coming in and we have current lawsuits on file and are litigating these types of matters. People have suffered life-changing debilitating injuries as a result of these clinical trials."

Phase II of a clinical trial involving BMS-986094 (sometimes referred to as BMS094) and Daclatasvir was halted on August 1 after one person died of sudden heart failure, The New York Times reported. At least eight others were hospitalized and some news outlets have reported that 113 people were enrolled in the trial. However, Clinicaltrials.gov shows the estimated enrollment at 360. In addition, news outlets have reported that Bristol is notifying 150 patients who took part in earlier trials.

About the Experimental Hepatitis C Drug

  • Current medications for Hepatitis C require painful injections over long periods of time and frequently do not work.
  • BMS-986094 was hoped to have a greater efficacy with an easier treatment in the form of an oral pill-based regimen.
  • Bristol-Myers Squibb had purchased the drug as part of a $2.5 billion acquisition of Inhibitex, Inc. in January. It was formerly known as INX-189.
  • This drug is a nucleotide polymerase inhibitor, once studied in combination with Daclatasvir and other drugs for Hepatitis C treatment.

Injuries from BMS-986094

The experimental drug may be toxic to the heart and kidneys. Reported injuries include:

  • Heart valve damage
  • Heart valve replacement
  • Heart attacks and heart failure
  • Kidney damage
  • Abnormal heart rhythm

Trial Locations

Trials for Hepatitis C drugs take place in various medical facilities across the country, including:

  • Texas
  • Arizona
  • California
  • Colorado
  • Georgia
  • Missouri
  • New York

Similar Drugs by Idenix Also Placed on Hold

Idenix Pharmaceuticals makes two drugs very similar to BMS-986094. Due to similarities, IDX184 and IDX19368 have also been placed on clinical hold, news outlets reported. The FDA has requested more cardiac testing related to IDX184. Idenix says that no patients were exposed to IDX19368.

About Hepatitis C

Information obtained from the CDC:

  • About 3.2 million Americans and 170 million people in the world are infected with Hepatitis C.
  • The virus can cause life-threatening liver damage.
  • About 75 to 85 percent of those infected develop a chronic infection.
  • The disease can stay dormant for years before it becomes fatal.

If you or a loved one participated in trials involving BMS-986094 or similar drugs and suffered damage, you are encouraged to contact an attorney immediately. Thomas J. Henry Injury Attorneys are available 24/7, night and day, at 1-888-956-8000 or thomasjhenrylaw.com.

Contact an Experienced Product Liability Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry Injury Attorneys immediately. We are available 24/7, nights and weekends.

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