Weekly Mass Torts Bulletin 2021-June-21
Sanofi Chemo Hair Loss Suit Tossed By 5th Circuit
A breast cancer survivor's lawsuit alleging Sanofi's chemotherapy drug Taxotere of permanent hair loss has been tossed by the Fifth Circuit upholding a lower court's ruling that claimed the plaintiff delayed in filing the litigation.
The panel of three judges who are overlooking the case stated that there is just a one-year limit to make claims in such cases, whereas the plaintiff waited for more than four years to sue the company. The rejection came considering the plaintiff's contention under the doctrine of contra non valentem that stops the deadline clock under certain circumstances.
The panel of the judges said that back when the plaintiff finished her chemotherapy in 2012, she did not consider Taxotere for permanent hair loss unlike other women with the same allegations. The panel even stated in a published ruling earlier that women should have soon addressed the hair loss issue after the chemotherapy within a reasonable time as per the court's guidelines.
In 2006, some women even opposed the drug virtually through social media, blaming the drug for hair loss. Canadian newspapers and U.S. broadcast news also published articles in 2010 with topics explaining if Taxotere causes hair loss.
As per the court documents, the plaintiff argued that her case is different, as the doctors ensured that her hair would grow back. The panel rejected her argument due to the lack of evidence.
The lawsuit is a part of multidistrict litigation that alleges Sanofi of failing to warn about the permanent hair loss caused due to Taxotere.
Taxotere (docetaxel) is a cytotoxic intravenous chemotherapy drug used to treat various cancers like breast, lung, prostate, stomach, etc.
Taxotere belongs to a class of chemotherapy drugs called plant alkaloids also known as antimicrotubule agents. Antimicrotubule agents inhibit the microtubule structures within the cell required for cell division and self-replication; inhibition of these structures ultimately results in cell death. Taxotere is approved in the treatment of breast cancer, non-small cell lung cancer, advanced stomach cancer, head and neck cancer, and metastatic prostate cancer. but doctors prescribe this drug mainly to treat breast cancer cases in the U.S making it the most prescribed drug in its class.
Taxotere has disfiguring side effects that include permanent hair loss, also known as Alopecia, which severely impacts the quality of life, which could lead to depression and distress. Other side effects include cutaneous reactions, neurologic reactions, eye disorders. The company Sanofi was aware by the year 2005 about the results of a trial GEICAM 9805 which was sponsored by Sanofi in the late 1990s that 9.2% of women who used the drug Taxotere suffered permanent alopecia. In spite of that Sanofi misled the public by falsely reassuring them that hair would grow back after chemotherapy.
Thousands of women are bringing product liability lawsuits against Sanofi-Aventis, alleging permanent hair loss. These plaintiffs are claiming that Sanfoi-Adventis knew about the effectiveness of Taxotere and the fact that the drug may cause permanent hair loss, yet did not provide any warning.
Taxotere was first approved in 1996 by the U.S. Food and Drug Administration. The label of the drug mentioned possible hair loss as a side effect, but it was finally confirmed in 2015 that the drug causes permanent hair loss.
33 lawsuits from 25 districts were consolidated under the MDL in 2016, which increased to 12,000 lawsuits as of January 2019. All the Taxotere lawsuits are consolidated before Judge Kurt D. Engelhardt under MDL No. 2740 IN RE: Taxotere (Docetaxel) Products Liability Litigation in U.S. District Court for the Eastern District of Louisiana.
Law Firms In Leadership Roles Announced For Zantac Lawsuits
Attorneys from six law firms have been appointed in a leadership position by a California judge to overlook the consolidated proceedings of Zantac lawsuits that claim the drug developed cancer to the plaintiffs.
The complaints allege that ranitidine, an active ingredient present in Zantac produces high levels of the known human carcinogen Nitrosodimethylamine (NDMA). The lawsuits even allege that the manufacturers were aware of the drug's side effects still, they continued to sell it in the market exposing the users to a higher risk of cancer.
Most of the cases are consolidated for pretrial proceedings in the Southern District of Florida whereas many additional cases have been brought in California state courts which are overlooked by Judge Winifred Smith who will preside over a Judicial Council Coordination Proceeding (JCCP) in Alameda County. Currently, the court handles 62 complaints representing 1,078 plaintiffs.
An order issued by Judge Smith on June 15 confirmed a leadership structure for the state court litigation. The attorneys appointed in the leadership roles will manage many responsibilities like reviewing discovery documents, taking depositions of common witnesses, arguing motions and other actions.
Currently, more than 70,000 potential product liability lawsuits are faced by Sanofi, GlaxoSmithKline, Boehringer Ingelheim, and other drug manufacturers, distributors, and retailers of Zantac throughout the U.S. The lawsuits claim that the active ingredient in Zantac when passed through the body or stored at higher temperatures converts high levels of the potent human carcinogen. Zantac recall lawyers are still reviewing the claims against the manufacturers and the number of claims is expected to grow as time passes.
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.
Zantac, available with a prescription and over-the-counter, works by reducing the amount of acid made by the stomach.
In September 2019, public concerns about the Zantac cancer risk emerged when an independent online pharmacy Valisure discovered that each pill may expose users to NDMA levels higher than the permissible daily intake limits set by the FDA. The pharmacy found that some 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA, while the daily limit deemed safe by the FDA is only 96 ng.
On April 28, 2021, Sanofi, another Zantac manufacturer announced that it is planning to release two new versions of Zantac including a 10 mg famotidine “Original Strength” version, and a 20 mg “Maximum Strength” version.
Monsanto To Pay $45M To Resolve Nationwide Roundup Claims
A group of Roundup users is seeking preliminary approval from Delaware federal court for Monsanto's deal where the company has agreed to pay up to $45 million to resolve nationwide claims.
The lawsuits allege Monsanto concealed the potential cancer links associated with the weedkiller Roundup. The motion presented by the plaintiffs' attorneys before U.S. District Judge Maryellen Noreika states that the attorneys will get up to 25% in fees and consumers will get 20% of the average retail price of Roundup products they purchased.
The approval of the deal will help in resolving many class-action lawsuits against Monsanto including eight lawsuits filed by the plaintiffs during last year in August. The class-action lawsuits against the company even include a high-profile case that is pending appeal before the Eleventh Circuit. The consumers have accused the company of misleading advertisements, violation of consumer protection, and hiding the cancer linkage of the weedkiller. The consumers portrayed their rage by stating that they would not have bought the products if the company had put a warning label earlier on its product.
Monsanto, Bayer's subsidiary even faces personal injury litigation in federal and state courts across the country and the majority of them are centralized in Northern California and Missouri. Bayer has even tried to settle the over a hundred thousand personal injury litigations which include California's three multi-million dollar plaintiffs' jury verdicts, two of which are upheld by state and federal appellate courts, and the third is pending appeal.
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.
Monsanto denied any liability and stated that the settlement is fair and should be approved. The company even mentioned that the cancer warning label on its products is as per the U.S. Environmental Protection Agency's guidelines and glyphosate is not carcinogenic.
Last month, U.S. District Judge Vince Chhabria rejected a deal where Bayer was ready to pay $2 billion to resolve future personal injury claims.