What Happened In The MassTorts World Last Week? 2019-Mar-25
Elderly Couple’s Roundup Trial Begins Today in California
As the first Roundup bellwether trial is still in progress before the federal jury, a separate state court trial will begin today involving claims brought by a California couple that they both developed non-Hodgkin's lymphoma due to years of exposure to popular weed killer Roundup.
According to a trial brief submitted last week, the plaintiffs regularly sprayed Roundup since 1982 at their home and rental properties they managed. On average, the plaintiffs sprayed the herbicide for roughly 1,500 days in total, believing it to be a safe product as promoted by Monsanto. The lawsuit filed by the couple seeks damages from Monsanto for misleading the consumers and failing to warn about the potential hazards of glyphosate exposure from Roundup. The case was granted an expedited trial since the elderly couple is battling cancer. The jury selection for their case will begin today in the California Superior Court in Alameda County.
All Roundup cases are consolidated as part of an MDL, before U.S. District Judge Vince Chhabria in the Northern District of California. Monsanto has been named as a defendant in more than 10,000 lawsuits in several state and federal courts in the U.S.
FDA Okays New Generic Version of Valsartan To Curb Shortage
On March 12, the Food and Drug Administration (FDA) approved a new generic version of valsartan (Diovan) to ease the recent shortage of blood pressure medicine owing to a series of safety recalls.
Scott Gottlieb, FDA Commissioner, told the valsartan recalls were the result of the findings that the drug was contaminated with nitrosamine impurities, and the agency reviewed the applications for new generic versions on priority to overcome the sudden shortage. The drug's brand version Diovan has not been recalled. The FDA evaluated Alkem Laboratories Ltd.'s manufacturing and testing reports to ensure the new generic valsartan was free from impurities found in the recalled medications. Gottlieb said, "we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products." There have been more than 15 safety-recalls of generic versions of popular blood pressure and heart failure medications such as valsartan, losartan, and irbesartan due to traces of carcinogenic impurities in them.
The FDA is still investigating the drugs belonging to the angiotensin II receptor blocker (ARB) class that contains nitrosamine impurities and fails to meet the agency's quality standards. Patients on ARB can periodically visit the FDA's website to check the lists of recalled medications, which are updated frequently.
Cook Medical Files Motion To Reverse $3M IVC Filter Verdict
On March 12, Cook Medical filed a motion for judgment as a matter of law (JMOL) in an IVC filter bellwether case, arguing that the verdict of $3 million, given out last month, must be reversed or a new trial must be ordered since the plaintiff failed to provide sufficient evidence for a jury to rule in her favor.
The company claimed that the court was at fault in allowing the evidence, which should have been prohibited, and argued that the court allowed testimony from unqualified experts. The case involved claims brought by a plaintiff who alleged that she developed severe complications after being implanted with the Cook Celect IVC filter to treat a pulmonary embolism. She was awarded $3 million in compensatory damages last month by an Indiana jury.
There are more than 5,400 similar lawsuits filed against Cook Medical as a result of complaints of device breakage and organ perforation issues faced by several individuals. The cases are centralized before Judge Richard L. Young in the Southern District of Indiana as part of a federal multidistrict litigation (MDL) for coordinated pretrial proceedings.
Jury Finds Roundup Was a Major Cause of Cancer in Plaintiff
On Tuesday, March 19, as a major setback to Monsanto, the first phase of the closely watched Roundup trial concluded with the San Francisco federal jury affirming that Monsanto's weed killer was a substantial cause of cancer in a California man.
The unanimous verdict was given by five women and one man in favor of a 70-year old plaintiff after a week of deliberations. The jury rejected Monsanto's argument that there was no possibility to detect the cause of the plaintiff's non-Hodgkin's lymphoma (NHL). The bellwether trial, which began on February 25, was split into two phases; in the first phase, the jury was supposed to decide whether scientific studies support the conclusion that Roundup and its active component, glyphosate, can lead to NHL and whether glyphosate exposure was the reason for the plaintiff's cancer. Damages and other claims would be decided by the jury in the second phase. The plaintiff used Roundup products on his Sonoma County property between the 1980s and 2012. He was diagnosed with NHL in 2015. Though Monsanto strongly denies responsibility for the man's cancer, the second phase of the trial would determine whether the company was liable or not.
U.S. District Judge Vince Chhabria overlooks the Roundup lawsuits, which are consolidated into multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation) in the Northern District of California.
Case Management Order Issued For Valsartan Recall Lawsuits
In a case management order issued on February 25, linked to valsartan recall lawsuits, U.S. District Judge Robert B. Kugler indicated that an initial status conference would be held on March 27, to appoint a liaison counsel after both the parties confer and take the court's approval.
A liaison counsel for each side will be performing administrative functions like receiving orders and notices from the court, maintaining complete files and additional duties decided during the conference. Both the parties are instructed to submit a proposal ahead of the conference based on their preliminary understanding of the case facts and legal issues. The discussion in the conference would also include the appointment of recall lawyers to serve in other leadership roles in the litigation; the status of any state proceedings; the chances of a consolidated Master Amended complaint and short form complaints; direct filing; tolling arguments, and the status of any motions and discovery already undertaken.
Valsartan drug manufacturers and distributors currently face 50 product liability lawsuits with claims that the distributed version of valsartan was contaminated with carcinogenic substances, including N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which happens to be a by-product of the generic drug manufacturing process.
FDA To Evaluate Medical Devices Causing Adverse Reactions
FDA Commissioner, Scott Gottlieb, and Dr. Jeff Shuren, director of the Centers for Devices and Radiological Health, issued a statement on March 15, medical devices might be causing hypersensitivity and inflammatory reactions to certain individuals due to the presence of certain metals and other materials in the products like breast implants, birth control implants, and metal-on-metal hip replacement devices.
According to the federal health officials, the FDA was reviewing a number of materials that might be responsible for the harmful side-effects and announced that the issue must be addressed at an upcoming advisory committee hearing. The warning stated that the symptoms of adverse reactions can include fatigue, muscle pain, rashes or inflammation; however, some symptoms may not appear for several years after the implantation. The agency suggested that these reactions might be the reason for a certain type of illnesses and cancer linked to breast implants, adverse effects to nitinol in Bayer's Essure implant, and complications related to the metal-on-metal design of the hip replacement devices like Zimmer’s Durom Cup. Bayer took off all Essure birth control implants from the market in December 2018, and although it claimed that it was a marketing decision, regulatory agencies had imposed restricted use on those implants due to its safety issues. The FDA indicated there are no metal-on-metal hip implants approved for use in the U.S. The FDA officials told an advisory committee meeting would be held this fall, to discuss metal implants and their associated risks in developing hypersensitivity and inflammatory reactions in patients.
Navy Product Manufacturers Held Liable For Navy Men’s Death
On Tuesday, March 19, the U.S. Supreme Court ruled that Navy product manufacturers were liable for exposure from asbestos-containing materials used in their equipment, though they did not make, distribute or install them.
The 6-3 ruling given by new Associate Justice Brett Kavanaugh involved Navy veterans who were not warned about the hazards of asbestos exposure from insulation added by a third party to pumps, turbines, and blowers in three different ships. As per Tuesday's ruling, the cases filed by the families of two Navy sailors can move forward against the manufacturers, Air and Liquid Systems; CBS; Foster Wheeler; Ingersoll Rand, and General Electric. Both the veterans died of cancer during the course of the litigation. They were suffering from lung cancer and malignant mesothelioma as a result of asbestos exposure.