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Benicar Lawsuit

Benicar Lawsuit

Japanese drug-maker Daiichi Sankyo is facing 1,800 lawsuits from people who took the blood-pressure drug Benicar and developed sprue-like enteropathy, a condition that causes chronic diarrhea, severe weight-loss, and intestinal damage.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Benicar induced injury cases in all 50 states. If you or somebody you know was diagnosed with sprue-like enteropathy, you should contact our lawyers immediately for a free case consultation. You may be eligible to file a lawsuit. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Lawyers Seek Summary Judgement on Causation

September 2, 2016 — After the FDA said there is “clear evidence” linking Benicar and sprue-like enteropathy, lawyers asked judges to agree that it causes enteropathy so they can pursue claims that drug-makers failed to warn about the risk. Click here to read more.

Trial Dates Set for 2017

Trial dates were originally set for 2016, but ultimately pushed back to 2017. The vast majority of the cases were filed in mid-2015, when the litigation skyrocketed from a few dozen cases in June to approximately 1,000 in August.

Lawsuit Filed by Man With Chronic Diarrhea

In February 2014, a Benicar lawsuit was filed by a man from Texas. He suffered for more than four years and was hospitalized 10 times for more than 100 days total. Due to permanent intestinal damage, he must eat through a feeding peg in his stomach. Click here to read more.

What is Benicar?

Benicar (olmesartan modoxomil) is a prescription medication for high blood pressure. It was developed by Daiichi Sankyo, approved in 2002, and is currently sold in the United States by Forest Laboratories. Nearly 2 million people received a prescription for Benicar in 2012.

What is the problem?

Diarrhea was a known side effect of Benicar when it was approved. Unfortunately, at least 23 people have developed sprue-like enteropathy — severe, chronic diarrhea — that occurred months or even years after starting Benicar.

Benicar and Sprue-Like Enteropathy

Dr. Joseph Murray, a Mayo Clinic gastroenterologist, was the first to link Benicar and sprue-like enteropathy. Between 2008 and 2011, he observed 22 patients who developed gastrointestinal symptoms after taking Benicar. Although symptoms resembled Celiac disease, the patients did not improve on a gluten-free diet.

Dr. Murray took the patients off Benicar, and all of them improved and gained weight. He concluded that Benicar could potentially cause sprue-like enteropathy, and results were published in August 2012 in Mayo Clinic Proceedings.

Misdiagnosis of Celiac Disease

Many patients with enteropathy from Benicar were misdiagnosed as having Celiac disease. However, unlike Celiac disease, symptoms do not improve when patients stop taking Benicar or use treatments like corticosteroids, which normally suppress intestinal inflammation.

Treatment for Enteropathy

The only way to cure enteropathy from Benicar is stopping the medication. Unfortunately, by the time doctors make a correct diagnosis, enteropathy can cause severe intestinal damage and villous atrophy, which permanently reduces the ability to absorb food. Severe weight-loss and malnutrition can also devastate a person’s health.

FDA Safety Warning for Intestinal Problems and Benicar

The FDA published a Drug Safety Communication after finding 23 reports of sprue-like enteropathy linked to olmesartan in their adverse event database.

FDA recommendations included:

  • Patients should contact a healthcare professional if they develop severe, chronic diarrhea with substantial weight loss while taking Benicar, even if it takes months to years for symptoms to develop.
  • If a patient develops these symptoms during treatment with Benicar, other etiologies, such as Celiac disease, should be investigated. If no other etiology is identified, Benicar should be discontinued and another antihypertensive treatment started.
  • Symptoms of sprue-like enteropathy may develop months to years after starting Benicar.

FDA Warning Letter for “False or Misleading” Benicar Advertisements

The FDA has found that certain ads for Benicar are “false or misleading,” in violation of federal law, because they claim that Benicar is superior to other ARB blood-pressure drugs without providing evidence. According to the FDA Warning Letter:

“The sales ad is false or misleading because it contains unsubstantiated effectiveness and superiority claims, and omits and minimizes information on the risks … These claims and omissions raise significant public health and safety concerns.”

What is Sprue-Like Enteropathy?

Sprue-like enteropathy is a type of gastrointestinal inflammation that causes chronic diarrhea and weight-loss. Symptoms are very similar to Celiac disease (gluten hypersensitivity). Over time, sprue-like enteropathy causes problems with the digestion and absorption of food. Itdamages the mucous lining of the intestines, destroys intestinal villi, and flattens the lining of the intestines.

What Causes Sprue-Like Enteropathy?

Benicar belongs to a class of drugs known as angiotensin II receptor blockers (ARB), which also includes Azor and Tribenzor. Other drugs in the ARB class have not been associated with sprue-like enteropathy. No one knows the exact cause, but is could possibly occur due to a localized hypersensitivity reaction, a cell-mediated immune response, or inhibition of TGF-β (an important mediator of gut homeostasis).

Benicar Enteropathy “May Not Be Rare”

In March 2014, researchers published a study of 5 cases of enteropathy from Benicar. All cases were observed in a small gastroenterology unit, which suggests that this adverse effect “may not be rare.”

Studies of Enteropathy and Benicar

  • November 2014 — Study suggests that abdominal pain and enteropathy may be side effects of Benicar (olmesartan), but not other blood-pressure drugs in the same class.
  • September 2014 — French researchers have reported 36 cases of sprue-like enteropathy in patients on Benicar, confirming other studies suggesting a causal connection to this serious side effect.
  • July 2014 — Researchers in France linked Benicar to a 10-fold increased risk of hospitalization for gastrointestinal problems. Benicar was also linked to a severe case of enteropathy that caused a colon perforation.

Benicar and Kidney Failure

Benicar may increase the risk of kidney failure for high-risk patients. This risk increases for certain patients on NSAIDs (such as apirin and ibuprofen) or diabetic patients on Tekturna (aliskiren). Talk to your doctor if you have kidney disease. The risk of kidney problems also increases for people with serious heart problems. Your doctor may give you a blood test to check kidney function before starting Benicar.

Cardiovascular Concerns of Benicar

In June 2014, despite several clinical trials linking high-dose Benicar with higher rates of deadly heart attacks and cardiac arrest, the FDA concluded that Benicar does not raise cardiovascular risks. However, some experts have questioned this assessment.

Benicar Side Effects

  • Sprue-like enteropathy
  • Chronic diarrhea
  • Severe weight loss
  • Nausea and vomiting
  • Dehydration
  • Malnutrition
  • Intestinal damage
  • Dizziness
  • High or low blood pressure (hypertension of hypotension)
  • Kidney failure
  • Headaches
  • Hospitalization
  • Cardiovascular events (heart attack, stroke)
  • Click here for more information

Benicar Lawsuits Centralized in MDL

In December 2015, lawyers asked federal judges to centralize Benicar lawsuits in a Multi-District Litigation (MDL). In April 2015, federal judges centralized Benicar lawsuits in New Jersey (MDL No. 2606) under Judge Robert B. Kugler. Within one month, dozens of lawsuits were filed by victims of sprue-like enteropathy.

Over 1,800 Benicar Lawsuits Filed

There are now over 1,800 lawsuits filed by people who were injured by Benicar. Some of the earliest lawsuits include:

  • January 2015 — Lawsuit filed by two men from California who developed sprue-like enteropathy.
  • October 2014 — Lawsuit filed by a woman from Ohio who developed a severe, chronic intestinal illness.
  • August 2014 — Lawsuit filed by a woman who endured more than three years of intestinal side effects because she was misdiagnosed.
  • July 2014 — Lawsuit filed by a woman from California with sprue-like enteropathy.

$39 Million Benicar Lawsuit Settlement

In January 2015, Daiichi Sankyo has agreed to pay a $39 million settlement to the federal government to resolve allegations of illegally marketing drugs like Benicar, Azor, and Tribenzor by paying kickbacks to prescribing physicians.

Do I have a Benicar Lawsuit?

The Schmidt Firm, PLLC is currently accepting Benicar induced injury cases in all 50 states. If you or somebody you know was diagnosed with sprue-like enteropathy, you should contact our lawyers immediately for a free case consultation. You may be eligible to file a lawsuit. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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