Dangerous drug lawsuits filed by patients who experienced severe gastrointestinal injury while taking the hypertension medication Benicar (olmesartan) may be having a negative impact on its manufacturer's bottom line. According to financial performance summaries released by Japanese pharmaceutical company Daiichi Sankyo in January 2017, the drugmaker's revenue was down 3.2 percent for the first three quarters of its fiscal year.
In addition to reporting that revenue was down company wide, the released summaries also showed a substantial decline in sales of Daiichi Sankyo's flagship product, Benicar. Drug sales experienced a 21.6 percent slide between March 31, 2016 and December 31, 2016.
The lawsuits, coupled with the loss of patent exclusivity for Benicar, could spell financial trouble for Daiichi Sankyo in the coming months and years.
As of May 2017, Daiichi Sankyo is facing more than 1,700 lawsuits alleging the company failed to sufficiently test Benicar for safety before it entered the United States prescription drug market. The lawsuits also claim that, once Daiichi Sankyo learned of the risks associated with taking Benicar, it didn't alert doctors and patients and instead, continued to market and sell a dangerous prescription drug.
The lawsuits were filed by patients all across the U.S. and in March 2015, a board of federal judges consolidated the lawsuits into a multidistrict litigation. As a result, all Benicar gastrointestinal injury lawsuits will be heard in the U.S. District Court for the District of New Jersey with U.S. District Judges Robert B. Kugler and Joel Schneider presiding.
The nearly 2,000 lawsuits have been narrowed to 10 bellwether trials, which are scheduled to begin in late 2017. Bellwether trials are cases selected from a larger group of cases, with the outcomes of the bellwether cases serving as a litmus test for the remaining lawsuits.
Expired Patent Exclusivity
The Benicar lawsuits aren't the only blow Daiichi Sankyo sustained in 2016. The company's exclusive patent for Benicar expired, meaning that competing companies can now develop generic versions of the popular drug. Currently, two drugmakers are planning Benicar generic for the United States market.
One such company, the West Virginia-based Mylan Pharmaceuticals Inc., already has a product ready and available to consumers. Mylan released generics of both Benicar and Benicar HCT® (olmesartan, medoxomil, and hydrochlorothiazide) in 2016, not long after Daiichi Sankyo's patent exclusivity expired.
The other company working to bring its Benicar generic to the U.S. market is Lupin Limited, which is headquartered in Mumbai, India. Working under the name Lupin Pharmaceuticals Inc. from its U.S. base in Baltimore, Maryland, the company plans to release its product later in 2017 and has already been granted tentative approval by the U.S. Food and Drug Administration (FDA).
What Is Sprue-Like Enteropathy?
At the center of all the Benicar lawsuits is a little-known gastrointestinal condition called sprue-like enteropathy, which causes an array of debilitating symptoms, such as:
- Severe, chronic diarrhea
- Abdominal pain
- Uncontrollable weight loss
Many Benicar patients have landed in the hospital with these symptoms. Adding insult to injury, sprue-like enteropathy is just rare enough and its symptoms just similar enough to better known conditions that it is often misdiagnosed, meaning that patients have a good chance of being exposed to treatments they don't need while the actual problem continues unabated.
Fortunately, for those who survive sprue-like enteropathy's life-threatening weight loss and dehydration, the condition and its symptoms are not permanent. According to a Mayo Clinic study that linked the gastrointestinal illness to Benicar, the symptoms clear up after the patient stops taking the drug.
Did You Experience Serious Side Effects While Taking Benicar?
If you suffered severe gastrointestinal injury while taking Benicar, you may be able to file a lawsuit and pursue compensation from Daiichi Sankyo in civil court. The seasoned attorneys with McGartland Law can help you every step of the way. For more information, or to schedule an appointment for a free initial consultation, contact McGartland Law today.