What Happened In The MassTorts World Last Week? 2021-Jan-11

Last week, a separate order was issued concerning the growing Zantac multidistrict litigation in which Judge Robin L. Rosenberg of the U.S. District Court for the Southern District of Florida dismissed a majority of the state product liability claims, stating that they are preempted by federal law.

Zantac (ranitidine hydrochloride) is an antacid and an H2 (histamine-2) receptor blocker used for treating and preventing ulcers in the duodenum, stomach, and intestines. It is also used for treating erosive esophagitis, heartburn, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome. In 1983, Glaxo Holdings Ltd, a company which is a part of GlaxoSmithKline PLC, received approval from the FDA to sell Zantac in the U.S. However, owing to patent expiry in 1987 in the United States, Glaxo had to face stiff competition by the generic alternatives launched immediately by competitors. Since 2017, the OTC version of Zantac was marketed by Sanofi in the United States and Canada. In 2004, Pfizer gained FDA approval to sell the Zantac OTC in the United States.

According to the December 31 order, Judge Rosenberg contended that state labeling and design defect claims against 32 Zantac generics makers, retailers, and distributors are preempted as the companies cannot alter brand-name drug labels or designs independently and comply with labels approved by the U.S. Food and Drug Administration (FDA).

The plaintiff had filed three separate master complaints against the defendants, which included a personal injury complaint, a proposed nationwide consumer class action, and a proposed class action on behalf of third-party payers. The defendants argued to toss the state claims stating that they are preempted by federal law as they would have had to seek permission or assistance from the federal government to make changes to the drug to adjust with state law requirements.

The judge dismissed the claims on preemption ground but gave the plaintiffs 30 days to replead their allegations based on the drugs' expiration dates, testing, storage and transportation conditions, FDA warnings, manufacturing defects, and warranty breaches.

In September 2019, the FDA issued a warning stating that it found traces of NDMA in Zantac and similar generic drugs. Earlier this year, the federal agency requested manufacturers to discontinue all versions of Zantac from the market. Several studies were also published last month that strengthened the problems associated with Zantac.

The litigation, which comprises approximately 1,000 lawsuits and is presided by Judge Rosenberg, alleges Pfizer Inc., Sanofi SA, Boehringer Ingelheim Pharmaceuticals Inc., and GlaxoSmithKline LLC, along with generics makers, distributors, pharmacies, and others in the supply chain, of misleading advertising, failure to warn, and other claims associated with the presence of cancer-causing chemical N-Nitrosodimethylamine (NDMA) in popular heartburn drug.

According to a study published in the medical journal Organic Process Research & Development, U.K researchers who are working with GlaxoSmithKline (GSK), the Zantac manufacturer have suggested that Zantac degrades the active pharmaceutical ingredient ranitidine which results in the formation of the cancer-causing chemical N-nitrosodimethylamine (NDMA).

On December 30, a court order was issued in which U.S. District Judge M. Casey Rodgers, presiding over 3M Combat Arms earplugs litigation, announced that the first bellwether trial, which is scheduled for April 5 through April 30, this year, will involve claims filed by three plaintiffs.

Earlier, the plaintiffs involved in the litigation filed a motion asking Judge Rodgers to consolidate five different claims from the “Group A” bellwether pool for one single trial, claiming that the lawsuits involve a substantial overlap of both law and facts, which is enough to justify the consolidation.

According to the recent order, the judge said that three separate trials would prove to be repetitive and will impact the burdens and delays that consolidation is meant to mitigate. The two additional cases are set to proceed individually on May 17, 2021, and June 7, 2021.

Defendants raised objections concerning the consolidation, stating that such a trial would confuse the jurors. However, Judge Rodgers rejected the argument and consolidated three cases for the first bellwether trial, and sent two cases for individual trials.

The result of these trials will not hold an obligation on other cases and will be closely monitored by the parties as it would influence settlements for veterans, helping avoid the need for individual trials nationwide in the coming years.

The Combat Arms Earplugs Version 2 (CAEv2) was manufactured by Aearo Technologies, Inc. prior to being taken over by 3M in 2008. The dual-ended 3M CAEv2 combat earplugs served as a standard form of military hearing protection in foreign conflicts for more than a decade, from 2002 to 2016. The 3M military earplugs are made of green and yellow with a double-ended design. The green end is inserted in order to block all sound, and the insertion of the yellow end reduces the sound of gunfire and explosives but still allowed the service personnel to be part of a conversation. According to several lawsuits filed, the defective military earplugs cause two primary medical issues, tinnitus and hearing loss, mostly among veterans in the Navy and Air Force. The product was discontinued in 2015.

Currently, more than 200,000 claims are filed by veterans against 3M Company and its subsidiary Aearo Technologies, each raising similar allegations that the hearing loss injuries were caused by defective 3M earplugs that were standard issue by the military between 2003 and 2015.

Judge Edmund A. Sargus of the U.S. District Court for the Southern District of Ohio, in a case management order issued on December 30, indicated that the second bellwether trial involving allegations over C. R. Bard's Ventralex hernia mesh is expected to go before a jury in late summer 2021. 

The lawsuit, filed in 2018, was selected as the second bellwether trial case by the court on January 24, 2020. The suit was brought by a couple who claimed that hernia mesh patch resulted in permanent injuries and significant pain and suffering, emotional distress, monetary losses, and diminished quality of life.

The following deadlines have been applied for Dispositive and Daubert motions in the second bellwether trial:

• January 22, 2021: Dispositive motions to be filed.

• January 29, 2021: Deadline for filing of any Daubert or other motions concerning any expert.

• February 19, 2021: Opposition papers to dispositive motions to be filed.

• February 22, 2021: Opposition papers to expert motions to be filed.

• March 4, 2021: Reply papers to expert motions to be filed.

• March 5, 2021: Reply papers to dispositive motions to be filed.

The manufacturer will tentatively undergo its first jury trial on April 19, 2021, which involves a plaintiff who claimed that the "Sepra Technology" coating on the company's products breaks down and is absorbed by the body too quickly, exposing the internal organs and other tissues to the polypropylene and increasing the risk of complications.

Last month, Judge Sargus ruled that the manufacturer cannot present its Ventralight ST device as "lifesaving" during the upcoming bellwether trial as the federal courts permitted the mentioned characterizations if there was some evidence in the record to support it.

The next case management conference will be held virtually through GoToMeeting on February 2, 2021, at 1:30 P.M.

Currently, the manufacturer is facing more than 8,000 product liability litigations against its products, which include Bard Ventralight, Bard Ventralex, Bard Prefix, Bard 3DMax, and other similar mesh systems. Each lawsuit claims that the company sold defective products in the market, which resulted in plaintiffs suffering from painful and debilitating complications.

The mesh products named in the lawsuits contain polypropylene material, which can easily break, shrink or wear off. This often leads to device migration, organ perforation, infection, and several other complications. Lawsuits allege the defective design of the hernia mesh often required the patients to undergo additional correction surgeries.

The U.S. district judge has also rescheduled the first bellwether jury trial of the Bard hernia mesh lawsuit from May 2020 to September 29, 2020, which is now rescheduled to January 2021. The case management order of November 23 states that the first bellwether jury trial will be held on April 19, 2021, followed by two final pretrial conferences on March 24 and April 1.

Allergan USA Inc. filed a supplemental brief on January 5 in the U.S. District Court for the District of New Jersey, asking the federal judge to dismiss claims against its breast implants on the grounds that the consolidated lawsuits are preempted by federal law.

According to the memorandum that supports the motion, the company stated that complaints filed by the plaintiffs challenge the U.S. Food and Drug Administration’s (FDA) regulatory oversight that governs the design, manufacture, labeling, and post-sale reporting for the breast implants and breast tissue extenders.

With this memorandum, the company first took a shot on failure-to-warn claims, arguing that the premarket approval (PMA) only allows the manufacturer to make specific label changes and doesn't restrict them to do so. Additionally, the company added that the PMA only defines when it has to apply for a label change with the FDA, without requiring it to provide a warning to physicians or consumers.

The company argued that the plaintiff's aim on the FDA-approved process must be preempted as no allegations are stating that Allergan's manufacturing methods deviated from the approved PMA.

Breast implants are used in both breast augmentation surgery (to increase the breast size) and in breast reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality).

Allergan Inc.’s breast implants include saline and silicone devices used in breast augmentation and reconstruction. The company is one of the largest breast implant manufacturers in the world and started selling breast implants in 2006. Allergan’s flagship breast implant brand is Natrelle, but it also sells implants under its subsidiaries Inamed and McGhan. The manufacturer received approval from the FDA on 11/17/2006.

Currently, Allergan is facing nearly 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 breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) yet failed to warn about those risks.

The lawsuits are consolidated before U.S. District Judge Brian R. Martinotti in the District of New Jersey under MDL No.: 2921. Also, lawsuits filed in New Jersey are consolidated as part of multicounty litigation (MCL) in the New Jersey Superior Court for Bergen County, where the claims will be presided by Judge Rachelle Harz for coordinated discovery and pretrial proceedings.