What Happened In The MassTorts World Last Week? 2019-Oct-21
FDA's Slow Assessment Over Valsartan Cancer Review
A new analysis by the U.S. Public Interest Research Group (U.S. PIRG) indicates that the U.S. Food & Drug Administration (FDA) took a long time to evaluate the safety of Valsartan and other generic heart and blood pressure drugs.
FDA began a series of recall in July 2018, after finding that the drug contained elevated levels of N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) or N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), following which other similar drugs like generic losartan and irbesartan pills were also recalled. The use of these drugs has been linked to reports of liver cancer, stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer, and other digestive tract cancers.
According to a report issued on October 10, U.S. PIRG showed that the FDA only assessed a quarter of valsartan and other blood pressure drugs for cancer-causing impurities. The report further indicates that around three-quarters of valsartan and similar drugs are yet to be checked, which the FDA had claimed to be done in about six months in February 2019. The analysis shows that about 26% of all drugs present in the market has been reviewed, out of which 61% had high levels of contaminants.
The FDA has been recommended to provide resources and tools to the companies whose drugs have been tested as free of contaminants to increase production. The agency has also been asked to set a clear timeline for the evaluation and help doctors and pharmacists to suggest an alternative.
Earlier, U.S. District Judge Robert B. Kugler in the District of New Jersey ordered the plaintiffs to submit a Plaintiff Fact Sheet (PFS), giving case-specific information about their valsartan cancer diagnoses and exposure.
According to a case management order published last week, each individual who filed Short Form Complaint in the valsartan litigation should complete a PFS within 90 days. The order includes individuals diagnosed with cancer, plaintiffs seeking medical monitoring through valsartan class action claims, and plaintiffs claiming other economic loss.
It is expected that Judge Kugler will establish a “bellwether” process, as part of the coordinated pretrial proceedings, where the parties will select a representative group of cases based on the information provided on the fact sheet. The group of cases will help the parties gauge how juries may respond to evidence and testimony, which will be repeated throughout the litigation.
Valsartan is used to treat high blood pressure and heart failure. It is also used to improve the chance of living longer after a heart attack. In people with heart failure, it may also lower the chance of having to go to the hospital for heart failure. Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.
Valsartan lawsuits filed across the country claim their use of toxic valsartan pills contributed to their cancer diagnoses. Plaintiffs claim cancers including liver cancer, small intestine cancer, stomach cancer, esophageal cancer, pancreatic cancer, and prostate cancers among others.
Nearly 130 product liability lawsuits and class action claims involving valsartan are currently pending in the federal court system. The complaints raise similar allegations that the pills were contaminated with N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and other chemicals, which are known to increase the risk of cancers. The long term exposure to these chemicals causes liver cancer, stomach cancer, small intestine cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other cancers.
J&J Comes Out Clean Twice In Talcum Powder Trial
On Wednesday, a California state court jury cleared Johnson & Johnson (J&J) in a lawsuit filed by a woman alleging the company’s talc-based products contained asbestos, which caused her cancer.
The jury rejected the allegations from the plaintiff by a vote of 10-2. This is the seventh jury that has passed the judgment in favor of J&J. The trial started in early September, where the plaintiff's attorneys had asked for $1.3 million in economic damages and unspecified punitive damages. The previous trial in the same case ended in a mistrial where the attorneys had asked for $28 million in damages.
Meanwhile, in Missouri, an appeals court reversed a 2017 judgment of $110 million verdict involving a Virginia woman who claimed she developed ovarian cancer after decades of using J&J's talc-based products.
Nearly 14,000 Talcum Powder and Shower-to-Shower lawsuits are consolidated under multidistrict litigation MDL No. 2738; In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation. Lawsuits are also pending in a coordinated California proceeding under Judicial Council Coordinated Proceeding No. 4877.
Earlier, the Sixth Circuit rejected the efforts by the Ohio attorney general and drug companies to impede an upcoming opioid trial accusing drugmakers of fueling the opioid crisis.
The panel, along with rejecting the state’s arguments that the counties involved usurped its parent of the nation authority, also rejected the drugmakers' bid to disqualify the judge overseeing the trial.
Attorney General Dave Yost argued through an August 30 petition that the lawsuits filed by the counties threatened the state’s authority to protect the public welfare. The panel ruled, stating that the state hadn’t met, the high bar required for obtaining a writ of mandamus, also Yost did not show how the state would have been harmed by the lawsuits brought by Summit County and Cuyahoga County.
Ohio’s governor, Mike DeWine, had opposed the attorney general’s bid stating that he would refuse any legislation that gives the attorney general control over the counties’ suit as the local governments have shown a significant impact of the opioid epidemic.
The FDA Approves J&J, Bayer's Xarelto
On Monday, Oct.14, Johnson & Johnson's (J&J) subsidiary Janssen Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) approved Xarelto (rivaroxaban) for the prevention of blood clots in acutely ill patients without a high risk of bleeding during and after hospitalization.
Xarelto is an anticoagulant manufactured by Bayer and jointly marketed by Janssen Pharmaceuticals. Including the latest approval, Xarelto now has eight indications, six of which are specifically for the treatment, prevention, and reduction in the risk of recurrence of blood clotting.
Xarelto has been allegedly linked to causing uncontrollable bleeding, which leads to unexpected serious injuries and even death. Xarelto lawsuits are consolidated under the federal multidistrict litigation (MDL No.2592; In Re: Xarelto (Rivaroxaban) Products Liability Litigation) in the Eastern District of Louisiana.
Long Beach Jury Clears J&J In Asbestos Talc Trial
On Friday, Oct.11, a California jury freed Johnson & Johnson (J&J) of allegations a plaintiff who claimed that the company's talcum powder contained asbestos, which caused his pleural mesothelioma, a cancer of the lining of the lungs often associated with asbestos exposure.
According to the court documents, the 64-year-old man used J&J baby powder for more than three decades as well as Clubman brand talc powder after haircuts, and he also worked with an auto shop during one summer, where he was exposed to asbestos, which he believed were the reasons for his terminal cancer.
The Long Beach jury, following a nearly three-week trial, rejected the plaintiff's claim that his cancer was caused due to the use of J&J baby powder. J&J was the only defendant when the case went to trial, and it is the second trial in the same week that favored the defendants. Another plaintiff's similar allegation against J&J was also rejected by a California state court jury.
Talcum powder lawsuits are presided by Hon. Freda L. Wolfson, U.S.D.J., and Hon. Lois H. Goodman, U.S.M.J., consolidated under MDL No. 2738.
FDA Issues Warning Letter To Torrent Pharmaceuticals
On October 8, the FDA issued a warning letter to Torrent Pharmaceuticals over its manufacturing plant in India involving the active pharmaceutical ingredient (API) in losartan.
The letter is a result of an inspection earlier this year, according to which there were around 340 batches of finished products tested as out of specification (OOS) over two years, and the manufacturer retested 73% of them, reversing the initial findings without any explanations. The retested products were then shipped to the U.S. and abroad.
The warning letter issued to Torrent’s Taluka-Kadi, Indrad, Gujarat facility outlines the following manufacturing violations:
Failure to follow written procedures for production and process control and failure to adequately investigate batch discrepancies.
Failure to correct these violations may result in further action by the agency.
Several lots of generic valsartan and losartan hypertension medications, manufactured by Torrent Pharmaceuticals, have been recalled since August 2018, after finding that the drugs contained elevated levels of N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) or N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Exposure to these recalled drugs is linked to reports of liver cancer, stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer, and other digestive tract cancers.
J&J To Pay $117M To Settle 41 States Mesh Lawsuit
On Thursday, New York Attorney General Letitia James and 41 other state AGs resolved the transvaginal mesh lawsuit involving J&J (Johnson & Johnson) and their subsidiary Ethicon, Inc. for $117 million.
The defendants were facing allegations for hiding the risks associated with its pelvic mesh products, which support women's weakening pelvic organs. The court papers further stated that the companies should now impart the irreversible risks including, chronic pain, inflammation, incontinence, painful sex, and scarring. The defendants are also barred from telling about its FDA approval, which was initially done in 2002, and now has been told to stop selling “due to safety concerns.”
Around four million women have vaginal mesh implants, and more than 150,000 developed complications associated with it. There are in all 7 MDLs to handle Transvaginal Mesh Litigations, which are being overseen by U.S. District Judge Joseph R. Goodwin.
Following FDA Alert, J&J Issues First Time Recall of Baby Powder
On October 18, Johnson & Johnson, the U.S. healthcare conglomerate facing thousands of lawsuits over its talc-containing products, announced a voluntary recall of a single batch of its baby powder after receiving an alert from the US Food and Drug Administration (FDA) that it tested positive for asbestos, a known cancer-causing substance.
As per the statement released by the healthcare company, the FDA found sub-trace levels of chrysotile asbestos contamination at concentrations not exceeding 0.00002% in a single bottle purchased from an online retailer. The recall applies to lot #22318RB resulting in recall of 33,000 bottles of talcum powder. J&J said it has started an investigation and is reviewing manufacturing records and collecting data on the distribution of the lot to determine where the product was shipped.
Time and again J&J has defended its talcum-powder calling it safe, stating that decades of studies have shown the products to be asbestos-free and that they do not cause cancer. However, the FDA said it stands by the quality of its testing and results and recommended that consumers stop using the product if it comes from the affected lot.
Nearly 14,000 Talcum Powder and Shower-to-Shower lawsuits are consolidated under multidistrict litigation MDL No. 2738; In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation. Lawsuits are also pending in a coordinated California proceeding under Judicial Council Coordinated Proceeding No. 4877.