Just when hopes were running high on the fourth Xarelto trial scheduled to begin this October in the US District Court ND Texas, we are informed that it has been postponed until early 2018. The verdicts for the three previous lawsuits went in favor of the defendants Johnson & Johnson's Janssen Pharmaceuticals and Bayer; however, expectations are pinned on this fourth trial as it represents circumstances which are quite different from the previous cases and could bring in a positive verdict for the plaintiff. Thousands of lawsuits have been filed against the defendants due to its severe side-effects including serious internal bleeding. Allegations involve failure to warn the patients and medical community about the associated risks. Xarelto lawsuits are consolidated under MDL 2592 in the US District Court for the Eastern District of Louisiana under Judge Eldon Fallon, and more than 18,000 lawsuits are pending in courts across the country. This delay may bring in settlement news between the defendants and plaintiffs.
Judge Fallon presiding over Xarelto MDL 2592 also denied a motion for new bellwether trials for the plaintiffs who had lost to the defendants in the first two bellwethers trials. The judge stood by his decisions stating that they were made on the right grounds. The plaintiffs had filed the motions highlighting the fact that certain data was deemed inadmissible by the court to be a part of the trials as it included international information. The plaintiffs also emphasized that the jury was informed to consider the drug manufacturers were required to disclose only the FDA approved tests to the patients that clearly excluded the prothrombin time test, which is a part of international labels, but not FDA approved.
Within weeks following the release of an FDA safety warning, 'FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines and requires its strongest warning,' comes an additional safety announcement that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS).
The study stems from research which showed that the harm caused by untreated opioid addiction outweighed the risk of serious side effects associated with the combined use of these drugs. The FDA added, with careful medication management these risks could be reduced. Buprenorphine and methadone are drugs that aid to reduce or stop the abuse of opioids, including prescription pain medications and heroin; the patient does not feel high and no withdrawal occurs as these drugs act on the same part of the brain where the opioid drugs act.
The FDA has released a letter to the health care providers according to which the use of thermoregulatory devices during surgeries are advised as research shows patients have shown less bleeding that has lead to a faster recovery and decreased risk of infections. The study was taken up when it was noticed that forced air thermal regulating systems were being avoided by health care providers during surgeries to bypass the chances of increased risk of surgical site infection. Moreover, it reported that the avoidance could lead to development of adverse health consequences for patients during the post-operative and recovery process. The letter stated clearly that the FDA was unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection. This is surely a good news for manufacturers of forced air thermal regulating systems like the 3M's Bair Hugger System who is currently facing thousands of lawsuits in the U.S. District Court, District of Minnesota under MDL No. 2666.
The JPML is reviewing the motion filed with them to transfer and consolidate the "National Prescription Opiate Litigation" which was long due to handle the Opioid crisis sweeping across the nation. Opiate drug makers are also facing lawsuits by cities, counties, and states. The US Department of Justice in every state has also taken up criminal investigations against the drug makers. Though not designated with an MDL number, it is under the JPML review.
A move made this September wherein the plaintiffs involved in the pelvic mesh related injury against Boston Scientific agreed for their cases to be heard in a courtroom other than the Philadelphia Court of Common Pleas. This decision has its roots in the June 2017 "Bristol-Myers California Plavix" U.S. Supreme Court opinion, according to which the non-resident plaintiffs cannot continue their cases in state courts where they do not reside or the defendant companies are not corporate residents.
However, after giving it quite a thought and favoring a smooth functioning without any jurisdictional issue creating legal issues, the plaintiffs have agreed to this move. Our sources also inform us that the parties have agreed to litigate the cases in either Massachusetts, headquarters of Boston Scientific, or in Delaware, its state of incorporation. Boston Scientific has shown interest in resolving roughly 37,000 product liability cases filed against it with a few thousand already settled.
The June 2017 "Bristol-Myers California Plavix", has already been adopted by Bayer, headquartered in Pennsylvania, in removing a good number of cases from the Missouri federal court in the Essure litigation. It is expected that Bayer might press on the same ruling to dismiss hundreds of lawsuits in the other jurisdictions, like Philadelphia Court of Common Pleas, where Xarelto blood thinner cases are piling up.
A Pennsylvania woman was awarded close to $57 million that included $50 million as punitive damages for injuries she suffered from the vaginal mesh devices; the lawsuit was filed against Johnson & Johnson subsidiary Ethicon Inc., it is also the first verdict to be awarded the highest amount as compared to the earlier four transvaginal mesh cases. This case was tried at the Philadelphia County Court of Common Pleas and is a part of more than hundreds of pelvic mesh lawsuits pending in the mass tort. The main allegations faced by Ethicon include manufacturing of defective pelvic mesh implants and failure to warn the doctors and patients about the potential risks. In all, more than 50,000 cases are pending in state and federal courts against J&J's - Ethicon, Bard-Davol, Boston Scientific, AMS (American Medical Systems/Endo), and others, under multiple MDLs. Lawsuits against J&J's Ethicon are filed in MDL No. 2327 at U.S. District Court of West Virginia.
Two big transvaginal settlements amounts, announced by Endo International Plc., for the U.S. TVM cases takes the total settlement amount to over a billion. The first settlement news came in 2014, when Endo announced the establishment of a fund worth $830 million to settle a significant number of TVM cases. This August too, Endo has announced a whopping $775 million to settle roughly 22,000 lawsuits in the US. Quarter four of 2017 is targeted to begin issuing the settlement installment amounts that would continue until the end of 2019.
The court website has shown an increase in Risperdal lawsuits with the addition of 534 cases to the Pennsylvania Risperdal Mass tort. With this, 6082 is the total count of Risperdal cases as compared to the June count of 5548 cases.
Two co-ordinated 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).
Prescribed mainly for severe psychiatric conditions, Risperdal came under the scanner when it showed side-effects in males due to the increased prolactin levels that led to sexual dysfunction, an inability to create sperm, and breast enlargement. Civil and criminal allegations involving the marketing of off-label and unapproved usage of Risperdal cost J&J $2.2 billion as settlement charges in 2013. Since 2012, J&J has settled numerous cases and has also lost to plaintiffs in trial proceedings.
Claims against AndroGel manufacturer AbbVie were rejected by the jury in Circuit Court of Cook County, Illinois; thereby, ruling in favor of the defendant. Allegations faced by AbbVie included failure to warn the plaintiff, James Couch, and his doctor about the risks associated with AndroGel, strict liability, negligence, breach of implied warranty, negligent misrepresentation and willful and wanton conduct. The trial went on for more-than-two-weeks and was a part of an MDL-based in Illinois federal court.
Couch approached his doctor for a check on his thyroid level being influenced by the ads. He suffered a heart attack six months later for which he was implanted with a defibrillator in his chest. This decision by the court stemmed from the fact that the plaintiff had stopped using AndroGel two months before his heart attack, re-filling his prescription only twice between receiving it in February 2013 and his heart attack. The first bellwether trial verdict for AndroGel came in June 2017, wherein $150 million punitive damages was awarded to the plaintiff with no compensatory amount. The defendant and plaintiffs have both filed post-trial motions for the judge to depict the verdict in their favor without ordering a totally new trial.
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