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

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Reuters |
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Former Coal Company CEO Gets Prison Time Following Blast That Killed 29 Miners

Former Massey Energy Chief Executive Don Blankenship was sentenced to a year in prison and fined $250,000 on Wednesday for his role in a 2010 West Virginia coal mine explosion that killed 29 workers.


Blankenship, known as West Virginia's "king of coal" for his rags-to-riches background and tough approach to business, was given the maximum sentence for the misdemeanor conviction by U.S. District Judge Irene Berger. He also was sentenced to a year of supervised probation after release.


Blankenship, who headed Massey from 2000 to 2010, was convicted in December of conspiring to violate safety standards at the Upper Big Branch mine, site of the blast. He was acquitted on felony charges related to accident.


Blankenship had been accused of conspiring to falsify dust samples and violating federal securities laws by lying about company safety practices. But the jury that convicted him of the misdemeanor found him not guilty of making false statements and of securities fraud. The jury had deliberated more than two weeks and had twice told Berger it was deadlocked.

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Reuters |

Jury Awards $4.2 Million to PA Families in Fracking Case

A federal jury ruled on Thursday that Cabot Oil & Gas Co must pay more than $4.2 million in damages to two families in northeastern Pennsylvania who said the company's fracking operations contaminated their ground water.


Six jurors in federal court in Scranton awarded $1.3 million each to Scott Ely and Monica Marta-Ely, a married couple in Dimock. Each of their three children received an award of $50,000.


A second couple, Ray and Victoria Hubert, also of Dimock, about 32 miles (50 km) south of Binghamton, New York, each received $720,000, and their daughter Hope was awarded $50,000.

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Sports Illustrated |

SI: Analyzing the $55 Million Erin Andrews Verdict

In a stunning award of damages that should force hotels to rethink guest privacy, a Davidson County (Tenn.) Circuit Court jury on Monday awarded Fox Sports broadcaster Erin Andrews $55 million in damages. The damages stem from Andrews’s successful lawsuit against two companies, West End Hotel Partners and Windsor Capital. These two companies operate the Nashville Marriott at Vanderbilt University. Michael David Barrett, who in 2009 pleaded guilty to interstate stalking of Andrews and sentenced to 27 months in prison, was also a co-defendant in the case. Barrett had stalked and videotaped Andrews on several occasions and in different cities. He duped a Nashville Marriott employee into confirming Andrews’s reservation and his request to book a room next to her was granted. Barrett then used a peephole to surreptitiously videotape her while she changed. He later placed his videos online and millions watched.

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Reuters |

Novartis Must Face Labeling Claim Six Years After It Sold Its Stake in a Drug

A California appeals court has ruled that Novartis Pharmaceuticals Corp must face negligence claims from twins who say their developmental disabilities were caused by off-label use of a generic asthma medication their mother took nearly six years after Novartis sold its stake in the drug.


California's Fourth District Court of Appeal reversed a lower court and said that although Novartis was not the manufacturer of the drug that allegedly caused the unnamed minor twins' developmental disabilities, it could be liable for negligence if it knew about the dangers involved in its off-label uses but failed to adequately warn the public.

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Reuters |

Home Depot to Pay Almost $20mln to Settle Data Breach Case

Home Depot Inc agreed to pay at least $19.5 million to compensate U.S. consumers harmed by a 2014 data breach affecting more than 50 million cardholders.


The home improvement retailer will set up a $13 million fund to reimburse shoppers for out-of-pocket losses, and spend at least $6.5 million to fund 1-1/2 years of cardholder identity protection services.


Home Depot also agreed to improve data security over a two-year period, and hire a chief information security officer to oversee its progress. It will separately pay legal fees and related costs for affected consumers.

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Forbes |

$646mln Olympus Kickback Settlement with DOJ Predicted to Lead to More Whistleblower Cases

Olympus Corp. of the Americas’ jaw-dropping $646 million settlement with the Justice Department this week was important not just because it set a new record for kickback cases, but also because it shows how important whistleblowers are to regulators’ global anti-corruption enforcement agenda.


Now, more than ever, international companies are vulnerable to a variety of legal charges in the US when they export illegal sales practices.


Those vulnerabilities are heightened even more by the possibility that employees – whether in the US or other countries – may decide to blow the whistle on those hidden practices because of US programs that offer whistleblowers significant rewards and also, in some instances, job protection and confidentiality.

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Reuters |

Embattled Endoscope Maker to Pay $623mln to Resolve Kickback Charges

A U.S.-based unit of medical equipment distributor Olympus Corp will pay $623.2 million to resolve criminal and civil allegations about kickbacks paid to doctors and hospitals, the U.S. Department of Justice said on Tuesday.


The agreement involves the Japanese company's U.S. Olympus Corp of the Americas and Olympus Latin America Inc unit, the Justice Department said. The misconduct helped the unit obtain more than $600 million in sales and $230 million in gross profits, the Justice Department said.


At issue are improper relationships between medical equipment companies and health care professionals who prescribe or use that equipment. In one situation, a doctor who played a major role in a New York medical center's decisions to buy equipment received free use of $400,000 in equipment from Olympus for his private practice, the Justice Department said.