What Happened In The MassTorts World Last Week? 2020-Dec-14
Nine PPI Drugs Bellwether Cases Selected For Discovery
On December 4, U.S. District Judge Claire C. Cecchi, overseeing the proton pump inhibitor (PPI) drugs litigation, issued a case management order (CMO) indicating that by agreement of the parties, the number of bellwether discovery cases has been reduced to nine.
According to the CMO, a new deadline of January 21, 2021, has been set for the completion of core discovery. Judge Cecchi had set forth a "soft cap" of four depositions per side in CMO 36, following which the pool shall ultimately have six cases by January 29, 2021, to serve as the bellwether trial cases.
The selection will be done by the parties as follows, which shall be subject to the approval of the court:
The plaintiffs' steering committee (PSC) will select one case from among its picks and one case from among the defense’s picks.
The defendants will collectively select one case from among their picks and one case from among PSC’s picks.
Special Master Ellen Reisman will select two cases, one from each group of picks, both of which must be, in her opinion, a representative case.
The cases will then undergo preparation for trial, including additional fact discovery, expert discovery, and dispositive and trial-related motion practice.
The first bellwether trial is expected to begin on November 15, 2021, which will be followed by other cases in the series until early 2022.
Currently, more than 13,000 Nexium, Prilosec, Prevacid, and other PPI drug lawsuits are pending across the federal court system. The lawsuits, consolidated under MDL No. 2789, claim that the manufacturers failed to warn about the risk of acute kidney injury, chronic kidney disease, and end-stage renal failure associated with the heartburn medications.
Nexium (esomeprazole magnesium) manufactured by AstraZeneca is a proton pump inhibitor (PPI) approved by the U.S. Food and Drug Administration (FDA) in 2001 for the treatment of peptic ulcer disease, gastroesophageal reflux disease, dyspepsia, and Zollinger-Ellison syndrome. In late 2010, AstraZeneca announced a co-promotion agreement with Daiichi Sankyo to distribute Nexium. Dexlansoprazole (Dexilant) Esomeprazole (Nexium) Lansoprazole (Prevacid) Omeprazole (Prilosec) Pantoprazole (Protonix) are popular heartburn drugs under the class of Proton Pump Inhibitors (PPI).
Bayer's Quarterly Analysis Reports Problems With Essure
On Monday, Bayer, the manufacturer of the controversial birth control device, Essure, issued the first quarterly analysis report required by the U. S. Food and Drug Administration (FDA) to track the adverse event information associated with the implant.
The analysis is based on the summarized data of the reports identified between June 2020 and August 2020 by the manufacturer. The report covered 7,509 reportable events, which included 7,332 cases involving serious injury, 104 cases of malfunctions, and 73 death reports.
Additionally, the FDA also included two reports about adverse events that noted there were 4,855 cases in September and 3,386 cases in October involving Essure. The common problems mentioned in the reports were pain, perforation, fragmentation, pregnancy, and heavier periods.
The company had released the first batch of adverse event reports based on social media posts in August, which contained 1,453 reportable events, including 53 deaths and 24 malfunction cases.
In August, Bayer officials also disclosed that the company had reached an agreement with plaintiff law firms to pay approximately $1.6 billion to settle nearly 90% of all the lawsuits, including the cases filed in the state of California Joint Council Coordinated Proceedings (JCCP) and the cases pending in the Federal District Court for the Eastern District of Pennsylvania (EDPA).
Conceptus Inc., a subsidiary of Bayer AG, developed Essure which is a Class III device for permanent surgical sterilization in women. Essure was approved by the Food and Drug Administration (FDA) on November 4, 2002. The device has two metal coils made from polyester fibers, nickel-titanium, stainless steel, and solder which are placed in fallopian tubes to induce fibrosis and block the fallopian tubes to prevent fertilization. Since 2002, it is estimated by Bayer that 750,000 women have received the Essure IUD.
Essure was suspended from the market in most countries since 2017, but Bayer continued to sell the device in the U.S. until the end of 2018. In July 2018, Bayer announced to remove all the Essure devices from the U.S. market by December 31, 2018. Following the removal, the FDA required Bayer to extend the postmarket surveillance study and report problems associated with the device.
3M Plaintiffs Seek To Combine 5 Cases For A Single Trial
On December 7, plaintiffs involved in the lawsuits over hearing loss from 3M Combat Arms (CAEv2) earplugs filed a motion asking the presiding U.S. District Judge, Casey Rodgers, to consolidate five different claims from the “Group A” bellwether pool for one single trial.
According to the motion filed, plaintiffs have noted that the claims involve a substantial overlap of both law and facts, which is enough to justify the consolidation. The motion further notes that the factual and legal issues are predominately common in all five cases, including CAEv2’s defects, 3M’s inadequate warnings, and misrepresentations.
The consolidation is being sought to allow the common issues to be presented only once as it would allow timely consideration of Group A Bellwethers’ claims and would help avoid unnecessarily burdening the court, the parties, and witnesses with the presentation of duplicative evidence and the relitigation of common issues.
The motion is the result of a case management conference held on November 20, following which an order was issued asking the parties to submit briefs on the issue of whether to consolidate trials among the first group of bellwether cases. The manufacturer is required to respond by December 15, and any reply brief by the plaintiffs is due by December 22.
The first series of individual bellwether trials are scheduled to begin in April 2021. 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, which would help avoid the need for individual trials nationwide in the coming years.
The Combat Arms Earplugs Version 2 (CAEv2) was manufactured by Aearo Technologies, Inc. before 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 220,000 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.
Mirena MDL Over Idiopathic Intracranial Hypertension Tossed
On Tuesday, the 2nd Circuit U.S. Court of Appeals dismissed the Mirena multidistrict litigation after finding that the plaintiffs lacked evidence over the allegations that the birth control device was the cause of idiopathic intracranial hypertension (IIH) in them.
Mirena is a type of long-acting, reversible hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals. It is a small T-shaped flexible device that is placed into the uterus by a trained healthcare provider during a routine office visit. Once implanted, Mirena releases small amounts of a progestin hormone called Levonorgestrel, locally into the uterus. It provides continuous, highly effective birth control.
It was approved in 2000 by the U.S Food and Drug Administration (FDA) and is one of two hormonal IUDs for use in the United States. In 2009, the FDA expanded Mirena's approval to treat heavy menstrual bleeding in women already using an IUD. It was also claimed to be more than 99 percent effective in controlling pregnancy for up to 5 years, after that the implant needed replacement.
The MDL consisted of more than 900 lawsuits, in which the plaintiffs linked the intrauterine device (IUD) to a disorder with similar symptoms to a brain tumor.
In October 2018, the district judge issued a 156-page opinion allowing Bayer's Daubert motion to exclude expert testimony. In June 2019, the manufacturer was granted summary judgment, and all the cases in the MDL were closed, ruling that the women failed to prove their allegations.
The plaintiffs appealed, stating that the district court focused too much on the conclusions instead of the methodologies and also argued the district court should have only excluded parts of the expert testimony.
In a recent opinion, the appellate panel upheld an award of summary judgment to Bayer, rejecting the plaintiffs' argument that the district court abused its discretion by stopping them from pursuing additional documents.
The panel noted that the rigorous analysis in the 156-page opinion undermined the women's assertion and said that the women did not identify which parts should have been included or how those parts would have shown the causation necessary for the suit to survive summary judgment.