What Happened In The MassTorts World Last Week? 2018-Sept-03

Following a unanimous verdict of $289 million for a cancer victim's lawsuits alleging Roundup's cancer link, mount to nearly 8,000 against Bayer in both state and federal courts. While the California jury's verdict opened many possibilities for similar cases, Bayer continues to deny glyphosate's involvement in causing cancer and plans to vigorously defend this case and all upcoming cases. When Bayer bought Monsanto in June 2018, it was facing nearly 5,200 Roundup product liability lawsuits.

Glyphosate present in Roundup weedkiller and Ranger Prov herbicides has been reported to cause Non-Hodgkin Lymphoma (NHL) in humans coming in close contact with the herbicide.

A recent lawsuit filed in the U.S District Court for the District of New Jersey claims that Invokana manufacturer Johnson & Johnson and its subsidiary Janssen Pharmaceuticals failed to warn patients consuming the diabetes drug about amputation risks of the medication.

The plaintiff developed severe tissue necrosis, dry gangrene, and blackening of the fingers when she was under Invokana treatment in 2015. In her lawsuit, she argues that adequate warning about the associated risks of the drug would have helped her to avoid such a disastrous effect and blames the drugmaker for hiding such critical information. In December 2015, the FDA ordered the makers to include diabetic ketoacidosis warnings on the Invokana label. In May 2017, following several reports on leg and foot amputations, a warning label update for the same was ordered by the FDA.

The hand amputation case by the plaintiff will be consolidated as a part of the multidistrict litigation (MDL No.: 2750) for Invokana lawsuits presided by Hon. Brian R. Martinotti for coordinated pretrial proceedings in the District of New Jersey. The first Invokana bellwether trial is slated to begin in September 2018.

Plaintiffs involved in the Biomet Hip implants lawsuits have time only until September 1 for direct filing of their cases in court; no direct filings will be allowed after that date. Recently, the court also released an order on August 24, wherein the presiding Judge Robert L. Miller Jr. of the U.S. District Court for the Northern District of Indiana asked the JPML to stop issuing conditional transfer orders to the MDL as of September 1.

Allegations include defects in Biomet’s M2a Magnum system of hip implant products. Plaintiffs blame the metal-on-metal design of the M2a Magnum system and the alleged tendency of the device to generate metal ions which cause metallosis in the adjoining tissue and tend to fail early.

Similar allegations are piling up in the federal courts across the U.S. against other hip implant manufacturers including Zimmer and Stryker. Zimmer has settled many of the lawsuits between 2016 and 2017, but as of August 2018, about 131 cases linked to complications due to Zimmer Durom Hip Cup Implant, are still pending in the Multidistrict Litigation (MDL No. 2158 (In Re: Zimmer Durom Hip Cup Products Liability Litigation), which is overlooked by Judge Susan D. Wigenton in the U.S. District for New Jersey. Lawsuits continue to be filed involving complications over Stryker Hip Replacement system centralized before U.S. District Judge Indira Talwani under MDL No. 2768 – in Re: Stryker LFIT V40 Femoral Head Products Liability Litigation.

Gauging the growing number of cases, a group of plaintiffs involved in the Linear Gadolinium-based Contrast Agents (GBCA) lawsuits filed a petition on July 31 before the U.S. Judicial Panel requesting for a multi-district litigation creation, on the grounds of easing coordinated pretrial proceedings, reducing duplicative discovery into common issues, and serving the convenience of witnesses, parties and the judicial system. The Northern District of California was requested by the plaintiffs as the preferred venue for centralization.

In response, an opposition was filed by six manufacturers, named as defendants in the litigation: Bayer, GE Healthcare, Bracco Diagnostics, Mallinckrodt Inc., Guerbet LLC and Liebel-Flarsheim Company, and McKesson Corp. A small pool of cases, diverse manufacturers and products, selection and case eligibility criteria not well defined were a few reasons stated for not agreeing with the creation of the MDL. Moreover, the defendants stated the alleged injuries fall under a broad category which would not be justified by placing under one umbrella of “gadolinium deposition disease (GDD).”

The U.S. JPML will hear the oral arguments on September 27, at the Phillip Burton U.S. Courthouse in San Francisco.

U.S. District Judge Ed Kinkeade bestowed $245 million on six plaintiffs involved in the lawsuits against Johnson & Johnson and its DePuy Orthopaedics, over the alleged Pinnacle Hip Implant defects. The verdict was declared in November 2017, by a federal jury in Dallas.

All these plaintiffs had similar allegations against the company for wrongfully marketing the hip implant used to treat osteoarthritis-related joint failure. The first trial over the Pinnacle Hip Implant defect ended in J&J's favor in 2014; however, subsequent jury trials found the company liable for the design defects in their Metal-on-Metal (MoM).

J&J and DePuy have been accused of failing to warn about devices getting eroded and releasing metal ions, which can lead to metallosis often requiring revision surgery. Over 9,400 Pinnacle Hip lawsuits are pending in the federal court for the complications caused due to the Metal-on-metal (MoM) hip implant. About 28,000 lawsuits have been filed against hip implant makers, involving defendants Zimmer, Stryker, Biomet, Wright, and Smith & Nephew.

A three-judge panel in the 11th U.S. Circuit Court of Appeals reversed the summary judgment granted to a plaintiff in a case against Johnson & Johnson unit Mentor Worldwide LLC over the alleged complications related to the company's defective ObTape Transobturator Sling. The appeals court opined that the case can head to trial, despite being late-filed contradicting the trial court's earlier findings.

The Florida resident filed her complaint seven years after the transvaginal mesh (TVM) was removed when she came across a plaintiff lawyer's advertisement. Until then she was not alerted about the potential claims against the manufacturer. While the company stands by the device's efficiency and safety, the sling was removed from the market in 2006. Cases against Mentor continue to be filed by women facing complications as the mesh gets too ingrained in the vaginal tissues to be removed safely. The company settled a handful of cases back in September and October of 2014. J&J agreed on settling Mentor TVM cases for 111 plaintiffs for an undisclosed amount in the U.S. District Court for the Middle District of Georgia.

The U.S. Food and Drug Administration (FDA) officials released a strong drug safety communication about the side effects of Invokana, Jardiance, Farxiga and similar diabetes drugs, causing serious genital infections. The infection is commonly referred to as a "flesh-eating" infection and is known as Fournier’s gangrene, a rare life-threatening condition, which kills soft tissues, muscles, and blood vessels. As per a 2006 study, if this condition is left untreated, it might lead to sepsis and organ failure soon.

The FDA has come across 12 cases of Fournier’s gangrene in patients under sodium-glucose cotransporter-2 (SGLT2) inhibitors treatment between March 2013 to March 2018. However, they indicate these figures are only from the reports submitted to the FDA,  there might be more cases which the officials are unaware of yet. Drug Experts claim out of hundreds of adverse event incidents, only 10% or lesser reaches the FDA level.

Regulators at the FDA ordered new label warnings for drugs belonging to SGLT-2 class including Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet, and Steglujan. Steglatro is the only drug among these which is not linked to the genital infection, but the agency still requires a label warning anyway.

The manufacturers of the blood thinner drug Xarelto won another case filed against them over the drug's alleged excessive bleeding effect. Philadelphia Court of Common Pleas announced the verdict after a four-week trial against Bayer and Johnson & Johnson.  

The case involves the allegations by a 63-year-old New Jersey resident that he suffered “gastrointestinal bleeding" under Xarelto treatment for his pulmonary embolism. The plaintiff had been prescribed the drug, which he continued to consume from November 2014 to December 2015. In his 2016 complaint, he alleges inadequate warnings regarding the health risks of the drug required him to be hospitalized for four days due to excessive bleeding. The jury ruled in favor of Bayer and J&J over claims that they failed to provide sufficient health risk warning, awarding them another victory in the massive Xarelto litigation.

Xarelto multidistrict litigation (MDL No.2592; In Re: Xarelto (Rivaroxaban) Products Liability Litigation) has more than 22,250 lawsuits claiming uncontrolled internal bleeding as a serious side-effect. The MDL is overlooked by Judge Fallon in the Eastern District of Louisiana.