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Does Off-Label Promotion Settlement Signal Change in FDA Policy?

Litigation
Law 360 | Mar 21, 2016

Drug Defendants Support Low-T MDL($)

A group of drugmakers including AbbVie Inc. and an Endo Pharmaceuticals Inc. unit have thrown their support behind a bid to create a new mass tort program in Pennsylvania state court to coordinate a cluster of cases over heart attacks and strokes allegedly caused by testosterone-containing products.


Endo, AbbVie Back Philly Testosterone Case Consolidation By Matt Fair Law360, Philadelphia (March 17, 2016, 5:44 PM ET) -- A group of drugmakers including AbbVie Inc. and an Endo Pharmaceuticals Inc. unit have thrown their support behind a bid to create a new mass tort program in Pennsylvania state court to coordinate a cluster of cases over heart attacks and strokes allegedly caused by testosterone-containing products. A brief submitted by attorneys for Abbvie, Endo and GlaxoSmithKline LLC was filed in the Philadelphia County Court of Common Pleas last Friday endorsing a motion filed by plaintiffs in February asking that the approximately 30 cases pending over...


Litigation
Legal Newsline | Mar 19, 2016
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SCOTUS Won’t Review Request for Heightened Standard of Ascertaining Class Members

The U.S. Supreme Court recently declined a request for review by a company arguing in favor of a “heightened” standard for ascertaining class members in federal class actions.


The nation’s high court denied Direct Digital LLC’s petition for a writ of certiorari, which was filed in October.


The company, which makes Instaflex Joint Support, a product aimed at relieving joint discomfort, argued the case was an important one because of an existing circuit split.

Litigation
Health News Review | Mar 19, 2016

Needed in Off-Label Promotion Debate: Acknowledgement of Deadly Risks

The drug company Amarin won a court case that essentially granted them a protected “free speech” right to promote their fish oil-derived product Vascepa for off-label purposes. And this week, Amarin’s free speech rights were further upheld in a settlement with the FDA and U.S. government over the same issue.


This means that Amarin can continue to promote Vascepa for off-label purposes. The drug is currently approved to treat people with severely elevated triglycerides, and the company sued to be able to “engage in truthful and non-misleading speech promoting the off-label use of Vascepa.” Essentially the company could say that “supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease,” but in that ruling the company also had to disclose that the FDA has not approved Vascepa to reduce the risk of coronary heart disease.


Extensive coverage – including stories in the New York Times, Bloomberg, STAT and ABC News, US News and World Report — delivers a lot of details on the freedom of speech issues this court case raises. But the stories mostly fail to dig into the crucial consumer impact of what constitutes “on-label” or “off-label” use of a drug — and whether it’s a good idea to let drug companies promote off-label uses.

Litigation
ABA Journal | Mar 19, 2016

Will Cosby’s Umbrella Policy Cover Claims?

Bill Cosby hopes to use an umbrella policy tied to his homeowners’ insurance to pay his legal fees and any judgments in defamation lawsuits against him.


American International Group has filed two lawsuits seeking declaratory judgments that Cosby isn’t covered because of exclusions for sexual misconduct, the New York Times reports. “So far, Mr. Cosby is winning,” the story says.


Ten women in three states have filed defamation suits claiming Cosby and his representatives defamed them by denying their claims of sexual assault. Cosby has extra liability coverage of $35 million tied to his homes in Massachusetts and California.

Litigation
Legal Newsline | Mar 18, 2016
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Drug Maker to Pay $124 Million to Settle SC Risperdal Claims

South Carolina Attorney General Alan Wilson announced last month that he and Ortho-McNeil-Janssen Pharmaceuticals have finally reached a settlement in the state's Risperdal case, ending a nine-year legal battle.


n a letter dated Feb. 16, Wilson informed Spartanburg County Clerk M. Hope Blackley that the defendant will pay $124,324,700 in satisfaction of the settlement to South Carolina, which alleged the illegal promotion of the anti-psychotic prescription drug for unapproved uses.


“We are pleased to have this matter put to bed. This landmark case has established guidelines that will be used for years to come,” Wilson said in a statement sent to Legal Newsline.

Litigation
Reuters | Mar 18, 2016

Whistleblower: VM Destroyed Emissions Evidence

A fired Volkswagen Group of America employee has filed a whistleblower lawsuit against the German automaker , accusing it of deleting documents and obstructing justice in the ongoing diesel emissions investigations.


Daniel Donovan, who worked as an information technology employee in VW's general counsel office since 2008, claims in the suit filed in Oakland County Circuit Court in Michigan last week that he was fired in December "because of his refusal to participate in a course of action" that would destroy evidence and obstruct justice.


Donovan alleges he was fired because he refused to participate in destroying evidence in ongoing probes of VW by the Justice Department and Environmental Protection Agency over software that allowed diesel vehicles to emit up to 40 times legally allowable pollution in real world driving.

Litigation
Reuters | Mar 18, 2016
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Second GM Ignition Trial: ‘Grand Failure’ v. ‘Errors in Judgment’

Lawyers for General Motors Co and two Louisiana residents suing the U.S. automaker over a 2014 car crash clashed in federal court in Manhattan on Monday about whether the accident was caused by icy roads or a faulty ignition switch that prompted the recall of millions of vehicles weeks later.


During opening arguments in the second lawsuit to go to trial over the switch, Randall Jackson, a lawyer representing plaintiffs Dionne Spain and Lawrence Barthelemy, told jurors that the crash could have been avoided if GM had taken action in response to numerous reports it had received since 2004 about problems with the switch. It has been linked to nearly 400 serious injuries and deaths.


Litigation
Arkansas Online | Mar 17, 2016

AR Supreme Court Upholds Nursing Home Arbitration Provision; Denies Patients Right to Jury Trial

Five current and former nursing home residents signed away their right to a jury trial and must submit to arbitration to resolve disputes, the Arkansas Supreme Court.


In a 5-2 decision, the majority ruled that the agreements were signed by people with the proper authority, and that the unavailability of the National Arbitration Forum to arbitrate does not mean the agreement "is unenforceable based on the defense of impossibility of performance," and the contract is not "unconscionable."


The lawsuit was filed by former residents, special administrators, guardians or attorneys-in-fact of former residents against GGNSC Holdings LLC of Fort Smith. The company is also known as Golden Horizons and Golden Living, according to a filing with the Arkansas secretary of state's office.

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