What Happened In The MassTorts World Last Week? 2020-Mar-30

A proposal to allow direct filing of Zantac cases in the federal multidistrict litigation (MDL) has been brought by the parties involved in the recalled heartburn drug lawsuits.

According to a joint statement filed on March 16, the plaintiffs and defendants submitted several proposed orders along with a plan that would allow direct filing of the Zantac recall cases in the Southern District of Florida, to streamline the filing of new lawsuits.

The proposal would help avoid delays associated with transferring cases from different U.S. District Courts nationwide. In any case directly filed in the Southern District of Florida pursuant to this order, plaintiff shall identify his or her federal district of residence in which the case would have been filed otherwise. Over the completion of all applicable pretrial proceedings the cases will be transferred to identified federal district of residence unless the parties jointly advise which venue is proper.

The Zantac litigation is expected to turn out one of the largest active mass tort claims in coming years, considering the widespread use of the heartburn and acid reflux drug for decades before it was removed from the market late last year.

Public concerns about the Zantac cancer risk first emerged in September 2019, when an independent pharmacy discovered that each pill may expose users to levels of NDMA that are drastically higher than the permissible daily intake limits set by the FDA.

The online pharmacy Valisure found that some 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA, yet the daily limit deemed safe by the FDA is only 96 ng.

These problems did not arise due to any changes in the manufacturing process, but appear to be part of the inherent molecular structure of the active pharmaceutical ingredient in Zantac, ranitidine. The levels of NDMA have been found to increase in this drug when stored at high temperatures or as it breaks down inside the human body.

More than 140 product liability lawsuits and class action cases have been filed throughout the federal court system, each raising similar allegations that the active ingredient in Zantac, ranitidine, produces high levels of the known human carcinogen Nitrosodimethylamine (NDMA). The plaintiffs claim that long exposure to the chemical causes bladder cancer, kidney cancer, colorectal cancer, stomach cancer, and other forms of cancer along the digestive tract.

Two environmental groups filed a lawsuit against the U.S. Environmental Protection Agency (EPA) claiming that it failed to protect U.S. health and environment by approving the active ingredient of Roundup, glyphosate.

On March 20, a petition was filed in the U.S. Court of Appeals for the Ninth Circuit, asking the court to review and abate EPA’s decision made on January 22, to approve the use of glyphosate in the U.S.

The two environmental groups, the Natural Resources Defense Council (NRDC) and the Pesticide Action Network North America, claimed that EPA ignored evidence by scientists and medical experts about the impact of glyphosate on human health and the environment to pacify corporate interests.

In 2015, glyphosate was claimed as a cancer-causing agent by the World Health Organization’s International Agency for Research on Cancer (IARC). The IARC indicated the links in the side effects of Roundup and other glyphosate-based herbicides with an increased risk of non-Hodgkin’s lymphoma.

However, in April 2019, the EPA issued a proposed interim registration review decision, stating they do not believe glyphosate can cause cancer, which was finalized in January 2020.

Roundup herbicide was once considered the best gift for agricultural fields. It ruled the market right from the mid-70s until 2013 when some shocking hidden facts were unveiled about this product. 

In March 2013 an email sent by a senior toxicologist from Environmental Protection Agency (EPA) to her colleague mentioned the carcinogenic attributes of Roundup herbicide, which were not disclosed to the public due to Monsanto’s strong control over EPA. 

Roundup, one of the most commonly and widely used weed killers, contains Glyphosate as one of its main ingredients. Glyphosate is a systemic and broad-spectrum herbicide that was patented by a U.S. company, Monsanto, in 1970. Bayer acquired Monsanto on June 7, 2018.

After the patent for Monsanto expired in the U.S. in 2000 and outside the U.S. in 1991, many other manufacturers started marketing their glyphosate products leading to a substantial increase in sales and global usage. The chemical name of glyphosate is N-(phosphonomethyl) glycine, and it blocks an enzyme in the plant, which helps in preparing amino acids and proteins, thus, killing the plants within a few days.

Initially, the users used Roundup as a non-selective herbicide just like paraquat and diquat. People attempted to use glyphosate-based herbicides to row crops, but crop damage problems restricted its use. In 1996 commercial introduction of a glyphosate-resistant soybean resulted in increased use of Roundup throughout the United States. Monsanto's "Roundup Ready" became the best-selling product of the company following the advertisement and the sales increased by around 20% per year between 1990 and 1996.

In 1996, the introduction of a glyphosate-resistant soybean resulted in the growing use of Roundup throughout the United States. Sales of Roundup increased around 20% per year between 1990 and 1996. The product was used in over 160 countries by 2015. It was mostly used on corn, soy, and cotton crops that are genetically designed to resist the chemical. But as of 2012, crops like almond, peach, cantaloupe, onion, cherry, sweet corn, and citrus have been treated by the glyphosate in approximately 5 million acres of California.

Roundup comprising of active ingredient glyphosate may cause eye or skin irritation. People who breathed in spray mist from products containing glyphosate usually experience irritation in their nose and throat. Swallowing products with glyphosate can cause increased saliva, burns in the mouth and throat, nausea, vomiting, and diarrhea. Fatalities have been reported in cases of intentional ingestion.

Even pets may be at risk if they touch or eat plants that are still wet with spray from products containing glyphosate. Animals exposed to products with glyphosate may drool, vomit, have diarrhea, lose their appetite, or seem sleepy.

Bayer and its Monsanto subsidiary have continued to defend the safety of glyphosate. They have faced massive verdicts in several early trials that have gone forward in the United States, over failure to warn about the risks associated with Roundup exposure. In addition to this, the Roundup manufacturers also got awarded with massive punitive damage designed to punish for withholding safety information from consumers and government regulators.

Currently, Bayer and subsidiary Monsanto are facing tens of thousands of Roundup lawsuits filed nationwide, each claiming that the weedkiller causes non-Hodgkin's lymphoma or other cancers.

The Covid-19 pandemic has urged U.S. District Judge Edmund A. Sargus, presiding over all hernia mesh lawsuits involving C.R. Bard products, to postpone the start dates for the first two bellwether jury trials that were expected to begin in May 2020 and July 2020.

According to a case management order issued on Tuesday, the start date of the first bellwether jury trial has been postponed to July 13, 2020, with a final pretrial conference scheduled for June 29 and the final pretrial conferences on July 7 and July 8.

And, in another order, the District Judge scheduled the second trial to September 29, with the first final pretrial conference on September 9, and the final pretrial conferences for September 15 and 16. The Dispositive and Daubert motions are to be filed by June 8.

Bard hernia mesh claims are consolidated under federal multidistrict litigation MDL No. 2846 in the Southern District of Ohio, presided by Honorable Edmund A. Sargus, Jr., and Honorable Kimberly A. Jolson.

Ethicon Physiomesh is a flexible, composite, macroporous, and partially absorbable mesh made of non-absorbable polypropylene by Johnson & Johnson. FDA approved the use of Ethicon Physiomesh in March 2010 for the repair of hernias and other fascial deficiencies that require the addition of strengthening or bridging material to obtain the desired surgical result. A hernia is a condition that occurs when an organ, intestine, and/or tissue squeezes through a hole or weak point in the surrounding muscle or connective tissue. The number of hernia repair operations performed every year in the USA is remarkable.

Despite the already existing mesh implants in the market, the sale of Ethicon Physiomesh increased after the FDA approval as it was promoted as a physiologically well-designed device, offering strong and comfortable healing and giving an exceptional intraoperative handling benefit. But within a few years, Ethicon globally recalled the Physiomesh after thoroughly considering the data which was revealed out of Hernia registries.

Also, lawsuits involving Ethicon Inc.’s Physiomesh Flexible Composite Mesh products are suspended from all proceedings that require in-person interaction, as per orders from the federal court. The order concludes that the Court will conduct regular telephone status conferences with Lead Counsel to determine when it is safe and appropriate to lift this suspension and resume normal litigation activities.

J&J’s subsidiary Ethicon is facing product liability lawsuits over Ethicon Physiomesh, consolidated in the federal court system as part of MDL No. 2782 in the Northern District of Georgia, presided by Honorable Richard W. Story.