What Happened In The MassTorts World Last Week? 2021-Mar-01

On Friday, Judge Leigh Martin May of the U.S. District Court for the Northern District of Georgia, presiding over the multidistrict litigation (MDL) docket for ParaGard IUD injury cases, appointed a group of 25 plaintiffs’ lawyers for various leadership roles.

According to the order issued, the federal judge has appointed one plaintiffs’ liaison counsel, two plaintiffs’ co-lead counsel, five will serve on a Plaintiffs’ Executive Committee, and seventeen will serve on a Plaintiffs’ Steering Committee. The attorneys who will serve in the leadership committee would also represent their individual plaintiffs.

A bellwether process is also expected, which would include a small group of representative claims that will be prepared for early trials to determine how juries respond to certain evidence and testimony during the process.

The result of these early trials will not hold an obligation on other cases and will be closely monitored by the parties as it would influence settlements for the plaintiffs, helping avoid the need for individual trials nationwide in the coming years.

The docket was formed in December 2020 when the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order confirming the centralization of all ParaGard IUD cases in the Northern District of Georgia for coordinated or consolidated pretrial proceedings.

Currently, around 116 complaints are pending in the MDL and the number of lawsuits seems to be growing, each involving common allegations that the birth control device has a risk of breaking upon removal, causing complications and injuries, including surgeries to remove the broken piece of the device, infertility, and pain.

Last month, Valisure researchers highlighted serious health risks inherent in Zantac through two new independent studies published in JAMA Network Open and MedRxiv.

In these studies, the online pharmacy established that under simulated gastric conditions the active ingredient ranitidine easily converts to cancer-causing chemicals N-nitrosodimethylamine (NDMA). The new findings also suggest that the formation of NDMA is an inherent Zantac risk, which exposes the user to the known carcinogen released inside the body.

According to the research published in the JAMA Network Open, the pharmacy evaluated the conditions that stimulated ranitidine NDMA production by imitating gastric processes. The researchers noted that after two hours a 150 mg tablet of cool mint Zantac converted into 947 nanograms (ng) of NDMA, a limit 10 times higher than the FDA’s daily acceptable limit of 96 ng of NDMA consumption. The research also revealed that an increase in nitrate concentrations increased the limit to 320,000 ng.

The research published in MedRxiv was the result of a study on more than 10,000 cancer patients, which showed a strong association between users of Zantac and an increased risk of breast cancer, thyroid cancer, bladder cancer, and prostate cancer as compared to the users who consumed heartburn drugs that did not contain ranitidine.

Zantac lawsuits are growing in numbers, and it currently comprises approximately 1,000 lawsuits. The litigation is presided by Judge Robin L. Rosenberg of the U.S. District Court for the Southern District of Florida.

The lawsuits allege Pfizer Inc., Sanofi SA, Boehringer Ingelheim Pharmaceuticals Inc., and GlaxoSmithKline LLC, along with generics makers, distributors, pharmacies, and others in the supply chain, of misleading advertising, failure to warn, and other claims associated with the presence of cancer-causing chemical NDMA in the popular heartburn drug.

An Annual Report Pursuant to Section 13 of the Securities Exchange Act of 1934, filed by the talcum powder giant Johnson & Johnson (J&J) indicated that the manufacturer has set aside $3.9 billion in litigation expenses in 2020, which is primarily associated with talc-related reserves and certain settlements.

The Form 10-K document filed on February 22 with the U.S. Securities and Exchange Commission (SEC) also indicated the company’s position in other ongoing litigations, which included hip replacement devices, Xarelto, Invokana, Risperdal, pelvic mesh products, and Elmiron.

In its filing, the company noted that it is facing more than 25,000 Baby Powder and Shower-to-Shower lawsuits by former users, claiming asbestos-laced talc in the product resulted in their cancers.

Last month, the Kentucky Court of Appeals reversed a verdict that favored the company over a lawsuit claiming its baby powder for a deceased woman's cancer. The appellate court reversed the verdict after finding that the trial court’s decision over allowing the defendant to elicit “irrelevant personal and family use testimony from its witness” prejudiced the plaintiff. The court also remanded the case for a new trial against the company.

A $2.12 billion verdict, which was awarded to women who alleged the company's products for their ovarian cancer is also being appealed by the company in the U.S. Supreme Court.

Last year the company stopped selling its talcum-based products in the U.S. and Canada, stating a decline in consumer demand and misinformation about the safety of the products.

On February 11, a new study was published in the medical journal Clinical Ophthalmology in which Northwestern University researchers provided stronger evidence that supports the link between Elmiron (pentosan polysulfate sodium or PPS) and the related cases of retinal maculopathy.

The study was conducted at the Northwestern Ophthalmology clinic, where the researchers reviewed the data of 131 Elmiron users. 40 patients from the total had undergone imaging and 5 of them had features believed to be of Elmiron maculopathy. Similarly, 5 patients from the remaining 91 patients also showed features of macular pigmentary changes.

The ten patients out of the total who showed signs of maculopathy had used Elmiron for 4.2 years on average with a cumulative dose of 380g. The median cumulative dose for the non-suspect group was only 188.1g, as compared to an average of 317g among the suspect group.

Thus, the new study indicates that Elmiron-related maculopathy has a distinct signature, which can be identified using multimodal imaging.

Currently, more than 100 product liability lawsuits are pending in the U.S. against the manufacturer of Elmiron, Johnson & Johnson's (J&J) subsidiary Janssen Pharmaceuticals, Inc., each claiming that its users suffered severe retina damage and permanent vision problems, including difficulty adapting to the dark light, spots, or floaters in the vision and complete blindness.

Elmiron lawsuits are consolidated under MDL 2973, which is presided by U.S. District Judge Brian R. Martinotti in the United States District Court for the District of New Jersey.

The litigation seems to be accelerating as the presiding judge appointed a 25-member leadership committee last month. The committee consists of three Co-lead Counsel and one Liaison Counsel, seven Executive Committee members, and 14 Steering Committee members.

On Wednesday, Judge F. Dennis Saylor IV of the U.S. District Court for the District of Massachusetts, overseeing the Zofran product liability litigation, announced that he is considering October as the start date for the first bellwether trial in the multidistrict litigation (MDL).

Zofran (Ondansetron) manufactured and originally marketed by GlaxoSmithKline (GSK) is an antiemetic drug used for nausea and vomiting caused by cancer chemotherapy, radiation therapy, surgery, and gastroenteritis.

It was never tested or approved for use by pregnant women, but 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.

The company is facing hundreds of lawsuits, each claiming that the drug was promoted for morning sickness despite having no evidence of its safety for pregnant women, and only having FDA approval for the treatment of nausea related to cancer and surgery.

The first bellwether trial was initially scheduled to begin in May 2020 but was put on hold in March due to the coronavirus pandemic.

Judge Saylor, during a monthly status conference, said that he proposed starting the trial on Monday after the Columbus Day holiday as he was feeling compelled to get a date back on the books. He also noted that the vaccination program in the state is also picking up and existing plans to have everyone in the court system vaccinated could help ease current jury trial restrictions.

The company and the plaintiffs involved in the litigation agreed for opening arguments to tentatively begin on October 18, this year, and told the judge that the trial should last for two to four weeks.

On Tuesday, the United States Food and Drug Administration (FDA) issued a warning letter to CooperSurgical, Inc., stating that the manufacturer did not communicate risk information associated with the ParaGard IUD birth control device in a direct-to-consumer video advertisement.

The warning letter states that the advertisement was titled “ParaGard: Family Planning During the Pandemic” and aired on WBTS’s The Hub Today on October 5, 2020.

According to the letter, the advertisement contained false or misleading information, and the manufacturer did not submit it to the FDA for review as per the Office of Prescription Drug Promotion (OPDP). The letter warns that this misleading presentation is particularly concerning from a public health perspective due to the serious and potentially life-threatening risks associated with the device, such as those contained in the WARNINGS AND PRECAUTIONS section of ParaGard’s PI (prescriber information).

The manufacturer is also asked to submit a comprehensive plan to disseminate truthful, non-misleading, and complete corrective communications about the concerns mentioned in the warning letter.

Meanwhile, Judge Leigh Martin May of the U.S. District Court for the Northern District of Georgia, presiding over the multidistrict litigation (MDL) docket for ParaGard IUD injury cases, appointed a group of 25 plaintiffs lawyers for various leadership roles.

The docket was formed in December 2020 when the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order confirming the centralization of all ParaGard IUD cases in the Northern District of Georgia for coordinated or consolidated pretrial proceedings.

Currently, around 116 complaints are pending in the MDL and the number of lawsuits seems to be growing, each claiming that the birth control device has a risk of breaking upon removal, causing complications and injuries, including surgeries to remove the broken piece of the device, infertility, and pain.