Weekly Mass Torts Bulletin 2021-May-03

JUUL Labs Inc. faces several lawsuits and new claims under the RICO argument from more than 4,500 individuals, school districts and municipalities for fueling nicotine addiction among teens and young adults.

The company introduced the JUUL pods in 2015, which in no time became much popular among teens and adults in the United States. There are currently more than 2,000 cases filed in the federal court system as a part of multidistrict litigation consolidated before Judge Orrick as mentioned in a Joint Case management Conference Statement issued on April 14. It includes claims presented by 146 school districts, 20 counties, 2 cities, and 20 tribes and JUUL nicotine addiction injury cases from 1,730 individual users.

Judge Ann I. Jones in the Los Angeles Superior Court is also overseeing 422 complaints that are pending in California state court as part of a JCCP. These complaints include more than 2,500 individual plaintiffs claiming nicotine addiction after using JUUL products.

The company even faces many personal injury lawsuits from parents of young adults who began vaping as teens and also from the parents of minor JUUL users. Government entities and school districts are blaming the JUUL products for destroying the communities, classrooms, and budgets by fostering the addictive products among the youngsters.

It is easier for the teens to hide the JUUL vape pens from the parents and school officials as it looks like a USB drive. These vapes are even sold in candy-like flavors that lure non-smokers and teens. The manufacturers thoroughly used social media and other marketing strategies to target teens without disclosing the high levels of nicotine present in the products that can lead to serious addiction problems.

JUUL Labs along with Altria Group Inc. is even accused of deliberately targeting teenagers by using fraudulent marketing strategies and the company miserably failed to knock out such racketeering claims in lawsuits. The complainants in these claims included consumers, local governments, and school districts. Although the judge dismissed the claims, the plaintiffs were allowed to revise their complaints considering a new RICO argument. The 1970 RICO law deals with the prosecution of organized crime and is also used in civil lawsuits.

Health officials of Canada said that talc may be harmful to lungs when inhaling certain loose talc powder products, and it may cause ovarian cancer when using certain self-care products containing talc in the female genital area.

Environment and Climate Change Canada along with researchers from Health Canada completed a final screening assessment of talc before concluding the risks mentioned in the press release. Based on the assessment, the Government of Canada is proposing measures to help manage the risks posed by the use of talc in a limited number of product types, such as certain cosmetics, natural health products, and non-prescription drugs. The statement  highlighted that talc is not harmful for the environment.

Canadian regulators conducted the screening assessment after finding that the consumer talc products that were sold in the United States consistently found to be contaminated with carcinogens such as amphibole asbestos, including tremolite and anthophyllite with no safe levels.

The researchers issued two risk factors by stating that everyday products such as baby powder and body powder have fine particles of talc present in them, which can be harmful if inhaled. They even raised concern over the use of body powder, baby powder, diaper and rash creams, genital antiperspirants and deodorants, body wipes, and bath bombs around the female genital area.

The officials even notified that there is no evidence intimating that ingesting or using talc on top of the skin through products like pressed powder makeup poses any risk. Exposure of talc through paper, plastics, paint, ceramics, putties, and in food, as well as many cosmetics, natural health products, and non-prescription drugs also did not show any human health risks.

Side effects from talc exposure due to toxic particles of asbestos have been a major concern among the people of the United States for a decade. Johnson & Johnson (J&J) and Shower to Shower are two major manufacturers of baby powders in the U.S. and currently face more than tens of thousands of lawsuits alleging that the companies knew about the human health risks, but still misguided the consumers for profits.

All the talcum products lawsuits are consolidated before Judge Freda Wolfson in the U.S. District Court, District of New Jersey under MDL No. 2738.

Indiana and the pharmaceutical distributor Indivior have entered a settlement of $4.3 million over allegations that the company was involved in improper marketing and sales of drug Suboxone, a drug approved for use by recovering opioid addicts.

According to the allegations surfaced in six whistleblower lawsuits, dishonest statements from the company and aggressive marketing tactics resulted in inappropriate expenditures of Medicaid funds. The attorney stated that earlier Indivior claimed that it will help to eradicate the problem of drug addiction in the country, but the company's actions have failed the cause.

Suboxone is used while undergoing treatment to avoid or reduce withdrawal symptoms among recovering opioid addicts. However, buprenorphine which is an active ingredient of Suboxone is harmful and addictive that leads to opioid abuse.

Indiana and other states have alleged Indivior of engaging in three types of fraudulent activity from 2010 through 2015.

• The company encouraged physicians to write prescriptions about Suboxone for unaccepted medical purposes.

• It even falsely claimed that the new form of Suboxone that dissolves under the tongue is less harmful than other buprenorphine products.

• The company controlled the pricing of Suboxone and fraudulently delayed the entry of generic competition into the market by submitting false pretences to the U.S. Food and Drug Administration.

Indivior will pay $300 million to settle civil fraud allegations that have impacted Medicaid and other government healthcare programs. $203.7 million from the settlement amount will go to go to Medicaid. Last year, the company and several of its officers were sentenced for deceptive marketing of Suboxone.

Settlement negotiations were looked upon by a team of the National Association of Medicaid Fraud Control Units. The team consisted of officials from the Offices of the Attorney General for Indiana and five other states. The attorney general of the lawsuit thanked the team for investigation and settlement in the matter.

The U.S. Department of Health and Human Services contributes 75% of the Indiana Medicaid Fraud Control Unit's funds. The State of Indiana contributes the remaining 25% of funds.

New Jersey appeals court reversed the verdict of $117 million in a lawsuit that claimed a man developed mesothelioma due to the asbestos present in the talcum powder products of Johnson & Johnson (J&J) and Imerys Talc America.

Improper testimony and lack of evidence from the plaintiff's lawyers resulted in the dismissal of the verdict. According to the published panel opinion by the Appellate Division Judge Joseph L. Yannotti, the experts did not support the testimony acknowledged by a defense expert who claims that the talc used in the baby powder contains "non-asbestiform amphiboles."

It is one of the biggest victories for J&J and Imerys in litigation across the country, which claims that the company purposely used asbestos in the talc products causing cancer among the consumers. J&J even claimed that their talc products are safe by stating that it does not contain asbestos and does not cause cancer as per the scientific tests done for decades.

The plaintiffs filed a lawsuit under the New Jersey Products Liability Act against J&J and Imerys in December 2016, claiming that the company's talc products contain asbestos that contracted mesothelioma for them.

One of the plaintiffs' attorneys informed that they will appeal the case in the New Jersey Supreme Court, as the case was earlier tried in 2018 when the investigative journalist and the U.S. Food and Drug Administration provided scientific studies linking talcum powder usage to mesothelioma.

In April 2018, at the end of a more than two-month trial, the jury stated that the plaintiff's exposure to the asbestos present in the company's products caused his mesothelioma. He was even awarded $37 million as compensatory damages and $80 million in combined punitive damages. But a state appellate court overturned the award and ordered new trials in the case.

In May 2020, J&J stopped the sale of its baby powder in the U.S. and Canada as the demand for the products drastically declined due to the thousands of lawsuits claiming it has caused cancer.

All the asbestos-related lawsuits are consolidated under MDL No. 875, which was created in 1991 in the Eastern District of Pennsylvania.

Sanofi has informed the investors that it is planning to bring back Zantac with the generic pharmaceutical ingredient found in Pepcid; famotidine.

Last year, Sanofi had to recall Zantaz OTC as per the orders issued by the federal regulators. The officials stated, the heartburn drug contained ranitidine that converts it into a chemical byproduct that causes cancer.

Zantac was first introduced in the 1980s and was most widely used as a medication for the treatment of heartburn and acid reflux. It was available as generic ranitidine and widely used by Americans.

It was discovered in late 2019, that the ranitidine-based medication contained high levels of a human carcinogen, N-nitrosodimethylamine (NDMA), which can get activated if the drug passes through the body or the pills are stored under certain conditions.

There are thousands of Zantac lawsuits filed by the consumers against Sanofi and other manufacturers of ranitidine-based drugs. All the defendants in the lawsuits allege that the exposure to NDMA produced by ranitidine caused them to develop breast cancer, prostate cancer, pancreatic cancer, stomach cancer and other injuries. Sanofi responded to the issue by stating the Zantac brand is not as toxic as the chemical that might have caused the problems for the consumers and still has some reputation in the market.

The spokesperson for Sanofi announced on April 28 that the company will launch a new product named Zantac 360. The company even notified that it will use famotidine, which is the active ingredient in Pepcid instead of ranitidine to manufacture the new product.

The company will release two versions of the new Zantac drug on the U.S. market in June 2021. The products include a 10 mg famotidine “Original Strength” version, and a 20 mg “Maximum Strength” version.

All the Zantac lawsuits are consolidated before U.S. District Judge Robin L. Rosenberg for a common outcome and coordinated discovery.