What Happened In The MassTorts World Last Week? 2018-Nov-12

On Friday, November 2, Stryker Incorporation announced a confidential, private settlement before the multidistrict litigation (MDL) Judge Indira Talwani in Boston for cases linked to both recalled and unrecalled components of Stryker LFIT Cobalt Chromium V40 Femoral Heads used in hip correction surgeries.

The settlement plan was announced for cases filed in the MDL 2768 in Massachusetts, the consolidated cases in the MCL 624 in New Jersey and/or other jurisdictions for already pending cases. The recalled and unrecalled cobalt chromium V40 heads and the compatible stem system configurations including Accolade TMZF, Accolade 2, Citation, Meridian and Rejuvenate are eligible for the settlement. An order was issued by the Honorable Judge Rachelle Harz of the New Jersey Superior Court implementing procedures to support the settlement. The individual settlement amounts would be based on the level of harm and the components removed. This settlement is not intended to resolve all the filed claims but is an essential move towards resolving claims in the hip implant  litigation. The first cases selected for initial bellwether trials are part of the settlement program and the discovery process is on hold through the summer of 2019. The lawsuits filed raise complaints of device dislocation, inflammation, loss of mobility, bone fractures around the components, local tissue reaction, and need for revision surgery.

Federally filed Stryker hip lawsuits associated with LFIT 40 Femoral Heads were consolidated into MDL No. 2768 ( In Re: Stryker LFIT V40 Femoral Head Products Liability Litigation) in the United States District Court for the District of Massachusetts on April 5, 2017.

Attorneys representing the two men who developed excessive breast tissue growth due to Risperdal medication filed a brief in the Pennsylvania Supreme Court on October 31, urging the justices to expand the statute of limitations for filing their lawsuits.

The brief stated that the plaintiffs discovered the breast tissue growth in their puberty making it impossible for them to notice the link between the drug and their excessive breast growth. The Risperdal label was updated in 2006, and the boys started the medication in the 1990s. Their mothers saw TV commercial warnings about the drug's gynecomastia risks around a decade later and sued Janssen Pharmaceuticals in 2014. However, Judge Arnold New, overseeing the complex litigation center, dismissed the cases, and granted summary judgment to the defendant. A Superior Court had ruled that the plaintiffs were supposed to be aware of the gynecomastia risk of the antipsychotic drug by 2006.

Attorneys involved in the litigation asserted that the issues raised in these two cases affect more than 40% of the 13,500 lawsuits lying in the Risperdal docket. Two coordinated 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).

One of the largest dialysis providers, DaVita Inc., recently agreed to pay $383.5 million to the families of three patients who died of cardiac arrest following dialysis treatment at DaVita's. The Denver-based company was ordered to compensate for the wrongful death by a Denver jury in June 2018. The compensation included $125 million in punitive and $1.5 million to $5 million in compensatory damages.

DaVita was blamed in the lawsuit filed by the families for not forewarning about the health risks of GranuFlo treatment which caused toxic pH imbalances and alkalosis in the patients. Attorneys representing the plaintiffs asserted that the dialysis provider was aware of the toxicity of the product. Granuflo lawsuits were centralized in the District of Massachusetts as a multidistrict litigation in 2013 (MDL No. 2428; In Re: Fresenius GranuFlo/NaturaLyte Dialysate Litigation) before Judge Douglas P. Woodlock.

Zimmer Biomet Holdings Inc. announced on October 31 that it received FDA 510(k) clearance for the Persona revision knee system used in the revision knee replacement procedures. The purpose of a 510(k) submission is to signify that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976).  

In the press release, Zimmer Biomet's vice president Todd Davis stated, "the clearance of the Persona revision knee system gives us the ability to provide surgeons with a full-service portfolio for the continuum of knee arthroplasty care, from diagnostic tools, cement spacer technologies to re-implantation solutions. The Persona revision knee system gives surgeons the flexibility to truly tailor an implant solution based on each patient’s unique anatomy for a natural fit and function.”

As of September 2018, there are 260 cases pending against Zimmer for inadequately warning patients and doctors about the adverse effects of the faulty knee implants manufactured by them. NexGen and Persona models of knee implants have been reported to fall out due to loosening of defective screws.

In an order issued on October 27, Minnesota federal judge Joan N. Ericksen denied a couple's motion for a new trial in the first Bair Hugger bellwether case against 3M. The order stated that the court did not exclude evidence that would have helped the plaintiff prove the design defect in the warming blanket.

The plaintiff from South Carolina sought to admit the evidence of the defendant's "knowledge of risk-utility." However, under South Carolina law, the focus in a strict liability "centers upon the alleged defectively designed product’’ and not the manufacturer's mental state. Plaintiff’s claims of negligence, failure to warn, deceptive trade practices, and misrepresentation were all dismissed on summary judgment in June 2018. The plaintiff suffered a deep joint infection in 2010 for which he underwent a total right knee replacement surgery when a 3M Bair Hugger warming blanket was used. In the lawsuit filed against 3M, the plaintiff blamed the defective design of the product which required him to undergo several antipsychotic treatments and revision surgery.

The second bellwether trial begins in December 2018, involving claims by a couple from Idaho. More than 4,467 hip and knee infection lawsuits are filed against the Bair Hugger warming blanket maker. Similar cases are consolidated into multidistrict litigation (MDL 15-2666; In Re: Forced Air Warming Devices Products Liability Litigation) in the District of Minnesota.

Plaintiffs' lawyers involved in the talcum powder litigation strive to keep the $4.7 billion ovarian cancer verdict intact. The massive verdict was awarded to 22 plaintiffs including families of 6 women who succumbed to ovarian cancer due to asbestos exposure from the talc.

Johnson & Johnson has filed several motions to toss the verdict, aggressively denying the asbestos presence and carcinogenic content in the talcum powder. In the motion, the company accused the plaintiffs' attorney of making deceptive and prejudicial statements to influence the jury, while the plaintiffs' lawyers argued that J&J's decade-long refusal to send adequate warnings about talcum powder hazards warrants the Missouri jury's verdict. They wrote, "defendants knew there was asbestos in what they marketed as ‘baby’ powder, but they deliberately targeted mothers and women in general with advertising misrepresenting the safety of their talc product."

J&J faces more than 10,000 talcum powder cancer lawsuits across the U.S. The majority of the lawsuits are filed over cases of ovarian cancer and mesothelioma due to prolonged use of J&J's Baby powder for personal hygiene purposes. Several lawsuits are filed against the baby powder manufacturer and suppliers over asbestos-linked mesothelioma and ovarian cancer. A multidistrict litigation (MDL No. 2738; In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation) was formed in 2016 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. for coordinated pretrial proceedings.

Amidst the opioid addiction crisis, the Food and Drug Administration (FDA) announced a new opioid for use called Dsuvia. It has been approved for use in wounded soldiers carried off the battlefield who does not have intravenous access for an injection or drip or for someone who cannot swallow medicine.

It is a massive relief for American soldiers who are in terrible pain due to the lack of usable opioids. Dsuvia contains sufentanil which is a synthetic opioid and 10 times more powerful as fentanyl. It is also 1,000 times stronger than morphine. The Drug  Enforcement Administration released a report highlighting the overdose deaths caused due to prescription opioids since 2001. On October 12, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 for Dsuvia to be recommended as an alternative medication to currently available opioids. FDA Commissioner Scott Gottlieb told in a statement, "There are very tight restrictions being placed on the distribution and use of this product. We've learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We've applied those hard lessons as part of the steps we're taking to address safety concerns for Dsuvia." Pamela Palmer, an anesthesiologist stated, “The FDA approval of Dsuvia is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings.”

Opioid overdose death lawsuits are centralized as a part of multidistrict litigation, MDL No. 2804 (In Re: National Prescription Opiate Litigation) in the Northern District of Ohio before U.S. District Judge Dan A. Polster. The first bellwether trial in the litigation has been scheduled for September 3, 2019.

In an opinion filed on November 6, a California Court of Appeal, 2nd District reinstated product liability cases against a group of drugmakers sued for providing an inadequate warning about the risk of developing pancreatic cancer linked to type-2 diabetes drugs.

The defendants who must face pancreatic cancer lawsuits are Merck Sharp & Dohme Corp, the maker of Janumet and Januvia; Novo Nordisk Inc, the manufacturer of Victoza; and AstraZeneca’s Amylin Pharmaceuticals. In November 2015, Judge Battaglia granted a summary judgment in favor of the defendants following a preemption protocol, dismissing all the cases which were a part of MDL 2452. The plaintiff attorney filed an appeal to the Federal Appeals Court that the Judge misinterpreted the U.S. Supreme Court preemption law, responding to which the court ruled in favor of the plaintiffs.

Januvia, Janumet, Byetta, and Victoza are popular type 2 diabetes drugs which have been reported to cause dangerous side effects like pancreatic cancer and pancreatitis. As of September 2018, there were 948 cases pending in the federal MDL presided by Judge Battaglia.