What Happened In The MassTorts World Last Week? 2019-Feb-25

As a result of the oral arguments heard last month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order last week affirming that all valsartan recall lawsuits in nationwide District Courts will be consolidated before U.S. District Judge Robert B. Kugler in the District of New Jersey for coordinated pretrial proceedings. The multidistrict litigation will include class action claims as well as individual injury claims filed by individuals who alleged they developed cancer due to the exposure to the contaminated blood pressure medicine.

Dozens of claims are filed against Zhejiang Huahai Pharmaceutical Company of China, following recent valsartan recalls for generic tablets, which were reported to have carcinogenic impurities like N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) linked to liver cancer, stomach cancer, kidney cancer, and other digestive tract cancers. Each lawsuit raised allegations that despite being aware of the defective and dangerous nature of the blood pressure drug, the defendants took no preventive measures to warn the consumers. A motion was filed last October with the U.S. JPML, requesting for the establishment of a federal valsartan recall MDL. Centralization of the cases before one judge will help reduce duplicative discovery, contradictory pretrial rulings, and will be convenient for the common witnesses, parties and the judicial system. Product liability lawsuits are part of multidistrict litigation (MDL No.2875; In Re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation).

U.S. District Judge Dennis Saylor issued a memorandum and order on February 5, denying summary judgment motion filed by GlaxoSmithKline to toss all Zofran birth defect lawsuits and allowed a group of cases to prepare for early bellwether trials.

GSK argued that the plaintiffs' failure-to-warn claims were preempted by federal law; however, Judge Saylor disagreed with the argument and indicated there was no clear evidence that GSK was prevented from updating Zofran's label warnings for birth defects. On the same day, Judge Saylor also issued a scheduling order for case-specific discovery, Daubert motions, and dispositive motions, affirming that the litigation is moving forward for a series of bellwether trials. The pretrial schedule stated that depositions including all case-specific experts must be concluded by May 24, 2019, and motions to exclude or restrict case-specific expert testimony or opinions, and case-specific dispositive motions must be filed by June 21.

Zofran is labeled as Pregnancy Risk Category B, meaning there is no evidence of risk to humans. Many mothers took this assurance to mean the drug was safe, but multiple studies show evidence to the contrary. Because Glaxo never proved the drug was safe, the FDA never approved market the drug to pregnant women. Regardless, Glaxo continued to advertise its anti-emetic for morning sickness.

Before getting a prescription for the Zofran drug, the patient must inform the doctor about being diagnosed with phenylketonuria (PKU) or not. Zofran is a disintegrating tablet that may contain phenylalanine. Patients should be aware of the side effects of Zofran which include blurred vision, trouble in breathing, anxiety, slow heart rate, and having urination problems.

If the patient comes across any of this problem, you should stop the use of Zofran immediately. The intake of Zofran should be avoided if the patient is using apomorphine (Apokyn) or allergic to ondansetron. To ensure the safety of the usage of Zofran drug, before getting prescribed, informed the doctor if you have been diagnosed with liver disease or not.

Also, if patients have a blockage in their digestive tract or suffer from a slow heartbeat, they should inform the medical prescriber about these health concerns, which will let them decide whether to go ahead with this drug or not.

More than 468 lawsuits have been filed against GSK alleging that the company knew about Zofran's pregnancy risks for several years, yet failed to adequately warn the medical fraternity. Zofran lawsuits were centralized in October 2015, before Judge Dennis F. Saylor as a part of multidistrict litigation (MDL No. 2657; In Re: Zofran (Ondansetron) Products Liability Litigation) in the District of Massachusetts.

In an order issued on February 15, the Court directed all plaintiff's counsel in the Abilify gambling litigation to appear for a case management conference as a global settlement has been reached to resolve most of the lawsuits pending in the federal court system.  

The terms of the settlement deal have not been disclosed yet; it will be reviewed by lawyers representing the individuals. The drug makers, Bristol-Myers Squibb and Otsuka Pharmaceuticals, filed a motion the same day, asserting that the Court must ask any plaintiffs' counsel rejecting the settlement agreement to furnish additional information to certify that the claims were appropriately reviewed.

In a motion filed on January 16, 2019, Bristol-Myers Squibb Co and Otsuka Pharmaceutical Company requested the judge overseeing the multidistrict litigation for the antipsychotic drug Abilify to toss gambling lawsuits filed by 550 plaintiffs unless they furnish more information linked to their Abilify use and past medical records.

The companies asserted that the plaintiffs violated a court order that required them to submit additional information latest by November 2018.

Aripiprazole is used predominantly for the treatment of schizophrenia and bipolar disorder but can also be used as an add-on treatment for major depressive disorder, obsessive-compulsive disorder (OCD), tic disorders, and irritability associated with autism.

Abilify is known to decrease hallucinations and improve concentration. When there is a hormonal imbalance, Abilify either increases or decreases the levels of dopamine or serotonin in the brain. The drug arbitrates its action by either blocking receptors or by binding to them and inducing an opposite response to the receptor's normal role.

A large number of patients treated with Abilify were reported to develop the habit of compulsive gambling and got racked up with large amounts of debts. Other pathological behaviors like excessive eating, excessive shopping, and Hypersexuality are also noted who started using or increased dosage of Abilify.

Young patients with depression and elderly patients with dementia consuming Abilify are found to be at a high risk of suicidal thoughts or actions. It also increases the risk of developing diabetes.

More than 2,000 Abilify product liability claims are pending against the drug makers over allegations that the drug makers failed to provide adequate warning about the serious side-effects of the antipsychotic drug, which include uncontrollable urges to gamble and engage in impulsive behavior. The multidistrict litigation MDL No. 2734 (In Re: Abilify Compulsive Behavior Products Liability Litigation) was formed in October 2016 in the Northern District of Florida overlooked by Judge M. Casey Rodgers for coordinated discovery and pre-trial proceeding.

Johnson & Johnson told on Wednesday it received subpoenas from the U.S. Justice Department and the Securities and Exchange Commission (SEC) seeking documents related to the company's popular baby powder and other talc-based products.

The disclosure was made during an annual federal report filed with the SEC. The company intends to comply with the subpoenas and respond to a request from Senator Patty Murray (D-Wash.) to produce documents related to the safety of its baby powder. A J&J spokesperson told the inquiries were the result of reports released in December linked to a large number of product liability lawsuits filed against the company over complaints of ovarian cancer and mesothelioma due to asbestos exposure from talc.

There are at least 13,000 lawsuits filed against the talcum giant who has been accused of concealing asbestos presence in its product and the cancer risks from consumers. Recently, J&J's talc supplier, Imerys Talc America Inc., was dropped from an upcoming talcum powder trial, after a Chapter 11 bankruptcy was filed on February 13 in Delaware.

Earlier, an appeals court in South Carolina upheld a $14 million asbestos verdict in a wrongful death lawsuit filed by the family of a victim who died of mesothelioma because of asbestos exposure while working at a polyester plant.

The victim worked as a contractor in a Celanese plant where he did maintenance and repair work for nine years since the 1970s. His work involved frequent contact with asbestos gaskets, packing, and insulation materials. According to court documents, he was diagnosed with mesothelioma in 2013 and died from advanced mesothelioma a year later. The victim and his wife sued Hoechst Celanese Corp., now known as CNA Holdings, for negligent conduct, failure to warn about the hazards of asbestos exposure, and failure to take adequate safety steps against asbestos exposure in the plant. In 2015, a South Carolina jury awarded the victim $12 million in compensatory damages and $2 million in punitive damages. CNA Holdings sought to dismiss the lawsuit and requested for summary judgment, asserting that the victim was a statutory employee, hence his case falls under South Carolina Workers' Compensation Act. 

The circuit court denied the motion for summary judgment at the conclusion of the trial, as a jury found that the plant’s negligence was the reason for the man's cancer. CNA Holdings filed several motions for a new trial; however, the circuit court declined the company's argument that the jury's decision had outside influences. 

Asbestos fibers from talcum powder have been the reason for ovarian cancer and mesothelioma in several individuals who used talc-based products.