What Happened In The MassTorts World Last Week? 2019-Dec-09

Johnson & Johnson's (J&J) request to toss the $70 million Risperdal verdict has been upheld by the Pennsylvania appeals court.

According to the 2013 lawsuit, the plaintiff, a Tennessee resident, had taken Risperdal since he was a toddler, which led to breast development, a condition called gynecomastia. Upholding the 2016 verdict has sent the case back to the Philadelphia trial judge for punitive damages. J&J was hit last month with $8 billion in punitive damages in another Philadelphia Risperdal case.

Risperdal (risperidone) is a class of drugs called atypical antipsychotic, developed and manufactured by Janssen Pharmaceuticals, a division of J&J. 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.

Claims against J&J are filed over Risperdal gynecomastia problems having devastating psychological damage and impact on the overall quality of life often requiring the need for surgery, which carries additional risks. Allegations include failure to adequately warn families or the medical community about the risk of gynecomastia.

J&J is facing several lawsuits over its talc and opioid, along with lawsuits over Risperdal. J&J has more than 13,000 lawsuits filed on it in terms of breast development cases in men, allegedly caused by the antipsychotic drug.

Two coordinated actions are filed for Risperdal cases: one in Los Angeles Superior Court (Risperdal and Invega Product Liability Cases, JCCP 4775, presided by Honorable William Highberger) and the other in Philadelphia (In Re: Risperdal Litigation, March 2010 Term, Case No. 100300296).

The U.S. District Court Judge Allison Burroughs in Boston has overturned parts of racketeering conviction against Insys Therapeutics founder and former sales executives, stating the prosecutors failed to prove that the manufacturer violated the Controlled Substances Act.

According to the order, the prosecutors did not present enough evidence against Insys founder John Kapoor and former executives Michael Gurry, Richard Simon, Sunrise Lee, and Joseph Rowan over allegations that the company bribed doctors to prescribe a powerful and addictive opioid spray for nonmedical purposes. The order will renounce the criminal conspiracy portion of defendants, which will have a huge impact on the sentencing scheduled for January in a Boston courthouse.

The executives convicted for the sales fraud charges will not be affected by the order. In June, the defendants agreed to pay $225M to end criminal and civil investigations imposed by the federal government. Following the settlement announcement, the company also declared bankruptcy and to undergo a court-supervised restructuring plan for the sale of its product, including the controversial Subsys. In September, a bankruptcy court approved to sell-off Subsys to Wyoming-based BTcP Pharma LLC, part of the MMB Healthcare network.

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 opioid class action, created to help settle thousands of lawsuits, has been weakened after the local governments in regions affected by the opioid epidemic opted to move forward with individual lawsuits against the drug industries involved.

According to a Monday court filing, the 541 local governments that opted out include Florida’s Palm Beach County and counties in West Virginia, which are among the hardest-hit areas. Houston’s Harris County, one of the largest U.S. counties, also opted out and has agreed to not receive funds from a nationwide settlement.

Altogether, 98% of some 34,000 local governments agreed to move forward with the class action against drug distributor McKesson Corp, drugmaker Johnson & Johnson, and pharmacy chain Walgreens Boots Alliance Inc.

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.

More than 2,600 lawsuits are alleging the defendants fueled the opioid crisis and contributed to 400,000 U.S. deaths between 1999 and 2017. U.S. District Judge Dan Polster is presiding over the opioid lawsuits consolidated under MDL No. 2804 (In Re: National Prescription Opiate Litigation).

The Miami-Dade County School Board, the nation's fourth-largest school district, filed a federal lawsuit against major manufacturers and distributors claiming that they should be compensated for the money spent to keep opioids out of school.

According to the 300-page lawsuit, the school claimed that it spent money on training nurses and school resource officers to treat overdoses and provided in-school nursing and mental health care to students and employees suffering from opioid addiction.

It seems to be the first school district in the country to file a lawsuit against opioid makers. Drug companies are already facing thousands of lawsuits from the states and have offered a settlement in millions and billions, so far.

Florida is second to California in terms of the number of opioids that moved in, totaling 42 pills per Floridian per year from 2006 through 2012. The lawsuit was filed in the Southern District of Florida and will be transferred to the Northern District of Ohio.

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.

In March, Ohioans could vote for a novel state constitutional amendment, proposed by Ohio Attorney General Dave Yost, to collect and distribute the millions of dollars that would be recovered from settlements with the opioids companies.

The new plan is being circulated at the highest levels of state government but is also facing many obstacles:

• The amendment must be approved by the legislature up until December 18.

• 60 of 99 in the House and 20 of 33 in the Senate that is three-fifths of each chamber should approve the amendment.

• The idea is not yet discussed by the House or the Senate GOP caucuses.

• Opposition from Governor Mike Dewine.

According to the governor, the constitutional amendment is still premature, as the state is awaiting to reach a settlement first.

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.

Opioid lawsuits consolidated under MDL No. 2804 (In Re: National Prescription Opiate Litigation), presided by U.S. District Judge Dan Polster.

The U.S. District Judge F. Dennis Saylor, in Boston, delayed the first bellwether trial scheduled for January 2020, as GlaxoSmithKline (GSK) is petitioning the FDA regarding Zofran's warning label.

According to a court memorandum filed last month, GSK filed a petition on November 1, asking the U.S. Food and Drug Administration to review Zofran’s warning label. In response to the request, the plaintiffs filed a memorandum questioning that the manufacturer is not asking the federal authorities to consider the most recent scientific developments or any regulations related to the drug. The memorandum further noted that the petition was filed before oral arguments whether the plaintiffs involved should be prevented from pursuing recovery under preemption.

Following a status conference held, Judge Saylor decided to move the trial from January 13 to May 4, giving time to the FDA to respond to the petition. The Daubert motions questioning the admissibility of expert witness testimony and the hearing on the request for summary judgment filed by the drug maker based on preemption will now be considered on January 15, 2020.

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.

More than 400 lawsuits have been filed against GSK alleging that the company knew about Zofran's pregnancy risks for several years yet failed to adequately warn the medical fraternity. Zofran lawsuits were centralized in October 2015, before Judge Dennis F. Saylor as a part of multidistrict litigation (MDL No. 2657; In Re: Zofran (Ondansetron) Products Liability Litigation) in the District of Massachusetts.