by manovermachine | Sep 26, 2022 | Zantac Linked Cancers
New Lawsuits Filed at the State Level
On September 14, law firm Baum Hedlund Aristei & Goldman filed 88 new lawsuits against GSK, Pfizer, Boehringer Ingelheim, and Sanofi in Delaware court on behalf of more than 7,000 claimants who allege that ranitidine heartburn products caused a variety of cancers.
And law firm Keller Postman filed claims on behalf of more than 10,000 clients from Delaware, California, Illinois, and Pennsylvania involving cancers no longer designated in the multi-district litigation created in 2020. The MDL now includes five types of cancer alleged to have been caused by ranitidine use—bladder, esophageal, gastrointestinal, liver, and pancreatic. Plaintiffs with breast, kidney, colorectal, prostate, and lung cancers are now pursuing their cases in state courts.
A Sanofi spokesperson said the recent surge in state court filings are due to plaintiffs who exited the federal multi-district litigation, or whose alleged injuries have been dropped from the MDL and reiterated their claim that there is no scientific evidence Zantac causes cancer.
Haleon Rejects Indemnification Requests
As reported by Reuters last week, London-based Haleon rejected indemnification requests from GSK (formerly GlaxoSmithKline plc) and Pfizer, with CEO Brian McNamara saying Haleon believes it is not liable for any claims that may arise from U.S. litigation over the heartburn drug, Zantac.
Zantac was originally marketed by a forerunner of GSK, and has been sold by several companies over the years, including Pfizer, Sanofi, Boehringer Ingelheim and many generic drugmakers.
In July, Haleon spun out of GSK as an independent company and comprises consumer health assets once owned by GSK and Pfizer. However Haleon has repeatedly said that it never marketed Zantac in any form in the United States, either as Haleon or GSK Consumer Healthcare.
Following a loss of market value due to uncertainty surrounding the litigation, McNamara wanted to make Haleon shareholders aware that they never agreed to accept a share of any liabilities if damages are accrued as a result of U.S. litigation over Zantac.
“We do not agree with Haleon’s position,” a GSK spokesperson said. “GSK believes that there are grounds for it to bring indemnification claims in respect of certain potential liabilities, including against Haleon.”
Pfizer was not immediately available for comment.
by manovermachine | Sep 23, 2022 | Non-Hodgkin's Lymphoma and Roundup
Attorneys for plaintiffs in Roundup lawsuits are urging the federal judge who is presiding over the pretrial proceedings to start “wrapping up” the Multi-district Litigation (MDL) Panel. Billions have already been paid in settlements, and lawyers want the remaining unresolved cases to be returned to U.S. District courts nationwide for trial.
Over the past seven years, Bayer and its Monsanto subsidiary have faced more than 120,000 product liability lawsuits alleging that consumers were not adequately warned about the risk of non-Hodgkins lymphoma (NHL) from Roundup.
The Roundup MDL was established in 2016, and U.S. District Judge Vince Chhabria in the Northern District of California has overseen coordinated discovery and a series of early “bellwether” trials to help gauge how juries are likely to respond to certain evidence and testimony that was repeated throughout the lawsuits.
Trials in 2018 and 2019 resulted in massive payouts, and since then, Monsanto has been attempting to settle individual injury lawsuits. Many plaintiffs have rejected the settlement offers and new claims continue to be filed as more former users develop cancer.
Plaintiffs submitted a statement this month stating that Monsanto still refuses to change the warning label on Roundup and is refusing to make meaningful attempts to settle remaining claims. As a result, lawyers have now scheduled a series of trials nationwide over the next ten months, and indicate that the time has come to “wind up” the Roundup MDL and start returning cases to U.S. District Courts nationwide if a global settlement can not be reached in the coming weeks.
Upcoming Roundup Cancer Trials
There are more than ten Roundup trials scheduled nationwide over the next ten months, none of which will be held in the federal court system. The upcoming trial dates include:
- 11/7/2022 – Langford v. Monsanto in California Superior Court (San Francisco)
- 11/29/2022 – Pied v. Monsanto in Hawaii Circuit Court (Hilo, Hawaii)
- 1/9/2023 – Griswold v. Monsanto in Missouri Circuit Court (St. Louis City)
- 1/23/2023 – Freiwald v. Monsanto in California Superior Court (San Francisco)
- 2/27/2023 – Chaplick v. Monsanto in Missouri Circuit Court (St. Louis County)
- 3/3/2023 – Weaver v. Monsanto in California Superior Court (San Diego)
- 4/3/2023 – Hedges v. Monsanto in Arizona Superior Court (Maricopa County)
- 4/24/2023 – Gordon v. Monsanto in Missouri Circuit Court (St. Louis County)
- 6/5/2023 – Lopez v. Monsanto in Florida Circuit Court (Wade County)
- 6/12/2023 – Moore v. Monsanto in Missouri County Circuit Court
- 6/26/2023 – Johnson v. Monsanto in California Superior Court (San Diego)
Plaintiffs argue that “the current ‘wave’ approach is not a viable, long-term plan for this MDL” and believe that as new cases are constantly being transferred from states to the MDL, waves will continue indefinitely. “Fundamentally, this MDL has accomplished nearly everything that should be expected of an MDL. Important common issues, such as preemption and general causation, have been vetted. Bellwether cases have been tried. Detailed orders concerning how to think about and adjudicate specific causation are available. Most cases have settled. Overall, this MDL has been a tremendous success,” according to the statement submitted by Plaintiffs Leadership attorneys. “It is, however, time to develop an exit plan – one that allows all the hard work that has been done to benefit cases as they are remanded back to their home jurisdictions for trial. In this vein, Plaintiffs propose a three-phase plan to wind up the MDL.”
Proposed Plan to Wind Up Roundup MDL
Phase One – One Last Attempt at Global Resolution
Plaintiffs propose that the Court give the Parties 60 days to see if they can negotiate a global settlement. If Monsanto does not want to engage in this process, then the Court would proceed to Phase Two.
Phase Two – Creation of Complete Trial Package
The Court would officially end the “wave” program and would order the Plaintiffs’ Leadership to update the existing trial package twice a year. This package would include exhibits, transcripts, videos, and depositions of each Monsanto witness, each third-party witness, each of Plaintiffs’ general causation experts, an outline for treating doctor depositions and much more, including PowerPoints, demonstratives, animations, outlines/binders, briefings, exhibits, and rulings from every trial, proceeding, appellate proceeding, discovery motion and more.
Once all of these materials are amassed, Plaintiffs’ Leadership would remain responsible for keeping the materials up to date, and Monsanto would need to cooperate with Plaintiffs in collecting documents and items from cases where Plaintiffs’ Leadership was not involved.
Phase Three – Wind up the MDL
Once the complete trial package exists, the Court would remand all cases still pending in this MDL to the appropriate federal district court, and the MDL would be terminated. The only cases remaining before this court would be the individual cases that were filed directly into the Northern District of California.
Monsanto Advocates For the Status Quo
In response to the plaintiffs’ proposal, Monsanto has requested that the Roundup MDL continue to prepare claims on a state-by-state basis, and push settlements through a court-ordered mediation process. They believe that the wave process is working well and they oppose terminating the MDL. In addition, Monsanto disagrees with many of the components of Plaintiffs’ proposed trial package.
Response from Plaintiffs’ Leadership states, “[A]lmost 2 years later, it is evidence that the current MDL mediation program is not advancing case resolution in a meaningful way. As an initial matter, because Monsanto must ‘approve’ the mediator’s offers, the offers made within the settlement program appear to be woefully inadequate. Thus, a substantial number of MDL cases remain unresolved by the settlement program, and it is highly unlikely that these cases will be settled absent a global resolution or imminent trial setting.”
Monsanto and Bayer are facing years of future litigation over Roundup, as unresolved claims work their way to trial and new lawsuits continue to be filed by individuals as more are diagnosed with non-Hodgkins lymphoma linked to use of the weed killer.
Bayer announced in 2021 that by 2023 it will remove glyphosate, the active ingredient that causes cancer, from Roundup sold to residential customers. However, glyphosate will still be used in products sold to agricultural businesses and farmers, and in product sold in other parts of the world.
Judge Chhabria has set a Status Conference for 11/9/22.
by manovermachine | Sep 19, 2022 | Ovarian Cancer and Talcum Powder
On Monday, September 19, lawyers for the plaintiffs in the talcum powder lawsuit against Johnson&Johnson argued that the federal appeals court should reverse a bankruptcy court’s decision that halted nearly 40,000 lawsuits against the company. Back in February, the bankruptcy court in Trenton, New Jersey had affirmed the ability of Johnson&Johnson’s use of Chapter 11 to hasten a settlement that would free the company from claims against its talcum products, which contain cancer-causing agents.
Last October, in an effort to claim protection under the Chapter 11 bankruptcy, J&J created a spinoff unit, LTL Management, that would file bankruptcy in order to manage the liability caused by their talcum powder products. As explained by Bloomberg Law, “The maneuver, known as the Texas Two-Step because of its reliance on Texas corporate law, involves a company spinning off a unit and transferring its tort liability to that unit. The spinoff is then put into bankruptcy to manage that liability without putting the assets of the original company into play.”
In refusing to dismiss the Chapter 11 case in February, U.S. Bankruptcy Chief Judge Michael Kaplan of the District of New Jersey concluded that LTL Management had not acted in bad faith.
Last week, J&J offered a $5 billion stock buyback program to its equity holders. Jeffrey Lamken of MoloLamken in Washington, D.C., representing the Official Committee of Talc Claimants, argued that the LTL Management Chapter 11 case violated core principles of bankruptcy law—most notably that creditors should get priority over equity holders.
“LTL or J&J is trying to turn what should be that shield of bankruptcy into a sword by not complying with any of the obligations,” said Sean Janda, an appellate attorney at the U.S.Department of Justice’s civil division in Washington, D.C.
The attorney representing LTL Management, former acting Solicitor General Neal Katyal, of Hogan Lovells in Washington, D.C., argued that the appeals court should uphold the ruling by the bankruptcy court, saying that the $61 billion funding agreement set aside for claimants was “a floor, not a ceiling.”
Lamken pointed out that it has taken years to get other bankruptcy cases resolved that involved a divisional merger. David Frederick, of Kellogg Hansen Todd Figel& Frederick in Washington, D.C., said bankruptcy would pay less money to claimants. “Johnson & Johnson did not go to all this trouble in order to pay claimants more money,” said Frederick, who represented 7,000 talc claimants for Houston plaintiffs firm Arnold & Itkin. “They went to this trouble to pay claimants less money, more slowly. The civil system is designed, with whatever flaws it has, to promptly move along cases and not to stop and stay all action.”
Plaintiffs’ attorneys presented oral arguments for three hours to the three-judge panel hearing the appeal. Justices Thomas Ambro, Luis Felipe Restrepo, and Julio Fuentes asked questions such as whether Bankruptcy court or multidistrict litigation was preferable for claimants, and whether arguments would differ if LTL Management had been formed much earlier than two days before filing for Chapter 11 bankruptcy.
Lawyers on both sides expressed optimism about the panel’s decision, which is expected to come down next month. Clay Thompson, from Maune Raichle Hartley French & Mudd, LLC, which represents some of the plaintiffs said the appeal will go to the Supreme Court if the ruling doesn’t go their way.
by manovermachine | Aug 23, 2022 | Philips Recalled BiPAP, CPAP, Ventilators
CEO steps down, additional devices added to recall
In a press release on August 16, 2022, Royal Philips announced that it is replacing its CEO Frans van Houten, who has been in the role for more than a decade, with Roy Jakobs. After the recall last year, revenues began slipping and fell 13 percent in second quarter 2022 as compared to second quarter 2021. The change in leadership will become official October 15, and Mr. van Houten will act as an adviser until April 30, 2023.
Following the recall of millions of ventilators in June 2021 that have been tied to 168 deaths, the company initiated a separate recall of additional devices that were not part of the original recall. All of its V60, V60 Plus, and V680 ventilators were recalled, more than 56,000 of which were distributed in the U.S. between May 2009 and December 2021, as reported by Fierce Biotech. All of these models are indicated for use only in healthcare facilities.
This recall was prompted by an issue with the internal power mechanism in the machines. An energy fluctuation could force the backup alarm controller to reboot, which could cause a complete shutdown of the device with no visible or audible alarm or warning.
Philips has issued guidance for healthcare providers who continue using the devices after taking some mitigating actions. They are strongly recommending that all users connect the devices to a nurse call or remote alarm system and make sure to respond promptly to every alarm issued by the device or the backup alarm system, regardless of priority level. They have also recommended that users install an oxygen analyzer and use pulse oximeters to serve as additional monitors for potential shutdowns.
Philips also recommends having backup ventilators at the ready in the event one of their devices does shut down. That would make it easier to immediately disconnect the patient from the faulty device and get them connected to a backup device as quickly as possible.
If these suggested additional protections are not instituted, Philips suggests that users analyze whether continuing to use the devices is worth the potential risk.
by manovermachine | Aug 18, 2022 | Camp Lejeune Contaminated Water
Chemical pollution of the drinking water at Camp Lejeune, North Carolina has been the subject of many studies and the target of many lawsuits from U.S. veterans, their family members, contractors, and others who were present at the base between 1953 and 1987.
How the Water Got Polluted
Volatile organic compounds (VOCs) were found in the drinking water provided by three of the eight water treatment plants at Camp Lejeune. The water from the Tarawa Terrace water treatment plant was primarily contaminated by an off-base dry cleaning company and their waste disposal practices. Perchloroethylene (PCE) or tetrachloroethylene from the dry cleaner contaminated the wells feeding that water treatment plant.
The Hadnot Point water treatment plant was contaminated primarily by trichloroethylene (TCE) but PCE, benzene, TCE degradation products, and vinyl chloride were also found in the water. The contamination came from multiple sources, including leaking underground storage tanks, industrial area spills, and waste disposal sites.
Areas served by the Holcomb Boulevard water treatment plant were intermittently supplemented by contaminated water from the Hadnot Point plant during high demand spring and summer months from 1972-1985. Holcomb Boulevard wells were generally not contaminated.
Water for drinking, cooking, bathing, laundry, gardening and other daily activities was found to have hazardous levels of chemical contamination for a period of 34 years total, affected hundreds of thousands of people.
How the Contaminated Water Affected Those Who Were Exposed
The chemicals that contaminated the water at Camp Lejeune for so many years are known human carcinogens. It is likely that increased risk of various cancers, birth disorders, fetal and infant death, and other illnesses resulted.
The CDC has stated that sufficient evidence for causation of certain health effects exists for the chemicals detected in the drinking water at Camp Lejeune as follows:
- TCE has been shown to cause kidney cancer, non-Hodgkin’s lymphoma, and various cardiac defects
- PCE has been shown to cause bladder cancer
- Benzene has been shown to cause leukemias and non-Hodgkin’s lymphoma
- Vinyl chloride has been shown to cause liver cancer
The CDC has also concluded that exposure to the drinking water at Camp Lejeune cannot definitively be said to cause the following illnesses, but there is enough evidence to support a link between the exposure and the health effects. This means the evidence is “equipoise and above”.
- TCE is equipoise and above for leukemia, liver cancer, multiple myeloma, end-stage renal disease, Parkinson’s disease, and scleroderma.
- PCE is equipoise and above for non-Hodgkin’s lymphoma and end-stage renal disease
- Benzene is equipoise and above for multiple myeloma
TCE and PCE have been shown to have health effects in populations other than Camp Lejeune for the following:
- Chonal atresia (nasal passages blocked with bone or tissue)
- Eye defects
- Low birth weight
- Fetal death
- Major malformations
- Miscarriage
- Neural tube defects
- Oral cleft defects (including cleft lip)
- Small for gestational age
- Breast cancer
- Cervical cancer
- Esophageal cancer
- Lung cancer
- Hodgkins disease
- Ovarian cancer
- Prostate cancer
- Rectal cancer
- Impaired immune system function
- Neurological effects (delayed reaction times problems with short-term memory, visual perception, attention, and color vision)
- Neurobehavioral performance deficits (i.e., delayed recall and deficits in visual perception), decreased blink reflex, and mood effects (i.e., confusion, depression and tension)
- Severe, generalized hypersensitivity skin disorder (an autoimmune-related disease
Benzene has been shown to have health effects in populations other than Camp Lejeune for the following:
- Aplastic anemia
- Myelodysplastic syndromes
- Miscarriage
Vinyl chloride has been shown to have health effects in populations other than Camp Lejeune for the following:
- Brain cancer
- Lung cancer
- Soft tissue cancer
- Liver cirrhosis
Since March of 1987 Camp Lejeune’s drinking water has been considered safe. It is in compliance with comprehensive federal and state laws and regulations. The water is checked for VOCs more frequently than required by law and the base issues annual Consumer Confidence Reports to all residents of the base on the quality of their water.