What Happened In The MassTorts World Last Week? 2020-Oct-05

Judge Vince Chhabria, overseeing the Roundup multidistrict litigation docket, in a case management conference held via zoom, indicated that he would retain the stay on the controversial weedkiller's litigation until November 2 and asked the parties to provide an update on the proposed more than $10 billion deal.

The September 24th conference was the result of the concerns raised by plaintiffs' attorneys over the settlement deal, announced this year in June, which plaintiffs believed the manufacturer was trying to revoke its proposal.

In the recent hearing, Judge Chhabria also noted that after the set date of the stay, he could remand cases for trials, likely in California, Nebraska, North Carolina, or Illinois. Kenneth Feinberg, who is mediating the settlement deal, stated that he expects that the manufacturer will soon settle the next set of cases scheduled for trial.

The attorneys involved in the litigation stated that the parties have binding deals to settle about 45,000 of the 125,000 filed and unfiled claims and agreements have been made with each lawyer who took cases to trial.

A week ago, three major law firms, California-based Baum Hedlund Aristei & Goldman law firm, the Andrus Wagstaff firm from Colorado, and the Moore Law Group of Kentucky, representing several plaintiffs involved in the Roundup litigation, indicated that they reached an agreement with the manufacturer and filed a “fully-executed and binding Master Settlement Agreement with Monsanto” in the U.S. District Court for the Northern District of California.

Earlier this month, Bayer had also released a statement indicating that progress has been made in the development of a “revised” plan to resolve potential future Roundup litigation, which will be finalized over the coming weeks and will be followed by a motion for preliminary approval of the plan.

Pelvic mesh manufacturer C.R. Bard, a unit of Becton, Dickinson and Company, commonly known as BD, agreed to pay $60 million to resolve lawsuits filed by 48 states and the District of Columbia alleging that the company did not adequately inform women about the side effects related to the surgical mesh devices.

The settlement news was announced by Attorney General Kwame Raoul on September 24 through a press release issued on behalf of a bipartisan coalition of attorneys general. Raoul and the coalition claimed that the manufacturer used deceptive marketing practices to promote its transvaginal mesh products and mislead or failed to adequately disclose serious health risks associated with the implant, which includes the risk of chronic pain, scarring, infections, erosion of the mesh through the vaginal walls, and other complications. The company denied admitting any wrongdoing but agreed to make a settlement.

C.R. Bard has stopped selling its transvaginal mesh products, and if the company wants to re-enter the market, it would have to adhere to certain injunctive terms. As per terms of the settlement, the company is also required to:

• Provide patients with understandable descriptions of complications in marketing materials.

• Include a list of certain complications in all marketing materials that address complications.

• Disclose complications related to the use of mesh in any training that includes risk information.

• Disclose sponsorship in clinical studies, clinical data, or pre-clinical data, being published.

• Comply with disclosure requirements before citing any clinical study, clinical data, or pre-clinical data regarding mesh.

• Require consultants to agree to disclose in any public presentation or submission for publication Bard’s sponsorship of the contracted for activity.

• Register all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov.

• Train independent contractors, agents, and employees who sell, market, or promote mesh, regarding their obligations to report all patient complaints and adverse events to the company.

• Ensure that its practices regarding the reporting of patient complaints are consistent with FDA requirements.

Illinois will receive more than $1.64 million from the settlement deal. The other participating states include Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin.

On September 24, the plaintiffs involved in the ParaGard IUD lawsuits filed a motion asking the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate the cases before one judge in the U.S. District Court for the Central District of California.

According to the motion filed, the plaintiffs are seeking consolidation of cases brought throughout the federal court system for coordinated pretrial proceedings to avoid conflicting pretrial rulings from different courts, avoid duplicative discovery, and serve the convenience of common witnesses, parties, and the judicial system.

Currently, at least 55 actions are pending in 29 different judicial districts, as per the plaintiffs, each claiming misconduct on the part of the defendants, which resulted in injuries and painful complications when the fractured or broken device was being removed. The plaintiffs further asserted that more actions against the device are likely to be filed in jurisdictions throughout the United States, considering its sales.

The motion also noted that transfer, coordination, and consolidation is relevant as many common questions of fact and law exist, which include but is not limited to the following:

• Whether ParaGard was defectively designed.

• Whether the ParaGard lots contained manufacturing defects.

• Whether ParaGard was marketed with an adequate label.

• Whether the defendants conducted adequate pharmacovigilance of ParaGard.

• Whether defendants engaged in negligent conduct resulting in plaintiffs’ injuries.

The defendants did not respond to the motion yet, and a hearing session is scheduled for December 3, 2020, in San Antonio, Texas, to hear the oral arguments from various parties involved in the lawsuits.

U.S. District Judge Claire C. Cecchi, overseeing the proton-pump inhibitor (PPI) multidistrict litigation docket, released a joint proposed case management order, which indicated that the bellwether pool would be reduced to six cases by the parties till November 9, 2020.

Previously, each party was asked to select 16 cases from an Eligible Case List to form a total of 32 eligible cases. The parties will then strike six cases each, narrowing down the bellwether discovery pool to 20 cases, which will then undergo case-specific discovery.

According to the latest order issued, a small group of representative bellwether cases is to be selected this month, which would go through expert discovery in preparation for the first scheduled trials, expected to go before juries in November of 2021.

The proposal also states that if parties are unable to agree on the common grounds, then the parties shall submit simultaneous letter briefs on November 9, 2020, setting out their respective recommendations over the cases that the court should select. The court shall then select the bellwether trial cases by November 20, 2020. The first bellwether trial is expected to begin on November 15, 2021, and additional trials are likely to be followed in early 2022.

The outcome of these cases will not be binding on other cases pending in the MDL. The parties will closely monitor the cases and gauge how juries are responding to certain evidence and testimony that will be repeated throughout the claims.

Currently, more than 13,000 Nexium, Prilosec, Prevacid, and other PPI drug lawsuits have been filed across the federal court system. The lawsuits, consolidated under MDL No. 2789, claim that the manufacturers failed to warn about the risk of acute kidney injury, chronic kidney disease, and end-stage renal failure associated with the heartburn medications.

On September 28, the Food and Drug Administration (FDA) issued a press release, providing final guidance on breast implant labeling recommendations and information regarding health complications, often referred to as “breast implant illness.” The Federal regulators had issued draft guidance of this document in 2019.

The final guidance recommends breast implant manufacturers to add a boxed warning informing the patients about the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with breast implants. Additionally, the guidance also provides a standardized checklist as part of the informed consent process, revised MRI screening recommendations for silent ruptures of silicone gel-filled breast implants, and calls for the implementation of greater transparency regarding materials present in breast implants.

In August, the agency released a report indicating that the number of BIA-ALCL cases increased by nearly 28% in the second half of last year, and most of the identified cases were specifically linked to the textured design of certain Allergan Breast Implants.

FDA's data indicated 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.

A rise in the number of breast implants lawsuits filed against Allergan has been noted since the manufacturer issued a recall for its textured Biocell implants last year after the FDA concluded the textured design as the reason for all cases of BIA-ALCL. Currently, the manufacturer is facing at least 150 product liability lawsuits and class action lawsuits over breast implant cancer problems.