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

Courtroom News
Law.com |

“Payback for the Big Short” – Goldman Mortgage Legal Fees Mount

Call it payback for the Big Short. Goldman Sachs Group Inc. ended 2015 with its third straight quarter of shrinking profits, and the investment bank primarily blamed legal costs associated with its role in selling shoddy mortgage securities during the financial crisis eight years ago.


In its latest financial report, released Jan. 20, the bank says noncompensation expenses were $12.36 billion for 2015, a 30 percent jump from 2014, “due to significantly higher net provisions for mortgage-related litigation and regulatory matters.”

Courtroom News
Reuters |

Securities Class Actions Up in 2015

Shareholders in 2015 filed 189 lawsuits accusing companies of making false or misleading statements or concealing bad news about their businesses or mergers, a study released on Tuesday by Cornerstone Research and Stanford Law School shows.

Courtroom News
Fierce Pharma |
Fuse_Thinkstock

Patients Bring RICO Suit Against J&J Over Levaquin Side Effects

Johnson & Johnson is facing yet another lawsuit over its antibiotic Levaquin from people who claim that the company hid serious side effects. The latest legal action comes a couple of months after an FDA panel flagged serious problems associated with the entire class of antibiotics and voted to change the meds' labels.

Courtroom News
Fierce Pharma |

Pfizer Hit With FDA C&D Letter Over YouTube Ad

In the first enforcement action from the FDA's marketing police this year, the Office of Prescription Drug Promotion put Hospira in the hot seat over a YouTube video for its sedative Precedex.


The OPDP sent an untitled letter dated Jan. 14 to the Pfizer-owned company, charging the video "omits risks and material facts" about the drug. The agency also rebuked Hospira for publishing the promotional video without submitting it to the OPDP for review.

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Reuters |

$1BN Here We Come! Emails Shed Light on Drug Company Exec’s Pricing Motive

A decision by Turing Pharmaceuticals to increase profits by raising the price of a lifesaving drug by 5,000 percent drove some patient co-pays up to $16,000, according to excerpts of documents that congressional committee members made public on Tuesday.


The excerpts, highlighted in memos released by Democrats on the powerful U.S. House of Representatives Committee in Oversight and Government Reform, give a rare behind-the-scenes glimpse into the business decisions behind drastic price increases at Turing and Canada-based Valeant Pharmaceuticals International Inc.

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Law.com |

Cybersecurity Company Sued Over Quality of Data Breach Investigation

A Las Vegas casino operator that filed a lawsuit against a cybersecurity firm the company hired in the wake of a 2013 data breach may be paving the way for other businesses to take contracted cybersecurity companies to court.


Trustwave, which is based in Chicago, was hired by Affinity Gaming to investigate a hack that exposed the details of credit cards belonging to as many as 300,000 customers, who used them at restaurants, hotels and gift shops on its casino properties.

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Find Law |

Lawsuit Filed Over Caffeine Pill Death

On September 26, 2014, Noah Smith frantically called his father. He told him he had taken some pills, and that “his heart was racing, that he could not think straight, and that he was desperately afraid something was very wrong with him.” Noah then collapsed, and died of cardiac arrhythmia.


The pills he took were Stay Awake tablets, caffeine pills sold over the counter at gas stations nationwide. Now Noah’s family is suing A&Z Pharmaceutical Inc., who manufactured the pills, claiming they contain dangerous amounts of caffeine, lack proper warnings, and marketed and sold to children.

Courtroom News
EcoWatch |

“In Michigan, from Flint water, to Crime and Murder, to GM Ignition Switches, It’s a Culture of Death.”

When the governor’s office discovered just how toxic the water was, they decided to keep quiet about it and covered up the extent of the damage being done to Flint’s residents, most notably the lead affecting the children, causing irreversible and permanent brain damage. Citizen activists uncovered these actions, and the governor now faces growing cries to resign or be arrested.


10 things that you probably don’t know about this crisis because the media, having come to the story so late, can only process so much. But if you live in Flint or the State of Michigan as I do, you know all to well that what the greater public has been told only scratches the surface.