Reuters reported that GlaxoSmithKline has agreed to settle a false advertising lawsuit filed by Johnson & Johnson. The lawsuit was in reaction to the ads that Glaxo released to promote their new over-the-counter allergy medication, Flonase. According to their ads, Glaxo claimed that Flonase “outperforms the number 1 allergy pill… and controls six allergy symptoms versus one by the other pill.” Although the pill was never named in the ads, the allergy drugs Benadry and Zyrtec by Johnson & Johnson units McNeil-PPC Inc and McNeil Consumer Healthcare are often common consumer preferences. McNeil emphasized that the claims made by Glaxo are not supported by scientific studies, and such exaggerations could create unfair competition between their respective products. The settlement came to light on Monday, during a hearing in Manhattan where McNeil was supposed to urge the court to disallow Glaxo from making any future claims comparing Flonase with their own allergy medications. Representatives from both camps said that the terms, while confidential, are “mutually acceptable and amicable.” As noted by Reuters, the case is officially referred to as McNeil-PPC Inc and McNeil Consumer Healthcare v. GlaxoSmithKline Consumer Healthcare LP, U.S. District Court for the Southern District of New York, No. 15-1866.
Court documents show that the number of lawsuits against Pfizer for Lipitor continues to increase, currently at 1,600. The main allegation of plaintiffs is that they were not adequately warned about the serious side effects of the drug, designed to manage cholesterol levels. Among these side effects is the increased risk of developing Type 2 diabetes (diabetes mellitus). Multidistrict litigation (MDL) records show that there are 1,604 cases under MDL 2502 for the consideration of Judge Richard M. Gergel. MDL 2502 was certified in February 2014 with 56 lawsuits, and climbed to 1,451 by November. Since then, about 150 cases have been added. Drugs that can lower cholesterol, or statins, in general have been associated with serious side effects such as the development of muscle problems as well as diabetes. Statins are a type of drug that inhibits the activity of the HMG-CoA reductase enzyme, which encourages the production of about 70% of cholesterol in the body. This is widely known in scientific circles, sparking the debate about whether the benefits accruing from statins are outweighed by their associated risks. However, the general public is largely ignorant to these risks. It is the responsibility of drug manufacturers to ensure that patients and doctors are well-informed about the dangers of taking a particular product. The next scheduled status conference for MDL 2502 is on January 22, 2015, where some lawsuits may be dismissed for lack of proper documentation. It is important for plaintiffs to have competent legal representation avoid losing out on a claim because of a technicality. The first bellwether trial is scheduled to be heard in court sometime in October 2015.
Fifty plaintiffs against Xarelto German manufacturer Bayer AG and US distributor Janssen Pharmaceuticals Inc (a division of Johnson & Johnson) are poised to have their lawsuits transferred from 15 different federal court districts to just one. The question is, where? Both sides of the soon-to-be multidistrict litigation (MDL) are in agreement that the cases are sufficiently similar to warrant consolidation into an MDL, and presented motions to the US Judicial Panel on Multidistrict Litigation (JPML). MDL is the preferred way to handle mass litigation which allows courts to hear the evidence for multiple cases at one time, but still allows individual plaintiffs to control the outcome of their cases. However, the JPML received the same motion for different districts. Xarelto plaintiffs want it in Illinois under Judge David Hendron while the defendants want it in New Jersey, where both companies have their US headquarters, under Judge Freda Wolfson. The arguments of both sides were heard in the District of South Carolina in Charleston on December 4, 2014, and both sides are waiting for the JPML decision before moving on with the next phase of the MDL. It is bound to be a long process, because the plaintiffs are claiming that Xarelto presents a high risk of bleeding to patients. Xarelto (rivaroxaban) is an anticoagulant, and by its very nature indeed poses a risk of bleeding. But this is a risk present in all blood thinner drugs, including warfarin, used as the standard anticoagulant treatment for more than 50 years. The biggest problem of Xarelto is that there is no way to reverse the effects in case of excessive bleeding; warfarin can be almost instantly counteracted with a dose of Vitamin K. If in the end Xarelto is deemed too dangerous to be sold, then all similar anticoagulant drugs will be headed out to court.
When last we heard about Stryker lawsuits, it was to discover that it had been transferred to multidistrict litigation (MDL 2441) in Minnesota at the end of the first quarter of 2014. The medical device company was in hot water for its Stryker Rejuvenate & ABG II Hip implants as well as related products when it was found in 2012 that they had abnormally high failure rates. Many patients that had already received these devices required several repair and replacement surgeries, experienced significant pain, and sustained internal damage. The devices were said to be designed defectively, which qualifies it for product liability lawsuits. It appears, however, that the legal battles are in its last stages. Stryker Co. has decided to offer settlement to plaintiffs, patient families, and insurers in excess of $1.4 billion. It was announced at the Minnesota district court, and could well turn out to be the most expensive settlement program in the history of medical devices as there are no limits set on compensation payouts to thousands of claimants. It seems that the proposed settlement program is fair and efficient, promising a quick turnaround the clients. However, it would be best not to get complacent. The same could have been said about the BP oil spill settlement program, which is still disputing the administration of the fund. Hopefully, this will not happen with Stryker Co.
People who suffer from medical conditions that increase their risk of abnormal blood formation, i.e. atrial fibrillation, are routinely prescribed blood thinners or anticoagulants to reduce the incidence of blood clotting that can lead to serious and potentially fatal complications such as strokes. The standard anticoagulant treatment is using warfarin which was first marketed as such in 1950. However, warfarin requires considerable effort in administration, including regular doctor visits, frequent dosage adjustments, and a special diet. Newer anticoagulants such as Pradaxa (dabigatran) and Xarelto (rivaroxaban) have no such requirements. However, Pradaxa came under fire not soon after it was approved by the U.S. Food and Drug Administration (FDA), and now Xarelto is in the same boat. While they belong to different anticoagulant classes and affect patients in slightly different ways, they share a common problem: uncontrollable bleeding. Unlike the bleeding effects of warfarin which can be reversed with a dose of Vitamin K, there are no reversal agents for Pradaxa and Xarelto. Pradaxa is already in the middle of multidistrict litigation. The first Xarelto lawsuit, a relative newcomer to the market, was only filed in February 2014. It is expected that more cases will be filed considering the huge popularity of Xarelto before complaints to the FDA and civil court began mounting up. The big difference between Pradaxa and Xarelto lawsuit is that plaintiffs in the latter cases claim that the manufacturer, Bayer Corp., and distributor, Janssen Ortho LLC, knew or should have known that the medication was too dangerous to be sold in the first place.
It seems that Johnson & Johnson (J&J) may soon be facing a new wave of personal injury litigation based on the findings of the most recent report from a journal and the somewhat successful ruling in a South Dakota courtroom. The report “Genital Powder Use and Risk of Ovarian Cancer: A Pooled Analysis of 8,525 Cases and 9,859 Controls” that was published online and in print in the June and August 2013 edition of the Cancer Prevention Research journal, respectively, was a meta-analysis of 8 separate but similar studies that established a causative link between the genital use of talcum powder and ovarian cancer. The ruling was for the first talcum powder lawsuit filed against J&J by one Deane Berg in 2009. She is a Sioux City resident who was diagnosed with ovarian cancer in 2006 after more than 30 years of using J&J talc-based products. The jury came out with a ruling in 2014 finding J&J negligent for failing to warn consumers about the risk of using these products in the genital areas and in fact marketed it as safe for this type of use. The studies speculate that talc particles found in cancer tissue suggests that they contributed to the activation and growth of cancer cells in the ovaries by traveling up the reproductive tract and causing inflammation. Regular and consistent genital use of talcum powder aggravated the condition until cancer resulted. Some researchers compare the size, persistence, and effect of talc particles in the tissue to that of asbestos fibers which causes mesothelioma, also a form of cancer. More talcum powder lawsuits have been filed against J&J since the 2014 verdict for its talc-based line of products. A putative class action lawsuit has also been filed, which, if enough people join to get certification, will become a true class action against the pharmaceutical company.