According to a study published by the Journal of the American Medical Association, from 2000 to 2015, opioid-involved poisoning deaths erased approximately two and a half months from overall life expectancy at birth in the United States. Other studies, news reports, government agencies, and medical journals are addressing opioid deaths as a public health crisis that cannot be ignored or discounted.

What is the Opioid Epidemic?

Many sources reiterate that the opioid epidemic is not about recreational drug use but rather originated from prescription drugs, manufactured by pharmaceutical companies, and distributed to doctors, who prescribed the drugs to patients.

Continue Reading Opioid Epidemic Lowers Overall Life Expectancy In U.S.

Amputation Risk Associated with Invokana Reported by FDA

In July 2017, an FDA-mandated cardiovascular outcomes trial (CANVAS) reported that Invokana use roughly doubles the risk of lower limb amputation (although lowering the risk of serious cardiovascular events). The findings of amputation risk prompted the FDA to order a black box warning for the drug. The data from CANVAS does not indicate why amputations are being seen years after the trials leading to the FDA’s original approval of Invokana to lower glucose.

Invokana is Johnson & Johnson’s brand name for canagliflozin, a type 2 diabetes drug approved by the FDA in March 2013. Invokana and other SGLT2 inhibitors lower blood sugar by causing the kidneys to excrete glucose through the patients’ urine, reducing the amount of glucose in the patients’ blood. However, the patients’ kidneys have been found to also excrete crucial blood components, allegedly leading to severe complications and side effects.

Continue Reading New Evidence of Amputation Risk Impacts Invokana MDL

The number of cases involving the anti-psychotic drug Risperdal almost tripled in the first half of 2017, jumping from approximately 2,000 cases at the beginning of the year to more than 5,500 as of June 2017, comprising the largest mass tort litigation in Philadelphia.

The new filings in the Risperdal litigation were largely triggered when Johnson & Johnson terminated tolling agreements on thousands of cases, which had paused the statute of limitations deadline. A Johnson & Johnson subsidiary, Janssen Pharmaceuticals, Inc., manufactures Risperdal.

The Risperdal litigation mostly involves a condition called gynecomastia, which causes breast tissue enlargement in males. Risperdal was originally approved in 1993 to treat schizophrenia in adults. In 2006, clinical studies linked an increased risk of gynecomastia in male adolescents to Risperdal use. The Risperdal gynecomastia lawsuits allege the manufacturer did not sufficiently warn doctors and patients of the male breast growth problem, and that Johnson & Johnson and Janssen Pharmaceuticals failed to properly share information with the FDA.

Continue Reading Philadelphia Risperdal Docket Almost Triples in First Half of 2017

A Third Circuit opinion in the In re: Lipitor Antitrust Litigation reinstated the pay-for-delay lawsuit accusing pharmaceutical companies Pfizer Inc. and Ranbaxy Laboratories Inc., of delaying generic competition for Lipitor and Effexor XR. Buyers of Lipitor and Effexor XR may proceed with their antitrust claims for alleged patent fraud and anti-competitive reverse payment schemes.

The appeals panel found that drug buyers adequately pleaded – at the dismissal stage – the companies’ patent dispute settlement agreements unlawfully delayed generic competition. The suits in the multidistrict litigation plausibly alleged varying tactics to artificially inflate the costs of the drugs.

Continue Reading Third Circuit Clarifies Pleading Standard in Pay-For-Delay Suits

The sixth pelvic mesh product liability trial against Ethicon, Inc., a Johnson & Johnson subsidiary, is underway in the Philadelphia Court of Common Pleas. The lawsuit alleges that the plaintiff was injured by Ethicon’s TVT Secur pelvic mesh product, requiring her to undergo multiple corrective surgeries and removal of mesh fragments from her urethra. The plaintiff alleges that the defective pelvic mesh product has caused perforations to her urethra, incontinence, and pain. The complaint alleges design defect and a failure to warn.

Citing the recent United States Supreme Court decision in Bristol-Myers Squibb v. Superior Court of California (BMS), Ethicon, Inc. argued that the company’s lack of tangible links to Pennsylvania prevented the Philadelphia County Court of Common Pleas from hearing pelvic mesh cases. Ninety of the cases filed in the Philadelphia court that alleging injuries caused by defective pelvic mesh implants were filed by out-of-state residents.

Continue Reading Johnson & Johnson Argues that Pelvic Mesh Cases Belong in New Jersey

A jury has ordered Johnson & Johnson to pay $417 million to a woman who filed suit alleging that she developed ovarian cancer from using its baby powder on a regular basis for feminine hygiene.

The Talcum Powder Lawsuit

The lawsuit filed against Johnson & Johnson claimed that the company’s talcum powder causes ovarian cancer when applied regularly to the genital area. The plaintiff asserted that she used Johnson & Johnson baby powder on a daily basis from the 1950s until 2016. She was diagnosed with ovarian cancer in 2007.

The plaintiff alleged that her cancer was the “proximate result of the unreasonably dangerous and defective nature of talcum powder.” She claimed that Johnson & Johnson failed to adequately warn consumers about the possible cancer risks of its talcum powder.

Continue Reading $417 Million Verdict in Johnson & Johnson Talcum Powder Lawsuit

New Jersey was once one of the premiere venues for Mass Tort filings (now termed Multicounty Litigations in New Jersey). One of the reasons for this was the obvious fact that many large pharmaceutical companies maintain their principal place of business in New Jersey, making it very difficult for those pharmaceutical companies to remove cases brought against them in New Jersey Superior Court to federal District Court, due to the “forum defendant” rule (28 U.S.C. § 1441(b)(2)). Perhaps a more significant reason was the makeup of the New Jersey Superior Court’s Mass Tort bench at a time when nationally recognized jurists, such as the late Judge Carol E. Higbee, were on the cutting edge of high-stakes pharmaceutical litigation, like the seminal Vioxx cases.

Continue Reading SCOTUS Decision in Plavix Litigation Could Lead to a Resurgence in New Jersey Mass Tort Filings

The products we use in day-to-day life range from medications to bicycles to household cleaners to cell phones. When we use these items for their intended purpose, we don’t expect to be harmed by them. Yet design defects, manufacturing defects, and failure to warn claims all arise from that unexpected harm. Product liability law is now largely governed by statute. But the case law preceding the statutes illustrates the underlying rationale for the application of strict liability to product liability cases.

Continue Reading Product Liability Claims in New Jersey

In case you missed it, Stark & Stark has garnered a significant amount of local, regional, and national press attention for our recent $20 million pelvic mesh verdict against Johnson & Johnson in Philadelphia, PA. In the case, plaintiff Peggy Edelman alleged that a Johnson & Johnson pelvic mesh device implanted to relieve stress urinary incontinence in 2007 failed due to defect. Subsequent attempts to surgically remove the mesh after Ms. Engleman began experiencing pain and discomfort were unsuccessful. Nationally, Johnson & Johnson is facing tens of thousands of additional pelvic mesh lawsuits, including nearly 200 more in Philadelphia.

Below are some of the local, regional, and national press mentions for Stark & Stark and this very important verdict: Continue Reading Stark & Stark Gaining Press Attention for $20 Million Pelvic Mesh Verdict

A Pennsylvania jury awarded a New Jersey woman $20 million for injuries she suffered after receiving a pelvic mesh implant made by Ethicon, a subsidiary of Johnson & Johnson.

Following a three-week trial in Philadelphia Common Pleas Court, Peggy Engleman of Cinnaminson, New Jersey, was awarded $2.5 million compensatory damages and $17.5 million in punitive damages.

Martin P. Schrama and Stefanie Colella-Walsh, both partners with Stark & Stark, filed the complaint on behalf of Ms. Engleman in 2013 and worked with a team of attorneys on the case.

The suit claimed that a TVT-Secur device manufactured by Ethicon, a subsidiary of Johnson & Johnson, was defective and the companies failed to warn users of the risks. Ms. Engleman had the device implanted in 2007 to relieve stress urinary incontinence, but said the device failed shortly thereafter. She began to experience pain and discomfort as the mesh started to erode inside her body and underwent multiple surgeries. Physicians were unable to remove all the shards of mesh in her abdomen.

Continue Reading Jury Awards $20 Million in Pelvic Mesh Implant Case Brought by Stark & Stark