The U.S FDA scheduled a joint meeting on August 3 of its Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees to discuss the outcome of the recent evaluations of risk evaluation and mitigation strategies (REMS) concerning the use of fentanyl patches.
Fentanyl patch, manufactured by a subsidiary of Johnson & Johnson, was introduced as a Duragesic pain patch to relieve persistent chronic pain for those who need constant pain treatment and are under other opioid medications. However, if the fentanyl gel comes in direct contact with the skin, it can cause severe complications. In September 2013, the FDA issued a public warning stating that the disposal procedure must be done with care as the patch can be dangerous even after it is discarded.
The State's Highest Court decided that New Jersey judges must follow "Daubert" standards instead of federal standards for expert witness testimony. This decision will apply while determining the authenticity of the opinions for juries to consider. The ruling issued on August 1, was the result of an ongoing Accutane litigation over claims that the acne drug leads to increased chances of Crohn's disease and inflammatory bowel disease.
The ruling backs the dismissal of the plaintiffs' expert witnesses, which closed the litigation many years ago. The dismissal verdict was reversed in July 2017, when a New Jersey appeals court discovered that the judge exceeded his authority by barring the witness testimony. However, the state supreme court ruling contradicts the appeals court's decision. The Daubert hearing ruling will affect a number of other lawsuits filed in New Jersey like Talcum, IVC Filter, and others.
In her opinion statement, Justice Jaynee LaVecchia told, “we perceive the little distinction between Daubert’s principles regarding expert testimony and our own, and believe that its factors for assessing the reliability of expert testimony will aid our trial courts in their role as the gatekeeper of scientific expert testimony in civil cases. In this matter, the trial court did not abuse its discretion in its evidential ruling and, therefore, the Appellate Division erred in reversing the trial court’s exclusion of the testimony of plaintiffs’ experts.”
Plaintiffs involved in the Linear Gadolinium-Based Contrast Agents (GBCA) lawsuits filed a petition on July 31 in the U.S. Judicial Panel requesting for a multidistrict litigation creation, stating that the number of cases against the Linear GBCAs used in MRA and MRI procedures will likely be in hundreds or more in the ensuing months.
MultiHance and OptiMark exposure have been reported to cause brain damages and complications to other organs due to gadolinium retention inside the human body. The U.S. FDA has already issued a black box warning about Nephrogenic Systemic Fibrosis (NSF) for 8 MRI gadolinium agents, applicable to people with a pre-existing kidney disorder. According to a December 2017 FDA new class warning, gadolinium deposits could remain in a patient's body and brain for a prolonged time even after a scan. A recent Gadolinium Deposition Disease (GDD) lawsuit filed by plaintiff Jeffrey Steiner states that the defendants have failed to warn doctors and patients about gadolinium retention resulting in fibrosis and the risks of linear gadolinium-based contrast agents to individuals with normal or near-normal kidney function.
Gadolinium multidistrict litigation related to NSF (MDL 1909; In Re: Gadolinium Contrast Dyes Products Liability Litigation) was created in 2008, presided by Judge Dan Aaron Polster in the Northern District of Ohio.