What Happened In The MassTorts World Last Week? 2020-Aug-10
Missouri Court Refuses To Reconsider $2.1B J&J Talc Ruling
Last Tuesday, a Missouri appellate court denied Johnson & Johnson's (J&J) motion to relook at its decision that upheld a jury's verdict over the company's talcum powder products but slashed the damages award to $2.11 billion from the landmark $4.7 billion.
On July 8, J&J and subsidiary J&J Consumer Inc. filed a motion for rehearing and applied for a transfer to the Missouri Supreme Court, both of which were denied by the Eastern District Court of Appeals as per a docket entry dated 28th of July.
J&J was attempting to reverse a ruling passed by a three-judge panel in June that affirmed the jury's findings that asbestos present in the baby powder and other talc products was the cause of increasing the risk of cancer in a group of 22 women. The damages award was reduced after the panel agreed with the defendant that out-of-state plaintiffs only have claims against its subsidiary, J&J Consumer Inc.
In May, J&J decided to stop selling its talcum-based products in the U.S. and Canada due to declined consumer demand and misinformation about the safety of the products. Last month, organizations from more than 51 countries sent a letter to Alex Gorsky, the Chairman and Chief Executive Officer (CEO) of J&J, asking to remove all talc-based baby powder products from the global market.
Talc, one of the main ingredients in baby powder, is considered cosmetic when used in makeup and body powders, which required very little federal oversight. The law does not require cosmetic companies to share their safety information with the Food and Drug Administration (FDA). Without sound scientific data to show that it is harmful under its intended use, the FDA cannot take any action.
Despite several studies highlighting the cancer risk, the FDA does not require Baby Powder warnings on talc-based product labels to be updated. Moreover, J&J has also refused to add one, willingly.
Nearly 19,000 talcum powder and Shower-to-Shower lawsuits are filed against J&J in courts nationwide, each raising similar claims about the presence of asbestos and the risk of cancer.
Zantac Manufacturers Face DOJ Probe Over Cancer Lawsuits
Sanofi-Aventis US LLC and GlaxoSmithKline LLC in a pair of U.S. Securities and Exchange Commission (SEC) filings said that they are facing a probe by the U.S. Department of Justice (DOJ) over allegations that the heartburn drug, Zantac, causes cancer.
Zantac (ranitidine hydrochloride) is an antacid and an H2 (histamine-2) receptor blocker used for treating and preventing ulcers in the duodenum, stomach, and intestines. It is also used for treating erosive esophagitis, heartburn, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome. In 1983, Glaxo Holdings Ltd, a company which is a part of GlaxoSmithKline PLC, received approval from the U.S. Food and Drug Administration (FDA) to sell Zantac in the U.S. However, owing to patent expiry in 1987 in the United States, Glaxo had to face stiff competition by the generic alternatives launched immediately by competitors. Since 2017, the OTC version of Zantac was marketed by Sanofi in the United States and Canada. In 2004, Pfizer gained FDA approval to sell the Zantac OTC in the United States.
According to a Q3 report published by GlaxoSmithKline (GSK) for the SEC, the manufacturers received a Civil Investigative Demand (CID) from the DOJ on the 18th of June 2020. The DOJ is investigating the information related to Zantac pursuant to the False Claims Act. The report also indicates that the New Mexico Attorney General filed a lawsuit against multiple defendants, including GSK, over the presence of ranitidine in Zantac and other products. Sanofi, in its filing, said that it was notified about the probe on June 6.
The DOJ will be investigating whether the drug makers knew about the presence of the known carcinogenic chemical byproduct N-nitrosodimethylamine (NDMA) in Zantac and yet failed to adequately inform regulators about the potential risks. It will also look into when the manufacturers discovered that the main ingredient in the recalled heartburn drug causes cancer.
The public was not aware of the high levels of NDMA produced by Zantac until the testing was done by an independent online pharmacy, Valisure, in September 2019. The pharmacy claimed that each pill might result in a level of exposure higher than the limit set by the FDA regarding the intake of NDMA and filed a citizen’s petition with the FDA, calling for a recall.
In April, the FDA requested manufacturers to discontinue all versions of Zantac from the market due to the presence of high levels of NDMA.
Currently, more than 230 Zantac lawsuits are pending in the Southern District of Florida. The lawsuits are consolidated and centralized before U.S. District Judge Robin L in Florida under MDL No: 2924, for coordinated discovery and pretrial proceedings.
Cases Identified For Trials In Ethicon Physiomesh MDL
U.S. District Judge Richard Story, presiding over all federal Ethicon Physiomesh lawsuits, identified four cases that will be prepared for early bellwether trials set to begin later this year.
According to a Practice and Procedure Order dated July 28, Judge Story identified four cases selected by the parties for trial work-up. The cases have gone through case-specific and expert discovery that will be completed in the following weeks.
The first trial is expected to begin on November 2, 2020, which will involve the lawsuit selected by the plaintiffs. The second trial will involve one of the remaining three claims that will be selected by the defendants by October 12 and is scheduled to start on February 22, 2021. The third trial is expected to involve the consolidation of the remaining two claims and is set to begin on May 10, 2021.
The outcome of these cases will not bind to other plaintiffs involved in the litigation. It is designed to help parties understand how juries respond to certain evidence in the cases, which will eventually influence any hernia mesh settlement that the manufacturer will offer to avoid the need for thousands of future claims to go before juries nationwide.
Ethicon Physiomesh is a flexible, composite, macroporous, and partially absorbable mesh made of non-absorbable polypropylene by Johnson & Johnson. FDA approved the use of Ethicon Physiomesh in March 2010 for the repair of hernias and other fascial deficiencies that require the addition of strengthening or bridging material to obtain the desired surgical result. A hernia is a condition that occurs when an organ, intestine, and/or tissue squeezes through a hole or weak point in the surrounding muscle or connective tissue. The number of hernia repair operations performed every year in the USA is remarkable.
Despite the already existing mesh implants in the market, the sale of Ethicon Physiomesh increased after the FDA approval as it was promoted as a physiologically well-designed device, offering strong and comfortable healing and giving an exceptional intraoperative handling benefit. But within a few years, Ethicon globally recalled the Physiomesh after thoroughly considering the data which was revealed out of Hernia registries.
Currently, about 2,800 Ethicon Physiomesh lawsuits are pending in the federal court system. Each lawsuit claims that the manufacturer sold an unreasonably dangerous and defective product that resulted in painful and debilitating complications, leading to revision surgery for removal of the product. The lawsuits are consolidated under MDL No.: 2782 in the Northern District of Georgia.
Bayer Reserves $1.47B To Settle Essure Lawsuits
On Monday, Bayer officials in a press release about second-quarter earnings indicated that the company has set aside 1.25 billion euros ($1.47 billion) to settle lawsuits brought by thousands of women claiming they suffered devastating injuries from the birth control device, Essure.
Conceptus Inc., a subsidiary of Bayer AG, developed Essure which is a Class III device for permanent surgical sterilization in women. Essure was approved by the Food and Drug Administration (FDA) on November 4, 2002. The device has two metal coils made from polyester fibers, nickel-titanium, stainless steel, and solder which are placed in fallopian tubes to induce fibrosis and block the fallopian tubes to prevent fertilization. Since 2002, it is estimated by Bayer that 750,000 women have received the Essure IUD.
The report follows a recent $10 billion settlement proposal made by the company over its controversial weedkiller Roundup. The German pharmaceutical company noted that both the litigations incur $11.2 billion loss in the second quarter of the year.
Bayer in the report also stated that it established appropriate provisions in the second quarter as the Essure litigation made good progress in recent weeks.
Last month, the legal public watchdog group, Public Justice, published an article revealing hundreds of recently unsealed documents over the complications associated with Essure. The documents indicate that the manufacturer was aware of the problems since it acquired Conceptus, the original creator of the Essure design, in 2013, and may have hidden the reports.
Bayer is currently facing 18,000 lawsuits nationwide, each claiming that the birth control device is defectively designed, and the women experienced painful and debilitating complications, including migration injuries, perforations, severe reactions, and other problems.
NJ Appeals Court Reinstates Two Talcum Powder Lawsuits
On Wednesday, a three-judge panel of the New Jersey Superior Court reinstated two lawsuits alleging Johnson & Johnson’s (J&J) talcum powder of causing cancer; the lawsuits were dismissed by a trial judge in 2016.
The lawsuits were brought by two plaintiffs, who claimed that they developed ovarian cancer from J&J's Baby Powder. The decision over the dismissal of the lawsuits is reversed nearly four years after Superior Court Judge Nelson Johnson favored the defendants claiming expert testimony offered by the plaintiffs was insufficient.
In an 86 page opinion, the panel of appellate judges indicated that plaintiffs’ expert witness testimony was not accurately weighed by Judge Johnson, and the ruling was a misuse of the judge’s responsibility, which prevented the cases from proceeding.
The cases will go back to the New Jersey state trial court, where several other cases are awaiting over the past few years, depending on the outcome of this appeal.
Ted Meadows, one of the lawyers representing women in talcum powder cases, stated that approximately 1,000 ovarian cancer cases are pending in the New Jersey state court, and many more are expected to be filed as the ruling paves the way to proceed to trial.
This is the second hit on J&J after a Missouri appellate court denied its motion to reconsider a $2.1B talcum verdict last month.
Talc, one of the main ingredients in baby powder, is considered cosmetic when used in makeup and body powders, which required very little federal oversight. The law does not require cosmetic companies to share their safety information with the Food and Drug Administration (FDA). Without sound scientific data to show that it is harmful under its intended use, the FDA cannot take any action.
Despite several studies highlighting the cancer risk, the FDA does not require Baby Powder warnings on talc-based product labels to be updated. Moreover, J&J has also refused to add one, willingly.
More than 20,000 Baby Powder and Shower-to-Shower lawsuits are filed against J&J in courts nationwide, each raising similar claims about the presence of asbestos and the risk of cancer. Most of the lawsuits are consolidated under multidistrict litigation, MDL No. 2738, whereas some are pending in state courts in Pennsylvania. Lawsuits are also pending in a California coordinated proceeding as a part of Judicial Council Coordinated Proceeding No. 4877.
WVa Opioid Lawsuit To Go For Trial in April 2022
West Virginia's lawsuit against several drugmakers alleging the manufacturers of misguiding information about the painkiller drugs opioid will go to trial next April, as indicated by the state's attorney general.
The lawsuit alleges that Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. and Endo Health Solutions Inc., along with Teva Pharmaceuticals Inc., caused a public nuisance by violating the state Consumer Credit and Protection Act.
Attorney General Patrick Morrisey claims that the companies deceived the prescribers by engaging in strategic campaigns to promote the products. The manufacturers' strategies eventually resulted in substance abuse in West Virginia, as opioids became the common cure for chronic pain.
The attorney general accused Teva of disguised marketing of opioids as the company guided the doctors to prescribe opioids without disclosing the risks of addiction. The manufacturer even got support from third-party advocates and professional associations for the same.
Johnson & Johnson (J&J) is also accused of refraining the side effects of opioids from the patients by distributing education guides that included misleading information that opioids are not addictive. Another opioid manufacturer, Endo, is also accused of reintroducing a 1960's drug with a change in color and name.
In 2019, McKesson Corp. and Cardinal Health Inc. made a settlement of $37 million and $20 million, respectively, with West Virginia in similar lawsuits. Earlier in 2017, AmerisourceBergen Drug Co. also settled $16 million for fueling the opioid epidemic in the state.
The rate of drug overdose deaths is higher in West Virginia as compared to other states in the nation.