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

Litigation
Law 360 | Mar 24, 2016
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Driverless Cars and Product Liability ($)

On Feb. 14, a Lexus SUV was traveling east on El Camino Real in Mountain View, California, about 12 minutes south of Google’s corporate headquarters. The Lexus was being operated by Google’s self-­driving car technology, a system of sensors and software that allows the car to navigate without the aid of a human operator, though there was a Google tester sitting behind the wheel.


As the SUV came to a red light at the intersection of Castro Street, it put on its right-hand turn signal and moved into the right side of the lane to pass some cars that were stopped at the light. There were some sandbags placed around a storm drain that were in the SUV’s way, though, so it came to a stop. When the light turned green, the other traffic began to move again, and the SUV made its way back to the center of the lane to get around the sandbags...


Litigation
Los Angeles Times | Mar 24, 2016

Portrait of a “Failing Marriage” Between Heath Insurer and Pharma Middleman

Money always ranks high among the reasons for divorce. In the failing marriage between Anthem Blue Cross and Express Scripts, it's reasons one through 15 billion. That's how many dollars the party of the first part thinks its been cheated by the party of the second part.


For those who missed the wedding announcement back in 2009, the first is the nation's second-largest health insurance company and his (or her) partner is the nation's biggest pharmacy benefits management firm, or PBM. They seemed to be in a marriage made in heaven, until household finances strained the relationship to the breaking point. To be precise, the issue is the run-up in pharmaceutical prices, which Express Scripts was tasked with moderating but -- according to Anthem -- failed to deliver or even pocketed the savings.


Now they're in litigation. Anthem on Monday sued Express in New York federal court, alleging that the latter owes it at least $13 billion, and as much as $14.8 billion, in undelivered savings from negotiating lower prices on prescription drugs for Anthem's customers. The filing is assumed by observers to be the final break after attempts at working things out failed. Earlier this year, Anthem Chief Executive Joseph Swedish told an investment conference that his company was overpaying for drugs by $3 billion a year, and blamed Express Scripts.

Litigation
Legal Newsline | Mar 23, 2016

Fifth Circuit: Lack of Notice Makes Arbitration Agreement Unenforceable

The U.S. Court of Appeals for the Fifth Circuit recently determined that an employee’s discrimination lawsuit should stay in federal court because the employment arbitration agreement didn’t give advance notice of changes, making it unenforceable.


In Nelson v. Watch House Int’l, LLC, the Fifth Circuit ruled that the employer’s arbitration agreement is not enforceable because it doesn’t require advance notice be given to an employee before changes to the agreement take effect.


Michael Nelson, a former employee, filed the suit in federal court, alleging employment discrimination. Watch House argued that the claim should go to arbitration in accordance with its employment agreement. Nelson appealed to the Fifth Circuit after a district court agreed with Watch House.

Litigation
ABA Journal | Mar 22, 2016

Court: NH Law Doesn’t Allow AG to Retain Private Law Firm to Pursue State Opioid Claims

New Hampshire’s attorney general can’t simply hire a private law firm to pursue a potential case against pharmaceutical companies that market opioids, unless the governor and state lawmakers agree, a state-court judge ruled.


Attorney General Joe Foster is mulling a possible appeal and Gov. Maggie Hassan also finds the decision troubling, reports the New Hampshire Union Leader.


“The governor is concerned that Merrimack County Superior Court’s decision undercuts the attorney general’s longstanding authority to pursue important cases and issues free of politics, in this case combating the heroin and opioid epidemic, which we know stems at least in part from the overuse, misuse and abuse of addictive prescription opioids,” spokesman William Hinkle told the newspaper.

Litigation
The Legal Examiner | Mar 22, 2016
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Tort Reform Victim Profile – 17 Year Old High School Student

We hear a lot about tort reform these days. Tort reform tries to reduce the viability of tort lawsuits by enacting caps on the damages that can be recovered in such a lawsuit. Typically, damage caps limit the amount that can be recovered by a plaintiff for non-economic damages – the pain and suffering. Proponents of tort reform argue that the defendants in a lawsuit are the victims of our litigious society. But what you rarely hear about are the victims of tort reform damage caps.



Litigation
Rueters | Mar 22, 2016

Massive DePuy Hip Verdict Expected to be Reduced Because of Tort Reform

Johnson & Johnson and its DePuy unit were ordered by a Texas federal jury on Thursday to pay about $500 million to five plaintiffs who said they were injured by Pinnacle metal-on-metal hip implants.


Following a two-month trial, jurors deliberated for a week before finding that the Pinnacle hips were defectively designed, and that the companies failed to warn the public about their risks. Jurors awarded about $140 million in total compensatory damages and about $360 million in punitive damages, said Mark Lanier, lead trial counsel for the plaintiffs.


A J&J spokeswoman said the company will appeal.

Litigation
The Wall Street Journal | Mar 22, 2016
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Spotlight on Faulty Blood Monitor Used in Xarelto Clinical Trials($)

Agency links erroneous clotting readings on patients taking anticoagulants to deaths


The Food and Drug Administration is striving to assess the scope of the danger from medical devices that sometimes produce erroneous readings of how quickly patients’ blood tends to clot when they are taking anticoagulant medicines such as warfarin.

Litigation
The Wall Street Journal | Mar 21, 2016

Reports: J&J’s Ethicon Unit Settling Morcellator Cases($)

Johnson & Johnson is settling a series of legal claims and lawsuits alleging that its now-discontinued hysterectomy device harmed women by spreading an undetected hidden cancer, according to court documents and plaintiff lawyers with knowledge of the settlements.

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