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

  • China finds more cases of African swine fever on Hainan island

    BEIJING (Reuters) – China has detected.

  • China draws up tighter rules on human gene and embryo trials: Xinhua

    FILE PHOTO: A student at Ayi.

  • Second death in Novartis gene therapy trials under investigation

    (Reuters) – Novartis AG, which this.

  • Judge upholds New York City’s mandatory measles vaccination order

    NEW YORK (Reuters) – A Brooklyn.

  • Dozens of doctors in Appalachia charged in opioid fraud bust

    (Reuters) – Dozens of medical professionals.

  • Germany to launch cannabis farming as Canada’s Aurora, Aphria win tenders

    FRANKFURT (Reuters) – Germany has awarded.

  • Most diabetes apps lack real-time advice on blood sugar management

    (Reuters Health) – Hundreds of smartphone.

  • U.S. measles cases surge nearly 20 percent in early April, CDC says

    (Reuters) – The number of confirmed.

  • Catalent to buy Paragon Bioservices for $1.2 bln – WSJ

    (Reuters) – Drug developer Catalent Inc.

  • Caito Foods recalls fresh cut melon over Salmonella outbreak

    (Reuters) – An Indianapolis food company.

  • FDA pulls up Walmart, Kroger, others for selling tobacco to minors

    FILE PHOTO: A Walmart sign is.

  • Clovis Oncology halts mid-stage bladder cancer trial, shares drop

    (Reuters) – Clovis Oncology Inc said.

  • South Korea WTO appeal succeeds in Japanese Fukushima food dispute

    FILE PHOTO: The World Trade Organization.

  • South Korea court strikes down law criminalizing abortion in landmark ruling

    SEOUL (Reuters) – In a landmark.

  • U.S. charges pummel drugmaker Indivior, hurt Reckitt

    (Reuters) – Indivior Plc lost three-quarters.

  • New York orders mandatory measles vaccinations, blasts misinformation fueling outbreak

    NEW YORK (Reuters) – New York.

  • Zogenix’s seizure drug filing fails to pass U.S. FDA scrutiny

    (Reuters) – The U.S. Food and.

  • China reports first African swine fever outbreak in Tibet

    BEIJING (Reuters) – China’s agriculture ministry.

  • China’s Inner Mongolia reports human infection of H7N9 bird flu virus: Xinhua

    BEIJING (Reuters) – China’s Inner Mongolia.

  • Factbox: Cyclone Idai’s death toll rises to 843, hundreds of thousands displaced

    BEIRA, Mozambique (Reuters) – Hundreds of.

  • CDC investigates E.coli outbreak in several states

    FILE PHOTO: A general view of.

  • Oklahoma drops several claims in opioid case against J&J, Teva

    (Reuters) – Oklahoma’s attorney general on.

  • U.S. House condemns Trump’s courtroom efforts to end Obamacare

    WASHINGTON (Reuters) – Calling it an.

  • Democrats mock Trump over healthcare delay ahead of 2020 election battle

    WASHINGTON (Reuters) – Democrats mocked President.

  • Trump says vote on healthcare can wait until after 2020 election

    (This April 1 story was refiled.

  • Swiss drugmaker Novartis must face doctor kickback suit, U.S. judge rules

    NEW YORK (Reuters) – Novartis AG.

  • First cholera death recorded since cyclone hit Mozambique port, cases double

    A woman walks with her children.

  • Ebola treatment center in Congo reopens after attack

    (Reuters) – An Ebola treatment center.

  • Cholera cases jump to 138 in Mozambique’s Beira after cyclone

    BEIRA, Mozambique (Reuters) – The number.

  • Fresenius Medical Care to pay $231 million to resolve criminal, civil foreign bribery charges

    FILE PHOTO: Samples of products of.

  • Frailty before surgery tied to more complications, higher costs

    (Reuters Health) – Patients who are.

  • U.S. jury says Bayer must pay $80 million to man in Roundup cancer trial

    SAN FRANCISCO/NEW YORK (Reuters) – A.