What Happened In The MassTorts World Last Week? 2021-Mar-22

Purdue Pharma Owner To Pay $4.3B Over Opioid Crisis

A source recently said that the owner of Purdue Pharma LP is now ready to contribute $4.275 billion to resolve the nearly 3,000 lawsuits filed against the company over fueling the opioid epidemic across the U.S.

The Sackler family owns the pharmaceutical company Purdue Pharma and the members of the family have raised the initially proposed settlement of $3 billion to roughly $4.3 billion. The company and the representatives for the family have not yet commented on the new proposal.

The details of the settlement are expected to be outlined in a Purdue reorganization plan filed in a U.S. bankruptcy this week. In 2019, the company filed for bankruptcy after facing a torrent of lawsuits, and last year it pleaded guilty to three criminal charges and agreed to pay $8.3 billion to settle federal probes over its marketing practices of the highly addictive painkiller.

According to the latest proposal, the sources said that the family could still use profits from sales of those businesses to cover the higher $4.275 billion payouts. The settlement is expected to happen over a period of years.

The litigation against the company and the family has been put to a halt since the company filed for bankruptcy, following which it has been working towards proposing a reorganization plan that would help resolve thousands of outstanding lawsuits.

Recently, the New York attorney general's lawsuit over the opioid crisis also got delayed due to the concerns related to COVID-19, and the Suffolk County Supreme Court Justice Jerry Garguilo indicated that the trial will likely begin on June 8.

Last month, a study was published in the medical journal The BMJ in which Harvard researchers highlighted the side effects of opioid use during pregnancy and indicated that the use increased the risk of a cleft palate, cleft lip, or other birth defects.

The data for research was collected from two sources, the Medicaid Analytic eXtract (MAX) from 2000 to 2014 and the MarketScan Research Database from 2003 to 2015, which included more than 1.6 million publicly insured pregnant women. The researchers had set the eligibility to at least three months before pregnancy to one month after delivery with infants’ eligibility for at least three months after birth.

The women with two or more prescription dispensations of an opioid painkiller, like Vicodin or OxyContin, during the first trimester of pregnancy, were considered by the researchers. Out of the total, nearly 70,000 publicly insured women and around 12,000 commercially insured pregnant women had two or more prescription dispensations.

The research revealed that in the MAX cohort the risk of abnormalities overall was 41 per 1,000 pregnancies as compared to 32 per 1,000 unexposed pregnancies and in the MarketScan cohort, the data revealed a risk of 42 per 1,000 exposed pregnancies as compared to 37 per 1,000 unexposed pregnancies. The researchers further noted that other birth defects, like heart malformations, club foot, or neural tube defects were comparatively lower.

In conclusion, the researchers stated that prescription opioids used in early pregnancy are not associated with a substantial increase in risk for most of the malformation types considered, although a small increase in the risk of oral clefts associated with their use is possible.

The same month, the U.S. Centers for Disease Control and Prevention issued the Morbidity and Mortality Weekly Report (MMWR) indicating that from 2013 to 2019 overdose deaths related to opioids, which involved fentanyl, and other synthetic versions of the addictive pain killers had skyrocketed.

J&J To Pay $2.6M Over An Australian Pelvic Mesh Case

Earlier this month, an Australian court dismissed Johnson & Johnson's (J&J) appeal over a $2.6 million ruling awarded to women who claimed that the company's subsidiary Ethicon misled patients and surgeons about the risks associated with its pelvic mesh implants.

A federal court judge had imposed the initial decision in November 2019, stating that Ethicon failed to warn women about the serious risks and negligently pushed the products into the market without testing.

More than 10,000 women joined the class action, which began in 2012. The trial started in July 2017 and is considered to be one of the largest class actions in Australian history.

J&J was ordered to pay three women who led the class action a total of $2.6 million along with legal costs as compensation. The company appealed the ruling last year and in the recent judgment, the full bench of the Federal Court of Australia upheld the decision.

The company is facing a torrent of similar lawsuits in the U.S. and recently a three-judge appeals panel reversed two verdicts worth $83 million awarded to two women who alleged that they suffered severe complications from pelvic mesh devices manufactured by Johnson & Johnson (J&J) and its subsidiaries and C.R. Bard, Inc. and its subsidiaries.

Around four million women have vaginal mesh implants, and more than 150,000 have alleged complications associated with it. There are in all 7 MDLs to handle Transvaginal Mesh Litigation, overseen by U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia for coordinated discovery and early bellwether trials.

Additional Injuries And Deaths Related To Essure Reported

On March 15, the U. S. Food and Drug Administration (FDA) issued an update on the ongoing analysis of serious injuries and problems linked to Bayer’s birth control device Essure, indicating that around 12,000 injury reports and at least nine deaths were recorded as of November 2020.

The analysis is based on the summarized data of the reports identified between September 2020 through November 2020 by the manufacturer. The report included a total of 11,884 reportable events out of which 11,830 were serious injury reports, 45 were malfunction reports, and 9 were death reports.

The most common patient problems reported were pain, perforation, foreign body/device fragment in the patient, pregnancy (including ectopic), heavier periods (menses/hemorrhage), and hypersensitivity.

Essure was developed by Conceptus Inc., a subsidiary of Bayer AG, and was used for permanent surgical sterilization in women. The device was suspended from the market in most countries since 2017, after receiving thousands of adverse event reports, which included perforation of the fallopian tube, neurological damage, severe pain, and even deaths.

The manufacturer continued to sell the device in the U.S. until the end of 2018, and in July 2018, it announced to remove all the Essure devices from the U.S. market by December 31, 2018. Following the removal, the FDA required Bayer to extend the postmarket surveillance study and report problems associated with the device.

Since 2002, it is estimated by Bayer that 750,000 women have received the birth control device, and 70% of those procedures happened in the U.S.

Last year, in August, Bayer officials had announced that the company reached an agreement with plaintiff law firms to pay approximately $1.6 billion to settle nearly 90% of all the lawsuits, including the cases filed in the state of California Joint Council Coordinated Proceedings (JCCP) and the cases pending in the Federal District Court for the Eastern District of Pennsylvania (EDPA).

McKinsey's $32M Opioid Deal With NY AG Approved

Last Friday, Suffolk County Supreme Court Judge Jerry Garguilo approved a $32 million deal between McKinsey & Co. and the New York attorney general over the company's alleged role in fueling the opioid crisis.

The approval faced challenges from counties and municipalities who argued that the deal would potentially block them from pursuing their claims against the American worldwide management consulting firm.

The deal is a part of the $573 million settlement which was announced last month by the company to resolve nationwide lawsuits, which allege that it turbocharged opioid sales for Purdue Pharma and earned profits from the crisis caused.

As per the settlement deal, the company is also required to produce all the internal documents that report its work with Purdue. The company denied any wrongdoing and has agreed to not take part in any opioid-related work moving forward.

The local governments objected to the parties' bid to approve the deal by filing an opposition brief on March 8, arguing that the settlement was made against the public interest. They noted that the parties are clearly not in agreement with respect to whether the settlement would release the company from future claims.

However, in the March 12 order, the judge agreed that the issue of whether a provision in the deal would release the firm from certain legal claims brought by other political subdivisions "is not ripe for determination."

This week in news was another opioid deal in which the Sackler family, the owner of Purdue Pharma LP, agreed to contribute $4.275 billion to resolve the nearly 3,000 lawsuits filed against the company.

The New York attorney general's lawsuit over the opioid crisis against other manufacturers, distributors, and pharmacies also got delayed due to the concerns related to COVID-19, and Judge Garguilo indicated that the trial will likely begin on June 8.

1 Out Of 5 Long-term Users Affected By Elmiron Maculopathy

On March 11, an article was published in the medical journal Current Opinion in Ophthalmology in which researchers indicated that one out of every five long-term users of Elmiron, an oral prescription drug used to treat pain caused by bladder disorder interstitial cystitis, or IC, are prone to be left with retinal maculopathy.

The research was conducted by researchers from the University of Kentucky who examined data from cross-sectional studies and found that the average case of retinal pigment dysfunction appears to occur with exposure to 1-2 kg over a 10-15 year period.

The researchers further noted that in patients with long-term exposures a prevalence range of 12.7% to 41.7%, with an overall rate of about 20% of maculopathy was reported.

The researchers have warned that the retinal changes can continue even after patients stop the usage and advised that health care professionals should consider baseline examinations and examinations at five years or after 500 g of exposure along with yearly screening.

In the legal world, in January, a motion was submitted for the appointment of a plaintiff leadership committee. A 25-member committee is proposed, which would include three co-lead counsel and one liaison counsel, seven Executive Committee members, and 14 Steering Committee members.

The number of women leadership positions is more as the plaintiffs in the MDL are expected to be women, as Elmiron disproportionately affects women.

Currently, more than 100 product liability lawsuits are pending in the U.S. against the manufacturer for Elmiron, Johnson & Johnson's (J&J) subsidiary Janssen Pharmaceuticals, Inc., each claiming that its users suffered severe retina damage and permanent vision problems, including difficulty adapting to the dark light, spots, or floaters in the vision and complete blindness.