What Happened In The MassTorts World Last Week? 2018-Oct-29

In a response filed in the Eastern District of Kentucky, Onglyza drugmaker AstraZeneca asked Judge Karen Caldwell, presiding over all Onglyza heart failure lawsuits to follow a phased pretrial schedule by giving priority to the "general causation" issue of whether the diabetes medication causes heart failure before proceeding with the case-specific discovery. The drugmaker claimed that the court must refrain from providing the plaintiffs with “unfettered discovery” until the court decides whether they can support the evidence presented to prove Onglyza ’s heart failure risks.

The order indicated to bifurcate the case proceedings and stated, “the Court should prioritize general causation because it is pivotal to every case in this proceeding and because Plaintiffs’ allegations on their face fail to support many of their causation claims." However, plaintiffs pointed out that such a move would delay the litigation and might result in duplicative discovery. Discovery into all other issues and the defendant's proposal would be on hold till May 2020. A quarterly status conference to discuss the status of Onglyza litigation has been scheduled for December 18, 2018. The multidistrict litigation (MDL Docket No. 2809) over Onglyza side-effects is overlooked by Judge Karen K. Caldwell in the U.S. District Court for the Eastern District of Kentucky, for coordinated pretrial proceedings.

On Monday, October 22, 2018, San Francisco Superior Court Judge Suzanne Bolanos declined Monsanto's request to toss the $289 million verdict awarded to a former groundskeeper who developed cancer due to Roundup and Ranger Prov herbicides. Judge Bolanos slashed the amount to be paid from $289 million to $78.5 million, even after a considerable effort by the jurors to maintain the original ruling.

The punitive damage was brought down to $39.25 million from $250 million, while the compensatory award remained intact as $39.25 million. The judge stated that under constitutional law, the punitive damages couldn't be more than compensatory damages; the ratio must be one-to-one. The plaintiff has time till December 7 to accept a total of $78.5 million. In case he rejects it, Bayer, who acquired Monsanto must face a new trial on punitive damages.

This is the first lawsuit to go to trial among hundreds of other cases alleging that glyphosate found in Roundup is carcinogenic. Bayer continues to vouch for glyphosate's safety, and it has been proven to be safe by health regulators in the U.S. and Europe. The plaintiff was diagnosed with non-Hodgkin’s lymphoma in 2014 when he used Monsanto's herbicides at a San Francisco Bay Area school.

3T Heater-Cooler System manufacturer LivaNova issued a medical device correction letter on October 18, indicating that the blood temperature regulating machines would be redesigned and new cleaning instructions would be issued to hospitals to reduce the risk of infections among patients. The manufacturer also provided the customers with an updated set of instructions regarding the monitoring and use of hydrogen peroxide in the  3T Heater Coolers.

The U.S Food and Drug Administration (FDA) issued a safety communication last week about the information actively supporting the manufacturer. The FDA stated that the U.S. Centers for Disease Control and Prevention (CDC) is actively evaluating LivaNova’s infection mitigation efforts and are doing their own scientific research to issue appropriate updates soon. Sorin 3T Heater-Coolers are used during heart bypass surgeries, valve replacement surgeries, and other cardiac surgeries to regulate a patient’s blood temperature. But in recent years, reports suggested that certain devices manufactured before September 2014 might be contaminated with bacteria. Lawsuits filed against the company claim that the contamination caused Mycobacterium chimaera or Mycobacterium abscessus infections in patients with compromised immune systems and an open chest cavity during heart surgery.

There are nearly 135 lawsuits filed against the Sorin Group with allegations that their Stockert 3T Heater-Cooler device spreads a bacteria called nontuberculous mycobacteria (NTM). The U.S. JPML consolidated similar lawsuits in February 2018 into a single multidistrict litigation (MDL No. 2816) in the Middle District of Pennsylvania before Judge John E. Jones III for coordinated pretrial proceedings.

As per an order submitted on September 7, hernia mesh lawsuits involving C.R. Bard Inc 's polypropylene implants can be filed directly in the multidistrict litigation which is underway in the U.S. District Court, Southern District of Ohio. The direct filing would eliminate delays in transferring the cases from other jurisdiction. Also, it would promote judicial efficiency and facilitate coordinated discovery and other pretrial proceedings. Any case remaining unresolved would be remanded back to appropriate jurisdiction and venue for trial by the Court.

There are more than 170 hernia mesh lawsuits pending in the federal MDL filed by individuals who suffered serious injuries allegedly due to the defective polypropylene hernia mesh implants. Ventralex, Perfix, and Composix devices sold by C.R. Bard and its Davol, Inc. subsidiary have been reported to be defectively designed in the lawsuits.

According to a lawsuit filed on October 11 in the U.S. District Court for the District of New Jersey, the use of Nexium, Prilosec, Nexium 24HR, and Prilosec OTC Prilosec caused him stomach cancer.

The plaintiff stated in the lawsuit that he took the heartburn medications in January 2013 and was diagnosed with stomach cancer in October 2015. This is one of the first lawsuits filed against the manufacturers of proton pump inhibitors (PPIs) over stomach cancer allegations. The lawsuit accuses the PPI manufacturers of negligent conduct and states, “despite their knowledge of the risks of stomach cancer associated with their proton pump inhibitors, Nexium, Nexium 24HR, Prilosec, and Prilosec OTC, defendants took no action to inform Plaintiff or Plaintiff’s physicians of this known risk.” Several individuals have filed lawsuits in the past blaming PPI drugs for their kidney problems. In December 2013, a study indicated the link between PPI drugs and gastric cancer and stated that the long-term use of the medication might double the risk.

This case is likely to be a part of the federal multidistrict (MDL No. 2789; In Re: Proton-Pump Inhibitor Products Liability Litigation |LS|No. II|RS|), which currently comprises about 2,333 kidney injury lawsuits. Similar PPI lawsuits are centralized before Judge Claire C. Cecchi in the District of New Jersey for coordinated pretrial proceedings. Judge Cecchi has scheduled the first bellwether trial in the litigation for September 21, 2020.

U.S. District Judge Paul Engelmayer excluded statements given by plaintiffs' seven expert witnesses in a Mirena contraceptive lawsuit as the judge found the witnesses unqualified to opine on Mirena's role in causing intracranial hypertension or the opinions provided were unreliable.

Ever since its introduction in 2000, the U.S. FDA has received about 70,000 injury reports filed by individuals who used the Mirena contraceptive device. Bayer failed to adequately warn the public that the device must be used only up to five years after its placement and must be replaced after that. Thousands of women sued Bayer Healthcare for concealing its health risks; the allegations include a range of different side-effects, including Pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (ITC), which causes a buildup of cerebrospinal fluid in the brain. This can lead to problems of vision changes, dizziness, nausea, memory problems, and Tinnitus (ringing in the ears).

There are three sets of multidistrict litigation covering side-effects of Mirena IUDs: MDL No. 2434 (In Re: Mirena IUD Products Liability Litigation (uterine perforation and migration) assigned to U.S. District Judge Cathy Seibel/and Judge Brian R. Martinotti of the Bergen County Superior Court; MDL No. 2767 (In Re:Mirena IUD Levonorgestrel-Related Products Liability Litigation (NO. II) ) in United States District Courts, and NJ MCL No. 297 in New Jersey State Courts. As of September 2018, there were 660 cases in the MDL No. 2767.

Johnson & Johnson agreed to settle a Mississippi plaintiff's case involving Risperdal side-effects, days before going to the trial. The plaintiff was a young boy when he was diagnosed with bipolar disorder in 2004 for which he took Risperdal medication. The lawsuit filed by his parents stated that he gained weight and developed breasts soon after starting the course.

A law firm also stated that the boy, “suffered considerable ridicule in school, causing a great deal of childhood trauma and shame.” Risperdal was approved to be used as a bipolar disorder drug for adolescents in 2007. However, J&J still faces 13,500 cases involving allegations by individuals that the company purposely concealed the gynecomastia risks from patients and doctors.

Two coordinated actions have been filed for Risperdal cases: one in Los Angeles Superior Court (Risperdal and Invega Product Liability Cases, JCCP 4775) and the other in Philadelphia (In Re: Risperdal Litigation, March 2010 Term, Case No. 100300296).

In a response filed on October 12, 2018, more than a dozen opioid manufacturers expressed their opposition regarding forming a separate MDL for infants addicted to opioid drugs. The manufacturers indicated that separating the cases would create a "dangerous precedent" as it would create uncertainty over current MDL judge's decisions when litigants pull out their cases from the existing MDL.

A leading global healthcare solutions company, AmerisourceBergen Corp., filed its own brief asking the JPML to reject the motion for a separate MDL for opioid affected babies. JPML has scheduled an oral argument on the issue on November 29, 2018, in New York.

In September this year, Endo Pharmaceuticals declared to settle about 1,000 lawsuits filed against them moving out from the federal MDL. Opioid overdose death lawsuits are centralized as a part of multidistrict litigation, MDL No. 2804 (In Re: National Prescription Opiate Litigation) in the Northern District of Ohio before U.S. District Judge Dan A. Polster. The first bellwether trial in the litigation has been scheduled for September 3, 2019.