Bayer, J&J settle thousands of U.S. Xarelto lawsuits for $775 million

(Reuters) – Bayer AG and Johnson & Johnson have agreed to settle more than 25,000 U.S. lawsuits alleging that their blockbuster blood thinner Xarelto caused unstoppable and in some cases fatal bleeding for a total of $775 million (588 million pounds), court documents on Monday showed.

FILE PHOTO: Logo of Bayer AG is pictured at the annual results news conference of the German drugmaker in Leverkusen, Germany February 27, 2019. REUTERS/Wolfgang Rattay/File Photo

The amount will be shared equally between the two companies that jointly developed the drug. Bayer and J&J do not admit liability under the agreement.

The settlement will resolve all pending U.S. lawsuits over Xarelto, which plaintiffs claimed caused uncontrollable and irreversible bleeding leading to severe injuries and even death among thousands of patients.

Plaintiffs accused the drugmakers of having failed to warn about the bleeding risks, claiming their injuries could have been prevented had doctors and patients been provided adequate information.

Bayer in a statement on Monday said it continues to believe the claims are without merit.

“However, this favourable settlement allows the company to avoid the distraction and significant cost of continued litigation,” the company said.

Lawsuits over Xarelto began piling up in 2014 and the companies had so far won all six trials over Xarelto’s alleged bleeding risk.

J&J in a statement said it continued to believe in the safety of Xarelto, but that the settlement was the right thing to do for patients and their doctors.

Xarelto is Bayer’s best-selling drug. It contributed 3.6 billion euros (3.09 billion pounds) in revenue to the German group’s pharmaceutical business last year.

Bayer said its share of the settlement amount will be partially offset by product liability insurance.

Bayer jointly developed Xarelto with J&J’s Janssen Pharmaceuticals unit, which sells the blood clot preventer under a licensing agreement in the United States.

J&J reported 2018 Xarelto sales of $2.47 billion.

The U.S. Food and Drug Administration approved Xarelto in 2011. It is prescribed for people with atrial fibrillation, a common heart rhythm disorder that increases the risk of stroke. The drug is used to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms.

The companies in the past have said Xarelto’s warning label provides “complete, accurate and science-based information on the medicine’s benefits and risks.”

The majority of the claims were consolidated in New Orleans federal court, where three cases were selected as so-called bellwether trials, aimed to help determine the range of damages and define settlement options. The companies won those three trials throughout 2017.

FILE PHOTO: A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake/File Photo

J&J and Bayer were also cleared of liability in three other state court trials in 2018.

Xarelto is among a class of oral blood thinners, including Bristol-Myers Squibb and Pfizer’s Eliquis, that are alternatives to decades-old warfarin. Most of the lawsuits over Eliquis have been dismissed by U.S. judges.

A similar drug, Boehringer Ingelheim’s Pradaxa, also became subject of thousands of lawsuits claiming the company understated its bleeding risk. Boehringer in 2014 reached a $650 million settlement to resolve more than 4,000 of those cases.

Reporting by Tina Bellon in New York; Editing by Bill Berkrot

Source

more recommended stories

  • South Africa to roll out sweeping health reform in stages

    PRETORIA (Reuters) – A proposed move.

  • FDA classifies Edwards Lifesciences Sapien delivery system recall as severest

    (Reuters) – The U.S. Food and.

  • Plastic particles in drinking water present ‘low’ risk: WHO

    GENEVA (Reuters) – Microplastics contained in.

  • AstraZeneca’s Imfinzi misses main goal of advanced lung cancer study

    FILE PHOTO: A sign is seen.

  • AstraZeneca diabetes drug shows promise in heart failure

    (Reuters) – AstraZeneca (AZN.L) made strides.

  • Study prompts call for lower fluoride consumption by pregnant women

    (Reuters Health) – Adding fluoride to.

  • CDC investigates lung illnesses linked to e-cigarette use

    FILE PHOTO: A man vapes outside.

  • E.coli in water forces Tokyo to cancel swimming at Paratriathlon World Cup

    TOKYO (Reuters) – High levels of.

  • E.coli risk forces Tokyo to cancel swim events at Paratriathlon World Cup

    TOKYO (Reuters) – High levels of.

  • First two Ebola cases confirmed in Congo’s South Kivu – officials

    FILE PHOTO: Children look at a.

  • Surgical training programs not supportive of new parents

    (Reuters Health) – Surgical residents say.

  • Liver disease related to obesity and diabetes rising in U.S.

    (Reuters Health) – The only liver.

  • Ebola ‘no longer incurable’ as Congo trial finds drugs boost survival

    LONDON (Reuters) – Scientists are a.

  • Scientists hail promise of first effective Ebola treatments in Congo trial

    LONDON (Reuters) – Scientists are a.

  • China cuts 2019/20 corn use forecast by 2 million tonnes due to African swine fever

    Corn kernels are seen at a.

  • WHO says no new Ebola cases in Goma, vaccinates over 1,300

    FILE PHOTO: A young woman reacts.

  • Dengue death toll rises in Malaysia, number of cases close to double

    KUALA LUMPUR (Reuters) – Malaysia saw.

  • Amgen wins U.S. patent battle on arthritis drug Enbrel, thwarting Novartis

    (Reuters) – A U.S. judge on.

  • AstraZeneca’s Tagrisso helps lung cancer patients live longer: study

    (Reuters) – AstraZeneca Plc said on.

  • Study shows Apple devices in combo with apps could identify dementia

    FILE PHOTO: The new Apple iPhone.

  • Moving during early pregnancy may increase preterm birth risk

    (Reuters Health) – Moving to a.

  • Drug assistance programs offer little charity to uninsured

    (Reuters Health) – Many patients who.

  • In extreme heat, electric fans inadvisable unless it’s humid

    In extreme heat, electric fans may.

  • Trump administration considers September unveiling of healthcare plan: WSJ

    FILE PHOTO: U.S. President Donald Trump.

  • Bulgaria to compensate owners who cull pigs to help stamp out swine fever

    FILE PHOTO: A pig rests at.

  • Yellow lens glasses don’t improve drivers’ night vision

    (Reuters Health) – – Touted to.

  • U.S. FDA approves Daiichi Sankyo’s treatment for rare joint tumor

    (Reuters) – The U.S. Food and.

  • For some surgeries, hospital rankings not tied to better outcomes

    (Reuters Health) – When it comes.

  • Congo says Rwanda has closed border near Goma

    Congolese customs agents gather at the.

  • Pluristem gets positive results from radiation treatment trials

    TEL AVIV (Reuters) – Israel’s Pluristem Therapeutics.

  • Congress seeks briefing on potential threat to U.S. heparin supply

    WASHINGTON (Reuters) – Leaders of the.

  • U.S. judge blocks Medicaid work requirements in New Hampshire

    (Reuters) – A federal judge on.