What Happened In The MassTorts World Last Week? 2018-Aug-27

Herbicide manufacturer Monsanto's appeal to boycott the decision to tag glyphosate found in Roundup weed killer as carcinogenic was rejected by the California State's Supreme Court.

The Supreme Court's decision came as a result of the announcement by California First District Court of Appeals that the state has the authority to place glyphosate on its Proposition 65 list, which requires that products containing the herbicide must carry a cancer warning label on them. Glyphosate was added to the State's Prop 65 list last July by the California Office of Environmental Health Hazard Assessment (OEHHA) and argued Monsanto and other herbicide manufacturers to follow cancer warning label instructions for all weed killers containing glyphosate. Recently, the first Roundup trial concluded with the California jury awarding a former school district groundskeeper dying of non-Hodgkin’s lymphoma with $289 million in damages.

More than 4,000 lawsuits have been filed against Monsanto by families of individuals suffering from cancer due to contact with glyphosate found in Roundup weed killer. All lawsuits claim the manufacturer purposely neglected to warn consumers regarding the carcinogenic product. Roundup lawsuits are consolidated as a part of multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation), presided over by Judge Vince Chhabria, in the U.S. District Court of  San Francisco.

In an August 8 complaint filed in the U.S. District Court District of Pennsylvania, a plaintiff alleges that Arthrex Inc.’s recalled iBalance knee replacement device, he was implanted with, was faulty and required him to undergo a revision surgery. The plaintiff blames the company for conducting inadequate testing before exclusively marketing the device. The device was recalled in February 2015, when Arthrex sent out urgent medical device voluntary recall letters to distributors, surgeons, and medical centers, reporting the removal.

More than 4 million Americans have undergone a knee replacement, and thousands have reported faulty device designs. Around 2,378 Arthrex iBalance units were affected by the 2015 FDA Class II recall.  DePuy Synthes Attune, Zimmer, and several other manufacturers are facing claims over faulty knee replacement systems causing severe internal injuries to patients.

A case management order was submitted recently in which Judge Wolfson confirmed general causation and Daubert hearings schedule on the link between Talc powder use and ovarian cancer. The order indicates that the court will make a decision about the admissibility of the plaintiffs’ evidence by next summer.

The sample testing for general causation expert reports is required to be completed by October 1, with the plaintiffs serving the expert reports themselves on or before November 16. The defendant gets time until December 17 to conclude any depositions of the plaintiff's general causation experts and February 15, 2019, to submit causation expert reports, and plaintiffs are supposed to complete depositions on those experts. The Daubert hearing is scheduled for June 11, 2019, for which motions must be filed by April 18, 2019.

More than 8,200 product liability lawsuits against Johnson & Johnson claim asbestos in talcum powder causes ovarian cancer and mesothelioma, yet the company false marketed the talc products extensively.

Recently, a Missouri jury ordered J&J to pay $4.7 billion to a group of 22 women who developed ovarian cancer. Lawsuits pending against the talc manufacturer, are centralized for pretrial proceedings in the District of New Jersey, presided over by Hon. Freda L. Wolfson, U.S.D.J./ Hon. Lois H. Goodman, U.S.M.J. as a part of a multidistrict litigation (MDL No. 2738; In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation).

The New Jersey Supreme Court announced a multicounty (MCL) status for hair-loss lawsuits against Taxotere manufacturers on Tuesday, confirming the centralization of the cases in the Garden State and assigned the group to Superior Court Judge James Hyland.

The Justices published a notice on August 15, granting multicounty litigation status to about 353 such cases against Sanofi U.S. Services Inc., Sanofi-Aventis U.S. LLC, Sandoz Inc. and Actavis LLC, all of which allege the makers failed to adequately warn consumers about the potential health risks of Taxotere use. Chief Justice Stuart Rabner approved the application on August 17.

A significant number of Taxotere cases were already before Judge Hyland before the designation as a mass tort. About 9,100 Taxotere lawsuits are centralized as a multidistrict litigation (MDL No.2740; In Re: Taxotere (Docetaxel) Products Liability Litigation) for pretrial proceedings Eastern District of Louisiana overlooked by Judge Kurt D. Engelhardt.  All of the lawsuits claim the chemotherapy drug is prone to cause permanent hair loss, the bellwether trial for the same is expected to begin in May 2019.

The Seventh Circuit sanctioned the appeal filed by GlaxoSmithKline (GSK), to reverse a $3 million jury award given to the widow of a victim, stating that the company cannot be held liable as the victim took a generic version of GSK's antidepressant Paxil.

The victim, a partner at a law firm, consumed the generic version of Paxil before jumping in front of a commuter train to commit suicide in 2010. As per a 2011 ruling by the U.S. Supreme Court, generic drug companies are not liable for failing to provide adequate label warnings since federal law requires them to use brand versions' labels only. The victim's widow filed a lawsuit against GSK in 2012, alleging GSK had underreported adult suicide rates during its trial studies to the FDA. However, GSK blames the FDA for failing to update Paxil label warnings regarding adult suicide despite several requests to do so. Paxil labels at present include warnings about suicide risks for patients below the age of 24.

The drugmaker also faces several claims associated with birth defects and autism in babies if consumed by women during pregnancy. Other complications include an increased risk of withdrawal symptoms. Lawsuits filed against GSK over Paxil side-effects are consolidated for pretrial proceedings in the Central District of California (withdrawal) and in the  Philadelphia County Court of Common Pleas (birth defects). GSK paid $160 million to settle 3,200 withdrawal symptom lawsuits. MDL 1574 (Ninth Circuit: In re Paxil Products Liability Litigation), presided over by U.S. District Court Judge Mariana Pfaelzer, in the Central District of California holds lawsuits filed for withdrawal symptoms.

As the complications related to transvaginal mesh used to treat pelvic prolapse and stress urinary incontinence continues to build up, Scotland takes measures to put a temporary ban on using the mesh for surgical procedures. The Holyrood Public Petition Committee has filed a request with the Scottish Parliament referring that vaginal mesh implants should be barred from use in Scotland.

The petition comes following United Kingdom's suspension of the device after recommendations by the Independent Medicines and Medical Devices Safety Review and the U.K. Department of Health and Social Care and National Health Service (NHS) England. C.R. Bard, Ethicon Inc., Boston Scientific and other manufacturers face lawsuits over design flaws in their vaginal mesh implants causing severe internal injuries to women across the U.S. and U.K. The FDA states that there is no additional benefit of using the transvaginal mesh in comparison to other traditional methods of treating pelvic prolapse.

Lawsuits included in the multidistrict litigation (MDL) formed over Transvaginal mesh (TVM) complications are overlooked by Judge Joseph R. Goodwin in the Southern District of West Virginia for consolidated pretrial proceedings.

In an order issued on August 16, Judge Martinotti presiding over Invokana lawsuits, instructed the plaintiffs whose claims remain unresolved to submit additional information related to their case. For proceeding, the plaintiffs are also required to inform the treating doctors and dispensing pharmacies to save evidence, medical records and fact sheets related to their claims. The order also implies that the resolution process would come into effect immediately for new Invokana cases filed. However, existing plaintiffs get time till October 30 for submitting the additional documents and evidence.

Defendants Johnson & Johnson and its subsidiary Janssen Pharmaceuticals face hundreds of lawsuits claiming the manufacturers failed to send out an adequate public warning regarding the risk of amputations of the leg and foot as potential side effects of the diabetes drug. The federal multidistrict litigation (MDL No: 2750) for Invokana lawsuits was formed in December 2016, in the U.S. District Court, District of New Jersey, presided by Hon. Brian R. Martinotti for coordinated pretrial proceedings. The first bellwether trial is slated to begin in September 2018.

A three-judge panel of the Missouri Court of Appeals in Kansas City granted a new trial in C.R. Bard's transvaginal mesh lawsuit. The jury allowed the plaintiff to question the company’s executive John Weiland, regarding their guilty plea in 1994, against the charges that they concealed information from the U.S. FDA about the defective Align transvaginal mesh (TVM) device.

The Missouri Appeals Court ordered a new trial in the pelvic mesh case, stating that the judge ruled in favor of the defense party and wrongly excluded testimony about the company's earlier criminal convictions. The plaintiff was implanted with Boston Scientific's Solyx pelvic mesh device to treat pelvic organ prolapse in 2010. Shortly after two months, the implant allegedly failed and an Align pelvic mesh manufactured by C.R.Bard was implanted in a correction surgery. In her lawsuit against Truman Medical Center Inc., she argued that the failure of the Align device caused her chronic pain and blamed Boston for using Marlex brand polypropylene mesh, which is unsafe for human implantation. The Missouri Court of Appeals on August 21, denied the plaintiff a new trial to her claims against co-defendant Boston Scientific, stating that the error conducted by the trial court did not rise to reversible error.

Pelvic mesh manufacturers across the U.S face thousands of lawsuits all claiming design flaws in the device causing organ perforation and devastating internal organ damage. Apart from C.R.Bard and Boston Scientific, other defendants include Ethicon, Coloplast, Cook Medical and American Medical Systems. TVM multidistrict litigation is overlooked by U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia.

In a motion filed on August 14 in the Eastern District of Tennessee, Exactech Inc. agreed on a summary judgment in a plaintiff's case involving allegations regarding the company's AcuMatch hip implant. The move was taken considering the company's declaration that there was no written warranty that the device had a shelf life of more than 15 years; hence, the case could be barred under Texas law. The manufacturer challenges the evidence and testimony, stating that neither the plaintiff nor the performing surgeon counted on the written warranty details for the hip implant.

Similar allegations are piling up in the federal courts across the U.S. against other hip implant manufacturers including Zimmer, Biomet, 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.

Judge Rex Burlison in Missouri’s 22nd Circuit Court, St. Louis, confirmed on Tuesday the $4.7 billion award for 22 plaintiffs who alleged that asbestos presence in Johnson & Johnson's talcum products causes ovarian cancer.

Even as the talcum giant strongly denies its products contain carcinogenic asbestos, the case concluded in July in Missouri, as the jury found documents affirming that the company was aware of the risks of talcum and falsely marketed the product.

As per jury's verdict, $550 million has been awarded to the plaintiffs as compensatory damages, and an additional $4.14 billion in punitive damages. Each plaintiff along with the families of 6 women who died of ovarian cancer has been awarded $25 million. The verdict was one of the largest involving Johnson & Johnson talcum powder litigation, which holds more than 10,000 claims. J&J vows to appeal Missouri court’s judgment soon. The talcum manufacturer also faces several claims regarding asbestos exposure causing mesothelioma, which is a rare form of cancer affecting the heart, lungs, and abdomen.

Taxotere lawsuits alleging permanent hair loss side effect continue to move forward in the federal litigation in the U.S. District Court, Eastern District of Louisiana. As per an order submitted on September 20, 2018, the Court permits the plaintiffs to amend their Master Complaint to add Sagent Pharmaceuticals, Inc. and Actavis LLC f/k/a Actavis Inc. as additional defendants in the multidistrict litigation (MDL No. 2740; In Re: Taxotere (Docetaxel) Products Liability Litigation).

Taxotere (docetaxel) is an FDA approved breast cancer drug, which was further proved to be effective in treating head and neck cancer, gastric cancer, prostate cancer, and non-small cell lung cancer. Chemotherapy drugs are likely to cause temporary hair loss in patients; however, plaintiffs claim Taxotere is more prone to cause permanent hair loss (alopecia) in comparison to other equally-effective alternatives. The multidistrict litigation involves about 9,300 cases pending over permanent hair loss and inadequate warning by the manufacturers. A series of bellwether trials are expected to begin in May 2019. Last month, about 300 lawsuits were centralized in Middlesex County Superior Court before a single judge. The case management conference for the multicounty litigation (MCL) has been scheduled for October 4, 2018.