Indian health officials are demanding a detailed list of the ingredients used in Johnson & Johnson's Baby Powder and other talc-based products due to concerns over the alleged carcinogenic asbestos presence in their products. India’s Central Drugs Standard Control Organization (CDSCO) sent out an email on July 19, requesting J&J to reveal the talcum powder contents.
Though in a March 2016 review, CDSOC cleared the company's products of asbestos presence during an inspection of a J&J manufacturing plant in Mumbai, the concerns sour high following a recent $4.7 billion verdict in a talcum trial in Missouri linked to ovarian cancer claims by 22 women.
Currently, there are two separate allegations against J&J, one regarding asbestos presence in their talc-based products causing ovarian cancer in women using it for personal hygiene purpose and the other linked to asbestos exposure causing mesothelioma, a fatal lung cancer. However, J&J continues to deny that their talcum products contain cancer-causing asbestos in them and plans to appeal all the jury verdicts against them.
U.S. District Judge David G. Campbell recently trimmed claims by plaintiff Lisa Hyde against C.R. Bard that the inadequate warnings for the G2X Blood vessel filter caused her complications. The federal judge stated that the plaintiff failed to prove that inadequate warnings were provided by the defendant to prevent the doctor from using the filter.
C.R. Bard's G2 Series of IVC Filter has been reported to break easily and migrate into the body, perforating blood vessels and other organs. The manufacturer faces more than 3,800 lawsuits over severe internal injuries caused due to the device breakage. A multidistrict litigation (MDL No.2641; In Re: Bard IVC Filters Products Liability Litigation) was formed on August 17, 2015, in the United States District Court District of Arizona, presided over by Judge David G. Campbell for centralized pretrial proceedings.
Johnson & Johnson and its subsidiary Ethicon's motion before Judge Kenneth Powell to recuse from the upcoming pelvic mesh trial for plaintiff Diana Perigo, slated to begin at the end of this month, was rejected on July 24. The defendants filed the motion reasoning that Judge Powell's mother was a plaintiff in a mass tort lawsuit in Philadelphia against J&J and Ethicon, and Powell had not previously disclosed the lawsuit.
The motion filed by Ethicon stated, “taken together, your honor’s mother’s pending lawsuit, the overlap in issues and the lack of disclosure, raise serious concerns about the appearance of impropriety that justify recusal to assure a fair trial and to avoid, at minimum, an appearance of partiality under the Rules of Judicial Conduct."
Perigo stated that Judge Arnold New, overseeing the pelvic mesh mass tort litigation, responded unfavorably to the request. The response stated, “instead of filing a motion to recuse Judge Powell with New and knowing the likely order of Judge New, Johnson & Johnson instead filed this motion with Judge Powell. This appears to be judge shopping.”
In mid-July, Ethicon requested the Superior Court for an en banc panel hearing in Carlino v. Ethicon case, which concluded with a $13.5 million verdict in 2016. The defendants now seek to have the verdict assigned to a different appellate panel. However, a three-judge panel has been scheduled to look into Carlino’s case next month.
Just a week after the United Kingdom's National Health Services (NHS) declared a temporary ban on the use of transvaginal mesh, Ireland's Chief Medical Officer Simon Harris has also announced a temporary suspension on the use of the mesh stating “understandable public and patient anxiety” concerning the safety of the implants.
Harris stated, "there are understandable public and patient anxiety about the ongoing safety of mesh devices following the considerable publicity that this issue has received, and this has been heightened by recent developments in the NHS. A pause on the use of mesh procedures, pending confirmation by the Executive that the key recommendations below have been implemented, is now considered proportionate and necessary to provide public assurance that these procedures are being carried out in accordance with internationally accepted good practice.” The ban will remain intact till Ireland's Health Service Executive (HSE) can provide possible recommendations related to surgical training, informed consent and an agreed dataset development on the mesh products.
Lawsuits against the manufacturers of Transvaginal mesh (TVM) continue to be filed in the U.S. District Courts, over design flaws causing severe internal injuries in several women. Ethicon, C.R. Bard, Boston Scientific are some of the defendants in the TVM litigation, overlooked by Judge Joseph R. Goodwin in the Southern District of West Virginia.
Gadolinium, used in magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) procedures, is facing allegations over its adverse effects on exposure. Recently, a lawsuit filed by a California man, Jeffrey Steiner, claims MultiHance and OptiMark contrast dyes used during his MRIs caused damages to his brain and other organs due to gadolinium retention.
Steiner's Gadolinium deposition disease lawsuit states, “defendants have repeatedly and consistently failed to advise consumers and their healthcare providers of the causal relationship between linear gadolinium-based contrast agents and gadolinium retention resulting in fibrosis in the organs, skin, and bones, retained gadolinium in the brain, and related injuries. Defendants knew or should have known of the risks posed by linear gadolinium-based contrast agents to individuals with normal or near-normal kidney function.”
The Food & Drug Administration (FDA) has declared 8 MRI gadolinium agents for use in the United States, all of which include a black box warning about Nephrogenic Systemic Fibrosis (NSF), which only occurs in people with a pre-existing kidney disorder. However, Steiner's case is one of the many cases which allege they had normal kidney functioning and experienced complications due to gadolinium retention from the MRI dyes. In December 2017, the FDA introduced a new class warning for all gadolinium-based MRI contrast dyes and stated that the gadolinium deposits could remain in a patient's body and brain after weeks, months or even years after a scan.
A growing number of patients are filing lawsuits over Gadolinium Deposition Disease (GDD) and similar side-effects, who received MultiHance, Magnevist, Optimark and other gadolinium contrast agents during an MRI and MRA examinations. Gadolinium multidistrict litigation concerning NSF (MDL 1909; In Re: Gadolinium Contrast Dyes Products Liability Litigation) was formed in 2008 which was overlooked by Judge Dan Aaron Polster in the Northern District of Ohio. The manufacturers previously agreed on paying millions for gadolinium settlements for individuals diagnosed with nephrogenic systemic fibrosis. NSF lawsuits have largely been avoided by not using gadolinium contrast agents among individuals with kidney problems, highlighting the importance of warnings provided by the manufacturers.
As the Taxotere litigation convened its status conference on July 18, a joint status report was submitted a day prior highlighting the case progress so far. Lawsuits involving the chemotherapy drug' s alleged hair loss is underway in the U.S. District Court, Eastern District of Louisiana, overlooked by MDL Judge Jane Triche Milazzo (MDL No.2740; In Re: Taxotere (Docetaxel) Products Liability Litigation).
The status report indicates about 9,100 Taxotere lawsuits are centralized for pretrial proceedings in Louisiana, and in state courts of California, Illinois, New Jersey, and Delaware, though most of these have been moved to federal court. Discovery of defendants and trial case is still in the progress. The report states, "Plaintiffs have served merits discovery on Sanofi, and the Sanofi Defendants have begun the process of producing responsive documents. Plaintiffs have also served merits discovery on Accord Healthcare, Inc., the Hospira/Pfizer Defendants, and Sandoz Inc. and have begun to receive productions. The parties have met and conferred multiple times about this discovery served by the Plaintiffs. Plaintiffs and Defendants are also conducting depositions in the cases selected for trial. The parties are generally addressing discovery disputes with Magistrate Judge North.”
Taxotere bellwether trials are slated to begin on May 13-24, 2019, and additional trials would be held on September 16, 2019; January 27, 2020; May 11, 2020; and September 14, 2020.
Bayer recently announced to take Essure Birth control device off the U.S. market by the end of 2018, blaming “inaccurate and misleading publicity” for poor sales. The decision was made following FDA's move to modify premarket approval (PMA) process for Essure in April 2018, considering about 12,000 adverse event reports that the birth control device was defectively designed. The FDA has ordered Bayer to conduct postmarket studies on the device's safety and effectiveness. The data for the same must be presented by them at the most by 2023.
Thousands of women affected due to the faulty device have filed lawsuits claiming complications ranging from hair loss to organ perforation. Essure lawsuits are filed individually by each plaintiff and not as class actions. The U.S was the last country where Bayer's Essure was sold.
The Seventh Circuit denied reviving a Testosterone Replacement Therapy (TRT) lawsuit filed against Auxilium Pharmaceuticals Inc. linked to its drug Testim stating that the District Court prevented the key witness from testifying. The lawsuit filed by plaintiff Isaac Owens was selected for bellwether trial in the multidistrict litigation over alleged deep vein thrombosis (DVT), which he developed in 2013 due to Testim use. The Seventh Circuit asserted that the testimony from the expert witness that the plaintiff decided to use does not match with the facts of his case.
About 6,000 TRT cases are pending in the multidistrict litigation, alleging that the products led to complications like cardiac arrest, stroke and sudden death. Other defendants in the litigation include Abbott Laboratories Inc., Pharmacia & Upjohn Inc., Pfizer Inc., Endo Pharmaceuticals Inc., Eli Lilly & Co., and Actavis Inc. In a recent announcement, Actavis Incorporation agreed to settle cases over its TRT drug Androderm, accusing them of failure to warn men about side effects.
Zofran, manufactured by GlaxoSmithKline is used for treating nausea and vomiting caused by cancer chemotherapy, radiation therapy, surgery, and gastroenteritis. The drug has been held liable for developing birth defects in babies when pregnant women took the medication to prevent nausea and vomiting.
Zofran manufacturer recently requested for a summary judgment in the multidistrict litigation centralized in Massachusetts federal court, asserting that the U.S. Food and Drug Administration (FDA) has repeatedly declined the decision to add pregnancy-related warning labels on the product. GSK argued that it cannot be held accountable for the complications caused due to Zofran consumption since the FDA never confirmed any links between the medication and birth defects.
Zofran multidistrict litigation [MDL No. 2657 In Re: Zofran (Ondansetron) Products Liability Litigation] was formed in October 2015 in the District of Massachusetts and is presided by Judge Dennis F. Saylor, IV.
Despite the death of ovarian cancer victim Eva Echevarria, her daughter and acting trustee appealed the California jury's decision to dismiss the $417 million verdict against Johnson & Johnson. The plaintiff's lawyer has requested for the appeals court to reinstate the verdict and reverse Judge Nelson’s order granting J&J’s motions for judgment notwithstanding the verdict and a new trial.
In August 2017, a California jury announced a $417 million verdict in favor of plaintiff Eva Echeverria over allegations that using J&J's talcum powder caused her ovarian cancer. J&J's request for a new trial was granted by Judge Maren E. Nelson, and the verdict was overturned on October 20, 2017. The jury supported J&J's statement that the evidence provided by the plaintiff was inadequate and did not confirm that the talc manufacturer conducted malice marketing tactics. In her argument, Echevarria's daughter claims there was enough evidence to prove that J&J was aware of the ovarian cancer risk associated with their talcum powder and they purposely false marketed the product. In a recent revolutionary verdict, J&J was ordered to pay $4.7 billion as damages to 22 victims and their families over allegations that asbestos present in the talcum powder developed ovarian cancer in them.
Several 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).
In a case management order submitted recently, U.S. District Judge Catherine C. Blake, presiding over the Smith & Nephew Birmingham Hip Resurfacing (BHR) systems complications, presented the protocols for preserving explanted hip implants. In the order, Judge Blake has approved the steps that must be filed for the explanted implants describing how the devices are to be identified, preserved and handled.
Both the parties or non-party medical practitioners and hospitals are required to make "good faith efforts" to preserve any explanted system. They are supposed to handle the preservation of any blood, fluid, tissue or serum samples carefully. Any destructive or non-destructive analysis or testing is completely prohibited without a written consent of all parties or an order by the court.
There are about 400 product liability lawsuits filed against the manufacturer of BHR systems over allegations that they failed to warn that the metal-on-metal hip implant is defectively designed and is prone to wear and tear, often requiring removal of the device. The U.S. Judicial Panel on Multidistrict Litigation consolidated hip implants lawsuits in the District of Maryland as part of a federal MDL for coordinated pretrial proceedings.
In a related hip implant litigation, lawsuits continue to be filed involving complications over Stryker Hip Replacement system centralized before U.S. District Judge Indira Talwani under MDL No. 2768 – in Re: Stryker LFIT V40 Femoral Head Products Liability Litigation.