What Happened In The MassTorts World Last Week? 2020-Apr-27
FDA Issues To Recall Another Heartburn Drug
On April 15, the FDA announced to recall Nizatidine Oral Solution, after finding the presence of the cancer-causing chemical N-Nitrosodimethylamine (NDMA).
Amneal Pharmaceuticals, following the announcement, declared for a nationwide recall of the generic oral heartburn medication nizatidine.
A similar nationwide recall was made on Zantac after the active pharmaceutical ingredient, ranitidine was found to produce high levels of NDMA when in storage. The presence of NDMA in Zantac surfaced in September 2019, when an independent pharmacy found high levels of the carcinogenic chemical in all doses and lots of the widely used heartburn drug.
More than 140 product liability lawsuits and class action cases have been filed throughout the federal court system, each raising similar allegations that the exposure to the active ingredient in Zantac, causes bladder cancer, kidney cancer, colorectal cancer, stomach cancer, and other forms of cancer.
The lawsuits are consolidated and centralized before U.S. District Judge Robin L in Florida under MDL No: 2924, for coordinated discovery and pretrial proceedings.
12 Missouri Hospitals File Lawsuits Against Opioid Makers
Last week, a group of 12 Missouri hospitals joined the suit against opioid manufacturers, distributors, and retailers by filing a civil lawsuit in the Greene County Circuit Court.
In the lawsuit, the lawyers argued, stating that nearly 2.2 billion pills were shipped to Missouri, between 2006-2014, by the opioid distributors, which equaled 362 opioid doses for every man, woman, and child in the state. The opioid prescription written was 71.8 per 100 persons by 2017, which was higher than the national average of 58.7 per 100 persons.
The lawsuit noted that the drug manufacturers' deceptive marketing to hospitals and physicians claiming the low risk of developing dependence led to the crisis and the associated health care costs. The retailers, distributors, and manufacturers ignored mounting evidence of the crisis and failed to identify, report, and take steps to stop suspicious orders.
The hospitals join more than 650 hospitals across the United States to file lawsuits against the manufacturers, distributors, and retailers of the opioid drug.
Earlier in March, a panel of judges from West Virginia has set a trial date of March 2021 for hearing the opioid lawsuits filed by counties, cities, towns, and hospitals claiming the damages caused due to the opioid epidemic by the opioid manufacturers and distributors. Judge Alan Moats even headed a status conference to discuss and calculate the damages caused by the manufacturers. West Virginia is the most affected state with a higher rate of overdose rate across the United States.
Zantac Litigation Speed Up Post New Pretrial Orders
Two new pretrial orders issued in the U.S. District Court, Southern District of Florida has accelerated the federal multidistrict litigation established for all Zantac lawsuits.
The first pretrial order was issued on April 10, after the formation of the multidistrict litigation arose from the recent Zantac recall. According to the order, the court appointed Sarah E. Johnston as "Interim Retailer Liaison Counsel."
The second pretrial order issued on April 15 established protocols to produce records needed for the litigation’s Initial Census for deceased and incapacitated Zantac claimants.
The court has also planned to assemble for an Initial Conference on May 12 via videoconference. Interviews for Plaintiffs’ Leadership Appointments will also be conducted via videoconferences scheduled for May 6 and 7.
Nearly 229 Zantac lawsuits are pending in the Southern District of Florida, which includes both personal injury lawsuits as well as class action complaints. The lawsuits and complaints are filed on behalf of individuals who alleged the heartburn drug for causing cancer.
Earlier in March, the U.S. Food & Drug Administrations (FDA) issued a notice to recall Zantac following which American Health Packaging suspended ranitidine tablets as the heartburn medication contained unacceptable levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen. The notice includes 11 lots of Ranitidine Tablets, USP 150 mg and 100 count Unit Dose Blisters. The company has informed its distributors to discontinue the tablets and has also arranged for the return of tablets in the market.
PPI Federal MDL Nears 14,000 Cases
Lawsuits involving Nexium, Prilosec, Prevacid, and other proton pump inhibitors have grown up to nearly 14,000 cases filed across the federal court system.
According to a joint status report submitted on April 17, by the parties involved in the litigation to the U.S. District Judge Claire C. Cecchi, there are at least 13,919 lawsuits filed, involving 13,950 different plaintiffs.
There are also more than 200 similar lawsuits filed in various state courts, including Delaware, Illinois, New Jersey, and Ohio.
The report also stated various agenda items for the status conference held on April 22. During the conference, the parties updated Judge Cecchi on the status of bellwether trial pool selections, the discovery proceedings, and other actions to move the litigation forward.
The lawsuits are consolidated under MDL No. 2789 presided by U.S. District Judge Claire C. Cecchi. Each plaintiff claims that the manufacturers failed to warn about the risk of chronic kidney disease associated with the widely used heartburn and acid reflux drugs.
Drugmakers Finding Ways To Prevent NDMA Contamination
The rising number of recalls, over the past years, on pharmaceutical products containing the cancer-causing chemical N-nitrosodimethylamine (NDMA) has made the drug industry to look for ways to prevent contamination.
Popular medication drugs, including the widely used heartburn and blood pressure drugs, Zantac and generic valsartan respectively, are facing many lawsuits and class action after the levels of NDMA in the pills exceed the threshold determined to be safe by federal regulators.
The pharmaceutical companies are facing pressure from the FDA to find solutions to prevent contamination, both from NDMA and other harmful contaminants as well.
The lawsuit against Zantac, valsartan, and other recalled drugs claim that the long term exposure to NDMA causes liver cancer, stomach cancer, small intestine cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other cancers.
Nearly 229 Zantac lawsuits are pending in the Southern District of Florida, which includes both personal injury lawsuits as well as class action complaints. The lawsuits are consolidated before U.S. District Judge Robin L in Florida under MDL No: 2924, for coordinated discovery and pretrial proceedings.
Nearly 130 product liability lawsuits and class action claims involving valsartan are currently pending in the federal court system. Valsartan claims are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.
The U.S. Food and Drug Administration (FDA) has even requested the manufacturers to discontinue all the versions of Zantac from the market due to its risk to public health. It is one of the top-selling products in the U.S. markets for decades. Earlier the people were not aware of the high levels of NDMA produced by Zantac, but the testing of independent pharmacy, Valisure highlighted the high level of exposure limit set by the FDA in terms of NDMA that causes cancer.
J&J's $4.7B Talc Verdict Bid: Jurisdiction Questions Rose
On Friday, Thomas Weaver, the attorney representing Johnson & Johnson (J&J) argued over a bid to reverse a jury’s $4.7 billion talcum powder verdict stating that the judge should not have combined all the 22 claims, particularly the 17 plaintiffs from Missouri, into a single trial.
The case involves a group of ovarian cancer victims and their family members, led by a plaintiff. The case ended with a $4.69 verdict in June 2018, after a six-week trial. Each woman or family was awarded $25 million in compensatory damages, along with $4.14 billion total in punitive damages, of which $3.15 billion was against J&J and $990 million against its subsidiary J&J Consumer Inc.
J&J also raised various other issues with plaintiffs’ experts, including William Longo, founder of Materials Analytical Services.
However, the panel of three judges seemed skeptical over challenging 22nd Circuit Judge Rex Burlison’s consolidation order or the reasoning behind the jury’s record award.
Previously, the Missouri Court of Appeals had reversed a $110 million award involving Bristol-Myers because the plaintiff was from Virginia and also reversed verdicts of $72 million, $70 million, and $55 million on similar grounds.
Due to the pandemic crisis, only two attorneys for either side were permitted in the courthouse, and the gallery was empty. The spectators were able to watch the arguments via a live video on the court’s Facebook page.