Benicar is a prescription drug that was designed for the treatment of high blood pressure. Unfortunately, some patients have noticed that they would start to develop significant gastrointestinal side effects. These included chronic diarrhea, intestinal damage, severe weight loss, and malnourishment. As a result, numerous patients and their loved ones have decided to sue Daiichi Sankyo and Forest Laboratories, the manufacturers of Benicar.
Benicar was originally manufactured by Daiichi Sankyo for the treatment of high blood pressure. More and more reports are coming in, however, of the drug causing gastrointestinal problems that mimic Celiac disease. People who have been prescribed the drug often had to be hospitalized due to the gastrointestinal side effects. As a result, people are now seeking compensation.
Daiichi Sankyo, Inc. is a Japanese pharmaceutical giant. They originally developed the brand name Benicar, with the main active ingredient being olmesartan medoxomil, which quickly proved to be very popular. The FDA (the U.S. Food and Drug Administration) originally approved it in 2002 and around 11 million prescriptions are written for the drug each and every year.
The active ingredient in the drug helps to bring blood pressure down by keeping blood vessels open and dilated. The drug can be taken on its own to treat high blood pressure, but it is also often prescribed as part of a full treatment with a combination of drugs. There are other brand names of drugs on the market that also contain olmesartan, which include Azor (amlodipine and olmesartan), Benicar HCT, and Tribenzor (olmesartan, amlodipine and hydrochlorothiazide)
Olmesartan is a type of medication that belongs to the angiotensin II receptor blockers (ARB) class. Angiotensin II is a protein found naturally in the body. It affects the cardiovascular system in many different ways. One of those ways is the control of blood pressure. When released, blood vessels narrow, which means blood pressure goes up. When blood pressure is up, it becomes more difficult for the heart to pump blood around. Additionally, it makes the body increase the amount of fluid and sodium it contains. Olmesartan is basically an angiotensin II blocker, stopping it from making the blood vessels constrict. As a result, blood can flow with ease.
In 2012, the Mayo Clinic officially contacted the FDA because they completed a piece of research that showed there was a correlation between certain specific gastrointestinal issues and olmesartan medoxomil. The Mayo Clinic saw 22 patients between 2008 and 2011 who all had symptoms similar to Celiac disease. The symptoms included malabsorption of nutrients, chronic diarrhea and significant weight loss. However, when testing these patients for Celiac disease, tests came back negative. All patients were currently prescribed Benicar.
The conclusion was that olmesartan was causing serious gastrointestinal side effects. Therefore, the drug should be used with care. Furthermore, the Mayo Clinic’s researchers demonstrated that no other drug in the same class also caused these types of symptoms. As a result of this communication, the FDA added a warning to the prescribing information of Benicar in July 2013.
Examples of Benicar Lawsuits
George Williams v Daiichi Sankyo
George Williams was one of the first to file a complaint against Benicar. His lawsuit stated that he spent over 100 days in hospital as a result of taking the medication. He subsequently developed a compression fracture in his back as well as cataracts, which were the result of treatment he received to deal with his chronic diarrhea caused by Benicar. Furthermore, Mr. Williams now has to use a feeding tube. He will have significant medical costs for the rest of his life due to his injuries.
MDL Case Against Daiichi Sankyo
Because of the sheer volume of cases being filed against Daiichi Sankyo, a multidistrict litigation (MDL) has now been created in the District of New Jersey. It is believed that further information will be made available later in 2016, as the sheer volume of documents that has to be submitted and reviewed will take a very long time to assess. Additionally, with an MDL, it is possible for more cases to be added at a later date.
Why People File Benicar Lawsuits
Benicar was promoted by Daiichi Sankyo between 2002 and 2008. Their marketing campaign cost around $1 billion. The company stated that Benicar was superior to other drugs in its class in terms of both effectiveness and safety. However, the FDA is now citing studies that no other drugs that are in the ARB class cause significant gastrointestinal issues, such as those caused by Benicar. As a result, a warning has been included on the label since 2014. While physicians usually believe that patients who present with Benicar side effects have Celiac disease, they are often then diagnosed with villous atrophy or sprue-like enteropathy. These illnesses are drug induced and Daiichi Sankyo is now being held accountable for this.
As a drug manufacturer, Daiichi Sankyo has a duty to protect the public. They must, therefore, conduct proper research and tests before they are able to launch their product and make it available to the public. Various complaints now allege that the company failed to meet these duties and that they put consumers at risk by manufacturing a product that is both dangerous and defective, without providing adequate warning. The complaints filed against the company so far include:
- Development negligence
- Consumer risk
- Misleading marketing
- Selling defective and dangerous products
- Concealing the known dangers of the drug, thereby effectively risking consumers’ lives.
- Failing to provide adequate warnings to doctors and consumers about the possible risks
The drug also has a black box warning. This warning is the highest possible warning for fetal toxicity. This means that anyone taking the drug should be informed about proper methods of contraception. If a woman finds that she is pregnant while taking the drug, she should discontinue the drug immediately, under consultation with her physician.
Do You Know Your Legal Rights?
The FDA recently issued an official warning about Benicar as it can cause severe gastrointestinal problems. If you have suffered such a problem after taking the drug, you may be entitled to file a complaint against the manufacturer. It is vital that you seek assistance from an experienced lawyer. Many suits are being filed against the manufacturer, and it is likely that more will follow. In fact, over 1,000 lawsuits have now been filed, with 70 cases turning into 960 cases in a period of just six months.