A federal judge in New Jersey recently granted summary judgment to Plavix drug makers Bristol Myers-Squibb Company (“BMS”), Sanofi-Aventis U.S., L.L.C., Sanofi-Aventis U.S., Inc., and Sanofi-Synthelabo, Inc. in a lawsuit alleging that plaintiff’s gastrointestinal bleeding was caused by defendants’ prescription drug Plavix.

Plaintiff alleged that she suffered injuries as a result of defendants’ design, development, manufacture, promoting, marketing, distributing, labeling, and sale of Plavix, an anti-clotting medication.

Plavix was initially approved by the FDA for individuals with recent heart attack, stroke (including Transient Ischemic Attack or “TIA”), or peripheral arterial disease. Plavix inhibits blood platelets from forming clots and therefore increases the risk of bleeding. Its labeling has included information about that risk.

Plaintiff’s complaint asserts product liability related causes of action under California state law, for defective design, manufacturing defect, failure to warn, and negligence.

Continue Reading Plavix Decision Raises Questions About Learned Intermediary Doctrine

On Thursday, October 26, 2017, President Donald Trump declared the opioid crisis a national health emergency.

What is the Opioid Epidemic?

From 2000 to 2015, more than half a million people died of drug overdoses across the country and most of those deaths involved opioids, according to the Centers for Disease Control and Prevention (CDC). The CDC estimates that 64,000 people died from drug overdoses in 2016 alone.

Continue Reading Trump Declares Opioid Epidemic a Public Health Emergency

Attorney General Christopher S. Porrino recently announced that New Jersey has filed a lawsuit against Insys Therapeutics, Inc. charging that the company engaged in a “greed-driven campaign of consumer fraud and submission of false claims to health insurers” to increase the market share for its opioid-fentanyl drug, Subsys.

What Does New Jersey’s Opioid Lawsuit Claim?

The complaint asserts that Subsys has Food and Drug Administration (FDA) approval only for the treatment of opioid-tolerant cancer pain, yet Insys unlawfully directed its sales people to “push Subsys for prescription to a broader patient population – patients suffering any type of chronic pain – and at higher doses.” The state’s lawsuit alleges that corporate decision-makers sought to expand the limited market for Subsys by aggressively pushing “off label” uses of the drug.

Continue Reading New Jersey Files Lawsuit Against Opioid Manufacturer

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