Bayer Paid Millions To Doctors For Essure Recommendations
Fri, 12/17/2021 - 08:05

As concerns over Bayer's birth control implant Essure build up, a new investigative report by CNN reveals Bayer influenced doctors by paying about $2.5 million, to recommend the product to patients. The report indicates that the patients stated the doctors aggressively suggested the device for permanent birth control method. From August 2013 through December 2017, Bayer paid 11,850 doctors to mislead patients, at least three doctors were paid in excess of $100,000.

The revelation report surfaced a day after a documentary was aired on Netflix named "The Bleeding Edge", highlighting the potential risks of unsafe medical technology and how it has been recommended in the United States. The focus was on Essure in the documentary, which described the severe complications suffered by women who used the birth control device. Reacting strongly to the documentary release, Bayer issued an "Open Letter" to all patients and doctors, indicating they support the safety of Essure and claimed that the reported problems are misleading and leading to inappropriate publicity.

The U.S. FDA revived the premarket approval (PMA) process for Essure in April 2018. Bayer announced to remove Essure from the U.S market by December 31, 2018, over marketing reasons. There are about 12,000 adverse event reports ranging from hair loss to organ perforation against the manufacturer over failure to warn patients about the potential health risks of the device.

First Androderm Bellwether Trial Date Vacated

First Androderm Bellwether Trial Date Vacated
Fri, 12/17/2021 - 08:04

A master settlement agreement has been finalized by the parties involved in the Androderm litigation against Actavis. According to the Docket Entry posted on July 26, the Court has announced that the first Androderm bellwether trial date scheduled for August 6 against Actavis has been vacated.

The claims in the litigation involve failure to warn charges regarding testosterone replacement therapy (TRT) side effects against Actavis and its subsidiaries. Other defendants in the TRT litigation are the makers of AndroGel, Axiron, Testim, and other TRT drugs, which have been reported to cause heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), blood clots, and other life-threatening health problems.

There are about 500 Androderm lawsuits pending before U.S. District Judge Matthew Kennelly, and he has agreed to put a stay on all cases involving Actavis and its subsidiaries. A series of bellwether trials has been lined up against TRT manufacturers as part of a multidistrict litigation (MDL No. 2545; In Re: Testosterone Replacement Therapy Products Liability Litigation) in the Northern District of Illinois for coordinated pretrial proceedings. Last year, Eli Lilly announced settlement for all cases involving their testosterone gel Axiron followed by Auxilium Pharmaceuticals, who also agreed on Testim settlement for about 1,300 lawsuits against them. These settlements would resolve about one-third of the TRT lawsuits from the MDL. Yet, AndroGel maker AbbVie has not yet declared any chances of TRT settlement and continues to defend large jury verdicts against them. About 19 AndroGel trials are scheduled for later this year.

MDL Request Filed For Linear GBCA Cases

MDL Request Filed For Linear GBCA Cases
Fri, 12/17/2021 - 08:03

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 a plaintiff 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.

New Jersey Judges Must Follow 'Daubert' Standards

New Jersey Judges Must Follow 'Daubert' Standards
Fri, 12/17/2021 - 08:01

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.”

FDA Public Hearing Set For Fentanyl Patch Safety

FDA Public Hearing Set For Fentanyl Patch Safety
Fri, 12/17/2021 - 07:59

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.

Earlier, an Ohio jury recently postponed the first bellwether trial date for the Opioid litigation to six months from the earlier date. U.S. District Judge Dan Aaron Polster announced all three cases filed by the local governments against opioid manufacturers, distributors, and pharmacies providing opioid drugs, would go for trial on September 3, 2019.

The move would delay the resolution of the opioid epidemic, the major concern among people across the U.S. battling to prove that prescription drugs are unsafe for prolonged use and can cause severe complications. Opioid overdose has been reported to cause abnormal breathing, unconsciousness, vomiting, and even death. Pregnant women taking opioid as a painkiller blame the drug for the alleged birth defects in their babies. As per 2016 statistics on drug overdose deaths in the U.S., 66% of events correspond to opioids addiction.
More than 400 opioid-related lawsuits are centralized as a part of multidistrict litigation, MDL No. 2804 (In Re: National Prescription Opiate Litigation) in the Northern District of Ohio before U.S. District Judge Dan A. Polster.

J&J's Plea For Out-Of-State Mesh Cases Rejected

J&J's Plea For Out-Of-State Mesh Cases Rejected
Fri, 12/17/2021 - 07:57

A Pennsylvania appeals court dismissed Johnson & Johnson's petition to conduct an en banc hearing for a $13 million verdict  awarded to an Indiana woman over pelvic mesh injury claims, in the state of Philadelphia County

J&J and its subsidiary Ethicon Inc. appealed to reconsider the decision made by a three-judge panel in June for a chunk of cases related to the company's pelvic mesh complications.

Ethicon Pelvic Mesh lawsuits are consolidated as a part of a multidistrict litigation (MDL No. 2327; In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation) overlooked by U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia.

In December 2015, a Bergen County Jury of New Jersey unanimously awarded nearly $15 million to a woman who alleged she suffered from debilitating pain caused by one of the two pelvic mesh devices that she received in 2008 sold under J&J’s Ethicon brand name Prolift. The verdict supported the claim that the manufacturer failed to adequately warn about the potential side effects.

Seven pelvic mesh manufacturers are facing thousands of lawsuits under individual MDLs consolidated by U.S. District Judge Joseph R. Goodwin, in early 2012, in the U.S. District Court for the Southern District of West Virginia. The total number of cases under the umbrella was over 102,133 cases as of March 2017. Formation of MDL No. 2327 in Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation was a part of the consolidation. Ethicon has consistently had the largest number of product liability cases filed in the federal court with about 38,035 cases filed and 5,547 cases closed. These cases all relate to the use of transvaginal surgical mesh to treat pelvic organ prolapse ("POP") and/or stress urinary incontinence ("SUI").

Ethicon released a statement minutes after the verdict saying that it would appeal.