Basis of Benicar Lawsuit
The Benicar Lawsuit is against Daiichi-Sankyo for failure to warn about the severe digestive risk associated with Benicar. The lawsuits allege that Daiichi-Sankyo failed to warn both doctors and patients of the gastrointestinal complications, such as severe diarrhea, weight-loss, vomiting, and gallbladder dysfunction associated with Benicar. Benicar lawyers argue that patients and/or doctors would have chosen alternative medications if the additional warnings on the potential gastrointestinal side effects were provided. The Benicar attorneys also allege that Daiichi-Sankyo knew of the risk associated with Benicar for years, but remained silent. Benicar lawyers have now filed over a 2,200 Benicar lawsuits nationwide.
United States Benicar Lawsuits
Most Benicar lawsuits are filed in the US District Court of New Jersey as part of a multidistrict litigation (MDL). The Honorable Robert Kugler and Joel Schneider are presiding over the Benicar (Olmesartan) Products Liability Litigation MDL No. 2606. The MDL grows by an average of approximately three Benciar lawsuits every day. There are also a number of Benicar lawsuits in state courts nationwide. On August 1, 2017, Daiichi-Sankyo entered into a settlement agreement regarding all filed claims on olmesartan containing products (Benicar, Benicar HCT, Azor and Tribenzor). The Benicar settlement process is expected to take over a year to administer. The Hollis Law Firm continues to review Benicar lawsuits for those who have experienced gastrointestinal side effects.
Worldwide Benicar Lawsuits
Recently, the Benicar litigation expanded into Canada, where the drug is known as Olmetec. The pressure against Daiichi-Sankyo and their dangerous drug Benicar is now multinational. Regulatory agencies in France have also begun to take notice and action against Benicar, including possibly delisting the drug for insurance reimbursement. It is likely that the lawsuits against Benicar will continue to grow, both in the United States and worldwide.
Drugs Involved in the Benicar Lawsuit
Many blood pressure medications contain olmesartan medoxomil, the same active ingredient that’s in Benicar. As such, the following medications are part of the Benicar Lawsuit:
- Benicar (olmesartan medoxomil)
- Benicar HCT (olmesartan medoxomil + hydroclorothiazide)
- Azor (olmesartan medoxomil + amlodipine)
- Tribenzor (olmesaratan medoxomil + amlodipine + hydroclorothiazide)
- Olmetec (olmesartan medoxomil as marketed in Europe and Canada)
It is important to note that switching from Benicar to another product containing olmesartan will not improve side effects. Talk with your doctor before discontinuing Benicar or any other blood pressure medications.
Benicar is an angiotensisn II receptor antagonist (ARB). ARBs are a specific drug class that are for the treatment of high blood pressure. There are many drugs that are ARBs. Benicar, Tribenzor, Azor, and Olmetec are the only ARBs that cause severe gastrointestinal side effects. Below are a list of alternative ARBs that your doctor might start you on instead of Benicar:
- Cozaar (losartan)
- Micardis (telmisartan)
- Diovan (valsartan)
- Avapro (irbesartan)
- Edarbi (azilsartan)
- Kanarb (fimasartan)
- Teveten (eprosartan)
- Atacand (candesartan)
The above listed alternatives are not part of the Benicar lawsuit.
Benicar Side Effects
Benicar causes life-threatening gastrointestinal side effects. Benicar causes these side effects by triggering an auto-immune response. The auto-immune response triggered by Benicar can also cause a lot of non-gastrointestinal side effects. New Benicar side effects continue to come to light. Side effects from Benicar can take months to years before they first appear. Below are various diagnosis
Severe Side Effects of Benicar
The following are serious, possibly life-threatening side effects of Benicar:
- Chronic Diarrhea: Watery diarrhea multiple times a day, every day. Some reports of 20+ stools a day. Usually takes months to develop.
- Severe Abdominal Pain: Unrelenting abdominal pain requiring hospitalization. Source of pain usually undetermined.
- Vomiting: Frequent, unexplained vomiting.
- Weight Loss: Malnutrition causing weight loss of 10 – 40% of total body weight.
- Gallbladder Complications: Removal of gallbladder due to sludging or a low ejection fraction. Symptoms worsen after gallbladder removal.
- Dehydration: Due to the amount of liquid lost from constant diarrhea.
- Acute Kidney Failure: Due to dehydration as a result of chronic diarrhea.
- Pancreas Complications: Removal of the pancreas. Symptoms worsen after removal of the pancreas.
- Heart Attack: Due to electrolyte embalances secondary to malabsorption.
- Sprue-like enteropathy: Blunting or flattening of the villi in the small intestine.
- Duodenitis: Inflammation of the duodenum (first part of small intestine). Thickening of the small intestine.
Less Severe Side Effects of Benicar
The following are serious, but typically less severe side effects of Benicar:
- Nausea: Sick to the stomach.
- Rash: Itchy red rash. Can develop anywhere on the body. Due to a drug reaction.
- Chronic Fatigue: Due to malabsorption.
- Vitamin Deficiencies: As a result of intestinal malabsorption.
- Headache: Chronic headaches without a known cause.
- Depression: Caused by vitamin deficiencies, malabsorption and dealing with other severe side effects.
- Anemia: Iron deficiency anemia.
- Chronic Sinusitis: Chronic upper respiratory infections, pneumonia, bronchitis or sinusitis.
- Chest Pain: Referred pain from the abdominal region.
- GERD (Gastroesophageal Reflux Disease): Stomach acid or bile irritates the lining of the esophagus.
- Severe Acid Reflux: Heartburn and other stomach acid related disorders. Commonly treated with Proton Pump Inhibitors (PPIs), such as Nexium.
- Gastritis: Inflammation of the stomach lining.
- Chronic Constipation: Onset typically before diarrhea. Can alternate with diarrhea.
The manufacturer has not properly warned on the possible side effects caused by Benicar. As a result, many patients are receiving incorrect treatment due to a misdiagnosis. Misdiagnosis related to Benicar side effects include:
- Celiac Disease: An autoimmune disease in which the patient cannot tolerate gluten. Celiac disease mimics several aspects of Benicar side effects and can be hard to distinguish.
- Crohn’s Disease: An immune related gastrointestinal disease. Some medications for Crohn’s disease can also improve Benicar related side effects.
- Lupus: Benicar can trigger an autoimmune response that mimics lupus. (Medications to treat autoimmune disease can also treat Benicar’s side effects)
- Irritable Bowel Syndrome (IBS): A generic diagnosis for abdominal pain and changes in bowel patterns.
- Psoriasis, Sunburns and Insect Bites: A Benicar drug induced rash is commonly misdiagnosed as other skin conditions.
- Flu: Flu-like symptoms attributed to the gastrointestinal side effects
- Food Poisoning: Due to uncontrollable vomiting and diarrhea.
Physicians must properly identify and diagnosis Benicar side effects. Benicar side effects can take months or even years to manifest. Luckily, Benicar related side effects typically resolve within days to months of Benicar cessation. Talk with you doctor before discontinuing or changing any of your medications.
Common Treatment and Procedures Related to Benicar Side Effects
- Endoscopy (EGD): A small camera and light attached to a flexible tube is inserted through the mouth to inspect the stomach and small intestine.
- Colonoscopy: A thin flexible tube with a camera and light is inserted through the anus to inspect the large intestine.
- Biopsy: Tissue samples are occasionally removed during an endoscopy or colonoscopy for microscopic evaluation.
- IV Fluids: Fluids are administered for dehydration related to severe diarrhea.
- Blood Test: Severe diarrhea results in electrolyte imbalances.
- Potassium Administration: Potassium is necessary for the heart to function properly. Severe diarrhea causes decreased potassium levels.
- Cholecystectomy: Many Benicar users require the removal of their gallbladder.
- Pain Medications: An early adverse effect from Benicar is severe abdominal pain.
- Anti-Nausea Medications: Severe nausea is another early adverse effect from Benicar. Many Benicar users require Zofran (ondansetron) to manage their constant nausea.
- Total Parenteral Nutrition (TPN): Some Benicar develop severe malnutrition and require all of their daily nutrients through an IV feeding line.
- Immune Supression Therapy: Benicar initiates an auto immune response. Drugs that suppress the immune system can also decrease Benicar side effects.
- Intestinal Surgery: Some severe reactions to Benicar necessitate surgery to repair intestinal perforation or a small bowel obstruction.
- Antibiotics: Used to treat suspected stomach bugs and chronic upper respiratory symptoms.
Daiichi Sankyo (Tokyo, Japan) manufactures Benicar, Tribenzor and Azor. Daiichi Sankyo is the second largest pharmaceutical company in Japan with approximately $12 billion in annual revenue. Daiichi developed Benicar in 1995 and gained FDA approval on April 5, 2002. In 2006, Daiichi Sankyo opened its first U.S. subsidiary, Daiichi Sankyo Pharma Development, in Parsippany, New Jersey. Worldwide, Daiichi employs approximately 30,000 people. Daiichi Sankyo and its subsidiaries are among the defendants in the Benicar lawsuit. Daiichi continues to manufacturer, market and sell Benicar as it tries to handle the growing Benicar lawsuit.
FDA Action Against Benicar and Daiichi
Benicar Warning Label Change
The FDA took action against Benicar on July 3, 2013. The FDA approved label changes for Benicar to include sprue-like enteropathy. The FDA noted that symptoms of sprue-like enteropathy associated with Benicar include severe, chronic diarrhea with substantial weight loss. The FDA also warned that symptoms could take months to years to surface and at times requires hospitalization. However, the FDA only recommended discontinuation of Benicar when the side effects had no apparent cause.
The Benicar lawyers believe that the current Benicar warning is still inadequate. Benicar can cause severe diarrhea and weight loss, even before test are positive for sprue-like enteropathy. Additionally, Benicar causes many more side effects than just chronic diarrhea and weight loss. The Benicar lawyers also argue that physicians should discontinue Benicar in a patient with gastrointestinal problems, regardless of possible alternatives. Benicar side effects are severe and discontinuation of the medication is a cheap and easy option. Benicar lawyers continue to urge the FDA and Daiichi to add additional warnings to the label of Benicar.
Daiichi Pays $39 Million to Settle Anti-Kickback Benicar Lawsuit
Less than two years after the Benicar warning label update, the U.S. took Daiichi to court. The U.S. alleged in its lawsuit that Daiichi violated the False Claims Act by paying kickbacks to induce physicians. The lawsuit specifically notes that Daiichi paid the physicians to prescribe Benicar, Tribenzor and Azor. The Anti-Kickback Statute is in place to prevent improper payments and gifts from compromising a physicians judgment. Daiichi had been providing kick-backs to doctors prescribing Benicar for seven years according to the lawsuit!
Daiichi eventually settled the anti-kickback Benicar lawsuit for $39 million. U.S. Attorney Carmen Ortiz for the District of Massachusetts took a hard stance against Daiichi and other pharmaceutical companies, stating
“Drug companies are prohibited from using lavish entertainment and padded speaker program payments to induce physicians to prescribe their drugs for beneficiaries of federal health care programs. Settlements like this one show that the government will continue to pursue health care companies that use kickbacks to promote their products.”
Benicar Generic Approval
The first application to produce a generic version of Benicar was submitted in April of 2006 by Mylan Pharmaceuticals Inc. A second application was filed to manufacture a generic Benicar by Apotex Inc. in June of 2012. Daiichi Sankyo held an exclusive patent on Benicar until April of 2016. Following the expiration of Daiichi’s exclusive patent, there is a 180-day exclusivity provision on marketing a generic Benicar. Daiichi has had to fight multiple lawsuits regarding who has the right to market a generic Benicar during the 180-days.
On June 20, 2016, the FDA tentatively approved a another generic version of Benicar (Olmesartan Medoxomil). The FDA granted its approval to make generic Benicar to Ascend Laboratories, LLC, a competitor of Daiichi Sankyo. Ascend’s FDA approval notes that the 180-day exclusivity provision remains intact. Generic versions of Benicar will likely come to market at the end of October 2016.
Recently, Daiichi released its annual investor relations report, which listed Benicar as generating over $2.5 billion in revenue in 2014. The investment report indicates that the largest portion of Benicar revenue comes from the United States. However, US revenue dipped approximately 10% after the FDA issued a warning on side effects caused by Benicar in 2013. Benicar sales have been falling year over year, but the company has steadily increased the price of the drug. A single pill of Benicar cost $2.25 in 2007. A single pill of Benicar now cost over $6.00 a pill!.
Scientific Articles on Benicar Side Effects
- May 2017: Short Article: Mortality and Differential Diagnoses of Villous Atrophy Without Coeliac Antibodies.
One in 274 patients diagnosed with villous atrophy were due to olmesartan-associated enteropathy.
A case study on hepatitis induced by Benicar.
Case report of a patient on Benicar who developed sprue-like enteropathy manifesting as Wernicke-Korsakoff syndrome due to vitamin b1 malabsorpotion with only minimally increased bowel movements. The researchers concluded that “it is important to consider changing the drugs before any serious malabsorption syndrome develops.”
- Oct 2016: Olmesartan-Induced Enteropathy.
“Olmesartan-induced enteropathy mimics celiac disease clinically and pathologically. As in celiac disease, the pathologic findings are villous atrophy and increased intraepithelial lymphocyes. Clinical prsentation of olmesartan-induced enteropathy includes diarrhea, weight loss, and nausea. In contrast to celiac disease, tissue transglutaminase is not elevated and there is no response to a gluten-free diet.”
A case study on a 75-year-old and a 69-year-old treated with benicar, each of which developed frequent diarrhea and significant weight loss.
- Apr 2016: Olmesartan-Associated Sprue-Like Enteropathy: A systematic review with emphasis on histopathology.
- Mar 2016: Olmesartan-Induced Enteropathy Associated with Cutaneous Lesions.
A 58 year old female took olmesartan for 5 years and then developed severe chronic diarrhea with malabsorption and skin lesions. This is the first case report in literature of skin lesions associated with Benicar’s side effects. She experienced liquid stools 4 to 6 times a day and lost over 30 pounds in 3 months. Her diarrhea and skin lesions quickly disappeared within days of discontinuing Benicar. Upon restarting Benicar her nausea, abdominal pain, and diarrhea reappeared within 2 days. She has now been symptom free for approximately two years without Benicar.
- Feb 2016: Potential Coeliac Disease Markers and Autoimmunity in Olmesartan Induced Enteropathy: A population-based study.
The study uncovered that autoimmune phenomena were present in a subset of cases and reversed after Benicar was discontinued.
“Olmesartan-associated enteropathy shares many features with coeliac disease, including symptoms and immunopathogenic pathways, such as increased numbers of CD8+ cells and corresponding overexpression of IL15 by epithelial cells. Taken together, the treatment of epithelial cells with olmesartan medoxomil induces a response by intestinal epithelial cells that is similar to the innate effects of gluten upon the epithelium of coeliac patients.”
An 84-year-old women was diagnosed with Benicar-induced sprue-like enteropathy after an extensive work up for chronic diarrhea, and without improvement despite multiple empiric treatments for 15 months! Discontinuing Benicar resulted in clinical and histological improvements.
- Aug 2015: Severe Intestinal Malabsorption Associated with Olmesartan: A French nationwide observational cohort study.
4.5 million patients were compared. The diagnosis of intestinal malabsorption was more than 10 times higher in those who were on Benicar as opposed to an alternative blood pressure medication.
Study notes that discontinuation of Benicar alone does not always result in resolution of side effects. Immunosuppressive drugs may be necessary to achieve remission of side effects.
- Apr 2015: A Review of Current evidence of Olmesartan Medoxomil Mimicking Symptoms of Celiac Disease.
Prior studies have identified Benicar as being the cause of 22% of unclassified sprue cases. The authors conclude by noting that “There is growing evidence supporting the association between olmesartan and sprue-like symptoms; however, further research is warranted. These symptoms can be life threatening and clincians should be aware of the potential association.
- Jan 2015: Sprue-like Histology in Patients with Abdominal Pain Taking Olmesartan Compared with Other Angiotensin Receptor Blockers.
Raises the possibility that there is a spectrum in the severity of side effects associated with Benicar. Previously Benicar was only associated with sprue like enteropathy, which is the most severe stage of Benicar’s side effects.
- Dec 2014: Acute Renal Failure Secondary to Diarrhea Due to Sprue Like-Enteropathy Associated with Olmesartan (Benicar)
- Apr 2014: Diarrhea and Malabsorption Due to Olmesartan (Benicar) Use.
a 63-year-old man presented with diarrhea, acute renal failure and metabolic acidosis. He was diagnosed with villous atrophy and started on a gluten-free diet, which did not improve his symptoms. The patient’s Benicar was discontinued due to dehydration and the patient’s diarrhea improved.
The first study to link Benicar to severe diarrhea and malabsorption was from the Mayo Clinic in Rochester, Minnesota. 22 patients from around the country with unexplained chronic diarrhea and weight loss while taking Benicar were treated. Various degrees of mucosal inflammation was observed. Diagnosis included lymphocytic gastritis and microscopic colitis. All patients improved once Benicar was discontinued.
Please call us to speak to one of our trained team members about the Benicar lawsuit. A Benicar lawyer will look over your case and let you know what they believe the best course of action is for you. Call today at 1-800-701-3672 for a free Benicar lawsuit evaluation. All case reviews are confidential and free of charge. The Hollis Law Firm operates on a contingency fee only basis. Follow our Benicar Lawsuit page to stay up-to-date on the Benicar litigation.
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