What Happened In The MassTorts World Last Week? 2021-Jan-18

Last week, the 4th Circuit U.S. Court of Appeals in Richmond, Virginia, reversed a jury decision to award $1.25 million to the family of a now-deceased West Virginia woman alleging Boehringer Ingelheim's blood thinner Pradaxa for the woman's gastrointestinal bleeding.

Pradaxa (Dabigatran) is an oral anticoagulant prescribed to lower the chance of stroke for those suffering from atrial fibrillation (not caused by heart valve issues) and to treat blood clots in the veins of the legs (deep vein thrombosis) or lungs (pulmonary embolism) and reduce the risk of them occurring again. Pradaxa was introduced in the U.S. market in 2010, as an alternative to warfarin, after gaining approval from the U.S. Food and Drug Administration (FDA). The drug is manufactured and marketed by a European pharmaceutical giant, Boehringer Ingelheim Pharmaceuticals, Inc.

According to the opinion dated January 6, the federal appellate panel ruled that the state-law fraud claims on which the jury held the drugmaker liable in 2018  are preempted by federal law.

The lawsuit was filed by the family of a woman who took Pradaxa for years, which allegedly resulted in her death after suffering from gastrointestinal bleeding and other complications. Her children accused the drugmaker of failing to adequately warn about the risks associated with taking the blood thinner.

A jury held the company responsible for the fraud claims and awarded the family $250,000 in compensatory damages and $1 million in punitive damages.

In the recent opinion, U.S. Circuit Judge Marvin Quattlebaum overturned the verdict stating that the company could not have unilaterally changed the drug's label to provide an adequate warning without approval from the U.S. Food and Drug Administration (FDA).

The family argued over the decision asserting that the label failed to warn patients with impaired kidney function to undergo blood testing to check Pradaxa concentration levels. However, Judge Quattlebaum said that as per FDA regulations, the company could only modify the labels based on "newly acquired information" about risks, and a study conducted after the FDA approved the drug did not constitute such information.

Last year, in November, Boehringer filed a brief in Connecticut Supreme Court indicating that it has reached a global settlement to resolve 2,935 lawsuits brought over by patients alleging failure to warn about the bleeding risks associated with the blood thinner. A status update concerning the settlement will be provided by August 2021, as noted by the drugmaker in the filing.

In August 2012, MDL No. 2385 was created by the U.S. Judicial Panel on Multidistrict Litigation to be convened in the Southern District of Illinois and to be presided by Judge David R. Herndon. Nearly 21 legal actions were transferred to this MDL, and thousands of lawsuits continued to be filed touching the count of approximately 4,000.

Last month, a study was published in the medical journal Microbiome, in which researchers noted that chronic exposure to Roundup and other glyphosate-based weedkillers may cause embryonic development failure and alteration of key metabolic functions in the keystone species of the food chain.

The study was conducted by researchers from the U.K. who examined the effect of glyphosate on the water flea, Daphnia. Daphnia is a member of the order Cladocera and is considered a keystone species for the aquatic food web. As the flea is the building block of the food chain, any impact on it can affect the rest of the surrounding ecological webs.

Daphnia is the preferred food of small vertebrates and invertebrates as well as a grazer of algae and bacteria; hence, it occupies a central position in the food web of aquatic ecosystems. The researchers discovered that this could result in DNA damage and other problems in the species, affecting their ability to deliver critical ecosystem services.

In November, an associated study was published in the Journal of Hazardous Materials in which researchers from the University of Turku in Finland determined that half of the core human gut microbiome are “potentially sensitive” to glyphosate. The study illustrated that 54 percent of the species in the core human gut microbiome might be impacted by the main ingredient of the weedkiller Roundup.

Glyphosate is classified as a probable carcinogen, and its presence in the weedkiller Roundup has raised concerns of non-Hodgkin’s lymphoma (NHL) and other cancers among its users.

IARC, considered to be the apex in the field of cancer research, classified glyphosate as a “probable human carcinogen.” According to IARC, Roundup is made up of other ingredients that are toxic in themselves, and are also known to increase the toxicity of glyphosate. Monsanto has known this for many years but still refuses to study the link between cancer and Roundup.

Monsanto has a brief history of legal troubles and Glyphosate is just another herbicide of the company to attract lawsuits. Plaintiffs across the U.S. have filed numerous lawsuits. 

In the legal world, attorneys representing Roundup manufacturer filed a joint case management statement and litigation plan in November with U.S. District Judge Vince Chhabria, overseeing the rising weedkiller litigation, indicating that the company missed the deadline set by the court. The deadline was set to the same day on which the statement was filed, and the judge had indicated to restart the litigation at full throttle over claims alleging the weedkiller of causing non-Hodgkin's lymphoma.

Bayer, the manufacturer of the controversial weedkiller, Roundup, is facing approximately 125,000 filed and unfiled claims. The lawsuits are presided by U.S. District Judge Vince Chhabria under MDL No. 2741 in the U.S. District Court for the Northern District of California.

On Tuesday, Judge Robert B. Kugler of the U.S. District Court for the District of New Jersey, presiding over the blood pressure drug valsartan lawsuits, said that consumers in the multidistrict litigation (MDL) cannot bring claims under laws of states in which they don't reside in.

Diovan (Valsartan) was manufactured by Novartis International AG and was approved by the FDA on August 14, 2002. Diovan lost its patent in September 2014. The launch of the generic drug had been on hold since patent expiry due to regulatory problems with the FDA. In 2014, a US-based Ohm Laboratories (Ohm), a subsidiary of Ranbaxy Laboratories, was the first to get the approval from FDA for generic Valsartan. Thereafter, many generic versions of Valsartan came into the market via many other pharma companies.

The usage of Diovan had no evidence of any adversity in its entire span, but the FDA did find that the generic versions of Valsartan were causing issues. The most serious issue reported was that it had the presence of an impurity called N-Nitrosodimethylamine (NDMA), which was believed to be formed as a byproduct through a chemical reaction. Not only was this an impurity, but a concern was also raised when it was detected that NDMA is carcinogenic and can lead to cancer in people consuming this drug for the long term.

According to the order dated January 12, Judge Kugler dismissed several claims in the master complaints stating that the named plaintiffs filed claims under the laws of all 50 states, whereas they represent only 21 states.

The plaintiffs are given a deadline of January 27 to amend their complaints as they brought the claims in states where they neither reside nor were injured, as per the order.

The plaintiffs raised arguments stating that only class representatives need to have standing, and they can file out-of-state claims. Judge Kugler rejected the arguments asserting that the Supreme Court's standing cases have made two principles of law, according to which a plaintiff must demonstrate standing for each claim he seeks to press, and class actions do not change the requirements of standing.

Last month, Judge Kugler rejected the defendants' preemption motion and announced the appointment of Hon. Gregory M. Sleet (retired) and Hon. Lawrence F. Stengel (retired) to work with the parties to resolve lawsuits brought against the recalled versions of the hypertension drug.

Currently, at least 650 cases are pending in the litigation docket, each raising similar allegations that long-term exposure to recalled valsartan drug results in stomach cancer, liver cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other injuries.

The lawsuits are consolidated under MDL No. 2875 in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.

Last week, the New York Supreme Court for New York County awarded summary judgment to the defendant, Nissan North America, Inc. (NNA), in an asbestos case after finding that the evidence did not support the asbestos exposure allegations.

According to the lawsuit filed, the decedent worked as a mechanic on Nissan branded vehicles at various service stations throughout the 1970s. The decedent died in 2012 due to lung cancer, for which allegations were made on Nissan, stating that exposure to asbestos from the manufacturer's brakes throughout his career was the reason for his lung cancer.

The defendant filed a motion for summary judgment, arguing that the plaintiffs failed to prove that the decedent’s lung cancer was caused due to products manufactured by NNA.

In its motion, the defendant noted that it did not make any changes to the vehicles until after the decedent’s alleged time of exposure. An affidavit of former Director of Product Safety, Environmental was also attached to the motion as a supporting document, which stated that NNA did not distribute Nissan branded vehicles until 1983.

The court agreed to the defendant's arguments that Nissan vehicles did not exist in the U.S. in the 1970s and hence is not responsible for the decedent’s injury. The defendant made a prima facie showing of entitlement to judgment as a matter of law, and the responsibility shifted to the plaintiffs to establish an issue of fact.

The plaintiffs raised an opposition, stating that their motion is based on gaps in testimony, and the defendant's counsel should have filled those gaps by questioning the decedent during his deposition.

The court stated that it did not find any gap in the testimony of the decedent, as he was asked to identify other brands and models of vehicles distributed by NNA. As the plaintiffs’ opposition failed to raise an issue of fact, the court granted summary judgment to NNA.

In the U.S., the earliest known asbestos-related lawsuit was filed by a woman in 1929 in the Newark (NJ) Federal Court. Along with her, at least 15 other individuals with asbestos-related claims were trying to get compensation. Unfortunately, the woman's lawsuit was thrown out in 1934, but it brought forth the wave of many such lawsuits. One of the biggest companies targeted by these lawsuits was Johns-Manville Corporation, which filed for bankruptcy in 1982.

Asbestos MDL No. 875 was created in 1991 in the Eastern District of Pennsylvania and is one of the largest and longest-lasting MDL.