What Happened In The MassTorts World Last Week? 2021-Mar-29

ParaGard MDL: Master Complaint Proposed For Direct Filing

On March 09, Judge Leigh Martin May of the U.S. District Court for the Northern District of Georgia, presiding over all ParaGard IUD injury cases, issued a case management order, asking the plaintiff to file a “Master Complaint” this month, which will allow the direct filing of future claims through a “Short Form Complaint.”

According to the order, the parties are required to meet and prepare an agreed-upon Short Form Complaint, along with a Direct File Order to streamline the process of filing new claims directly in the Northern District of Georgia.

The plaintiffs are required to file the Master Complaint by today and the defendants are also required to file any responsive pleadings by May 6, 2021.

The process is intended to assist the parties coordinate, categorize and evaluate the claims and will also help avoid costs and delays associated with transferring claims from U.S. District Courts nationwide.

Currently, around 116 complaints are pending in the multidistrict litigation (MDL) and the number of lawsuits seems to be growing, each claiming that the birth control device has a risk of breaking upon removal, causing complications and injuries, including surgeries to remove the broken piece of the device, infertility, and pain.

The MDL docket was formed in December 2020 when the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order confirming the centralization of all ParaGard IUD cases in the Northern District of Georgia for coordinated or consolidated pretrial proceedings.

Last month, the United States Food and Drug Administration (FDA) issued a warning letter to CooperSurgical, Inc., stating that the manufacturer did not communicate risk information associated with the ParaGard IUD birth control device in a direct-to-consumer video advertisement.

According to the letter, the advertisement contained false or misleading information, and the manufacturer did not submit it to the FDA for review as per the Office of Prescription Drug Promotion (OPDP). The letter warns that this misleading presentation is particularly concerning from a public health perspective due to the serious and potentially life-threatening risks associated with the device, such as those contained in the WARNINGS AND PRECAUTIONS section of ParaGard’s PI (prescriber information).

McKinsey To Settle Opioid Marketing Claims With NV For $45M

On Monday, Nevada Attorney General (AG) announced that McKinsey & Co. Inc., the American worldwide management consulting firm, has reached a $45 million deal with the state to resolve claims alleging the company's role in fueling the nationwide opioid crisis.

The Nevada AG’s Office said that the settlement will resolve claims that the company violated the Nevada Deceptive Trade Practices Act when it was hired by opioid drugmakers as a marketing and consultancy firm to help increase opioid sales in Nevada. The funds will be used to address "harms and costs" caused by the opioid epidemic.

The AG, in a statement announcing the deal, said that several Nevadans died due to the opioid crisis, which is the reason why the state's bureau of consumer protection fought hard to achieve the settlement with the company.

The deal follows a $573 million multistate settlement 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.

Washington and West Virginia have also entered separate settlements with the company for $13.5 million and $10 million, respectively.

In a statement, the company noted that it has now reached settlements with all 50 state attorneys general, along with five U.S. territories and the District of Columbia.

Recently, Suffolk County Supreme Court Judge Jerry Garguilo approved a $32 million deal between the company and the New York AG over similar claims and the deal is also a part of the multistate settlement.

The approval faced challenges from counties and municipalities who argued that the deal would potentially block them from pursuing their claims against the consulting firm. However, Judge Garguilo said 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."

Bayer To Not Seek Reversal Of A $20.5M Verdict

Last week, Bayer AG indicated that it would not pursue a further appeal over a $20.5 million verdict awarded to a California school groundskeeper who alleged the company's weedkiller Roundup for his non-Hodgkin's lymphoma (NHL).

While announcing the decision, the company said that it was careful and extensive consideration and reflects a legal strategy to end the state court case and instead focus on the second Roundup verdict, in federal court.

The lawsuit was the first to go before a jury and a state court jury initially awarded the man a landmark verdict of $289 million, including $250 million in punitive damages. The company was held liable for disregarding the health and safety of consumers.

The presiding judge later reduced the award to about $78 million, which included $38 million in compensatory damages and about $39 million in punitive damages. The award was further reduced by a California appeals court to $20.5 million, which now stands as the final judgment and over which Bayer decided to not ask for a final review by the U.S. Supreme Court.

Currently, Bayer is facing more than 125,000 Roundup lawsuits, and the company has acknowledged the filing of 52,500 lawsuits. The lawsuits are consolidated under MDL No. 2741 in the U.S. District Court for the Northern District of California.

The company has indicated that it has reached an agreement to resolve nearly 88,500 cases, which would cost the company around $9.6 billion. Additionally, the company has also proposed a $2 billion deal to resolve future legal claims. According to the proposed plan, the company will be paying $2 billion over a period of four-years to cover outreach and diagnostic assistance of individuals who have been diagnosed with NHL and were exposed to Roundup prior to their diagnosis.

Boston Scientific Settles Claims Over Pelvic Mesh For $189M

On Tuesday, New York's Attorney General (AG) announced that Boston Scientific Corp. has agreed to resolve deceptive marketing claims over its pelvic mesh devices by paying $188.6 million to 47 states and the District of Columbia.

According to the announcement, New York will receive $6.3 million and the settlement comes after a multistate investigation, which affirmed that the company violated state consumer protection laws by claiming its mesh products safe.

The manufacturer denied any misconduct or liability and the payment will be covered by the Marlborough, Massachusetts-based company’s existing reserves.

Additionally, as a part of the settlement, the company has agreed to several marketing reforms, including revealing the complications in understandable terms in its marketing materials and refraining from representing that the risks of mesh can be eliminated or are common to other types of treatment for the same conditions.

In 2019, a similar multistate settlement was made by Johnson & Johnson (J&J) and its subsidiary Ethicon for $117 million, which was followed by another settlement of $60 million, last September, by Becton Dickinson and Co. and its C. R. Bard, Inc. unit.

Pelvic mesh devices, also called transvaginal mesh devices, are surgical net-like implants used in the form of a sling to treat stress urinary incontinence (SUI) and Pelvic organ prolapse (POP) in women. The Food and Drug Administration (FDA) approved the first surgical mesh specifically designed for SUI in 1996. Later, in 2004, the FDA approved the first surgical mesh specifically for use in POP.

Several lawsuits were filed by women against the manufacturers for covering serious risks associated with the devices, which include chronic pain, urinary dysfunction, and new onset of incontinence.

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.

Bankruptcy Judge Puts A Stay On Purdue's Opioid Litigation

On Wednesday, U.S. Bankruptcy Judge Robert Drain extended an injunction staying over opioid litigation against Purdue Pharma L.P. and the owner of the company, the Sackler family.

The New York bankruptcy judge, at a virtual hearing, extended the stay until April 21, stating that the continuation of the litigation might irreparably harm Purdue and its creditors' ability to work out the aspects of the Chapter 11 plan.

The company filed a proposed Chapter 11 plan of reorganization last week, which also included an agreement that the Sackler family would contribute $4.275 billion to a trust that is set up to resolve opioid-related claims. 

The company had already asked the court to extend an injunction for 30 days before filing the plan. Similarly, in October 2019 as well the company was issued a preliminary injunction, putting thousands of lawsuits filed against the company on hold.

The states that did not consent to the 2019 settlement along with an ad hoc group of five personal injury claimants raised concerns over the extension, where the personal injury claimants argued that the proposed plan does not provide enough "accountability" for the Sacklers.

Additionally, Judge Drain noted that he would not have the authority to order nonconsensual waivers of criminal charges and suggested to the members of the family that they could break the stay with the nonconsenting states by agreeing to donate additional money to opioid abatement beyond the proposed settlement.

The New York Attorney General's (AG) lawsuit over the opioid crisis has 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 in June.

Plaintiffs Seek To Revive Reversed $83M Pelvic Mesh Verdicts

Earlier this month, a three-judge appeals panel had reversed two verdicts worth $83 million awarded to two women and their husbands over complications from pelvic mesh medical devices and now the two couples have appealed to the New Jersey Supreme Court to reinstate the same.

Last Friday, the two couples challenged the March 2 opinion of the Superior Court of New Jersey Appellate Division and told the Supreme Court justices that the appellate panel incorrectly tossed the verdict over the exclusion of evidence that the companies' pelvic mesh products were cleared through the U.S. Food and Drug Administration's 510(k) process.

The New Jersey appeals court panel had consolidated both the cases and overturned the verdicts, which were awarded by two separate Bergen County juries to the plaintiffs.

The first case was brought against Johnson & Johnson (J&J), Ethicon Inc., Ethicon Women's Health and Urology, and Gynecare, in which a Bergen County jury had awarded the woman and her husband $5 million in compensatory damages and $10 million in punitive damages. The jury held the defendants liable under independent theories of defective design and inadequate warning under New Jersey product liability laws.

The second case had resulted in $33 million in compensatory damages, along with stipulated medical expenses, and another $35 million in punitive damages. The jury held C.R. Bard, Inc., Bard Medical Division, and Bard Urological Division responsible for design and failure to warn defects claims.

The couples further added that the appellate opinion is internally inconsistent and fails to provide clear guidance to the MCL judge on remand and that both the defendants were not limited in submitting any substantive evidence or argument in their defense, including about their failure to perform clinical studies on the marketed devices.

The couple appealed to the reversal as they felt it was unjust and the opinion would also leave the door open for the MCL Judge to decide that the exclusion of 510(k) evidence remains appropriate on remand, especially outside of punitive damages.