Benicar Drug Lawsuit
In July 2013, the US Food and Drug Administration (FDA) issued an alert requiring the manufacturer of the blood pressure medication, Benicar, to add a warning to their label and marketing alerting the possible risks associated with use. Daiichi Sankyo Company, Ltd. and Forest Laboratories, Inc. have been ordered to pay a $300 million settlement due to the dangerous side effects associated with the drug.
If you or someone you love have suffered due to the use of Benicar, you may be eligible for compensation.What is Benicar?
In 2002, the FDA first approved the brand name drug Benicar to treat high blood pressure (hypertension). The generic formulation for Benicar is olmesartan medoxomil and belongs to the angiotensin II receptor blocker (ARB) and works by blocking the hormone angiotensin II, which causes blood pressure constriction and subsequently high blood pressure.
One year later, the FDA approved Benicar HCT. This drug contains both Olmesartan and hydrochlorothiazide – a blood pressure drug found in the thiazide diuretic drug category. Of the ARB class of medications, only Benicar has been singled out for patients developing a gastrointestinal disorder called sprue-like enteropathy.Side Effects of Taking Benicar
|More Common Side Effects|
|Back Pain||Elevated Triglyceride Levels||Bronchitis|
|Flu-Like Symptoms||Increase in Creatinine Phosphokinase||Inflammation of the Pharynx or Back of Throat|
|Diarrhea||Inflammation of Mucous Membrane||Headache|
|Blood in Urine||Sinusitis||High Blood Sugar|
|Less Common Side Effects|
|Chest Pain||Decrease in Hemoglobin and Hematocrit Levels||Fast Heart Rate|
|Elevation in Liver Enzymes and/or Serum Bilirubin Levels (Jaundice)||Weakness or an Overall Lack of Energy||Increased Blood Creatinine Levels|
|Vertigo||Joint Pain||Abdominal Pain|
|Nausea||Rhabdomyolysis (causes destruction of skeletal muscles)||High Levels of Cholesterol in the Blood|
|Rash||High Concentration of Fat in the Blood||Acute Kidney Failure|
|Excess Levels of Uric Acid in the Blood||Hair Loss||Chronic Diarrhea|
Often misdiagnosed as Celiac disease, sprue-like enteropathy is a disease that is defined by severe gastrointestinal symptoms, including chronic diarrhea, nausea, significant weight loss, and overall malnutrition. These symptoms can develop months to years after beginning the high blood pressure therapy, and in severe cases, may lead to hospitalization.Symptoms of Intestinal Damage Caused by Taking Benicar
Patients may experience some early indicators if they are developing intestinal damage caused by taking Benicar. The damage occurs to the hair-like structures within the small intestines, called villi, and may present with symptoms such as:
- Vitamin Deficiency
- Slightly Bloody or Cloudy Urine
- Fatty, Foul Smelling Stool
- Unusual Fatigue
Not only has Benicar been proven to cause gastrointestinal problems, but it has also been shown to result in complications that can be fatal to fetuses. The medication is not approved for use in children under one due to the negative growth and development of the kidneys. Those who should not take Benicar are:
- Pregnant women
- Children under the age of one
- Nursing mothers
- Patients with blood volume or sodium depletion (requires a lower starter dose)
- Patients suffering from renal complications such as the stiffening of renal arteries (renal artery stenosis)
Created through a merger, Daiichi Sankyo is the manufacturer of Benicar, Benicar HCT, Azor, and Tribenzor – all of which are included (in generic form as well) in the lawsuit against Daiichi Sankyo. The roots of Daiichi Sankyo can be traced back to 1899 when three Japanese businessmen formed a joint venture, then known as Sankyo Shoten. The first digestive enzyme was soon launched, made from fungus, and taking the name Taka-Diastase.
In 2005, the merger between Daiichi Pharmaceuticals took place, resulting in Daiichi Sankyo. The manufacturer averages around $8.9 billion in annual sales and has an approximate value of $17 billion in assets. Despite lawsuits over Benicar, the manufacturer still maintains its position on the corporate conduct charter – “to act with the highest ethical standards and a good social conscience appropriate for a company engaged in a business that affects human lives.”Benicar Studies
In a study conducted at the Mayo Clinic in 2012 by Dr. Joseph Murray, the connection was made between gastrointestinal complications and the use of Benicar in 22 patients. The patients were initially diagnosed with Celiac disease. Still, they did not respond to a gluten-free diet nor have detectable tissue transglutaminase in their blood samples, which is required for a positive Celiac diagnosis.
In Murray’s study, upon discontinuation of Benicar, all 22 patients began experiencing relief from the symptoms they were exhibiting. They also began to gain weight after stopping the medication. He concluded that there was a direct link between the use of Benicar and the development of sprue-like enteropathy.
The 2012 study results are as follows:
- The 22 patients involved in the study presented similar clinical results to individuals of 23 adverse event reports identified by the FDA through the FDA’s Adverse Event Reporting System
- Of the 22 patients from 17 states treated by the Mayo Clinic between 2008 and 2011, 14 required being hospitalized due to weight loss averaging almost 40 pounds, one patient lost approximately 125 pounds
- None of the 22 patients responded to the gluten-free diets
- All patients were taking Benicar (Olmesartan) in doses ranging from 10 mg to 40 mg
- When the patients discontinued use of the medication, all improved, including some degree of weight gain
Not only has Daiichi Sankyo paid lawsuits concerning Benicar and its related family of drugs, but it has also been ordered to pay an additional settlement ($39 million) which stemmed from a whistleblower lawsuit. The lawsuit was settled by Daiichi Sankyo after the manufacturer was accused of paying kickbacks to doctors who prescribed drugs (including Benicar).
The lawsuits cited that Daiichi Sankyo and Forest Laboratories halt claims that Benicar was a superior drug. The FDA ordered that all of the literature and labeling reflect the true nature of the risks associated with taking the drug. The majority of these lawsuits are filed under the theory of strict liability. In Florida, the Supreme Court follows strict liability, which is defined as being a defective condition that is unreasonably dangerous to the user or consumer.Filing a Benicar Drug Lawsuit in Florida
If you or someone you love needs to file a lawsuit against Daiichi Sankyo or Forest Laboratories, Frankl Kominsky Injury Lawyers can help. With experience handling over 7,000 clients and more than $100 million recovered, each legal representative is qualified to handle your case.
Our service area extends to the north and south of Palm Beach County, covering Broward, Miami-Dade, Monroe, Collier, Martin, St. Lucie, Indian River, Okeechobee, and Brevard Counties (by appointment only). Not only can we handle Benicar drug lawsuits, but as a premier Florida personal injury legal firm, we handle clients who have been injured in truck accidents, boat accidents, motorcycle accidents, slip and fall accidents, medical malpractice, and more.
If you are ready to take the next step and talk to one of our legal professionals about your Benicar drug lawsuit, you can contact us to begin your free, no-obligation discussion about your case. We are available online and through our offices by calling (561) 800-8000. You can reach us 24 hours a day, seven days a week. You don’t have to suffer any longer from the pain caused by taking Benicar. Frankl Kominsky Injury Lawyers can help you seek the compensation you deserve for pain and suffering, lost wages, and more.