Class Actions

Benicar Lawsuit

Benicar, a prescription medication used to treat high blood pressure, has been linked to several dangerous side effects and gastrointestinal injuries, including sprue-like enteropathy.

This has led to thousands of Benicar lawsuits against drug maker Daiichi Sankyo for producing an inherently defective drug that harms patients and for failing to warn consumers and the medical community that drug posed a risk to patients.

If you or someone you love was harmed after taking Benicar, do not hesitate to contact The Law Offices of Peter T. Nicholl to schedule a free, no obligation consultation. Our trusted class action attorneys will review your claim to help you determine if you may be entitled to compensation for your injuries and losses. All of our services are provided on a contingency fee basis, which means there will be no fees or costs unless we recover compensation for your case.

Call 410-244-7005 to schedule a free consultation.

Dangerous Benicar Side Effects

Benicar was first approved by the U.S. Food and Drug Administration (FDA) in 2002 to lower blood pressure associated with hypertension. Benicar is a member of the drug class angiotensin II receptor blockers (ARB) and works by keeping blood vessels dilated by blocking angiotensin receptors.

However, thousands of patients have reported suffering serious adverse medical conditions after taking Benicar, such as:

• Lymphocytic colitis: An inflammation of the large intestine that causes persistent watery, non-bloody diarrhea.
• Microscopic colitis:  A condition that causes inflammation in the colon/large intestine, resulting in chronic diarrhea and cramping.
• Collagenous colitis: An inflammatory bowel disease affecting the colon that also results in chronic, watery diarrhea.
• Sprue-like enteropathy: An inflammatory condition that causes severe, chronic diarrhea that results in substantial weight loss, long-term malnutrition, liver and kidney/renal failure.

In addition to suffering dangerous gastrointestinal injuries, patients who filed Benicar lawsuits also reported experiencing:

However, many Benicar side effects are delayed injuries and symptoms that may not appear until several months or years after the patient began taking the drug.

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Benicar Linked to Gastrointestinal Conditions

Since Benicar’s release in 2002, several studies have been published reviewing the adverse Benicar side effects patients reported after taking the drug.

The first link between Benicar and gastrointestinal injuries was discovered in a 2012 Mayo Clinic study where researchers evaluated patients taking Benicar. The study’s researchers analyzed patients who took Benicar and reported suffering chronic diarrhea and extreme weight loss with a median of 40 pounds.

Out of the 22 patients surveyed in the study, 14 required hospitalization. Originally, the study’s researchers diagnosed them with celiac disease, but later reversed this conclusion when it was found no patients suffered signs or symptoms. However, when the patients were taken off Benicar, they recovered and began gaining weight back at an average of 27 pounds.

In October 2012, researchers attending an American College of Gastroenterology meeting noted that Benicar was linked to 40 cases of sprue-like enteropathy.

Furthermore, researchers found that patients taking Benicar may have an increased risk of damaging their intestinal villi, which are small, finger-like projections that aid digestion, according to a 2013 study published in the American Journal of Gastroenterology.

Additionally, many Benicar lawsuits claim the drug’s manufacturer was aware of the risk Benicar posed to patients, but it concealed this knowledge from consumers and the medical community. This resulted in the U.S. federal government taking action against Daiichi Sankyo on several occasions for releasing a potentially dangerous drug without adequately warning consumers about of the risks of taking Benicar.

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FDA Issues Safety Warning Against Benicar

In the year following the Mayo Clinic’s study connecting Benicar to gastrointestinal injury, the FDA evaluated several negative events received by the FDA’s Adverse Event Reporting System (FAERS).

The FDA’s evaluation found clear evidence of an association between Benicar and sprue-like enteropathy. In total, 23 serious cases reported to FAERS involved patients suffering late-onset diarrhea with significant weight loss and intestinal villous atrophy. All patients reported clinical improvements after stopping Benicar.

In response to the FAERS findings, the FDA issued a drug safety communication in July 2013 warning patients that Benicar can cause gastrointestinal problems, including sprue-like enteropathy. The FDA’s warning noted that patients taking Benicar and experiencing sprue-like enteropathy symptoms should immediately consult their treating health care provider and stop taking the drug.

Furthermore, the FDA also required Daiichi Sankyo to change Benicar’s label to include a warning that patients taking the drug are at risk of developing gastrointestinal injuries.

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Daiichi Sankyo Accused of Misleading Consumers

In 2006, the U.S. Department of Health & Human Services (DOH) accused Benicar manufacturer Daiichi Sankyo of violating FDA regulations by misleading consumers about the effectiveness of Benicar.

The DOH issued a letter relaying its findings that Daiichi Sankyo repeatedly advertised Benicar as being a more effective ARB than other similar types of medications. The DOH’s letter stated these claims were unsubstantiated and that no evidence existed proving Benicar’s superiority.

Furthermore, the DOH’s letter also claimed Daiichi Sankyo omitted and minimized the serious health risks that Benicar posed to several groups of patients, including those:

• Who are pregnant
• With renal artery stenosis, a condition that narrows arteries that carry blood to one or both kidneys
• With impaired liver functions
• With systemic lupus erythematosus, a form of lupus that results in severe fatigue and joint pain
• Who are taking lithium

The DOH stated that the marketing materials Daiichi Sankyo promoted should have stated the risks associated with Benicar more prominently.

Additionally, the DOH sent Daiichi Sankyo another warning in 2013, once again calling out the company’s marketing materials as misleading the public about Benicar. The DOH claimed Daiichi Sankyo used unsubstantiated evidence and clinical studies to promote Benicar as a superior ARB.

Call 410-244-7005 if you were injured after taking Benicar.

Previous Benicar Lawsuits

Following the FDA’s Safety Communication Warning in 2014, patients began filing Benicar lawsuits against Daiichi Sankyo claiming the drug caused them to suffer several types of gastrointestinal injury.

In 2015, several federal judges ordered Benicar lawsuits filed in different states to be combined into a single multidistrict litigation (MDL) in New Jersey. By 2017, approximately 3,200 claims were consolidated into the MDL.

Benicar lawsuits included in the MDL alleged that manufacturer:

• Marketed products that caused severe gastrointestinal injuries
• Inadequately warned consumers about Benicar’s risk of gastrointestinal injury
• Misrepresented the safety of Benicar, despite knowing the drug was potentially unsafe when used as directed
• Designed a defective, unsafe and inherently dangerous drug
• Failed to adequately test Benicar before marketing it to consumers
• Breached its duty to create a safe and reliable product
• Created a product that’s risk outweighs its benefits
• Caused patients physical harm and financial losses

On August 1, 2017 Daiichi Sankyo agreed to a $300 million settlement with patients who filed Benicar lawsuits before the MDL could go to trial. However, despite agreeing to a settlement, Daiichi Sankyo denied any wrongdoing against patients injured by Benicar.

Daiichi Sankyo Settles Lawsuit with the Federal Government

In addition to the lawsuits filed by Benicar patients, Daiichi Sankyo also agreed to a $39 million settlement with the U.S. federal government and state Medicaid programs in 2015.

The settlement was paid to resolve allegations that Daiichi Sankyo violated the False Claims Act by bribing physicians in an effort to encourage them to prescribe Benicar and several other drugs the company manufactured.

The U.S. Department of Justice accused Daiichi Sankyo of paying kickbacks to physicians in the form of speaker fees at Daiichi’s Physician Organization and Discussion programs that ran from January 2005 to March 2011, as well as other speaking events held between January 2004 and February 2011.

Complete a Free Case Evaluation form to discuss filing a Benicar lawsuit.

Find Out if You Can File a Benicar Lawsuit

Benicar manufacturer Daiichi Sankyo had an obligation to produce a pharmaceutical drug that was safe and reliable for patients to use. Because the company failed to do this, it can be held liable for its negligence.

If you suffered a gastrointestinal injury or another type of adverse health effect after taking Benicar, do not hesitate to contact The Law Offices of Peter T. Nicholl to schedule a free, no obligation consultation. We have the experience and resources you need to hold large pharmaceutical corporations liable for causing your injury and financial losses.

All of our services are provided at no upfront cost and there are no fees or costs unless we recover the compensation you need. There is no risk in consulting with our class action attorneys to find out if you are entitled to file a Benicar lawsuit.

Call 410-244-7005 today to schedule a free, no obligation consultation.