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

Litigation
The Wall Street Journal | Mar 30, 2016

Internet Giants Ordered to Disclose Research on Jurors in Copyright Trial

Internet research by jurors is a common concern for judges. In a high-stakes copyright fight between two Silicon Valley giants, it’s Internet research on jurors that’s drawing particular scrutiny from the bench.


As the long-running Oracle Corp. v. Google Inc. copyright dispute nears trial, the federal judge hearing the case is urging both sides to respect the privacy of jurors. The judge has given lawyers a choice: either agree not to conduct Internet and social media research about jurors until the trial is over or be forced to disclose their online monitoring.


Litigation
Reuters | Mar 29, 2016
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Judge Sentenced to 10 Years for Accepting Nursing Home Bribes

A former Arkansas judge was sentenced to 10 years in prison on Thursday in a federal court in Little Rock after he pleaded guilty to lowering the amount of damages a jury awarded in a civil suit in exchange for campaign contributions.


Michael Maggio, 54, a former state district judge, reached a plea deal in 2015 where he admitted to receiving the bribes to reduce a $5.2 million judgment in a civil negligence case against a nursing home company to $1 million, according to court papers.


In the plea deal, Maggio admitted that he "corruptly accepted and agreed to accept from another something of value, that is campaign contributions," in connection with a business matter in his court.

Litigation
The Wall Street Journal | Mar 29, 2016
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Law Firm Partner Convicted of Posing as a Lawyer

Becoming a lawyer can be prohibitively expensive, with elite schools charging more than $150,000 for a three-year law degree. But there’s a much cheaper and quicker way to start working as an attorney: forge documents and pose as one.


The downside is that it’s a crime and you’re liable to get caught.


Such was the outcome for Kimberly Kitchen, a 46-year-old of James Creek, Pa., who was convicted Thursday on charges of forgery, unauthorized practice of law and felony records tampering.

Litigation
Bloomberg | Mar 28, 2016

DOJ: Drug Maker Provided Kickbacks, Held 80,000 ‘Sham’ Events for Doctors

The U.S. is asking Novartis AG to provide records of about 80,000 “sham” events in which the government says doctors were wined and dined so they would prescribe the company’s cardiovascular drugs to their patients.


The Swiss drugmaker and the Manhattan U.S. Attorney are engaged in a whistle-blower lawsuit that alleges Novartis provided illegal kickbacks to health-care providers through bogus educational programs at high-end restaurants and sports bars where the drugs were barely discussed.


In a filing Friday, the U.S. said it needs Novartis to provide information to support its allegation that the company defrauded federal health-care programs of hundreds of millions of dollars over a decade by inducing doctors to prescribe its medications through sham speaker events.

Litigation
Stat | Mar 25, 2016
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“Unconscionable”: Drug Company Raises Price of Assisted Suicide Drug

Want to die with dignity? There is a coupon for that, too.


This may sound like a morbid joke, but it’s making the rounds on the Internet thanks to Valeant Pharmaceuticals.

True to its widely vilified business model, the drug maker more than doubled the price of Seconal, a drug used for physician-assisted suicide, from $1,500 to $3,000, early last year. This occured a few months before California lawmakers proposed legalizing the practice (it was signed into law last October). The company was able to readily slap a higher price on the drug because there are no generics available, although a compound version can be obtained.


“It’s just pharmaceutical company greed,” Dr. David Grube, a family doctor in Oregon, where physician-assisted death has been legal for 20 years, told KQED, which first reported the price hike. “It’s not a complicated thing to make, there’s no research being done on it, there’s no development. That to me is unconscionable.”

Litigation
Harris Martin | Mar 25, 2016

Judge: Device Sales Reps May Have Duty to Warn($)

Louisiana federal judge has allowed plaintiffs in a Medtronic titanium implant action to add the company’s sales representative as a defendant, finding the representative may have had a duty to warn the implanting surgeon of the device's risks.


In a March 21 order, Judge Nannette Brown of the U.S. District Court for the Eastern District of Louisiana also granted plaintiffs’ motion to remand the action, noting the addition of the nondiverse sales representative as a defendant destroys diversity.


Litigation
American Bar Association | Mar 25, 2016
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Court: Insurer Must Provide Independent Counsel For Its Insured When a Conflict Arises

An insurer must provide independent counsel for its insured when a conflict of interest arises between the insurer and the insured. State Farm Mut. Auto. Ins. Co. v. Hansen. The court’s decision in Hansen, requiring independent counsel when an insurer asserts a reservation of rights that creates a conflict of interest, represents a growing trend across the country.

Litigation
Pharmafile | Mar 25, 2016

Drug Company to Pay $25 Million to SEC to Settle Bribery Charges

The SEC issued a cease and desist order Wednesday, which said that between 2009 and 2013, employees and agents of Novartis subsidiaries “engaged in transactions and provided things of value to foreign officials, principally healthcare professionals ("HCPs").”


The order claimed that these employees made varied payments and gifts to influence the HCPs to boost sales of Novartis drugs, as well as trying to cover up these actions by incorrectly recording the transactions in records. For example, some payments were recorded as legitimate expenses for travel and entertainment, conferences, lecture fees, marketing events, educational seminars, and medical studies.


“Novartis also failed to devise and maintain an effective system of internal accounting controls or an effective anti-corruption compliance program,” the SEC said.

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