Benicar (olmesartan) is part of a class of drugs called angiotensin receptor blockers (ARBs) and is approved to treat hypertension. The drug works by relaxing blood vessels so blood may flow more easily. Olmesartan is the active ingredient in the brand-name drug Benicar and is manufactured by Daiichi Sankyo. Olmesartan is prescribed alone and in combination medications such as Benicar HCT.
Olmesartan drugs include Azor, Benicar, Benicar HCT, Tribenzor, and Welchol.
National law firm, Parker Waichman LLP is actively investigating potential lawsuits involving these allegedly defective drugs. If you or someone you know suffered an injury due to the use of olmesartan products on or prior to May 1, 2015; the injury occurred on or prior to August 1, 2017; and medical treatment was sought or received due to this drug, our attorneys would like to hear from you today. In fact, retainers must be signed by August 23, 2017 so that you area able to participate in the settlement agreement.
$300 Million Benicar Settlement
Daiichi Sankyo and Forest Laboratories Agree to $300 million settlement of multidistrict litigation (MDL) by users of Benicar who suffered severe diarrhea, according to the New Jersey Law Journal.
Attorneys just placed the settlement on the record before U.S. District Judge Robert Kugler in Camden, New Jersey and would be applicable to approximately 2,000 cases nationwide that were consolidated before the judge, as well as another 100 cases pending in state Superior Court in Atlantic County, New Jersey. Judge Kugler appointed former state Superior Court Judge Marina Corodemus, who served as a state mass tort judge, to oversee compliance with the agreement and dismissal of any claims that fail to meet its conditions, New Jersey Law Journal reported.
Payments to plaintiffs depend on variables, including hospitalization days, and extent intestinal damage. The settlement terms require a 95 percent participation rate, but to be compensated, plaintiffs must submit documentation of their treatment. Injuries include and involve:
- Sprue-Like Enteropathy (intestinal disease)
- Diarrhea, vomiting, nausea, abdominal pain, dehydration, or unexplained weight loss concurrent with use of the medication
- Aggravation of symptoms of a pre-existing intestinal condition while taking the medication
- Renal failure
- Celiac disease-like symptoms
- Weight loss (five percent or more of body weight attributable to the symptoms)
- Hospitalization attributable to the symptoms
The agreement comes two years after the Judicial Panel on Multidistrict Litigation (JPML) consolidated the lawsuits before Judge Kugler. The lawsuits cited a July 2013 announcement by the U.S. Food and Drug Administration (FDA) that Benicar may cause intestinal problems that lead to severe diarrhea and substantial weight loss. The FDA announcement indicated that the intestinal problems might not develop for months or years following Benicar treatment, and those who stop taking it after developing such problems saw an improvement in symptoms, according to the New Jersey Law Journal.
The lawsuits allege that the drug makers were aware of the issues associated with Benicar and other ARBs prior to the FDA announcement, yet touted Benicar in a way that minimized any health risk references.
Attorney fees will be paid out of a common benefit fund consisting of eight percent of the settlement. Daiichi Sankyo issued a statement that it did not admit liability and believes that the claims in the litigation are without merit. Daiichi’s chairman and president, Glenn Gormley, said that, “We believe a settlement is in the best interest of all, and will allow us to continue our focus on bringing to market innovative medicines that help people live healthy and meaningful lives.” The Daiichi Sankyo statement indicated that the settlement would not hurt its financial health as the $300 million would come primarily from insurance companies.
Daiichi, whose U.S. subsidiary is based in Parsippany, New Jersey manufactured Benicar and Forest Laboratories marketed the drug. Forest, which was based in New York with offices in Jersey City, was acquired in 2014 by Actavis, known as Allergan. An Allergan spokesman declined to comment.
Benicar Uses and Side Effects
A 2016 report found that, while Benicar does lower blood pressure, the drug is not without its side effects. Benicar works by dilating blood vessels, which enables blood to travel more easily, which causes less strain on the heart.
Some Benicar side effects include back, joint, and muscle pain; dizziness; rash; upper respiratory infections; and weakness. The two most significant side effects of Benicar involve the gastrointestinal tract and are known as villous atrophy and sprue-like enteropathy. These adverse reaction may affect the body’s ability to absorb nutrients, which results in malnutrition. Patients taking Benicar who suffer from chronic, uncontrollable diarrhea, lose vital nutrients and fluid. Some patients may experience excessive weight loss and some may require hospitalization for treatment of malnutrition and dehydration.
Individuals who suffer from chronic diarrhea often develop fear and anxiety concerning the potential of uncontrollable bowel movements, especially when in public. Individuals may isolate themselves and fear leaving their homes if they do not have immediate access to a bathroom. Some people are forced to stop working if their diarrhea is severe and frequent and some people have to stop working because of the severity and frequency of the diarrhea. Many Benicar users who suffer from these debilitating conditions develop depression and anxiety.
Benicar Lawsuit Allegations
One Benicar lawsuit contains multiple counts, including allegations of design defect, failure to warn, negligence, fraudulent concealment, negligent misrepresentation, breaches of express and implied warranties, and violation of Iowa consumer protection laws. The plaintiff requested a jury trial and seeks compensatory damages, punitive damages, interest, court costs, and any additional relief that is deemed proper by the court.
The lawsuit was brought against drug maker Daiichi Sankyo and allegations also include that Benicar caused the plaintiff psychological damage and a variety of physical injuries. The man, 60, began taking Benicar/Benicar HCT in April 2009. Lawsuit allegations include physical injuries and economic losses. Alleged physical injuries include nausea, abdominal pain, urgent diarrhea, bloody stool, weight loss, loss of appetite, dizziness, Benicar-related enteropathy, and symptoms and problems associated with irritable bowel syndrome (IBS). Alleged economic impact includes lost earnings;, lost earning capacity; and past, present, and future medical expenses. The plaintiff also alleges that he suffers emotional distress and loss of enjoyment of life.
The lawsuit is a part of the multidistrict litigation (MDL) underway in New Jersey federal court and was comprised of approximately 1,700 similar lawsuits as of 2009.
The first bellwether trial in the Benicar multidistrict litigation (MDL) is scheduled for 2017. A bellwether trial is the first case tried in a group litigation—such as an MDL—to be tried; its outcome is used to predict the remaining litigation.
In a joint report filed on August 29, 2016, plaintiffs told the court that they intend to file motions for partial summary judgment. This is when a court enters a judgment for one party in a lawsuit against another without going through a full trial. Summary judgment may be awarded when the court agrees that no facts are being contested. A partial summary judgment may occur if the court does this for only some of the claims. According to court documents, motions for partial summary judgments are based on the issues of general causation in which Benicar causes sprue-like enteropathy, leading to severe diarrhea and weight loss. Plaintiffs also “intend to file a motion for partial summary judgment establishing the inadequacy of the [Benicar] prescribing information as a matter of law.”
MDLs bring together lawsuits with similar allegations in one court before one judge. This consolidation helps make the legal process more efficient as it eliminates duplicate discovery. In the Benicar MDL, the plaintiffs allege that Daiichi Sankyo and Forest Laboratories failed to study the risk of sprue-like enteropathy with Benicar. Plaintiffs also allege that the drug makers misled patients and physicians about the risks in marketing materials.
Research Ties Benicar to Serious Gastrointestinal Injury
In 2012, Mayo Clinic researchers published 22 case reports that detailed sprue-like enteropathy in patients who were being treated with Benicar. In some cases, patients were initially diagnosed with celiac disease, in which patients develop intestinal symptoms due to gluten. When these patients failed to improve on a gluten-free diet, physicians concluded that the symptoms were linked to Benicar.
A 2010 study published in Lancet Oncology wrote that Ilke Sipahi and colleagues at University Hospitals in Cleveland analyzed five studies involving 68,402 patients. The team learned that people taking ARBs experienced an 11 percent increased risk of developing new cancer overall and a 25 percent increased risk of developing new lung cancer, compared with patients who did not take ARBs, according to The Wall Street Journal.
FDA Updates Benicar Label
In 2013, the U.S. Food and Drug Administration (FDA) updated the label on Benicar and other similar medications to include the risk of sprue-like enteropathy when taking these drugs. After conducting a review of its adverse event database, the FDA indicated that it found “clear evidence of an association between olmesartan and sprue-like enteropathy.”
Angiotensin receptor blockers (ARBs) are sold in the United States under brands, including Daiichi Sankyo Co.’s Benicar. ARBs are taken by millions of people and are prescribed to prevent heart attack, stroke, and heart failure, according to The Wall Street Journal.
Filing a Benicar
Parker Waichman has years of experience representing clients in medical device and drug injury lawsuits. If you or someone you know is interested in participating in the Benicar settlement, please contact one of our experienced drug injury lawyers before August 23, 2017. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
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