What Happened In The MassTorts World Last Week? 2020-Oct-19

On October 8, a study was published in the New England Journal of Medicine where the researchers from the Netherlands indicated that patients with a transcatheter aortic valve implant (TAVI) who were administered with a combination of aspirin and Plavix stood twice the chance of increased bleeding risk over the patients given aspirin alone.

The oral antiplatelet agent Clopidogrel was marketed jointly by Bristol-Myers Squibb Co. and Sanofi SA under the brand name Plavix. It is used to treat the formation of blood clots in peripheral vascular disease, cerebrovascular disease, and coronary artery disease. The U.S. Food and Drug Administration (FDA) approved the use of Plavix on November 17, 1997.

The study involved a randomized, controlled trial of over 665 patients, out of which 331 were administered with aspirin alone, and 334 patients were given aspirin plus Plavix. The researchers found that 50, or 15.1% of aspirin-only patients suffered a bleeding event over a year, whereas the rates of death due to bleeding, strokes, and heart attacks among 89, or 26.6% of aspirin and Plavix patients were also a lot more similar.

The researchers concluded that patients undergoing TAVI who did not indicate oral anticoagulation, the incidence of bleeding, and the composite of bleeding or thromboembolic events at 1 year was significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months.

A similar study published in 2018 by the researchers from the University of Texas also warned about the increase in bleeding risks associated with the drug combination. The study also noted that the combination also lowered the risk of stroke when used together.

A federal judge of West Virginia has rescheduled the trial of the nation's largest drug distributors over their role in the opioid epidemic. The trial, originally scheduled for October 19, will now begin on January 4, 2021, as per the two-page order by U.S. District Judge David Faber.

In 2017, Cabell County Commission and City of Huntington filed lawsuits against the major drug distributors AmerisourceBergen Drug Corp, Cardinal Health Inc, and McKesson Corp, alleging their role of causing death and addiction by flooding the market with powerful painkillers like OxyContin and hydrocodone. Additionally, more than 3000 local governments across America have filed similar lawsuits against the distributors.

Last week, the three top distributors argued that holding the trial in this month amidst the pandemic will risk the lives of 200 witnesses and many lawyers by making them more vulnerable to contracting COVID-19 as many of the witnesses would come from outside the state to attend the trial.

Attorneys for Cabell County and Huntington responded to the drug distributors' suggestion by saying that it is just an excuse to delay the landmark trial. They even urged the federal judge to reject the distributors' plea to postpone the trial to January 2021.

Huntington’s and Cabell’s lawyers allege that the delay in the decision will result in more people getting addicted and dying due to opioids. The attorneys even provided the required reports that support their claim that the opioid death rate exceeded the COVID-19 crisis death rate in West Virginia. The reports claim, so far, 364 people have died due to the coronavirus, while 800 people die every year due to the opioid epidemic in West Virginia.

West Virginia has recorded with the highest drug overdose death rate in the U.S., and current preliminary reports indicate that overdoses increased during the pandemic.

Mallinckrodt Pharmaceuticals, the Irish–based manufacturer of generic drugs, agreed to pay $1.6 billion to resolve the mounting lawsuits that claim the manufacturer of fueling the opioid epidemic, which resulted in tens of thousands of deadly opioid overdoses across the U.S. The news was announced by Connecticut Attorney General William Tong on Monday.

The company, after losing on multiple fronts, filed for bankruptcy in Delaware on the same day. Filing bankruptcy allows companies to drop the debt and other liabilities and stay in business. According to the settlement agreement, the company agreed to pay the money to a trust, which will be used to address individual claims brought against the company for causing the opioid crisis.

Tong’s office said that the settlement requires the company to pay $450 million when it emerges from Chapter 11 bankruptcy, $250 million in the first and second year after emerging from bankruptcy, and then $150 million a year for the third through the seventh year after leaving bankruptcy.

Several officials and local governments in Connecticut have also filed lawsuits against Mallinckrodt and other opioid manufacturers. The agreement is an effort to resolve all the lawsuits that have emerged over the years.

Mallinckrodt CEO and President Mark Trudeau, while announcing the plan to enter bankruptcy, said that the company worked diligently to reach a resolution over the rising litigation and debt issues the company is facing. He further noted that the company is processing the agreement in a highly organized manner with a key group of opioid plaintiffs, other governmental parties, and the company's guaranteed unsecured noteholders.

On Tuesday, Johnson & Johnson (J&J) issued a press release indicating that it would contribute $1 billion more to the originally proposed $4 billion opioid settlement fund in October 2019 to end the nationwide deluge of litigation that alleges the company of fueling the opioid addiction crisis in the U.S.

J&J, while disclosing the 25% increase to the previously announced proposal, stated that it is the result of continuous negotiations and the company's intention to maximize participation in the settlement. The company also noted that the deal is not an admission of liability or wrongdoing, and it will continue to defend against any litigation that the final agreement does not resolve.

The deal will resolve lawsuits brought by various government entities over the damages incurred while dealing with the abuse and addiction. The settlement will provide certainty for involved parties and critical assistance for families and communities in need, as per J&J.

The New Brunswick, New Jersey-based drugmaker, is currently facing at least 3,000 opioid lawsuits brought by local governments and Native American tribes. The litigation is presided by U.S. District Judge Dan A. Polster in the Northern District of Ohio, for coordinated discovery and pretrial proceedings as part of a multidistrict litigation (MDL).

Last week, J&J also agreed to pay over $100 million to resolve about 1,000 lawsuits over its talcum powder products for causing cancer brought by at least three law firms, which include Simmons Hanly Conroy, Simon Greenstone Panatier PC, and the Lanier Law Firm.

Last week, a report was published in the medical journal JAMA Surgery, where South Korean researchers suggested an association between the use of textured breast implants and an increased risk of breast cancer relapse.

The cohort study over the question of whether the surface type of the breast implant alters the outcome of the original breast cancer was carried at Samsung Medical Center in Seoul, South Korea. 

The study included 650 women, identified from a prospectively maintained database, who underwent 687 breast implant procedures, including tissue expanders and breast reconstruction, from January 1, 2011, to December 31, 2016. They were further categorized into two groups according to the surface type of implant, i.e., smooth or textured implants. Of the 687 cases, 274 (39.9%) received a smooth implant, and 413 (60.1%) received a textured implant.

The patients were followed up for at least two years after the surgery, and an analysis was performed from February 15, 2020, to March 5, 2020. The analysis revealed that women who had textured breast implants faced three times the risk of relapse and significantly lower disease-free survival rate as compared to the ones who received implants with smooth surfaces.

The researchers concluded that the use of textured implants in reconstruction appears to be associated with the recurrence of breast cancer, and further investigation is required to verify these results.

In August, the Food and Drug Administration (FDA) released a report indicating that the number of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) cases increased by nearly 28% in the second half of last year. The report showed a total of 733 BIA-ALCL diagnoses, along with 36 patient deaths globally. Out of the known cases where the manufacturer has been identified, 620 are linked to breast implants sold by Allergan, Inc., and in 47 cases, the manufacturers were unknown. Only 16 manufacturers were identified, of the 36 deaths, and 15 of those involved Allergan implants.

Currently, Allergan faces at least 150 product liability lawsuits and class action lawsuits over its breast implants, each claiming that the textured design was unreasonably dangerous and defective, and the manufacturer knew that it increased the risk of BIA-ALCL yet failed to warn about those risks.