What Happened In The MassTorts World Last Week? 2020-Mar-23

On Friday, Bayer AG agreed to outline settlement terms with half a dozen law firms representing tens of thousands of plaintiffs claiming that its weedkiller Roundup causes cancer.

A spokesperson for Bayer said the mediation discussions are moving allegiantly under a court order requiring confidentiality, and the company cannot comment on speculation about outcomes, timing, or progress. Ken Feinberg is the court-appointed mediator, who is working closely with Bayer and plaintiffs lawyers to settle the lawsuits.

According to Bayer, based on average analyst predictions, the settlement would be worth about $10 billion.

IARC, considered to be the apex in the field of cancer research, classified glyphosate as a “probable human carcinogen.” According to IARC, Roundup is made up of other ingredients that are toxic in themselves, and are also known to increase the toxicity of glyphosate. Monsanto has known this for many years but still refuses to study the link between cancer and Roundup.

Monsanto has a brief history of legal troubles and Glyphosate is just another herbicide of the company to attract lawsuits. Plaintiffs across the U.S. have filed numerous lawsuits. A plaintiff from one of the Roundup lawsuits claims that she worked as a grower’s assistant on a crop field in New York from 1994 to 1998 where Roundup was regularly sprayed indoors and outdoors resulting in chronic lymphocytic leukemia in 2012. She eventually quit the job and is currently seeking reasonable compensation and punitive damages in court.

More than 40,000 product liability lawsuits are consolidated under MDL No. 2741, presided by U.S. District Judge Vince Chhabria in the U.S. District Court for the Northern District of California.

A trial date of March 2021 has been set by a panel of judges from West Virginia for hearing the lawsuits filed by counties, cities, towns, and hospitals claiming the damages caused due to the opioid epidemic by the opioid manufacturers and distributors.

Last week a status conference took place, which was headed by Judge Alan Moats, who heads the panel of the lawsuits. The conference was to discuss and calculate the amount of damage caused by the drug manufacturers, as West Virginia is the most affected state with a higher rate of overdose death rate in the nation.

The lawsuits filed by the counties and cities claim that a large number of people got affected due to the opioid crisis, which was caused because of the negligence of manufacturers and lack of awareness of the use of opioid painkillers whereas, the company responded that the drugs were distributed only to the licensed pharmacies.

McKesson, Cardinal Health, and AmerisourceBergen are the companies involved in the lawsuit, who have agreed to pay a combined settlement of $72 million to the states of West Virginia. Counties and cities have filed their separate lawsuits apart from the state.

Companies manufacturing opioids convinced the medical community that these medications were not addictive and were purely beneficial. This belief raised the number of prescriptions and sales unwarrantedly, resulting in a mass misuse of these drugs, to the extent that this was identified by the U.S. Food and Drug Administration (FDA) as a public issue and named it an 'opioid crisis'.

The U.S. District Judge Edmund A. Sargus rejected the request made by the defendants to exclude supplemental expert reports submitted by plaintiffs over the first Bard hernia mesh bellwether trial that approaches within two months.

On March 10, two evidentiary motion orders were issued by Judge Sargus, both of which were in regards to the request from the manufacturer to strike supplementary reports submitted by plaintiffs’ expert witnesses, which involved the link between hernia mesh complications and the design of the hernia patches.

According to the first order, Judge Sargus addressed Bard’s effort to strike a supplemental report and reliance list by Dr. David Grischkan, whose testimony would be an integral part of the first bellwether trial, scheduled for May 11, 2020. The judge allowed the company to submit an expert's report to rebut Grischkan’s findings in the case selected as the first bellwether plaintiff.

The second order is an almost identical situation with another plaintiff’s expert who is also filing a pair of supplemental reports in support of the same case. However, the court granted Bard’s request to strike most of one report but cleared a second report by El-Ghannam for use in the upcoming trial.

The mesh products named in the lawsuits contain polypropylene material, which can easily break, shrink or wear off. This often leads to device migration, organ perforation, infection, and several other complications. Lawsuits allege the defective design of the hernia mesh often required the patients to undergo additional correction surgeries.

A Californian man who was awarded $75 million in punitive damages in a bellwether trial over Bayer AG's weedkiller Roundup, said that the verdict shouldn't have been reduced as the company refused to test its weedkiller for cancer risks.

Initially, a jury of five women and one man found Monsanto liable for the plaintiff's allegations that decades of exposure caused him non-Hodgkin lymphoma. The plaintiff received $200,967 in economic damages, approximately $5 million in future and past non-economic damages, and $75 million in punitive damages.

In July, Judge Chhabria after finding the punitive damages verdict "constitutionally impermissible," reduced the $80 million jury verdict to $25 million.

The plaintiff, in his arguments, claimed that his claims were equivalent to the law's requirements, which states that a pesticide can be found misbranded if its label leaves out necessary warnings, which Roundup's label did. The claims were refuted by the defendant stating the claims are barred by federal law under the Federal Insecticide, Fungicide, and Rodenticide Act.

IARC, considered to be the apex in the field of cancer research, classified glyphosate as a “probable human carcinogen.” According to IARC, Roundup is made up of other ingredients that are toxic in themselves, and are also known to increase the toxicity of glyphosate. Monsanto has known this for many years but still refuses to study the link between cancer and Roundup.

Monsanto has a brief history of legal troubles and Glyphosate is just another herbicide of the company to attract lawsuits. Plaintiffs across the U.S. have filed numerous lawsuits. A plaintiff from one of the Roundup lawsuits claims that she worked as a grower’s assistant on a crop field in New York from 1994 to 1998 where Roundup was regularly sprayed indoors and outdoors resulting in chronic lymphocytic leukemia in 2012. She eventually quit the job and is currently seeking reasonable compensation and punitive damages in court.

The first bellwether trial against GlaxoSmithKline's anti-nausea medication Zofran has been postponed due to the coronavirus pandemic.

In a monthly status conference, held via telephone, U.S. District Judge F. Dennis Saylor IV in Massachusetts, said that there is no timetable for a case that will go for trial, which was slated to begin May 4. The parties have also been asked to let the U.S. Food and Drug Administration know about the uncertain delay.

Zofran (Ondansetron) manufactured and originally marketed by GlaxoSmithKline is an antiemetic drug used for nausea and vomiting caused by cancer chemotherapy, radiation therapy, surgery, and gastroenteritis. US FDA approved Zofran in January 1991.

While Zofran was never tested or approved for use by pregnant women, it is often prescribed off-label for morning sickness and hyperemesis gravidarum, a serious type of morning sickness that causes severe nausea and weight loss.

In the past few years, however, disturbing results from a number of studies surfaced linking Zofran to congenital birth defects. Mothers and families of babies born with serious mental and physical deformities are now pursuing lawsuits against the medication's maker, claiming they were misled and lied to about the drug's risks and safety.

The lawsuits were consolidated in Massachusetts in 2015, which claimed that GSK promoted Zofran for morning sickness despite having any evidence of its safety for pregnant women, and only having FDA approval for the treatment of nausea related to cancer and surgery.

GSK is prompted to end all of the 419 lawsuits, referring to the federal preemption because the FDA rejected a warning label. The company filed a citizen petition with the FDA arguing that, even with additional information about the drug presented to the federal government, a warning label would still not be required. GSK says, If the FDA agrees with the citizen petition, then it would likely resolve the preemption issue.

Another telephone conference has been scheduled for April 15, where Judge Saylor indicated that a trial schedule would be discussed.

The Pennsylvania Supreme Court has denied Janssen's appeal to review an intermediate court’s reinstatement of action over a lawsuit alleging that its antipsychotic drug Risperdal causes gynecomastia.

The bid followed after the state's Superior Court overturned a Philadelphia County trial judge's mid-trial decision in July to discard claims against the Johnson & Johnson unit for lack of evidence.

The court records state that the plaintiff consumed Risperdal for about four years since 2004, to overcome attention deficit hyperactivity disorder, oppositional defiant disorder, and depression. Two years later, after he stopped the use of drugs, his doctor diagnosed him with gynecomastia or the abnormal growth of female breast tissue in men.

Judge Sean Kennedy discarded the lawsuit, filed in 2013, during a trial in December 2016 after ruling that medical experts had failed to clear legal standards followed in Texas, where the plaintiff lived when he started taking the drug, for evidence they hoped would show a link between Risperdal and the plaintiff's condition.

In July, a 3-judge-panel of the Pennsylvania Superior Court ruled that the case should be evaluated under Pennsylvania law since it was procedural, thereby remanded the case back to Philadelphia and ordered a new trial.

The drug, when the plaintiff started using it, was only approved to treat schizophrenia in adults. The warning label included gynecomastia as a "rare" side effect occurring in fewer than one in 1,000 patients. The drug, when finally approved for treating symptoms of autism in children in October 2006, had a warning label indicating a 2.3% rate of gynecomastia in adolescent patients.

Risperdal (risperidone) is a class of drugs called atypical antipsychotic, developed and manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson. It was initially approved in the U.S. by the FDA in 1993 for the treatment of schizophrenia and for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder. In 2008, Janssen announced the launch of an authorized generic version of Risperdal (R) and added that it would continue to make available branded Risperdal. 

Due to its antiadrenergic, antiserotonergic, and anti-histaminergic properties and being a dopamine antagonist, Risperdal is used in the treatment of schizophrenia in adults and adolescents aged 13-17 years; for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10-17 years; for the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years. Risperdal has also been marketed as an off-label treatment option for people with Attention Deficit Disorder (ADD).