What Happened In The MassTorts World Last Week? 2019-Apr-01

LA County Imposes Ban On Roundup Weedkiller

Los Angeles County is the latest to issue a ban on the infamous glyphosate-based weed killer, Roundup after a San Francisco federal jury ruled in the first phase of the bellwether trial that glyphosate exposure was a substantial reason for a California man, Edwin Hardeman's cancer.

The Los Angeles County Board of Supervisors, on Tuesday, March 19, instructed all its departments to stop using the weed killer, which has been in the headlines for being carcinogenic. Though the board did not give out its opinion on the recent court verdicts, Supervisor Kathryn Barger said the ban on glyphosate-containing herbicides would remain until public health, and environmental professionals can develop a safer alternative for Roundup to be used in L.A. County properties. The supervisory board asked the Department of Public Works to look for better substitutes and provide a report with recommendations within 30 days. While the outcome of the second phase of the bellwether trial involving Hardeman’s claims is still awaited, Bayer, which took over Monsanto in 2018, maintained that the product is safe to use and non-carcinogenic.

All product liability lawsuits filed against Monsanto over cancer concerns are consolidated into multidistrict litigation (MDL No. 2741; In re: Roundup Products Liability Litigation) before Judge Vince Chhabria in the Northern District of California.

Eight Sackler Family Members on The Hook For Opioid Crisis

More than 500 cities, counties and Native American tribes sued eight members of the billionaire Sacker family, who own Purdue Pharma, in the Southern District of New York, accusing them of the opioid epidemic worrying the nation.

The federal lawsuit accused them of purposely misleading the public about the dependency factor of their prescription opioids, and paying no heed to doctors who were accused of wrongfully prescribing high doses of opioids or diverting the supply to the black market. For a long time, Purdue Pharma had faced charges for negligently handling and fraudulent marketing of OxyContin; it pleaded guilty for misbranding the blockbuster painkiller and paid $600 million in 2007, as fine for criminal charges of misbranding OxyContin. However, lawsuits continue to be filed alleging that the company took little or no effort to change anything since then.

The lawsuit includes Richard Sackler, Jonathan Sackler- sons of late Purdue owner, Raymond Sackler; Beverly Sackler- Raymond's widow; David Sackler- Raymond's grandson; Ilene Sackler Lefcourt, Kathe Sackler, and Mortimer David Alfons Sackler - children of another founding member, Mortimer Sackler; Theresa Sackler- widow of Mortimer Sr., as defendants. These same people were also named as co-defendants in a lawsuit brought by the Massachusetts Attorney General. Responding to the lawsuit, Purdue gave out its usual defense statement that this complaint was part of the deliberate effort to single out Purdue and blame it for the entire opioid crisis in the U.S. The opioid addiction has led to 60,000 overdose deaths in 2017 alone, with more than 17,000 linked to prescription opioids.

Xarelto Defendants Announce A Whopping $775M Settlement

A favorable settlement amounting to a total of $775 million was announced on Monday by Bayer AG and Johnson & Johnson’s subsidiary Janssen Pharmaceuticals to resolve over 25,000 lawsuits pending in the U.S. courts over Xarelto, their blockbuster blood thinner.

The drug is prescribed mainly to prevent and treat blood clots and lower the risk of deep-vein thrombosis (DVT), pulmonary embolism, and stroke; it was jointly developed by the two defendants who have agreed to settle the lawsuits without admitting liability under the agreement. Allegations hurled by the plaintiffs included uncontrollable and irreversible bleeding leading to severe injuries and even death. Claims also included failure to warn doctors and patients about the bleeding risks, claiming the injuries could have been prevented had adequate warnings been provided.

The settlement will resolve both state and federal cases. As per  the court papers, the cost will be split equally between the two defendants. A statement was released by Bayer stating, ‘’the settlement allows the company to avoid the distraction and significant cost of continued litigation.” Also, some of Bayer’s settlement costs will be offset by liability insurances. J&J announced through a statement, it continued to believe in the safety of Xarelto. A detailed settlement document had not been filed as of Monday midday.

Other than the state filed cases, federal cases belong to multidistrict litigation, MDL No. 2592; In Re: Xarelto (Rivaroxaban) Products Liability Litigation, presided by Judge Fallon in the Eastern District of Louisiana.

Okhlahoma’s OxyContin Lawsuits To Be Settled For $270 Million

OxyContin maker Purdue Pharma and its owners, the Sackler family, agreed to pay $270 million to escape from a state court trial over the company's involvement in the opioid addiction which took more than 200,000 lives in the U.S. over the past two decades.

The amount negotiated was larger than the previous two settlements by Purdue Pharma for other states and would resolve a case brought by the state of Oklahoma. The deal was reached two months before the beginning of a television trial in Oklahoma, where charges based on Purdue's deceptive marketing tactics would be on display in the state, which was hit hard by the opioid crisis. As per the terms of the settlement, Purdue and the Sackler family vowed to pay $197.5 million for the expansion of an addiction treatment and research center at Oklahoma State University in Tulsa. The company is willing to provide $102.5 million in cash, $20 million worth of addiction treatment medicines, and an additional $75 million will be provided by Sacklers over the next five years starting in 2020. Purdue also agreed to pay $60 million for litigations costs and an additional $12.5 million to the state to fight the opioid addiction crisis. According to state officials, a foundation associated with the Oklahoma State University Center for Health Sciences Center for Wellness and Recovery will be established to receive funds. A trial against other defendants sued by Oklahoma will begin in late May.

2nd. Circuit Court Refuses To Revive 60 Eliquis Lawsuits

On Tuesday, March 26, the 2nd U.S. Circuit Court of Appeals in New York upheld the dismissal of 60 Eliquis lawsuits targeted at Bristol-Myers Squibb and Pfizer Inc., related to the dangers of their blood thinner drug.

According to the federal court of appeals, a lower court was not wrong in refusing to send 45 cases back to Delaware state court and ruling that all of the plaintiffs' state law claims raised in the 60 cases were preempted by federal law. The companies named in the lawsuits are blamed over the drug labels requiring warnings about internal bleeding and correction in dosages to minimize those risks.

Another popular blood thinner drug, Xarelto has been blamed for causing gastrointestinal bleeding, hemorrhagic stroke, deep vein thrombosis (DVT), and other serious complications. Defendants Bayer AG and Janssen Pharmaceuticals recently announced the $775 million settlement which will be resolving more than 25,000 Xarelto lawsuits consolidated in the federal multidistrict litigation (MDL No.2592; In Re: Xarelto (Rivaroxaban) Products Liability Litigation) in the Eastern District of Louisiana.

Case Management Order Issued For Bard Hernia Mesh Lawsuits

U.S. District Judge Edmund A. Sargus, presiding over all federal hernia mesh lawsuit issued a case management order on March 22, approving 12 cases selected by both parties to be part of bellwether discovery pool.

The court will shortlist six cases, following a preliminary discovery into case-specific facts, from which three representative claims will be selected as the first to go to trial in May, July, and September 2020. Each of the cases involved similar allegations that the polypropylene mesh, used in C.R. Bard's hernia mesh products, was unreasonably dangerous and posed a huge risk to patients who were forced to undergo additional corrective surgery to get the patch removed. The parties will next meet with the court on April 17, 2019, to review the status of the Bard hernia mesh claims.

There are more than 240 product liability cases pending against Bard over painful complications experienced by plaintiffs due to design defects in several polypropylene products sold by the company. As per a prediction made by plaintiff lawyers, there might be roughly 3,000 claims by the year-end in the federal multidistrict litigation (MDL No. 2846; In Re:  Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation), which was formed in the Southern District of Ohio for coordinated pretrial proceedings.

Plaintiff Awarded $80M in The First Roundup Bellwether Trial

A California man was awarded $80 million in damages in the first federal trial against Monsanto, as the jury found that glyphosate exposure from Roundup was the reason for the man's cancer.

The verdict was given by a six-person jury in San Francisco in favor of a 70-year-old man who was diagnosed with non-Hodgkin’s lymphoma in 2015. The jury granted $200,967 in economic damages, approximately $5 million in past and future non-economic damages, and $75 million in punitive damages. This was the second phase of the trial to determine liability and damages after the jury concluded the first phase on March 19, when it was ruled that Roundup played a crucial role in the man's cancer.

In the second phase, the jury heard the evidence, during the period of 1980 and 2012, Monsanto was well aware of a vast number of scientific studies linked to Roundup products and cancer. The plaintiff's counsel argued that, despite being aware of the studies, Monsanto failed to warn consumers or conduct its own research to take preventable steps. Bayer plans to vigorously appeal the verdict.

Monsanto has been accused in more than 11,000 lawsuits in several state courts. U.S. District Judge Vince Chhabria overlooks the federal multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation) in the Northern District of California.

J&J Settles Three Asbestos-in-Talc Cases; Wins Another in NJ

On Wednesday, March 27, in three separate trials held in Oklahoma, Los Angeles and New York, J&J confidentially settled three women's lawsuits which blamed asbestos-in-talc for their mesothelioma.

One of the plaintiffs was a 77-year-old woman who was diagnosed with peritoneal mesothelioma in 2017. Her attorneys said at trial that she used J&J's talc products for 50 years, which was the reason for her cancer.J&J confirmed the settlement in the Los Angeles trial involving claims filed by the 36-year-old plaintiff who developed pleural mesothelioma due to asbestos exposure from J&J's talcum powder. The third settlement involved claims filed by a 41-year-old woman who stated in her New York suit that she developed peritoneal mesothelioma due to the use of J&J's talcum powder for feminine hygiene purposes. J&J failed in an attempt to stop a plaintiff's expert from testifying that he detected asbestos and talc in the third plaintiff's ovarian and fallopian tissue. The trial was slated to begin on April 9 in Manhattan state court.

On the same day, Middlesex County Superior Court in New Brunswick ruled in favor of J&J in a lawsuit filed by a plaintiff, which linked asbestos presence to the man's mesothelioma. In a unanimous decision, the jury found that J&J's talc was free from asbestos and was not the reason for the plaintiff's cancer. One of his attorneys, Monica Cooper, told, they were quite disappointed with the jury verdict, particularly because there was immense scientific and documentary evidence to support the allegations against the company.

Monsanto Faces Third Roundup Trial A Day After $80M Verdict

A day after a California jury awarded $80 million to a man suffering from cancer due to Roundup use, an Oakland jury heard opening statements for a married couple's claim filed against Monsanto that the weed killer caused them non-Hodgkin's lymphoma (NHL).

This is the third Roundup trial to go before a jury; it involves claims filed by an elderly couple, who allege that the agro-giant, Monsanto, failed to warn them about the hazards of glyphosate exposure from its popular herbicide. At the start of the trial, the plaintiffs' attorney told a 16-member jury that the couple was using Roundup on their four properties between 1975 and 2011 to kill weeds. They sprayed roughly 1,500 gallons of Roundup and stopped it when the husband came across a commercial, saying it could probably cause cancer. The couple filed their case in 2017 as both were diagnosed with NHL. Wisner told the jurors that he would specify in the closing arguments how the evidence against the company justifies compensatory and punitive damages. The trial's closing arguments are expected by the end of April. An attorney representing Monsanto argued that the couple was suffering from numerous diseases for years and asked the jury to consider the evidence, which says Roundup may not have caused their cancers.

The suit is one of the 11,000 cases filed against Monsanto over allegations that the company hid cancer risk linked to the herbicide, ran a campaign of misinformation to convince government agencies, farmers, and the general public that Roundup was non-hazardous.  

FDA Updates REMS For Close Monitoring of Fentanyl Overdoses

The U.S. Food and Drug Administration (FDA) declared that the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medications was updated on March 27, in view of implementing a new opioid monitoring system particularly for tracking trends and drug overdose deaths due to synthetic forms of fentanyl.

The FDA outlined new protocols for health care professionals to follow while prescribing the drugs. The protocols for TIRF will include prescribing doctors to track patient's opioid tolerance during each prescription and requires inpatient pharmacies to verify opioid tolerance in patients who need TIRF medicines for treatment. Pharmacies will be advised to give opioid medications to only those patients who provide documented proof approved by their physician that they can receive TIRFs. The FDA will be maintaining a new patient directory to monitor adverse reaction, both fatal and non-fatal, related to prescription opioids, to figure out whether patients were properly screened for opioid tolerance.

TIRF medicines contain fentanyl which is 50 to 100 times more powerful than morphine and was the cause of half of all drug overdose cases in the U.S. Scott Gottlieb, FDA Commissioner, told earlier this year that the agency will be reevaluating the prescription criteria, indicating that nearly half of all patients who were prescribed opioids didn't need them for pain relief.

Pa. Judge Tosses Essure Birth Control Suits As Time-barred

U.S. District Judge John Padova dismissed numerous claims brought by plaintiffs who sued Bayer over Essure birth control device's complications finding that the claims were not filed within the two-year statute of limitations.

Bayer had filed a summary judgment motion to toss 12 claims filed by affected women. In his opinion, Judge Padova evaluated those 12 cases over the device's hazards and ruled that many of the claims must be tossed at the summary judgment phase. Plaintiffs who discovered their alleged Essure-related injuries outside the two-year timeframe were allowed to pursue their tort claims past the summary judgment phase. Judge Padova dismissed those plaintiffs' claims that Bayer breached its warranty to provide permanent birth control; these plaintiffs did not become pregnant; or claimed that the device migrated; nor have they removed Essure device. According to Wednesday's ruling, Judge Padova allowed six women to pursue their claims as they had presented sufficient evidence to support their suspected injuries including pain, bleeding and autoimmune disorders caused by Essure; two of the women became pregnant despite using Essure.

All Essure lawsuits are consolidated under Judicial Council Coordination Proceedings (JCCP) before Judge Winifred Y. Smith of the Alameda County Superior Court.

LivaNova To Settle 75% of 3T Heater-Cooler Litigation

LivaNova PLC, leading medical technology provider declared to settle close to 75% of litigation in the U.S. linked to the company's 3T heater-cooler device.

The company agreed to a settlement framework that will facilitate comprehensive resolution of the pending personal injury cases in the multidistrict litigation, a related class action case pending in the U.S. federal court, and also some cases in the U.S. state courts.  The company plans to resolve the cases for up to $225 million, out of which $135 million will be paid by July 2019 and the remaining amount will be paid in January 2020. LivaNova had set aside $294 million in its fourth quarter of 2018 in connection with the 3T heater-cooler litigation. LivaNova made no admission of liability in the settlement agreement and can void the agreement if certain conditions are not met, including, 95% participation from each category of plaintiffs. Damien McDonald, Chief Executive Officer of LivaNova told, "we believe entering into the settlement is in the best interest of the company, its shareholders and patients because it will remove ongoing costs and uncertainty as we focus on executing our strategy to deliver quality care to patients around the world."

Each year about 250,000 heart bypass surgeries are conducted, and 60% of hospitals use the 3T heater-cooler device, sold under the brand name, Stockert Heater-Cooler System (3T). Lawsuits filed against the company states that there is the potential for Nontuberculous mycobacteria (NTM), specifically Mycobacterium chimera bacteria to grow in the water tank of the heater-cooler units.