What Happened In The MassTorts World Last Week? 2019-Aug-19
Arizona Opioid Lawsuit Remanded From Federal To State Court
The Arizona District Court granted the City of Prescott’s Motion to send back its lawsuits over the opioid crisis in Arizona, from federal court to state court where it was initially filed. The decision was granted last Friday in favor of the city’s motion to remand, denying the defendant's motion to stay.
One defendant argued and removed the case stating that it should be tried in the massive multidistrict litigation(MDL), pending in Ohio federal court. Also, two other defendants filed a motion for the cases to remain in the Arizona District Court, so that the cases would be transferred to the MDL in Ohio following a Conditional Transfer Order (CTO) issued by the Judicial Panel on MDL.
The case dawned from a February 2019 motion filed by the Prescott City Council to pursue a civil lawsuit against the opioid manufacturers and distributors alleging their desire for profits above the health and well-being of Prescott’s residents.
The lawsuits will be presented before the Honorable John Napper of Yavapai County Superior Court. More than 1,900 opioid lawsuits have been filed under MDL No. 2804 (In Re: National Prescription Opiate Litigation) which is presided by U.S. District Judge Dan Polster.
Earlier, the U.S. Supreme Court refused to hear a petition filed by the parents of a National Hockey League player. The petition stated that the player lost his life due to an overdose of opioids prescribed by the team doctors. The ruling ended the five-year-old litigation in which the player's parents blamed NHL for his recurring concussions during his career.
The 28year old player died in 2011. He played for the Minnesota Wild and the New York Rangers; an autopsy revealed he suffered from chronic traumatic encephalopathy, or CTE, a devastating brain condition common among ice-hockey players. His parents filed a wrongful death lawsuit in 2013 against NHL and argued that a trial judge improperly tossed the suit under a Minnesota procedural rule, which requires wrongful death and other survival actions to be presented by a court-appointed trustee. The U.S. Court of Appeals for the Seventh Circuit found that the family fortified their claims by failing to respond to the NHL's argument that the complaint filed against the league was unjust. The U.S. District Court for the Northern District of Illinois dismissed the case in 2017 and warned that the ruling, “should not be read to commend how the NHL handled the victim's particular circumstances or the circumstances of other NHL players who over the years have suffered injuries from the on-ice play.''
The lawsuits are consolidated as a part of multidistrict litigation, MDL No. 2804 (In Re: National Prescription Opiate Litigation) in the Northern District of Ohio before U.S. District Judge Dan A. Polster. The first bellwether trial in the litigation has been scheduled for September 3, 2019.
Allegations are made against opioid manufacturers that they violated the rules by not informing the Federal authorities about the unusual size, suspicious purchases, or the frequency of bulk purchases. There is an allegation that huge benefits were reaped by manufacturers, and they intentionally failed to inform the medical providers about the addictive nature and consequences of opioids.
Federal Regulators And EPA Block Roundup Cancer Warnings
Federal regulators under the Trump administration and the U.S. Environmental Protection Agency (EPA) stated that the warning labels for products that contain glyphosate, a chemical in the weed killer Roundup, would not be approved. This decision targeted the California regulation Proposition 65 that requires labels to warn consumers that the Roundup ingredient glyphosate is cancer-causing.
On August 7, the EPA sent a letter to registrants indicating that they would consider any Roundup cancer warnings to be false and misleading after the agency’s analysis has found that glyphosate is not a cancer-causing agent.
The EPA guidance stated that their discovery found glyphosate non-carcinogenic, they considered the Prop 65 warning language, based on the chemical glyphosate to constitute a false and misleading statement and also stated that the Proposition 65 warning statement for glyphosate-containing products would no longer be approved.
EPA has made an effort to undercut California’s ability to regulate hazardous substances. The agency claimed that their research is in line with other regulatory agencies worldwide.
Roundup lawsuits are consolidated under federal multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation) in the Northern District of California, presided by U.S. District Judge Vince Chhabria.
On November 16, attorneys representing a plaintiff in a lawsuit filed against Monsanto company requested U.S District Judge Vince Chhabria for an expedited trial as the plaintiff has less than six months to live as per his oncologist. On Friday, November 30, Monsanto told the California federal judge the dying man should not be granted a fast-track trial. The lawsuit filed on behalf of the 66-year-old California resident stated he was diagnosed with non-Hodgkin's lymphoma (NHL) due to exposure to glyphosate-containing weed killer Roundup.
The second bellwether trial case selected is the lawsuit filed by a plaintiff, which is scheduled to go for trial on February 25, 2019. A California couple allegedly affected by Roundup's adverse effects was granted an expedited trial by Superior Court Judge Ioana Petrou in Oakland last month; the case will head to trial on March 18, 2019, in California.
Several individuals affected by Roundup herbicides have sued the agricultural company in California, Missouri, and Delaware state courts. Multidistrict litigation has been formed in the U.S. District Court, Northern District of California, overlooked by Judge Vince Chhabria.
Monsanto has a brief history of legal troubles and Glyphosate is just another herbicide of the company to attract lawsuits. Plaintiffs across the U.S. have filed numerous lawsuits. IARC, considered to be the apex in the field of cancer research, classified glyphosate as a “probable human carcinogen.” According to IARC, Roundup is made up of other ingredients that are toxic in themselves, and are also known to increase the toxicity of glyphosate. Monsanto has known this for many years but still refuses to study the link between cancer and Roundup.
FDA Issued MRI Safety Guidance For Medical Devices
The FDA issued new federal draft guidance on August 2, 2019, titled “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment,” providing an outline about medical devices such as pacemakers, neurostimulators, insulin pumps, artificial heart valves, and cochlear implants that are meant to undergo Magnetic Resonance (MR) environment. The new guidance would supersede the FDA’s 2014 recommendations.
Many medical devices and implants cannot enter a Magnetic Resonance Imaging (MRI) machine as they are metallic and can cause abnormalities to the images or harm the patient. However, manufacturers have started designing MRI compatible medical devices. Pacemakers implanted in 2018 were 70% MRI-compatible as compared to 12% compatibility in 2016.
The guidance explains how to determine the medical devices and implants that are safe to enter a magnetic resonance imaging (MRI) machine, whose exposure to powerful magnetic fields could dangerously affect the patient's body. The guidance states that the devices should also include safety labeling, indicating the device is “MR Safe,” “MR Unsafe,” or “MR Conditional,” according to its compatibility with the MR environment or have special guidance for use in the MRI machine.
The details on how to undertake testing to evaluate the safety and compatibility of medical devices in the MR environment along with a format of MRI was also mentioned in the guidance.
Warning Letter Against Lantech For Violating FDA Rules
On August 8, 2019, The Food and Drug Administration of U.S. issued a warning letter to Hyderabad-based Lantech Pharmaceuticals Limited after finding that the company failed to investigate complaints related to the blood pressure medicine Valsartan.
In December 2018, Lantech Pharmaceuticals was notified by their customer firm that the solvent recovered by the company contained the potential mutagenic impurities, N-Nitrosodiethylamine (NDEA) which resulted in cancer. A year after, concerns related to cancer-causing impurities found in samples of Valsartan were raised in the US.
The letter stated that the company failed to investigate and resolve complaints raised by its customer firm that used its contract solvent recovery services to make the valsartan active pharmaceutical ingredient (API). This included their failure in investigating the solvent that contained N-Nitrosodimethylamine (NDMA), a cancer-causing impurity found in samples collected from equipment used by the company to recover the solvents. The company acted as a solvent recovery facility for other companies that manufacture API used in Valsartan, a generic version of Diovan.
Valsartan claims are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.