Weekly Mass Torts Bulletin 2021-June-14

Tasigna Lawsuits Consolidated In New Jersey Multicounty Litigation

New Jersey’s Supreme Court has announced centralization of all Tasigna lawsuits across the country before Superior Court Judge Rachelle Harz in Bergen County for coordinated pretrial proceedings.

Novartis, the manufacturer of Tasigna, faces several lawsuits claiming that it failed to warn the users about the risk of blood flow problems that might lead to artherosclerosis, a stroke, heart attack, amputations or death due to the drug.

Currently, 64 plaintiffs have filed lawsuits in New Jersey Superior Courts alleging that the consumption of the drug has caused severe injuries to them. All the lawsuits claim that the manufacturer intentionally hid the risks associated with the drug that results in heart attacks, strokes, peripheral vascular disease, and amputations.

Centralized cases consolidated before the judge as part of a New Jersey MCL involves the transfer of claims pending throughout the state or all pretrial proceedings. The MDL will consider each lawsuit as an individual case and will also help in preventing repeated evidence and testimony throughout the litigation.

Tasigna is a part of a class of drugs known as kinase inhibitors and was approved by the FDA in 2007. It is prescribed for the treatment of adults suffering from Philadelphia chromosome-positive chronic myeloid leukemia. The professionals even prescribe it to the adults intolerant to prior therapy of chronic phase and accelerated phase Ph+ CML.

In April, a similar request for consolidation of the cases was made in the U.S. District Court for the Southern District of Illinois where the plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all claims brought in the federal court system.

U.S. District Judge Robin Rosenberg, of the Southern District of Florida, issued an order on July 9, 2018, granting part permission to the plaintiffs in the Tasigna lawsuit to pursue claims against Novartis; however, he barred them from pursuing punitive damages in one claim.

The ruling allowed a product liability case filed by a couple to proceed, involving allegations that the Tasigna manufacturer failed to provide adequate warning about the drug’s side effects like constricting and hardening of arteries, which caused the plaintiff to develop a stroke. Judge Rosenberg refused to dismiss the case based on preemption. To prove a preemption claim, the defendants were supposed to present that the state failure-to-warn laws conflict with the drug's federal approval. 

The Court ruling indicated that Novartis failed to prove that the FDA would have disapproved of a stronger label warning for Tasigna. However, the Court supported the defendant in denying punitive damages to the plaintiffs due to the New Jersey law which prohibits awarding punitive damages if the drug is approved by the FDA.

Plaintiffs filed a motion on July 13 to allow partial reconsideration of the summary judgment requesting to allow pursuing punitive damages. The motion stated, “Under New Jersey law, punitive damages are available ‘where the product manufacturer knowingly withheld or misrepresented |LS|material and relevant|RS| information required to be submitted under the agency’s regulation. Plaintiffs showed that Novartis not only withheld from the FDA material information related to atherosclerosis-related conditions associated with Tasigna but that it knowingly made material misrepresentations to the FDA.”

Tasigna is a kinase inhibitor that is said to work in the body by interfering with protein signaling cancer cells to multiply. This medication is used to treat adult patients who have been diagnosed with chronic myeloid leukemia. This drug is also effective in the treatment of Philadelphia chromosome-positive myeloid leukemia that can be chronic as well as accelerated. Tasigna comes along with side effects like skin rash, itching, headache, diarrhea, constipation, and minor cold symptoms.

The patients should immediately consult with the doctor if patients using Tasigna comes across severe side effects like painful urination, rapid weight gain, high blood sugar, and signs of liver disease.

Tasigna comes in the form of a gelatin capsule which has a strength of 150 - 200 mg. The dosage recommendation is usually twice a day which should be eaten one hour before eating food or two hours after having food. The physicians sometimes need to alter the dosage depending upon various health factors. Tasigna might interact with various other drugs, therefore doctors should be well informed about the other medication being taken by patients.

Pregnant women should stay away from taking Tasigna as unstudied risk can be pass on to the newborn baby while breastfeeding. There has been no establishment of Tasigna safety usage in pediatrics.

Patients need to note that while taking Tasigna they should avoid grapefruit and grapefruit juices as they interact with this drug and leads to unwanted side effects. Stomach acid reducers like Pepcid, Tagamet, or Zantac should be taken 10 hours before taking this medication or 2 hours after having the drugs. Also, an antiacid that contains aluminum like Di-Gel, Gaviscon, Maalox, etc should be taken two hours before or after this medication. Tasigna can cause severe heart problems to patients who are already taking medication for asthma, mental illness, high blood pressure, and depression.

A Court trial was scheduled for September 17, 2018, and a status conference for August 15, 2018. Growing number of Tasigna lawsuits claim it causes atherosclerosis (hardening of the arteries), which can develop a stroke, heart attack, or can even lead to death.

Paraquat Lawsuits To Be Centralized In Illinois District Court

A panel of federal judges announced to centralize all pretrial proceedings of nearly 80 paraquat lawsuits with similar allegations like Roundup litigation in the U.S. District Court for the Southern District of Illinois.

Paraquat is banned in many countries but is still sold on the U.S. market with restrictions that mandate special training and certification process for users on the handling of paraquat as a minor amount of paraquat ingestion can result in death. The product liability lawsuits against the manufacturers of paraquat allege that the manufacturers withheld the risks included among the users due to the herbicide exposure.

Plaintiffs have asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all the paraquat lawsuits in the Northern District of California to avoid duplicate findings and testimony for a common outcome.

Earlier, this week JMPL issued a transfer order considering the oral arguments of the case that took place in May. The order indicates to centralize the paraquat lawsuits in the Southern District of Illinois before Judge Nancy J. Rosenstengel.

If the MDL proceedings do not reach the settlements, then the individual paraquat lawsuits would return to the U.S. District Court where it was originally filed.

Paraquat is sold throughout the U.S. as a weed and grass killer since 1962. It is widely used on farms and is sold under different brand names through farm supply stores like Gramoxone, Blanco, Cyclone, Helmquat, Bonedry, and others.

Earlier, Bayer announced a five-point plan to deal with potential future Roundup claims following the denial of the proposed preliminary motion plan by Judge Vince Chhabria of the U.S. District Court for the Northern District of California.

The plan includes a combination of legal and commercial actions to help the company resolve the ongoing and future Roundup claims effectively.

The denial of the preliminary approval has closed the chances of a fair mechanism for all the parties as it has eliminated the MDL that would have prevented future Roundup claims. Bayer can still deal with future claims with the help of the current plan the company has put forward in court. The spokesperson for Bayer stated that worldwide expert regulators are in support of glyphosate-based herbicides by saying that they are safe for use. Even the brief affirmed by the U.S. Environmental Protection Agency (EPA) in the U.S. Court of Appeals for the 9th Circuit claimed that glyphosate is not harmful to humans.

The five-point plan:

1. Bayer will create and promote a new website that will include relevant scientific studies of Roundup's safety and EPA approved labels. It will help the company to maintain transparency about its products and ensure safety to the users. Users can evaluate the provided studies and labels before using the products.
2. Bayer will continue to sell its product in the residential lawn and garden market. The company will discuss the future of glyphosate-based products in the U.S. residential market as most of the claimants alleged the use of Roundup Lawn and Garden products. The discussion would not affect the sale of glyphosate-based products in the market.
3. The company will create a scientific advisory panel of external expert scientists to review scientific information regarding the safety of Roundup. The results of these researches will be displayed on the website for better transparency and a detailed record about the safety of the products.
4. Bayer will settle existing claims by thoroughly reassessing them. The company will focus on resolving the claims if they are on appropriate terms.
5. Continuing the appeals of pending cases to manage future liability risk for the company as it will continue through the legal process. The company has a favorable decision by the U.S. Supreme court and strong legal arguments to deal with the claims and reduce future liability risk.

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 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 analysing samples for residues of glyphosate. Monsanto has even admitted that the studies have since been repeated.

The company is confident enough that the five-point plan will surely manage and address future liability risks of potential Roundup claims.