Daiichi settles undisclosed drug side-effects case for $300 million

pharmafile | August 2, 2017 | News story | Research and Development, Sales and Marketing Benicar, Daiichi Sankyo, biotech, drugs, pharma, pharmaceutical 

Daiichi Sankyo has settled a case alleging that it did not fully disclose adverse side-effects of its drug, Benicar, with a $300 million pay-out for those patients who had complications using the drug. The company did not admit any wrongdoing on its part, claiming that the litigation was “without merit” and that it “does not admit liability”.

There were 2,300 cases lined up against the company suggesting that the gastrointestinal problems associated with the drug were covered up and that they wilfully avoided disclosing the information to patients. In 2013, after studies revealed that the drug was linked with intestinal damage, the FDA ordered the company to include label warnings regarding the risk.

Users of the drug began suing the company in 2014 over the revealed side-effects that included: abdominal pain, diarrhoea, colitis and nausea. Now, those involved in the suit, will be able to claim their part of the $300 million fund set up to address the claims.

The accord requires 95% of all plaintiffs to agree to the terms of the accord, which will include submitting documentation of their treatment with the drug. Plaintiffs will be given compensation depending on how severely they suffered as a result, which will be measured by the number of days spent in hospital and the degree of intestinal damage.

“Daiichi Sankyo is committed to the health and safety of all patients taking our medications,” said Glenn Gormley, Executive Chairman and President, Daiichi Sankyo. “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.”

Daiichi will not be financially impacted by the decision, after it revealed that the fund will be comprised of proceeds from the company’s insurance protection, with some supplementation from its own funds.

The case is the second case that Daiichi has had go against them regarding the drug, after it was forced to pay a $39 million fine to the US government over paying kickbacks to doctors to prescribe the drug. This particular settlement came after a whistle-blower lawsuit was launched by a former sales representative.

Ben Hargreaves

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