Daiichi Sankyo Settles Blood Pressure Drug Benicar MDL 2606 for $300 Million

Daiichi Sankyo settles U.S. lawsuits for $300 million over blood pressure drug Benicar in Multidistrict Litigation No. 2606

Daiichi Sankyo on Tuesday said it has agreed to pay up to $300 million to settle 2,300 U.S. cases (see Benicar MDL 2606 Settlement Order of August 1, 2017) accusing the Japanese drugmaker of failing to warn that its blood pressure medication Benicar can cause gastrointestinal illness, that were being heard in MDL 2606 Benicar US District Court of New Jersey see Benicar MDL No. 2606 Mass Tort Nexus Link.

The four olmesartan products at issue in this litigation are: Benicar®, Benicar HCT®, Azor®, and Tribenzor®. With respect to each of these products, Defendants exaggerated their benefits and understated, omitted and/or failed to adequately warn patients and physicians about the risks associated with such products.

The settlement will become finalized if at least 95 percent of all claimants agree, or opt in, Daiichi Sankyo said in a statement. The company said the settlement fund was capped at $300 million. Daiichi Sankyo said it was not admitting liability by settling and that it continues to believe that the Benicar claims were without merit. The settlement relates to the federal actions  in US district court, and excludes a separate Benicar litigation, where another 76 cases in New Jersey State Court, see multicounty litigation in Atlantic County, New Jersey.

“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,” Glenn Gormley, the group’s executive chairman, said in a statement.

The first lawsuits over Benicar were filed in 2014 and the cases were eventually consolidated in a multidistrict litigation in federal court in New Jersey under MDL 2606 before US District Judge Robert B. Kugler.

The Tokyo-based drugmaker said the agreement would not have a material impact on its financial position, as the settlement is expected to be funded by several of the group’s insurance companies.  As far back as 2012, doctors wrote a total of approximately 10.6 million prescriptions for Benicar, and approximately 1.9 million patients received a dispensed prescription for olmesartan-containing products from U.S. outpatient retail pharmacies in a year, reflecting Benicar as a significant source of income for the company..

Plaintiffs alleged that the company’s blood pressure medication Benicar, along with its sister drugs Benicar HCT, Azor and Tribenzor, did not carry labels that warned of gastrointestinal side effects, such as sprue-like enteropathy, until a decade after it was introduced.

The U.S. Food and Drug Administration approved olmesartan medoxomil, Benicar’s active ingredient, in 2002. But, the agency required Daiichi Sankyo to change its label to include the warning in 2013, when studies showed the drug to be linked to intestinal problems and the FDA issued a warning in July 2013 that olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. Plaintiffs, who filed their first suits in 2014, accused the company of inadequately warning about the drug’s risks and misrepresenting its safety.

 

 

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1,800 Cases Against Daiichi and Forest Labs in Benicar Product Liability MDL

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A Pennsylvania man is the latest of 1,800 plaintiffs to file a mass tort claim against the makers of the blood pressure medication Benicar (olmesartan), charging that it causes gastrointestinal side effects including diarrhea, colitis and sprue-like enteropathy.

Dale W. Hank, Jr., of New Kensington, PA, filed suit on Dec. 30 in Benicar Product Liability Litigation in MDL 2606, Case No. 1:16-cv-09590-RBK-JS, in federal court in Camden, New Jersey before US District Judge Robert B. Kugler.

The number of federal actions is up from 1,430 since June 2016. (In separate litigation, another 76 cases in a multicounty litigation in Atlantic County, New Jersey.) The federal defendants include:

  • Daiichi Sankyo, Inc.
  • Daiichi Sankyo U.S. Holdings, Inc.
  • Daiichi Sankyo Co., Ltd.
  • Forest Laboratories, LLC, f/k/a Forest Laboratories, Inc.
  • Forest Pharmaceuticals, Inc.
  • Forest Research Institute, Inc.

In 2007 Hank began taking Benicar and Benicar HCT. As a result he suffered nausea, diarrhea, vomiting, abdominal pain/discomfort, malabsorption, fatigue, malnutrition, dehydration, inflammation, villous damage/atrophy/blunting, sprue-like enteropathy, olmesartan associated enteropathy, colitis, intestinal injury and damage.

Widely prescribed despite FDA warning

In 2012, Doctors wrote a total of approximately 10.6 million prescriptions for Benicar, and approximately 1.9 million patients received a dispensed prescription for olmesartan-containing products from U.S. outpatient retail pharmacies.

The drug will become more widely available because of the expiration of the olmesartan patent. Mylan Pharmaceuticals Inc. and Lupin Limited began making generic versions of Benicar and Benicar HCT in 2016.

The U.S. Food and Drug Administration issued a warning in July 2013 that olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.

The FDA concluded in 2013 that Benicar was responsible for 23 serious reports of health related problems, which in some cases required hospitalization. The FDA found, “clear evidence of an association between olmesartan and sprue-like enteropathy.” It ordered changes to the labels of these drugs to include this concern.

Meanwhile, litigation has been stalled until April, when the first bellwether trials may be held. Plaintiffs’ expert reports were due on November 30. Upcoming deadlines in the federal litigation include:

  • January 31, 2017 – Defendants’ expert reports due;
  • February 28, 2017 – Expert depositions completed, and
  • March 31, 2017 – Motions for summary judgment and Daubert motions due.

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Plaintiff’s Motion for Summary Judgment Denied in Benicar MDL

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US District Judge Robert B. Kugler in Camden, New Jersey, denied a motion for summary judgment filed by plaintiffs in Benicar Product Liability Litigation in MDL 2606, ruling that 14 exhibits based on defendants’ depositions or documents did not show that the company was liable.

The plaintiffs submitted a request to file a motion for partial summary judgment on the issue of general causation, asserting that the exhibits are defendants’ admissions of general causation that show that defendants’ pharmaceuticals caused sprue‐like enteropathy (SLE). The case is In Re: Benicar (Olmesartan), Case No. 15‐2606. SLE symptoms, which include nausea, vomiting, diarrhea and weight loss.

The FDA concluded in 2013 that Benicar, a drug commonly prescribed to control blood pressure, was responsible for 23 serious reports of health related problems, which in some cases required hospitalization. Following the release of the FDA warning, Daiichi, and Forest continued manufacturing and promoting Benicar to consumers and their doctors, despite the fact that it had been blacklisted as a dangerous drug.

1,900 plaintiffs

The MDL involves about 1,900 plaintiffs, who ingested defendants’ olmesartan‐containing prescription drugs  to alleviate hypertension.  The defendants are Daiichi Sankyo, Inc., Daiichi Sankyo Co., Ltd., Daiichi Sankyo U.S. Holdings, Inc., Forest Laboratories, LLC, Forest Laboratories, Inc., Forest Pharmaceuticals, Inc., and Forest Research Institute, Inc.

In parallel litigation, 76 cases about Benicar have been filed in multicounty litigation New Jersey state courts in Atlantic County.

The plaintiffs argued that the 14 exhibits, which are excerpts of defendants’ deposition testimony or defendant‐produced documents, were admissions that defendants generally caused plaintiffs’ injuries.

But Judge Kugler wrote, “Plaintiffs’ request lacks not only an explanation as to how these summaries and excerpts constitute incontestable facts upon which to base a summary judgment motion but also any jurisprudential support that defendant alleged admissions during discovery in and of themselves properly substitute for expert testimony to demonstrate general causation.”

“No exhibit or combination can resolve the inevitable jury speculation as to the complex biochemical, biological, and epidemiological information that underpins the general causation question here,” the judge wrote.

To date, plaintiffs have taken at least 20 depositions of present and former Daiichi U.S. employees and eighteen 18 depositions of present and former Daiichi Japan employees.  The first phase of fact discovery regarding causation issues was all but completed by September 30, 2016.

The litigation has now entered the next phase with plaintiffs’ causation expert reports due November 30, 2016, defendants’ expert reports due January 31, 2017, expert depositions to completed by February 28, 2017, and Daubert and summary judgment motions due by March 31, 2017. The date for the Daubert hearing has not yet been set.

 

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Considerations for Plaintiff Attorneys when Starting a Successful Mass Tort Practice

John Ray
John Ray

Mass Tort Litigation has emerged as the only effective check on pharmaceutical and medical device companies that make dangerous products injuring thousands of Americans. Mass tort attorneys have filed 140,000 lawsuits in 250 federal multidistrict litigation dockets as of September 2016.

Many attorneys are expanding their personal injury practices to include mass torts because the US Judicial Panel on Multidistrict Litigation has organized the litigation so effectively against the multi-billion-dollar drug and medical device industry.

“The FDA is not a check or a balance on the pharmaceutical industry,” said Mass Tort Nexus Consultant John Ray, recently teaching a four-day course about mass torts in Fort Lauderdale, FL. “Plaintiff attorneys are the only check on the pharmaceutical industry.”

In recent years mass tort lawyers have recovered $10 billion in settlements for injured Americans: $4.8 billion for Vioxx, $1.8 billion for Yaz, $1.3 billion for the Stryker hip and $2.5 billion for the DePuy hip.

“The drug companies bake these cases into their business model,” Ray said. “Defendants call it a win when they don’t put a warning on their labels, don’t get sued and don’t have to pay a judgment at all. This means they got away with it. That happens a lot.”

When a federal MDL is created, the supervising judge will approve a standard short-form or long-form complaint, plus a plaintiffs’ fact sheet which replaces interrogatories. The consolidation of cases means that a mass tort lawyer can file a notice of appearance and file cases regardless of the jurisdiction of the plaintiff, defendant company or the location of the plaintiff’s attorney.

Criteria for a viable case

Cases that are attracting many mass tort attorneys now involve Xarelto, IVC filters and Pradaxa. Among the many factors determining the viability of a mass tort are:

  • Preemption. Congress has expressly preempted certain claims. Further, courts have ruled that generic manufacturers cannot be sued.
  • Statute of limitations: State laws govern when the statute of limitations starts to run, but in most federal litigation, the date that the FDA issues a “black box warning” for a drug marks the date when the time limit begins to run.
  • Legal viability. In many cases, research will show a connection between a drug and injuries among patients, but specific causation must be proved in a trial. Experts must be found who will survive a Daubert motion to disqualify.
  • Financial viability of the defendant. While Johnson & Johnson had $46.8 billion in annual income in 2015, some small makers of IVC filters went out of business before they could sell one.
  • Average case value. The average Pradaxa case settled for $160,000 in 2014, with some settlements valued up to $500,000, according to a grid created by US District Judge David R. Herndon.
  • Plaintiff numerosity. Cases in the Syngenta Corn Market Crash Litigation involve every corn producer in America, and IVC Filters have been implanted in millions of patients over the last 40 years.
  • Cost per client acquired. Costs can add up with Facebook advertising, website marketing, and lead generation companies. For example, The Sentinal Group will advertise for clients for a fee of $100,000 to obtain 250 calls for Xarelto plaintiffs, with 1 out of 5 calls leading to a signed client.
  • Case duration. Mass torts are litigation for the long haul, with the average case lasting 5 years and 4 months before settlement, according to Ray, with 7 years being a good benchmark for the duration of a case.
  • Case value. An example of a good outcome is with Pradaxa. The average settlement is $162,000. Calculating 40% in gross contingent fees would equal $64,800. Another 7% is deducted ($4,536) for the common benefit to pay the steering committee. Of the remaining fee of $60,204, a 40% referral fee of $24,015 is deducted for the co-counsel that handled the litigation. This leaves a net fee of $36,189 for the attorney who originated the case.
  • Financial resources. Costs to fund a case can be in the tens of thousands of dollars, with costs reaching hundreds of thousands for members of the plaintiffs steering committee.
  • Personnel resources. A law firm will have to train a small army of intake specialists to answer incoming calls when advertising is running. Additional personnel will be needed to obtain and review medical records.

Perfect timing

There are three phases of mass tort litigation, and perfect timing will be needed to enter a particular case.

Emerging Phase Cases. In this early phase, the cost to acquire a client is the least expensive, but there many issues of case viability. For example, the courts are still considering motions to consolidate cases involving Abilify and Roundup. With Abilify the FDA has issued a safety warning but not a black box warning. With Roundup the EPA has not classified the herbicide as a carcinogen, but foreign governments have.

Litigation Phase Cases. It is considered an ideal time to enter into a mass tort when the JPML has created a multi-litigation docket (MDL). Some 250 MDLs include mature litigation involving Benicar, Lipitor, Viagra, Xarelto and Zofran, and many legal issues have been settled. The supervising judge will schedule bellwether or test cases for trial.

Settlement Phase Cases. This is the very safest time to enter litigation because all an attorney must do is find qualified plaintiffs. Example cases involve transvaginal mesh, Levaquin and Pradaxa. However at this late phase the cost to acquire a client is at its highest.

“Whatever you do, maintain your single-event plaintiff’s practice,” Ray advised. “You will have to keep paying the costs of a mass tort case until it settles, and you will need a huge cash supply or credit line.”

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Thousands of Benicar Side Effect Lawsuits Filed Against Allergan and Warner Chilcott

Thousands of Benicar Side Effect Lawsuits Filed Against Allergan and Warner Chilcott

At least 1,239 Benicar side effects lawsuits have been filed against Allergan plc and Warner Chilcott Ltd., according to Lawyers and Settlements. This is according to their Form 10-K filing with the US Securities and Exchange Commission submitted in February.

The cases are consolidated in the US District Court in Camden, New Jersey, In Re: Benicar (Olmesartan) Products Liability Litigation, MDL 2602. A discovery conference call was held on June 14, 2016 with Magistrate Judge Joel Schneider.

After completing multiple tests and rigorous studies, the Food & Drug Administration (FDA) concluded that Benicar, generically known as olmersartan medoxomil, is an unreasonably dangerous drug that is the cause of sprue-like enteropathy.

The FDA concluded in 2013 that Benicar, a drug commonly prescribed to control blood pressure, was responsible for 23 serious reports of health related problems, which in some cases required hospitalization. FDA warnings were distributed to the leading manufacturers of Benicar including Daiichi Sankyo Inc. (Daichi), and Forest Laboratories (Forest). Following the release of the FDA warning, Daiichi, and Forest continued manufacturing and promoting Benicar to consumers and their doctors, despite the fact that it had been blacklisted as a dangerous drug.

Four products at issue

According to the Benicar MDL 2606 Master Complaint:

The four olmesartan products at issue in this litigation are: Benicar®, Benicar HCT®, Azor®, and Tribenzor®. With respect to each of these products, Defendants exaggerated their benefits and understated, omitted and/or failed to adequately warn patients and physicians about the risks associated with such products.

Plaintiffs have suffered personal injuries as a direct and proximate result of Defendants’ conduct and misconduct in connection with the design, development, manufacture, testing, packaging, promotion, advertising, marketing, distribution, labeling, warning, and sale of the olmesartan products.

The physical injuries suffered by Plaintiffs include, but are not limited to, serious gastrointestinal injuries, Olmesartan Associated Enteropathy (“OAE”), sprue-like enteropathy, villous atrophy/blunting/damage, inflammation, nausea, vomiting, chronic diarrhea, malnutrition, dehydration, atrophy, kidney failure, weight loss, abdominal and gastrointestinal pain, colitis, gastritis, and including permanent injuries resulting therefrom, and death.

Plaintiffs’ injuries are serious, longstanding, and permanent, resulting in multiple hospitalizations and even death in some cases. Had Plaintiffs or Plaintiffs’ health care professional(s) been properly warned by Defendants about the risks from ingesting Defendants’ olmesartan products, the Plaintiffs would not have ingested these drugs and/or would have ceased use of the olmesartan products.

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