Weekly Mass Torts Bulletin 2024-June-12
FDA Allows JUUL to Remain on Shelves Amid Safety Review
The U.S. Food and Drug Administration (FDA) has agreed to rescind its ban on JUUL e-cigarettes, signaling that it continues to review new case law and information from the manufacturer while evaluating the safety of the nicotine levels and their potential to promote teen addiction.
JUUL vape pens, which resemble USB drives, were introduced in 2015. Their discreet design allowed teens to hide their vaping habits from parents and school officials. The manufacturer aggressively marketed a variety of fruity and sweet flavors through social media influencers, leading to JUUL becoming the most widely used e-cigarette among teens in the U.S. This marketing strategy has been blamed for fueling a teen vaping crisis, creating a new generation of Americans addicted to nicotine.
In June 2022, the FDA issued a marketing denial order (MDO) affecting all JUUL products marketed in the U.S., determining that the manufacturer had failed to provide sufficient evidence to indicate that their products could be marketed safely. However, one month later, the FDA agreed to review certain scientific issues, resulting in a stay of the decision. The vaping devices remained on the market while awaiting further decisions. On June 6, the FDA provided an update, rescinding the MDO.
“This action is being taken, in part, as a result of the new case law, as well as the FDA’s review of information provided by the applicant,” the FDA update stated. “Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied.”
JUUL’s application for product approval has now returned to a “pending” status and will undergo further FDA review. The initial decision to remove JUUL from the market followed the FDA's order for all vape manufacturers to submit premarket tobacco product applications (PMTAs) for any nicotine-based e-cigarette and vaping products in September 2021.
The FDA has not elaborated on why it initially rejected JUUL’s application beyond noting that the company’s marketing plans failed to demonstrate how they would protect public health from the dangers posed by their nicotine-based products, which have a reputation for enticing teens and underage tobacco users.
Despite authorizing several other vaping products in recent years, the FDA previously determined that JUUL had not provided sufficient evidence to assess relevant health risks and that continuing to sell JUUL would not protect public health.
“We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health,” JUUL Labs stated on June 6. “These products will remain on the market during this review.”
Thousands of families, young adults, and communities, along with states, have filed individual and class action lawsuits against JUUL, alleging that the company’s actions led to teens developing lifelong nicotine addictions. Claims have also been brought by local school districts, which have incurred increased costs due to teen vaping problems in the U.S.
In response to the litigation, JUUL has reached several settlement agreements in recent years. In January 2023, the company agreed to a $1.7 billion settlement to resolve thousands of individual injury lawsuits. Additionally, JUUL agreed to a $438.5 million settlement to resolve claims filed by 40 different states and a separate $462 million agreement to resolve claims by six other states and the District of Columbia. As part of these settlements, JUUL Labs has not admitted to any wrongdoing.
The FDA’s latest decision to review JUUL’s application further underscores the ongoing scrutiny and controversy surrounding the company and its role in the teen vaping epidemic. As the review process continues, the market awaits the FDA’s final determination on the safety and regulatory status of JUUL products.
GSK Plunges 9% as U.S. Court Allows Testimony in Zantac Cases
Shares of British pharmaceuticals giant GSK plunged 9% after a U.S. court ruled that scientific evidence could be presented in the ongoing lawsuits concerning the discontinued heartburn drug Zantac.
The Delaware State Court decided that plaintiffs’ expert witnesses could testify in approximately 75,000 cases alleging that ranitidine, the active ingredient in Zantac, may cause cancer.
“This case has always been about getting the science in front of a jury,” said a lawyer representing many of the plaintiffs. The dispute, which has been ongoing for years, involves several pharmaceutical companies. GSK initially sold Zantac as a prescription drug in the 1980s before it transitioned to an over-the-counter medicine. After its patent expired in the 1990s, other companies, including France’s Sanofi, U.S. firm Pfizer, and Germany’s Boehringer Ingelheim, also sold it.
Zantac was withdrawn from European and U.S. markets in 2019 and 2020 after regulators conducted a safety review, raising concerns that it contained a probable carcinogen called NDMA. The companies involved deny there is a scientific consensus linking the drug to cancer.
In a statement, GSK expressed disagreement with the Delaware ruling and announced plans to appeal, arguing that the decision contradicted a federal court’s multi-district litigation ruling in December 2022, which dismissed all cases alleging five types of cancer. GSK emphasized that the court's decision only pertained to the reliability of the plaintiffs’ experts' methodology to be presented as evidence at trial.
“Following 16 epidemiological studies looking at human data regarding the use of ranitidine, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer,” GSK stated. While most cases are in Delaware, smaller numbers are being heard in California, Illinois, and Pennsylvania.
In late May, analysts at Jefferies noted a potential positive outcome for GSK after an Illinois jury found GSK and Boehringer Ingelheim not liable for colorectal cancer in the first Zantac case to reach trial. Despite this, GSK, being the most exposed company to these cases, could face settlement costs ranging from $1 billion to over $3 billion, according to various analysts.
Sanofi, named in approximately 25,000 of the 75,000 cases, expressed disappointment with the decision and plans to appeal, noting that it was disappointed with the decision not to exclude the plaintiffs’ experts. As a result, Sanofi shares dropped by 1%.
Pfizer, implicated in a fraction of the Delaware cases, reported having resolved a substantial number of cases where it was named as a defendant. Pfizer reiterated that there is no reliable scientific evidence linking Zantac to cancer. “While we have great sympathy for plaintiffs in these cases, there is no reliable scientific evidence that Zantac, which was reviewed and approved by FDA, causes cancer,” Pfizer stated. The company also highlighted that it has not sold a Zantac product in over 15 years and only did so for a limited period, without ever manufacturing the product itself.
Last month, it was reported that Pfizer agreed to pay between $200 million and $250 million to settle more than 10,000 Zantac lawsuits. This reflects the ongoing legal challenges faced by pharmaceutical companies in light of the allegations surrounding Zantac and its potential health risks.
Two More Exactech Optetrak Knee Implant Lawsuits Set for Trial
The U.S. District Judge overseeing all Exactech Optetrak knee lawsuits has announced start dates for the third and fourth bellwether cases.
These early test trials aim to gauge jury responses to evidence and testimony that will be central to over 1,200 product liability claims concerning defective packaging, which heightened the risk of early failure.
The lawsuits allege that Exactech used “out-of-specification” vacuum-sealed bags for a plastic tibial insert component in their Optetrak knee implants and other systems before 2022. These bags allowed oxygen to reach the implants after they were placed in the body, leading to component degradation, premature failure, and often necessitating additional surgeries to remove and replace the faulty components within a few years.
Affected implant recipients began filing lawsuits following an Exactech recall announced in February 2022. The recall impacted over 140,000 Optetrak, Optetrak Logic, and Truliant knee replacement systems implanted since 2004, as well as 15,000 components used in Exactech Vantage ankle replacements. Similar issues had previously led to the recall of Exactech Novation and Acumatch hip implants in June 2021. The Exactech hip recall was further expanded in August 2022 after identifying another 40,000 joint replacements at risk of premature failure.
Due to the large number of lawsuits over defective Exactech implants, the litigation has been consolidated for pretrial proceedings before a U.S. District Judge in the Eastern District of New York. A small group of representative claims has been selected for early bellwether trials.
Four Exactech Optetrak knee lawsuits were chosen for the initial trials since these components account for the majority of the litigation. The first two bellwether trials are set for June and August 2025, involving plaintiffs from New York who encountered issues with an Optetrak Logic knee implant.
On May 22, the Judge announced that the third and fourth bellwether trials would commence in October 2025 and January 2026. The October 2025 trial involves a plaintiff from New Jersey who received an Optetrak Logic implant during right total knee replacement surgery in October 2009 but was later diagnosed with aseptic loosening and osteolysis, leading to revision surgery in September 2017. The fourth trial in January 2026 will involve a plaintiff from Texas who received an Optetrak Logic implant in August 2016 and had it removed in August 2022 due to accelerated wear of the tibial insert.
These four claims will serve as early bellwether trials in the federal court system. However, the first Exactech knee lawsuit to go before a jury will occur at the state court level in Florida, with a case set to begin in October 2024.
Although the outcomes of these early trials will not be binding on other lawsuits, they will be closely monitored. The results may significantly influence any settlements Exactech offers to avoid hundreds of individual trials in the future. The bellwether trials will provide insight into how juries might respond to the allegations and evidence, potentially shaping the course of the litigation and any settlement negotiations.
The Exactech litigation highlights the significant impact of defective medical devices on patients' lives and the legal processes involved in addressing widespread product failures. These trials will be crucial in determining the manufacturer’s liability and the extent of compensation due to affected individuals.