What Happened In The MassTorts World Last Week? 2019-Jun-17
GSK Proposes Reconsideration In Zofran Lawsuits
GlaxoSmithKline has requested the federal judge presiding over all federal Zofran birth defect lawsuits to revisit the preemption defense, based on a recent ruling by the U.S. Supreme Court.
According to the court documents, the plaintiffs have alleged GSK failed to provide sufficient pregnancy warnings on Zofran, which is commonly prescribed for symptoms of morning sickness. The drugmaker previously tried to dismiss the case, arguing that the claims are preempted by federal law since the FDA would not have allowed a pregnancy warning. However, U.S. District Judge Dennis Saylor issued a memorandum and order on February 5, denying summary judgment motion filed by GlaxoSmithKline to toss all Zofran birth defect lawsuits and allowed a group of cases to prepare for early bellwether trials.
More than 468 lawsuits have been filed against GSK alleging that the company knew about Zofran's pregnancy risks for several years yet failed to adequately warn the medical fraternity. Zofran lawsuits were centralized in October 2015, before Judge Dennis F. Saylor as a part of a multidistrict litigation (MDL No. 2657; In Re: Zofran (Ondansetron) Products Liability Litigation) in the District of Massachusetts.
Direct Filing of New Bard IVC Filter Lawsuits Obstructed
According to a case management order issued on May 31, Judge Campbell has declared that new cases of Bard IVC Filter can no longer be filed directly in the District of Arizona.
Following the declaration, any new cases filed in the MDL will be rejected by the court, and the filing fee will be refunded. Each IVC filter lawsuit has to be filed in appropriate U.S. District Court and proceed with an individual trial schedule; the parties can access the consolidated discovery and rulings that were made in the MDL. Judge Campbell had previously indicated that the MDL work was towards completion, following which each case was to be returned to the court for a separate trial date where it was originally filed.
U.S. District Judge David G. Campbell is presiding over more than 7,000 IVC Filter lawsuits filed against C.R. Bard under MDL No. 2641; In Re: Bard IVC Filters Products Liability Litigation. Additionally, around 4,000 Cook IVC filter lawsuits are pending in a separate MDL, alleging that the devices sold by this competing manufacturer carry similar design defects. In February, an Indianapolis jury awarded a plaintiff $3 million in compensatory damages.
Tainted Valsartan Alleged For Kidney Cancer Diagnosis
According to the latest lawsuit filed in the Superior Court of New Jersey on June 5, a woman from Tennessee has alleged Solco Healthcare, Prinston Pharmaceutical, Inc., and Huahai US, Inc. for her kidney cancer caused due to the intake of the recalled valsartan pills.
The plaintiff claims she underwent diagnosis and treatment of kidney cancer, which included the surgical removal of a tumor and a partial nephrectomy following the exposure to the pills that were recalled in recent months due to the presence of cancer-causing chemicals N-nitrosodimethylamine (NDMA) or N-Nitrosodiethylamine (NDEA). The defendants further face allegations of a manufacturing defect, strict liability, negligence, failure to warn, and loss of consortium. The plaintiff and her husband both have claimed compensatory and punitive damages.
The case joins a growing number of lawsuits pending in District Courts across the U.S. against Valsartan. Valsartan claims are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) 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.
Protocols Established For Bard IVC Filter Lawsuits
In a case management order for Bard IVC Filter lawsuit released on June 7, in the U.S. District Court, Southern District of Ohio, the federal court has established protocols for the filing of Amended Complaints in bellwether cases against C.R. Bard, Inc. and its Davol, Inc. subsidiary.
The plaintiffs should file an Amended Complaint within 7 days from the date of the order issued. Any plaintiff failing to file an Amended Complaint, who had previously filed a Short Form Complaint, should notify the Defendants’ Counsel via email. The defendants should submit strong and detailed answers and defenses, including all affirmative defenses, no later than 10 days after the plaintiffs have filed an Amended Complaint.
U.S. District Judge David G. Campbell is presiding over more than 7,000 IVC Filter lawsuits filed against C.R. Bard under MDL No. 2641; In Re: Bard IVC Filters Products Liability Litigation. Three bellwether trials will begin on May 8, 2020, July 13, 2020, and September 14, 2020, as indicated by the Southern District Court of Ohio. The Court established a pool of 12 Bard hernia mesh lawsuits in March. These cases are now undergoing case-specific discovery in preparation for bellwether trials; once the discovery is complete the court will reduce the pool by half. The final selection for the bellwether trial will be announced on February 14, 2020.
IIH Allegations On Mirena Dismissed For Lack Of Proof
U.S. District Judge Paul Engelmayer passed a summary judgment motion in a suit that alleged Mirena causes idiopathic intracranial hypertension, or IIH, further stating clearly in the multidistrict litigation, Bayer AG cannot be held responsible for causing IIH as the plaintiffs failed to show there was any admissible evidence proving Mirena could cause IIH.
The ruling was a result of a lack of proof against the pharmaceutical giant. Around 920 women allege Mirena use caused them to develop Idiopathic Intracranial Hypertension (IIH), which if left untreated, can cause headaches, vision problems and, in extreme cases, blindness. The judge said there is no scientific literature reviewed by medical organization, regulator or peer that has found Mirena, or any contraceptive, to be a cause of IIH.
As per the statement released by Bayer, "Judge Engelmayer's decision on summary judgment is a significant ruling that dismisses all cases pending in the MDL." Three multidistrict litigations have been set-up covering alleged 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 the United States District Courts; and NJ MCL No. 297 in New Jersey State Courts.
Teva's $85M Opioid Settlement Hits Another Checkpoint
Teva's $85 million opioid lawsuit settlement approval has been declined by an Oklahoma judge until it complies to a new law governing how state-involved settlements are paid before it will be approved.
The suit is the nation's first trial against numerous pharmaceutical companies that make opioids, including Teva and Johnson & Johnson for an epidemic of painkiller abuse. The allegations also cover multiple companies that Teva has acquired over the years, including Cephalon Inc. and Actavis Generics. Following the lawsuit, Teva announced its $85 million settlement in May, just before the trial began. In a similar trial held in March, OxyContin maker Purdue Pharma LP made a settlement of $270 million.
U.S. District Judge Dan Polster is presiding over more than 1,900 suits filed by U.S. cities and counties of which more than 1,600 cases are filed largely by local governments, Native American tribes, and hospitals. The first trial in the MDL No. 2804 is set to start in October 2019.
19 Off 21 Children’s Cereals Detected With Roundup Chemical
Popular children’s cereals have been detected with Glyphosate, the active ingredient found in Monsanto Roundup and other widely-used herbicides.
The Environmental Working Group tested 21 kinds of breakfast cereals, out of which 19 had high levels of Roundup chemical. The Environmental Working Group’s health benchmark for children is 160 ppb. The levels detected in General Mills’ Honey Nut Cheerios Medley Crunch is 833 ppb, and in Cheerios, is 729 ppb. Glyphosate is the most popular weed killer in the world; more than 250 million pounds of the Roundup chemicals are sprayed on U.S. agricultural crops every year. Olga Naidenko, Ph.D., vice president for science investigations at the Environmental Working Group, stated as per the latest tests, a box of Cheerios or other oat-based foods on store shelves available today have the presence of a carcinogenic chemical.
Bayer AG overtook Monsanto last June and is currently defending 14,000 Roundup cancer lawsuits. In a Roundup trial that concluded last month, a California jury awarded $2 billion to an elderly couple with NHL disease. U.S. District Judge Vince Chhabria is presiding overall the federal multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation) in the Northern District of California.
Special Forces Officer Files a Lawsuit on 3M Combat Earplugs
In the latest complaint filed in the Northern District Court of Florida, a U.S. special forces officer, alleged that he suffered hearing loss and tinnitus due to defective design of the combat arms earplugs.
3M Combat Arms earplugs were provided to the plaintiff and other service members when they were stationed at Fort Bragg since 2002; assuming that the issued earplugs were not defective, the plaintiff also purchased a pair at a store.
Plaintiff's lawsuit stated that he first noticed his hearing problems in late 2005 or 2006. In 2011 the condition worsened, and the plaintiff was diagnosed with hearing loss. The lawsuit stated that the plaintiff wore combat arms earplugs whenever he got exposed to noises louder than background noise and now experienced one to four episodes of tinnitus every day.
An increasing number of military earplugs hearing loss lawsuits have been filed in recent months over design defects stating the earplugs were too short to properly fit in the ear, but 3M continued to sell them to the U.S military. In July 2018, 3M reached a $9.1M settlement over the combat arms earplugs problems with Department of Justice.
Plaintiff Wins $12M in Talcum Powder Lawsuit
The Alameda County Superior Court jury has awarded $12 million to a woman diagnosed with mesothelioma linked to the usage of talcum powder products made by Johnson & Johnson (J&J) and Colgate-Palmolive Co.
According to the lawsuit filed, the plaintiff alleged that she got mesothelioma in 2018, after using J&J’s talcum powder and Colgate-Palmolive’s Cashmere Bouquet throughout her life. The jury found that Colgate-Palmolive and J&J failed to warn about the risks associated with their talcum powder products, which is a substantial factor in the lawsuit. According to the jurors, J&J and Colgate-Palmolive, both were 40% at fault, with the remaining 20% against Avon, which was not a defendant at trial. The verdict award was for compensatory damages. The jury has also imposed punitive damages against the defendants. J&J filed a motion for mistrial after the trial began, and Colgate-Palmolive filed a motion for nonsuit.
J&J is facing nearly 14,000 similar allegations against the company’s talc-based products. Hon. Freda L. Wolfson, U.S.D.J./ Hon. Lois H. Goodman, U.S.M.J. overlooks J&J's talcum powder multidistrict litigation (MDL No. 2738; In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation) in the District of New Jersey.
Gastric Cancer Lawsuits Over PPI's To Be Excluded From MDL
According to the letter sent by Proton Pump Inhibitors (PPI) defendant attorneys on June 12, Judge Cecchi was requested to remove 13 pending cases in the MDL No. 2789 that involve gastric cancer or stomach cancer injuries, as they do not involve kidney injuries for which this MDL was established.
The complaints about failure to warn on the effects of Prilosec, Nexium, Prevacid, and heartburn medications continue to grow; the drug manufacturers indicated that the gastric cancer lawsuits should not be centralized together with other claims and to handle cases differently as it involves different science, different experts, different testimony and argue that the claims involving stomach and gastric cancer should be handled separately as gastric cancer lawsuits will distract the parties and the MDL Court’s resources from the pending kidney claims.
Currently, there are more than 12,300 Prilosec, Protonix, Nexium, Prevacid lawsuits, and other claims brought by plaintiffs indicating that they developed chronic kidney disease, acute kidney injury, and other renal complications.
Judge Cecchi established a bellwether process where a small group of representative cases involving kidney injury is being prepared for early trial dates according to the schedule provided by the court. The first bellwether trial is expected to begin on September 21, 2020.
Lawsuits over PPIs are filed across the U.S., which are centralized as a part of multidistrict litigation (MDL No. 2789; In Re: Proton-Pump Inhibitor Products Liability Litigation |LS|No. II|RS|) in the District of New Jersey before Judge Claire C. Cecchi for coordinated discovery and pretrial proceedings.
Losartan Recall Expanded Over The Presence Of NMBA
On June 11, the FDA announced recall expansion of Teva losartan potassium tablets, indicating the presence of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
Teva initially recalled 35 lots (six lots of 25 mg strength and 29 lots of 100 mg strength) of bulk Losartan Potassium tablets due to NMBA contamination in April this year. Following the expansion announcement, it is now recalling at least six more bulk lots, two of 50 mg strength and four of 100 mg strength generic losartan tablets, from hospitals and pharmacy shelves.
NMBA is the third chemical impurity which is found largely in generic blood pressure drugs. The acceptable exposure limit for the levels of NMBA is 9.82 parts per million (ppm). Research shows nitrosamines are linked to gastrointestinal tract cancers, including colon cancer, stomach cancer, and esophageal cancer. Also, nitrosamines may cause liver cancer, kidney cancer, and pancreatic cancer. There are 50 valsartan lawsuits pending in the federal litigation underway in New Jersey. The proceeding involves over 40 valsartan recall defendants, including Zhejiang Huahai, Teva Pharmaceutical Industries Ltd., Mylan NV, and CVS Health Co.
J&J Talc Lawsuit: U.S District Judge Rejects Transfer
U.S. District Judge Mark Kearney of the Eastern District of Pennsylvania on Tuesday dismissed Johnson & Johnson’s request to move a talcum powder cancer lawsuit out of Philadelphia, as he did not have jurisdiction over the claims. It is the first talc-related case to come before a Philadelphia jury.
A couple alleged J&J's talcum powder products for the wife's ovarian cancer in the Philadelphia County Court of Common Pleas in January 2017. The plaintiffs initially filed a claim against Imerys as well, but later dropped it in February. The plaintiffs are represented by Nancy Winkler and Todd Schoenhaus from Eisenberg, Rothweiler, Winkler, Eisenberg, & Jeck, as well as Ted Meadows of Beasley Allen.
Nearly 12,000 J&J Baby Powder lawsuits and Shower-to-Shower lawsuits are pending in courts nationwide, claiming that the manufacturer failed to warn about the risks of using talcum powder. Hon. Freda L. Wolfson, U.S.D.J./ Hon. Lois H. Goodman, U.S.M.J. overlooks J&J's talcum powder multidistrict litigation (MDL No. 2738; In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation) in the District of New Jersey.