What Happened In The MassTorts World Last Week? 2020-Apr-06
Allergan Biocell Lawsuits: Plaintiffs Seek To Form MCL
The plaintiffs involved in the Allergan Biocell breast implant lawsuits asked the New Jersey Supreme Court to consolidate all the cases before one state judge for pretrial proceedings.
Last month, Glenn A. Grant, the Acting Administrative Director for New Jersey state courts, issued a Notice to the Bar, stating that the New Jersey Supreme Court has received the application from several plaintiffs who have filed claims against the recalled implants alleging the textured design increases the risk of cancer.
The application seeks to establish multicounty litigation (MCL) in Bergen County, and centralize all current and future claims before one judge.
According to the application, the plaintiffs noted that the federal Allergan Biocell litigation has already been centralized in New Jersey, where the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated the claims before U.S. District Judge Brian R. Martinotti in the District of New Jersey under MDL No. 2921.
The legal proceedings have emerged post the recall of Allergan Biocell breast implant recall issued in July 2019. This recall was made after FDA determined that Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) which is a rare type of T-cell lymphoma is associated with Allergan's device. For many years there has been a concern for the development of rare cancer near tissues surrounding the area of the implant.
As per FDA's data over the summer, approximately 573 known cases of ALCL diagnosis have been reported worldwide. Amongst these, 481 ALCL cases have been linked to Allergan's breast implant device. Since the recall of the breast implant device, the number of lawsuits against Allergan has risen drastically with common allegations that the textured design of the device is harmful and defective.
The plaintiffs in their petition also argued that the consolidation in Bergen County, where Allergan has its U.S. headquarters, will assure judicial efficiency, and all parties will benefit from the coordinated discovery.
The consolidation is meant to reduce duplicative discovery into common issues in the cases, avoid conflicting pretrial schedules from different judges, and serve the convenience of the common parties, witnesses, and the judicial system.
Misleading Roundup Ads Cost Bayer $40M
Bayer has agreed to pay nearly $40 million to resolve a class-action lawsuit claiming misleading and false advertisements over its controversial weed killer Roundup.
According to the lawsuit filed by several plaintiffs in Missouri federal court in February 2019, Scotts Miracle-Gro Products, Inc. and Monsanto Company, now owned by Bayer, face allegations that the manufacturers falsely claimed that the active ingredient, glyphosate, only targets an enzyme that is not found in humans or pets.
Monsanto, Bayer’s subsidiary, has agreed to pay $39.5 million as part of the Roundup class action settlement. The manufacturer also agreed to remove language from Roundup Weed and Grass Killer labels, which previously indicated glyphosate only affects plant enzymes.
Allegations raised by consumers state that glyphosate attacks an enzyme found in humans and some animals which can become a major cause of cancer. Bayer is actively working to resolve 13,000 plus lawsuits that have blamed the herbicide manufacturer for cancer spread. The German giant is confident of their product not causing cancer and denies linkage of glyphosate to this chronic disease. Bayer has already faced defeat in its last three cancer trials where the combined damages have summed up to $191 million. Due to the postponement of the next round of Roundup trials, there will be more time with Bayer for negotiations.
Bayer shares were seriously attacked after they acquired Monsanto in June 2018, where their value fell by 47% in the market as the trial loss increased and new cases developed.
Chris Loder, a US-based spokesman for Bayer stated that the current settlement of $39.5M for misleading ads will not have any impact on the ongoing negotiations. The WHO's agency for cancer research has confirmed the presence of the active ingredient carcinogen in Roundup in its report released in 2015.
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.
Currently, Bayer faces many lawsuits over its Roundup weed killer, but this case is different from thousands of cases faced by the manufacturer over allegations that long term exposure of glyphosate causes non-Hodgkin’s lymphoma and other injuries to the users of Roundup.
Many state court cases have already been postponed following a settlement discussion between the parties and the prominent mediator Ken Feinberg.
All Versions Of Zantac Suspended By FDA
The U.S. Food and Drug Administration (FDA) has requested manufacturers to discontinue all versions of Zantac from the market, as it poses a risk to public health.
The FDA has urged the consumers to stop using any version of Zantac. Zantac is one of the top-selling products in the U.S. market for decades. It became the first medication to surpass 1 billion annual sales in 1988. But, it seems the manufacturers knew for years that Zantac causes cancer since the active pharmaceutical ingredient is inherently unstable and produces high levels of the NDMA, which is considered a carcinogen.
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 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.
The recall notice includes 11 lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters, which American Health Packaging has notified its distributor to arrange the return of all recalled ranitidine products to Inmar Pharmaceuticals Services.
An online pharmacy Valisure first announced that it had detected high levels of NDMA in every drug sample it tested, following which Zantac and ranitidine recall began last year. The pharmacy petitioned the FDA, noting that the NDMA levels sometimes far exceeded the agency’s recommended guidelines. It also asserted that the ranitidine molecule resulted in the production of NDMA when the drug was subjected to conditions that mimic human digestion, which the agency is yet to determine.
After the decision to recall Zantac, the Director of FDA's Center for Drug Evaluation and Research stated that they did not come across unacceptable levels of NDMA in their samples, however, they are unsure since when the products have been stored. Therefore, they decided to make Zantac unavailable for consumers, until its quality is being assured.
Zantac (ranitidine hydrochloride) is an antacid and an H2 (histamine-2) receptor blocker used for treating and preventing ulcers in the duodenum, stomach, and intestines. It is also used for treating erosive esophagitis, heartburn, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome.
In 1983, Glaxo Holdings Ltd, a company that is a part of GlaxoSmithKline PLC, received approval from the FDA to sell Zantac in the U.S. However, owing to patent expiry in 1987 in the United States, Glaxo had to face stiff competition by the generic alternatives launched immediately by competitors.
Since 2017, the OTC version of Zantac was marketed by Sanofi in the United States and Canada. In 2004, Pfizer gained FDA approval to sell the Zantac OTC in the United States.
NDMA is a human carcinogen that can lead to cancer. It must be noted that low levels of NDMA come in contact with humans while having their daily diet, as a low amount of human carcinogen is present in food and water which does not cause any harm and increase the risk of cancer. However, exposure to a higher level of NDMA can lead to severe health consequences, mainly cancer.