What Happened In The MassTorts World Last Week? 2020-May-04

Last week, the U.S. Food and Drug Administration (FDA) issued a letter to Bayer indicating requirements for submitting adverse event reports and postmarket activities associated with Essure, a permanent birth control device sold in the U.S. until 2018.

According to the letter issued, Bayer gets a variance, considering the anticipated volume and nature of the information, which gives the company a year to submit postmarket adverse event reports. The variance was requested by the manufacturer as it was receiving information about problems with the recalled Essure birth control device through social media and other adverse event reports.

The variance is valid for one year unless the FDA extends it, after which the manufacturer will be required to follow the regular adverse event reporting requirements for all Essure-associated reportable events.

The reports received by the manufacturer will be made publicly available by the FDA at pre-specified time points over the next year, starting in July 2020.

Nearly 18,000 lawsuits have been filed against Bayer, each involving similar allegations that the permanent birth control device resulted in painful and debilitating complications.

On Monday, the U.S. District Judge Freda L. Wolfson issued an opinion, rejecting the efforts made by Johnson & Johnson (J&J) to exclude plaintiffs’ expert witness testimony, allowing more than 17,000 talcum lawsuits to proceed further.

According to the 141-page opinion issued, Judge Wolfson determined that expert opinions offered by plaintiffs are sufficiently reliable and sound. J&J always defended the safety of its widely used talc-based products, arguing that general causation experts should be prevented from testifying at the trial.

Before scheduling the cases for trial, the judge listened to the challenges faced by the parties for the admittance of expert witness testimony under the federal Daubert standard, which requires that the opinions meet an evidentiary standard to ensure they are reliable enough to present to a jury.

Some of the opinions have also been limited that may be presented by the plaintiffs’ experts. Only general causation testimony that the talcum powder can cause cancer based on epidemiological studies will be allowed.

On February 27, a Miami jury ordered Johnson & Johnson (J&J) to pay a Florida-based woman $9 million after finding that their talc-based product caused the woman's mesothelioma. The verdict is considered to be the first in the Sunshine State.

According to the jury, J&J was negligent and sold a defective product, which contained asbestos. The plaintiff will receive $3 million for past medical expenses and $6 million for past and future pain and suffering.

Two days ago, attorneys for J&J and the plaintiff, a 62-year-old woman who had alleged that asbestos in its baby powder caused her mesothelioma, reached settlement bringing a halt to the trial that was underway and had completed opening statements.

Johnson's Baby Powder, one of the most popular products containing talcum powder, is linked to increasing a woman's risk of ovarian cancer if she uses it regularly in the genital area. In a few cases, the cancer tissue was studied using an electron microscope and was found to have talc in it, which supported the claim that the cancer was caused by the body powder and increases the talc-related cancer risk.

Also, Earlier this month, during a different trial, a New Brunswick, New Jersey, jury hit J&J with $750 million in punitive damages, which was immediately reduced to $186 million due to a state cap on punitive damages.

Bayer executives, in an annual general meeting, indicated that the company is currently facing Roundup lawsuits brought by more than 52,000 plaintiffs.

The general meeting also had a shareholder vote, during which the executives informed the investors that the ongoing pandemic crisis slowed Roundup settlement negotiations, as the company is facing economic challenges resulting from the outbreak and due to difficulties caused by social distancing procedures.

The company, following substantial pressure from shareholders to negotiate settlements for Roundup claims, engaged in a court-ordered mediation process with lawyers nationwide.

Mediator attorney Kenneth Feinberg, appointed by the court, is overseeing the controversial lawsuit. Ken Feinberg has overseen some of the largest mass-tort settlements in recent years, which includes funds to pay claims related to the BP oil spill, Volkswagen emissions scandal, General Motors ignition switch recall, and September 11th Victim Compensation fund.

U.S. District Judge Vince Chhabria is presiding overall the federal multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation) in the Northern District of California.

Earlier, Bayer agreed to pay nearly $40 million to resolve a class-action lawsuit claiming misleading and false advertisements over its controversial weed killer Roundup.

According to the lawsuit filed by several plaintiffs in Missouri federal court in February 2019, Scotts Miracle-Gro Products, Inc. and Monsanto Company, now owned by Bayer, face allegations that the manufacturers falsely claimed that the active ingredient, glyphosate, only targets an enzyme that is not found in humans or pets.

Monsanto, Bayer’s subsidiary, has agreed to pay $39.5 million as part of the Roundup class action settlement. The manufacturer also agreed to remove language from Roundup Weed and Grass Killer labels, which previously indicated glyphosate only affects plant enzymes.

Currently, Bayer faces many lawsuits over its Roundup weed killer, but this case is different from thousands of cases faced by the manufacturer over allegations that long term exposure of glyphosate causes non-Hodgkin’s lymphoma and other injuries to the users of Roundup.

Many state court cases have already been postponed following a settlement discussion between the parties and the prominent mediator Ken Feinberg.

Amid the on-going coronavirus pandemic, the first bellwether trial involving polypropylene hernia mesh products manufactured by C.R. Bard, Inc. and its Davol, Inc. subsidiary has been delayed to September 2020.

Earlier, U.S. District Judge Edmund A. Sargus identified three cases that were expected to go to trial in May 2020, July 2020, and September 2020. According to the new pretrial order issued on April 24, the first trial will now not start until September 2020, and it could be delayed further until 2021, as requested by both the parties initially.

Judge Sargus, in the pretrial order, stated that the court will closely monitor the current situation and be in touch with the parties about the September 29, 2020 trial date. The court might also reconsider the date if the situation does not improve.

A telephone conference has also been scheduled for May 21, during which the court will update the parties regarding the second and third cases selected for the bellwether process.

Currently, Bard is facing more than 6,800 product liability lawsuits, but according to recent court records, around 500 new cases are being filed each month throughout the federal court system. The lawsuits involve plaintiffs alleging that they suffered painful and debilitating complications following the use of its mesh products.

Bard hernia mesh claims are consolidated under federal multidistrict litigation (MDL No. 2846; In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation) in the Southern District of Ohio, presided by Honorable Edmund A. Sargus, Jr., and Honorable Kimberly A. Jolson.

Earlier, on Friday, Thomas Weaver, the attorney representing Johnson & Johnson (J&J) argued over a bid to reverse a jury’s $4.7 billion talcum powder verdict stating that the judge should not have combined all the 22 claims, particularly the 17 plaintiffs from Missouri, into a single trial.

The case involves a group of ovarian cancer victims and their family members, led by a plaintiff. The case ended with a $4.69 verdict in June 2018, after a six-week trial. Each woman or family was awarded $25 million in compensatory damages, along with $4.14 billion total in punitive damages, of which $3.15 billion was against J&J and $990 million against its subsidiary J&J Consumer Inc.

J&J also raised various other issues with plaintiffs’ experts, including William Longo, founder of Materials Analytical Services.

However, the panel of three judges seemed skeptical over challenging 22nd Circuit Judge Rex Burlison’s consolidation order or the reasoning behind the jury’s record award.

Previously, the Missouri Court of Appeals had reversed a $110 million award involving Bristol-Myers because the plaintiff was from Virginia and also reversed verdicts of $72 million, $70 million, and $55 million on similar grounds.

Due to the pandemic crisis, only two attorneys for either side were permitted in the courthouse, and the gallery was empty. The spectators were able to watch the arguments via a live video on the court’s Facebook page.