What Happened In The MassTorts World Last Week? 2019-Jan-14

On January 7, 2019, a California jury heard opening statements in the latest talcum powder trial over allegations against Johnson & Johnson that their baby powder was contaminated with cancer-causing asbestos fibers. An attorney representing a dying woman told the jury that J&J knew for decades about asbestos exposure risks but failed to warn the general public or take necessary actions.

The lawsuit filed by a plaintiff in Alameda Superior Court in Oakland is the first case to go for trial this year among a dozen talc cases filed against J&J. The plaintiff claimed in her lawsuit that she was exposed to the company's cosmetic talc that originated from South Korea during the first two years of her life in the Philippines. She moved to the United States in 1968 and was diagnosed with mesothelioma only in 2017. Her attorney,  Joseph Satterley told, testing done on Asian talc samples from the 1960s and 1970s by his own experts would show Korean-mined talc contained asbestos in them. In the court filings, J&J said fibers found in Korean talc or any of its talc cannot be classified as asbestos and asserted they were harmless non-asbestos fibers.

According to a Bloomberg report, J&J would face nearly three times as many talcum trials this year including a case with 38 plaintiffs scheduled for an August trial in Missouri’s St. Louis Circuit Court. In a one of its kind settlement agreement, J&J recently declared to pay more than $1.5 million to settle a Manhattan woman’s lawsuit in which she blamed exposure to asbestos fibers from J&J's talcum powder for her mesothelioma. J&J faces more than 11,000 talcum powder lawsuits across the U.S. filed on behalf of individuals who claimed they were diagnosed with mesothelioma and ovarian cancer due to asbestos exposure from the company's talc-based products. So far, J&J has won three cases and another five have ended in mistrials, and the company has appealed all of the plaintiff victory verdicts.

Johnson & Johnson (J&J) failed to escape the talcum powder lawsuit filed by the state attorney in the Chancery Court of Mississippi. Chancellor Dewayne Thomas denied the motion appealed by the company. The lawsuit alleged that the company failed to warn the residents about the risks of its talc-based products, which can cause ovarian cancer due to asbestos exposure in the talc.

On December 19, 2018, J&J failed to overturn another attempt as Judge Rex Burlison in St. Louis rejected the company’s bid to set aside a $4.7 billion July verdict which was awarded to 22 women who blamed asbestos exposure from the company's Baby Powder and other talc products for their ovarian cancer.

Regulators in India are testing J&J's Baby Powder after a stunning report suggested that the company was aware for years that some of its talc products had the presence of asbestos in them. The talcum giant confirmed that officials from India’s Central Drugs Standard Control Organization (CDSCO) and some state-based Food and Drug Administrations (FDA) visited its manufacturing plants in India. As per Reuters, J&J has tested asbestos presence since the 1970s, and several tests conducted revealed traces of asbestos in the Baby Powder and Shower-to-Shower powder. Reuters suggested Internal memos and documents indicated the test reports made officials at Johnson & Johnson worried, but still, they failed to warn consumers or regulators about asbestos traces in their talc-products.

In a press release issued last week, Portola Pharmaceuticals announced that the Food and Drug Administration (FDA) has finally sanctioned the Prior Approval Supplement (PAS) for large-scale commercial production of Andexxa, an antidote designed to stop potentially deadly side effects like bleeding from blood thinner drugs Xarelto and Eliquis.

It was initially granted accelerated approval in May 2018 for patients who were treated with rivaroxaban or apixaban medication. The agency had approved Andexxa for a restricted release to only to 40 to 50 hospitals earlier. The antidote for Factor Xa blood thinner effects would allow doctors to counter the uncontrollable bleeding problems linked to the new generation anticoagulants available in the market. Portola’s president and chief executive officer,  Scott Garland, said in the press release, “it is clear from the response to the Andexxa Early Supply Program that there is a significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban. We are pleased to now be able to stock hospitals nationwide and serve all patients in the U.S. who could benefit from the potential life-saving impact of Andexxa." The FDA has been cautious about the reversal agent and has called for more evidence on this matter, as doctors feel the researchers involved in a 2016 study about Andexxa's benefits might be exaggerating about its effectiveness.

More than 20,000 Xarelto lawsuits are pending as part of federal multidistrict litigation (MDL No.2592; In Re: Xarelto (Rivaroxaban) Products Liability Litigation) in the Eastern District of Louisiana which is presided by U.S. District Judge Eldon Fallon. Each of the lawsuits claims the patients and the medical community were not given an appropriate warning about the uncontrollable bleeding effects of Xarelto and Eliquis.

Xarelto (Rivaroxaban) is an anticoagulant that got its U.S. Food and Drug Administration (FDA) approval in November 2011. Xarelto is manufactured by Bayer and jointly marketed by Johnson & Johnson's subsidiary Janssen Pharmaceuticals. It works by blocking certain clotting proteins in the blood and was promoted as a replacement for Warfarin, a blood thinner that had been on the market for a number of years.

Xarelto is indicated in Atrial fibrillation for people who have just had hip or knee replacement surgery to reduce the risk of forming a blood clot, and also to treat Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). It is the first orally administered active direct factor Xa inhibitor slowing down blood clot formation. It was heavily marketed, and equivalently the usage also increased, until it was noticed that it causes uncontrollable bleeding. As Xarelto has no antidote that can help stop the bleeding, it led to unexpected serious injuries leading to death.

On Tuesday, January 8, Judge Thomas Moukawsher of the Hartford Superior Court dismissed opioid lawsuits filed by 37 cities and two towns in the Connecticut state against Purdue Pharma and two dozen other drug companies. The lawsuits were tossed as they were not government enforcement actions and were "ordinary civil cases" seeking damages for "indirect harm" from the opioid crisis in the nation.

Judge Moukawsher said, "their lawsuits can’t survive without proof that the people they are suing directly caused them the financial losses they seek to recoup. This puts the cities in the same position in claiming the money as the brothers, sisters, friends, neighbors, and co-workers of addicts who say they have also indirectly suffered losses by the opioid crisis. That is to say — under long-established law — they have no claims at all.”

City and town lawyers are still reviewing the judge's ruling and plan to appeal the decision soon. The plaintiffs, in this case, are Bridgeport, New Haven, and Waterbury. Judge Moukawsher did not reject the entire litigation against opioid producers. This is a first of its kind dismissal of government lawsuits in the recent rounds of litigation against opioid manufacturers. Last month an Ohio federal judge rejected a request by drugmakers to dismiss claims brought by local governments and other groups. Purdue Pharma, the Connecticut-based company, denied allegations in lawsuits that it indulged in false marketing to improve sales of its painkiller drug OxyContin.

More than 50,000 Americans died due to a drug overdose in 2017, and the toll has been spiking for two decades according to the federal Centers for Disease Control and Prevention. Judge Dan Aaron Polster of the U.S. District Court overlooks the opioid litigation in the Northern District of Ohio Eastern Division.

Earlier, San Francisco sued opioid manufacturers and distributors alleging that they went against the federal laws by illicit marketing of opioids. Drug providers like Purdue Pharma are accused of fraudulent practices that resulted in the public suffering from a health epidemic. The lawsuit will be transferred to Ohio federal court where 1,200 similar lawsuits are filed by various cities, counties, and states. The MDL is overlooked by the U.S. District Judge Dan Polster. 

Pharmaceutical companies filed a motion to dismiss the lawsuits filed against them in the U.S. District Court in the Northern District of Ohio Eastern Division, but Judge Dan Aaron Polster denied it. The judge allowed 1,500 lawsuits brought by communities across the nation, including the city of Providence, to move forward in the litigation. Oxycontin, oxycodone and fentanyl are such opioids that are linked to respiratory disorders, heart complications, addiction, and overdose deaths. Fentanyl is being declared as the most dangerous drug used in the U.S. as per the recent report by the U.S. Centers for Disease Control and Prevention (CDC)’s National Center for Health Statistics.