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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

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

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

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

Huge Victory in Hip Replacement Lawsuit

Despite multiple attempts by Johnson & Johnson (J&J) to delay and dismiss the third DePuy Pinnacle hip implant bellwether trial, the case moved forward with outstanding results. After 12 weeks of trial, which included 32 witnesses called and 1,346 total admitted exhibits, Jurors awarded the six plaintiffs more than $1 billion in punitive damages and an additional $32 million in compensatory damages.

This recent hip replacement lawsuit verdict was governed by California law, so it is not subject to the same punitive damages cap as was seen in the earlier trial which was governed by Texas law. The impressive verdict sends a clear message to J&J, which plaintiffs hope will finally encourage J&J to settle the remaining 8,500 claims.

Continue Reading Billion Dollar Verdict in DePuy Pinnacle Hip Replacement Lawsuit

Another talcum powder lawsuit has seen favorable results in Missouri. Unlike in New Jersey, where Multicounty Litigation (MCL) Judge Nelson C. Johnson rejected the science linking talc to ovarian cancer claims, a Missouri court again ruled in favor of the plaintiff—this time to the tune of $70 million. The plaintiff, Deborah Giannecchini of Modesto, California was diagnosed with ovarian cancer in 2012. In April and May of 2016, a Missouri court awarded $72 million and $55 million, respectively, for claims against Johnson & Johnson for ovarian cancer linked to its talcum powder products.

Continue Reading Missouri Court Awards $70 Million in Johnson & Johnson Talcum Powder Lawsuit