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What Happened In The MassTorts World Last Week? 2020-Aug-03

Study Finds Vision Problems Progresses Post Elmiron Treatment

A new study by researchers of the Emory School of Medicine on the interstitial cystitis drug, Elmiron, indicates that vision problems can continue to progress even after the usage of the drug is stopped.

Elmiron, also known as pentosan polysulfate sodium or PPS, is sold by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the U.S. and is used to treat interstitial cystitis (IC) or “painful bladder syndrome,” a chronic condition with no known cure.

The study was published in the medical journal JAMA Ophthalmology, which found that the drug leads to maculopathy and also worsens the condition even after ten years of completion of the treatment.

The study included 11 females, aged between 53 to 63 years old, who were diagnosed with Elmiron-induced maculopathy. The researchers looked at these patients to learn what happens after drug cessation for at least six months and up to 10 years. The findings revealed the women did not show any improvement in their conditions after discontinuing Elmiron. However, the vision problems continued to worsen in 9 of the 11 patients.

Last month, the U.S. Food and Drug Administration (FDA) changed the label for Elmiron in the U.S., indicating the risk of eye disease associated with the drug. The new warning label was the result of multiple research studies and peer-reviewed publications, an FDA citizen petition, and a growing number of lawsuits.

The number of lawsuits alleging failure to disclose safety warnings against the manufacturer is growing day by day throughout the U.S., post the addition of new warnings, since many long-term users were unaware of the link.

Earlier, a union representing the teachers of Philadelphia demanded the school to remove asbestos from school as it will harm the health of teachers as well as the students. The president of the union filed a lawsuit against the School District of Philadelphia (PSD) and its superintendent as the growing impact of asbestos in school campuses resulted in the shutting down of six schools comprising 125,000 students and 13,000 employees in the district.

 

BASF & Its Former Counsel Reaches $73M Asbestos Settlement

In a motion, dated 23rd of July, for preliminary approval of the class action settlement, BASF Catalysts LLC and its longtime national counsel agreed to establish a $72.5 million settlement fund to compensate those plaintiffs, who alleged that the company concealed potential asbestos in industrial and commercial talc.

The lawsuits were brought by 20,000 plaintiffs against BASF or its predecessor Engelhard Corp between 1984 and 2011 over its Emtal Talc products, used for manufacturing purposes.

The claims were voluntarily dismissed, settled, or involuntarily dismissed by the trial court before March 2011. The plaintiffs asserted that the dismissals/settlements were done falsely by the company and its former counsel.

The proposed class was revived on appeal by the Third Circuit Court, after which it underwent years of discovery disputes and attempts at mediation.

The proposed class action settlement was the result of more than nine years of contentious litigation and extensive discovery, along with the assistance of mediators. Each plaintiff, who contended about the harm caused by asbestos-containing talc product, will seek between $500 and $175,000 from the fund.

 

Opioid Negotiation Class Creation Questioned

On Tuesday, the Sixth Circuit Judge, David McKeague, questioned the requirement of the opioid negotiation class after hearing arguments from the manufacturers and distributors who claimed that the class created by a federal judge is unconstitutional.

U.S. District Judge Dan Polster, presiding over all federal opioid lawsuits, certified the negotiation class last September with an intent to allow more than 30,000 government entities across the country to get a share of any potential settlement proceeds from national, multidistrict litigation over the opioid crisis.

The attorneys for the negotiation class will try to make a nationwide settlement with individual drug companies. The approval of any settlement will be done by polling and would require approval by 75% of voting governments by number, by population, and by the allocation of settlement funds. These thresholds will be managed separately by governments that had sued as of June 14, 2019, and those that had not.

The arguments were conducted via videoconference, where defendant Attorney Sonya Winter of the San Francisco-based firm Covington and Burling LLP claimed that the invention of the negotiation class violated Rule 23 of the Federal Rules of Civil Procedure, which governs class actions.

New York University law professor Samuel Issacharoff, representing municipalities and favoring the class action, asserted that the mechanism would allow the class members to participate directly in the settlement process and maximizes their advantage.

Judge McKeague indicated that he isn't in favor of "judicial inventiveness," stating that there are already mechanisms for litigating and settling class actions.

Earlier, Indivior Solutions Inc. a subsidiary of Indivior PLC, a Chesterfield County-based drug company, agreed to pay $600 million after citing guilty in federal court in Abingdon over its opioid addiction treatment drug Suboxone.

The company will pay the amount over seven years to federal and state authorities. It has even agreed with the Federal Trade Commission (FTC) to take necessary precautions by not engaging in similar conduct and will also establish a corporate integrity agreement with the Department of Health and Human Services' inspector general.

Last year a federal grand jury in western Virginia raised a criminal and civil liability lawsuit jointly with the U.S. Department of Justice after an investigation by the FTC, against Indivior. The investigation claimed that the company used fraudulent marketing strategies to increase profits from Suboxone Film.

The company pleaded guilty in 2012 for making false statements and was also charged with one count of health care fraud, four counts of mail fraud, and 22 counts of wire fraud, as well as other charges as mentioned in the court records. It has even paid more than $2 billion over the marketing of Suboxone including $1.4 billion during the last year with Indivior's former parent company Reckitt Benckiser Group PLC.

Currently, the company is required to make a settlement that comprises  $289 million to end the criminal charges, including fines, forfeiture, and restitution; $300 million to end civil allegations from state and federal enforcers; and $10 million to settle charges claiming that the company violated the antitrust laws. It is considered as the largest-ever resolution in a case brought by the Department of Justice involving an opioid drug.

 

3M's Government Contractor Defense Motion Rejected

U.S. District Judge Casey Rodgers, presiding over all 3M earplugs lawsuits, issued an order last Friday, rejecting the manufacturer’s government contractor defense motion.

Motions for summary judgment were filed by both the parties asking the court to provide a ruling on whether the manufacturer should be allowed to claim immunity from design defect and failure-to-warn claims. 3M Company, through its motion, invoked the government contractor defense, which would protect them from state-law product liability claims arising out of compliance with the federal government contract.

The manufacturer also argued that the claims were pre-empted by federal law because the Combat Arms earplugs were designed to military specifications. However, Judge Rodgers agreed over the plaintiffs' argument that the manufacturer could not meet the bar for defense contractor immunity. The order also noted that there was no evidence showing the participation of the military in discretionary design decisions for the earplugs, which opposes the argument that they were designed as per specific military standards.

Last month, Judge Rodgers issued a pretrial order indicating that the first 3M earplugs bellwether case will go to trial on April 5, 2021.

Currently, more than 150,000 claims are filed by veterans, each raising similar allegations that the hearing loss injuries were caused by defective 3M earplugs that were standard issue by the military between 2003 and 2015. The lawsuits are consolidated under MDL No. 2885 in the Northern District of Florida.

Earlier, 3M pleaded to reject the claims from nationwide military veterans over its defective earplugs lawsuits considering the “government contractor defense.” The company faces lawsuits from more than 140,000 army veterans who claim that a defective design of the earplugs resulted in them suffering hearing loss, tinnitus, and other injuries.

The spokesperson for the company said that it distributed the earplugs according to the guidelines provided by the military and relied on the “government contractor defense.” Whereas the jury representing the veterans argued that the company's plea cannot be accepted as it is blaming the military for being careless.

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