Benicar Generics Likely to Hit Market Next Year, As Lawsuits Continue to Mount

As patent protection is set to expire next year for the hypertension drug Benicar, Daiichi Sankyo will face generic competition as the drug maker continues to face a growing number of product liability lawsuits that allege inadequate warnings were provided about the potential side effects of Benicar.

Benicar (olmesartan medoxomil) is part of a family of Daiichi Sankyo blood pressure drugs, which also includes Benicar HCT, Azor and Tribenzor. All of the medications include the active ingredient olmesartan, which loses patent protection in 2016, opening the door for generic equivalents.

While the medications have been on the market for years, concerns have emerged in recent years about the link between Benicar and chronic diarrhea, malnutrition and other symptoms of a medical condition known as sprue-like enteropthy.

According to allegations raised in a growing number of Benicar lawsuits filed against Daiichi Sankyo over the past year, the drug maker has known about the potential risk for years, yet withheld information from consumers and the medical community to avoid any damage to sales of their blockbuster product.

The FDA forced the drug maker to add warnings about the risk of sprue-like enteropathy from Benicar in July 2013, indicating that the agency found a “clear connection” between the diarrhea problems and Benicar use, with symptoms resolving when the medication is no longer used and often resuming if the drug is restarted.

As a result of the lack of knowledge about the link within the medical community over the past decade, Benicar problems have often been misdiagnosed as Celiac disease or unclassified sprue, resulting in continued use of the medication, which could leave users with long-term intestinal damage.

Although the diarrhea symptoms associated with sprue-like enteropathy typically resolve when the medication is no longer used, the problems can cause permanent damage to the intestines, known as villous atrophy from Benicar.

One of the latest lawsuits filed against Daiichi Sankyo was brought by Willie Jones in the U.S. District Court for the Middle District of Louisiana on February 20. According to allegations raised in the complaint (PDF), Jones suffered sprue-like enteropathy after taking Benicar HCT, which included severe, chronic diarrhea, substantial weight loss, dehydration and acute kidney failure.

Jones was prescribed Benicar HCT in 2003 and suffered sprue-like enteropathy for years before the link between Benicar and the condition was revealed. he is seeking damages for pain, mental anguish, loss of income, loss of future earning capacity, and diminished enjoyment of life.

Another complaint (PDF) was filed by Roger and Carol Deming in the U.S. District Court for the District of Minnesota on February 18, indicating that Roger Deming suffered chronic diarrhea, weight loss, nausea, vomiting, malnutrition and dehydration due to Benicar side effects. Deming was hospitalized numerous times and had a number of emergency room visits due to Benicar sprue, the lawsuit claims.

“At several of these various hospital stays, the physicians did not know about the association between Benicar and Plaintiff’s injuries, and as a result, Plaintiff was treated for several different types of conditions for which the treatment included a gluten free diet and high dosages of steroids,” the lawsuit states. “Plaintiff has suffered from several other ailments that developed and/or worsened as a result of the Plaintiff suffering from chronic diarrhea (and associated symptoms) and/or physicians’ attempted various treatments to alleviate his symptoms.”

The cases join a growing number of lawsuits filed by individuals nationwide, which all raise similar allegations that Daiichi Sankyo knew or should have known about the risk of sprue-like enteropathy for years, yet failed to adequately warn consumers.

A motion was filed in December seeking to consolidate the Benicar litigation in the federal court system, centralizing the cases before one judge for coordinated pretrial proceedings and a series of early test trials to gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

If the request is granted, lawsuits filed in U.S. District Courts nationwide will be transferred in a multidistrict litigation (MDL). However, if Benicar settlements or another resolution for the litigation is not reached following pretrial proceedings, Daiichi Sankyo could face hundreds of individual trials throughout the country.