What Happened In The MassTorts World Last Week? 2020-Apr-20
Cross-Appeal Of Monsanto Trial To be Heard In June
A California appeals court has slated to hear oral arguments for cross-appeals in the first week of June, over a $289 million Roundup verdict, resulting from the first-ever trial claiming that the herbicide causes cancer.
According to the oral argument notice issued by the court, the case involves a former school groundskeeper who sued Monsanto, alleging that its glyphosate-based herbicide resulted in developing non-Hodgkin’s lymphoma.
In August 2018, a unanimous jury awarded $289 million to the plaintiff, including $250 million in punitive damages, after finding Monsanto’s glyphosate-based herbicide liable for his cancer.
The total verdict was lowered to $78 million by the trial judge, which was appealed by Monsanto. The plaintiff cross-appealed to reinstate the $289 million verdict.
The appellate court, while preparing for oral arguments on the appeal, rejected an application by the California Attorney General to file an amicus brief on the plaintiff’s side.
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.
Monsanto was accused of false and misleading advertising of glyphosate products in 1996, resulting in a lawsuit by the New York State attorney general. The company claimed that the spray-on glyphosate-based herbicides were non-toxic, safer than table salt, environment friendly, and biodegradable. Later, Monsanto removed the misleading advertisement to settle the case and avoid higher penalties. Some contractors faked the tests conducted on glyphosate along with other pesticides. Craven Laboratories in 1991 and Industrial Bio-Test Laboratories in 1970 conducted toxicology tests by fraudulently analyzing samples for residues of glyphosate. Monsanto has even admitted that the studies have since been repeated.
Last week, the United States Court of Appeal First Appellate District slated the hearing for June 2. The hearing will take place nearly after two years since the initial trial and also since Bayer AG bought Monsanto.
Impotence Drugs Defeat Cancer Claims
Last week, US District Judge Richard Seeborg issued a summary judgment in favor of pharmaceutical giants Pfizer and Eli Lilly, over claims that Viagra and Cialis cause skin cancer.
In the ruling, Judge Seeborg rejected the opinions of three experts claiming that they failed to apply a Bradford Hill analysis to their findings, which requires nine factors to determine causation that include: the strength of the association, consistency, specificity, temporality, biological gradient or dose-response, biological plausibility, coherence with other scientific knowledge, experimental evidence, and analogy.
During a four-day hearing in October last year, the judge listened to expert witnesses from both parties but found that evidence provided by plaintiffs’ experts did not support a strong association or relied on smaller studies over the link between impotence drugs and skin cancer.
The recent summary judgment, dismissing all claims in the MDL, was issued in favor of the drug makers, following the decision on January 13 to exclude the general causation opinions offered by plaintiffs’ experts.
In 2016, the U.S. Food and Drug Administration placed Viagra and other erectile dysfunction drugs collectively known as phosphodiesterase type 5 inhibitors on its watch list of medications with possible safety issues.
The FDA action followed a 2014 report in the Journal of the American Medical Association (JAMA) that linked an increased risk of melanoma with Viagra use. Loeb's team, in 2015, published a detailed analysis in JAMA of the medical records of 20,000 men in Sweden that found no evidence that Viagra or similar medicines cause melanoma.
The drug makers were facing more than 1,000 lawsuits, consolidated into multidistrict litigation in San Fransisco. Each lawsuit was seeking billions of dollars in damages over cancer allegations.
COVID-19 Might Delay First Atrium C-Qur Hernia Mesh Trial
The U.S. District Judge Landya McCafferty is considering postponing the start of the first bellwether trial over lawsuits involving Atrium C-Qur hernia mesh, due to the current outbreak of coronavirus.
According to a motion filed on April 8, the defendant asked the court to delay the start of the trial to more than six months and extend all pretrial deadlines by about 90 days.
The original trial was scheduled to begin on May 20, which might be pushed back to January 2021. The defendant requested expedited consideration of the motion, following the fast-approaching deadlines associated with the original trial date.
The Court had set continued deadlines for selecting the final trial cases that were supposed to be done this week, and the plaintiffs have been ordered to file a response on or before April 16.
C-QUR mesh products, utilized for hernia and another soft tissue repair, act as permanent implants. Atrium’s C-QUR hernia mesh products incorporate a fish-oil-derived coating, a component the company claimed would prevent adhesions and inflammations, therefore reducing potential hernia mesh complications.
Several studies suggest C-QUR products may have a higher rate of infection and adhesion compared to other types of mesh. Multiple reports of patient complications such as bowel obstructions, hematoma, seroma, and fistula formation, have been received by the U.S. Food and Drug Administration.
The company’s history of legal scrutinization started years ago when the FDA sent Atrium a warning in 2012 following an inspection that revealed critical problems with sterilization and manufacturing procedures. The FDA noted complications as early as 2008 and held four inspections on the C-QUR manufacturing plant between 2009 and 2013.
Subsequently, in 2013, the FDA solicited an order to stop the manufacturing of C-QUR until these issues were properly addressed. More than 145,000 C-QUR units were recalled during this year. Atrium paid 6 million dollars for the issues outlined in the injunction and agreed to pay another $6 million if the problems were not corrected shortly.
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.
Currently, Atrium Medical Corp. faces nearly 2000 product liability lawsuits throughout the federal court with the allegations that the C- Qur hernia mesh system increases the risk of an inflammatory response, bowel adhesions, and other painful complications, often resulting in additional surgery.
Defense Health Agency Ask Beneficiaries To Stop Zantac Use
On Monday, Defense Health Agency (DHA) officials, who manage Tricare, warned military beneficiaries to stop the use of the over-the-counter version of Zantac, as the heartburn medications might contain high levels of N-nitrosodimethylamin (NDMA), a probable human carcinogen.
Recently, on April 1, the Food and Drug Administration ordered all the manufacturers of Zantac to withdraw all prescription and over-the-counter ranitidine products, stating that the levels of NDMA increase over time, and when stored at higher than room temperatures.
Last September, several manufacturers of generic ranitidine, including Novartis and Apotex, voluntarily recalled their products sold in the U.S. Three weeks later, Sanofi also issued a recall of its products.
In the April 1 announcement, FDA officials stated that they did not observe unacceptable levels of NDMA in the samples of ranitidine they tested. However, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research stated that since they are unsure about the product storage, they have decided that this heartburn drug should not be available to consumers and patients unless its quality can be assured.
DHA officials said patients should follow FDA advice, speaking with doctors before stopping prescription versions of the medication and disposing of all versions of the drug.
The FDA has advised consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly, and not buy more. Patients who wish to continue treating their condition should consider using other approved over-the-counter products, the FDA has stated in its statement.
The FDA has also recommended consumers some guidelines for the disposal of heartburn drugs. Consumers who wish to dispose of Zantac should mix uncrushed pills or liquids with an unappealing substance, such as dirt, cat litter, or used coffee grounds.
The public was not aware of the high levels of NDMA produced by Zantac until September 2019. An independent pharmacy, Valisure, conducted testing on Zantac, which claimed that each pill might result in a level of exposure higher than the limit set by the FDA regarding the intake of NDMA. The testing by Valisure indicated that 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA, contrary to 96 ng set by the FDA.
Considering the facts about Zantac, the FDA has requested to recall all the Zantac products from the U.S. drug market. In the ongoing investigation of Zantac to check the contamination level of N-Nitrosodimethylamine (NDMA) in this drug used for preventing ulcer.
FDA has determined that Zantac, technically known as ranitidine has shown the result of an increase in impurity over time and when kept at a high temperature. Due to the request by the FDA for immediate market withdrawal of this drug used for heartburn treatment., Zantac will now not be available for prescriptions or over-the-counter usage.
The U.S. Food & Drug Administrations (FDA) posted a recall notice on its website following which American Health Packaging recalled ranitidine tablets, as the heartburn medication contained unacceptable levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen.
After this, the mixture should be placed in a container, such as a sealable plastic bag. Then the container should be thrown away in a bag after removal of all personal information on the prescription labels of empty medication bottles or packaging and recycling.
DHA officials have asked the patients to follow the FDA's advice to dispose of all versions of the drug and speak with their doctors to switch prescriptions.