May 2017 brought in some interesting news and critical milestones were crossed in the MDL litigations. One such landmark and record-setting verdicts came in from the jury of the Missouri Court, ordering Johnson & Johnson (J&J) to pay $110 million to the plaintiff, which is one of the highest settlement amounts to be paid so far. J&J lost on the grounds of failing to disclose the cancer risk of its talcum powder which led to the development of the plaintiff's ovarian cancer which had also spread to the liver. J&J, on the other hand, is planning to challenge this and the other verdicts in court; it is also preparing for the future trials. According to our sources, more than 3000 cases have been filed against J&J, to be tried in different state courts of New Jersey, Delaware, and California.
MDL 2592, the first trial verdict came in favor of Xarelto manufacturers, Bayer and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, in the first federal bellwether trial. The defendant won on the grounds that it did not fail to disclose the adequate warning to the patient's doctor. The plaintiff solely lost as the jury rejected his singular claim regarding a Prothrombin test that neither the FDA nor any other health regulator has said should be used by doctors to determine if patients should use or continue with Xarelto therapy. This verdict will play a major influencing factor for the other three cases scheduled to follow. However, every case has its own uniqueness in terms of a distinctive set of claims and circumstances, so the tide can turn either way. This is just the beginning as more than 18,500 lawsuits have been filed under the MDLs in the U.S. District Court, Eastern District of Louisiana along with litigations established in state courts in Pennsylvania, Delaware, California, and Missouri.
Meanwhile, some development was seen on the Taxotere litigation front; a Louisiana federal judge clarified that claims against generic drug manufacturers could be included in the MDL Docket No. 2740: Taxotere (Docetaxel) Products Liability Litigation resulting in eight generic manufacturers now listed as defendants along with Sanofi-Aventis fighting allegations of permanent hair loss faced by cancer patients due to non-disclosure by the manufacturers. The litigation now focuses on the makers of 'docetaxel' as Sanofi-Aventis lost the patent right in 2010 and most of the injuries are reported post-2011 qualifying them to be a part of the MDL.
Early May witnessed another shocking revelation from three executives of Purdue Pharma, the company that markets the narcotic painkiller OxyContin; they pleaded guilty and agreed to pay some $600 million in fines and other payments. This is one of the largest amount ever paid by a drug company. The company pleaded that it misled the regulators, doctors, and patients about the drug's risk of addiction and its potential to be abused. What comes as a shock is that the company allowed fake scientific charts to be distributed to doctors to support their misleading abuse-related claim. Of the $600 million settlement amount, around $470 million is to be paid as fines to federal and state agencies, and the rest as settlement amount for the civil litigations brought by patients and other private plaintiffs.
The FDA has also announced a delay of a rule, by almost a year, that would regulate the off-label promotion of a drug and medical device. The new proposed date is March 19, 2018, which was originally scheduled to take effect on March 21, 2017. As per a notice from FDA, this decision was made to include the public comments on the language that was introduced in the final rule that did not first appear in a proposed rule. May 19, 2017, was the last date for submission of the public comments.
The 3M Bair Hugger Forced Air Warming Blanket Litigations have also made some progress as a total of 32 cases have been chosen out of a pool of 150 cases to be a part of bellwether trial selection, of which the first case is scheduled to go to trial on February 5, 2018.
An unpredictable rise and fall have been seen in these litigations. The FDA has reported that the number of Essure implants related to adverse events reports has gone up. On the other hand, drugmaker AbbVie will face the first bellwether trial in a federal court in Chicago for its low-t product, Androgel, accusing the company of its aggressive marketing strategies leading to thousands of men and their doctors to believe that they had low-t levels, which was actually a normal sign of aging.
The mass-tort litigation and class actions in state courts are about to face a challenging time with the recent ruling from the U.S. Supreme Court that has passed a limited liability lawsuits order, which might restrict the ability of plaintiffs, commonly injured by the product, to join together to sue companies.
The mass tort litigations keep the lawyers and plaintiffs on their toes all the time, and the keen attention required to minor the major changes announced is a real-time necessity. All the players in the scene: lawyers, plaintiffs, manufacturers, pharmaceutical companies have to gear up promptly as and when needed. The number of drugs and devices getting trolled is increasing day by day, and a conscious alertness accelerates the progress of mass torts in a timely manner.