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

Litigation
Reuters |

Appeals Court Give Go-Ahead to $1bln False Claims Case Against Defense Contractor

A U.S. appeals court on Monday revived a $1 billion lawsuit accusing defense contractor Raytheon Co of fraudulently overbilling the federal government under a contract to develop a weather sensor for a costly environmental satellite system.


By a 3-0 vote, the 9th U.S. Circuit Court of Appeals in Pasadena, California said the engineer Steven Mateski could pursue claims that Raytheon violated the federal False Claims Act for at least a decade starting in 2002.


The court said Mateski's claims went beyond publicly disclosed problems in developing the National Polar-Orbiting Operational Environmental Satellite System, which suffered from delays and cost overruns, including problems outlined in a U.S. Government Accountability Office report from November 2005.


"If his allegations prove to be true, Mateski will undoubtedly have been one of those whistle-blowing insiders with genuinely valuable information, rather than an opportunistic plaintiff who has no significant information to contribute," Circuit Judge Michelle Friedland wrote for the appeals court.

Litigation
The New York Times |

NYT: Fed Immunity May Bar Claims Against Gun Makers

The world recoiled in horror in 2012 when 20 Connecticut schoolchildren and six adults were killed at Sandy Hook Elementary School by a deranged teenager using a military-style assault rifle to fire 154 rounds in less than five minutes. The weapon was a Bushmaster AR-15 semiautomatic rifle adapted from its original role as a battlefield weapon. The AR-15, which is designed to inflict maximum casualties with rapid bursts, should never have been available for purchase by civilians.


This is the eminently reasonable point that the parents of the 6- and 7-year-old students cut down at the school are now pressing in Connecticut state court. They are attempting to sue the gun manufacturer, Remington; the wholesaler; and a local retailer for recklessness in providing the weapon to the consumer marketplace “with no conceivable use for it other than the mass killing of other human beings.”


The question of whether the lawsuit will be allowed to proceed is at issue because Congress, prodded by the gun lobby, in 2005 foolishly granted the gun industry nearly complete immunity from legal claims and damages from the criminal use of guns.

The Sandy Hook parents argue that their suit should continue because that law, the Protection of Lawful Commerce in Arms Act, allows claims against companies — gun shop dealers, for example — if they knew or should have known that the weapons they sold were likely to risk injury to others. The parents contend that the maker of the Bushmaster is no less culpable because it knowingly marketed a risky war weapon to civilians.

Litigation
The National Law Journal |
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DOJ Overreach Claimed as Device Maker CEO Acquitted of Fraud Charges

A Minnesota-based medical-device maker and its chief executive have been cleared on all counts in a fraud case that some viewed as a test of new U.S. Justice Department guidelines that emphasize holding more executives accountable for corporate misconduct.


In November 2014, a San Antonio grand jury indicted Vascular Solutions Inc. and its chief executive officer, Howard Root, on one count of conspiracy and other charges relating to the company’s allegedly illegal promotion of a device for treating varicose veins.


Prosecutors alleged that Root instructed sales staff to sell the now-discontinued Vari-Lase Short Kit to treat veins deep in the leg, even though the U.S. Food and Drug Administration had only approved the treatment for veins near the skin’s surface. A jury in San Antonio federal district court on Friday found Root and Vascular Solutions not guilty.

Litigation
The Legal Intelligencer |
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Third Time’s The Charm for Zoloft MDL Causation Expert?

Arguing that plaintiffs have already tried—and failed—twice to submit general causation experts in the Zoloft birth-defect MDL, Pfizer said in court papers Tuesday that it opposes a new bid to bring in specific causation experts for 300 cases.


Pfizer's position was outlined in a memorandum of law in support of its motion for summary judgment filed in the U.S. District Court for the Eastern District of Pennsylvania. U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania ruled last December to exclude the testimony of the plaintiffs' general causation expert, Dr. Nicholas Jewell, a professor of biostatistics at the University of California, Berkeley. Rufe had earlier barred testimony from the plaintiffs' noncardiac birth injury expert, Dr. Anick Bérard, as a factor in the decision to dismiss the cases.


With the main plaintiffs experts out of the case, the continued existence of the MDL is in jeopardy. The plaintiffs have not yet filed a reply to the defendant's memorandum, and the timetable for Rufe to rule on summary judgment is not clear.

Litigation
Reuters |

NewsCorp Pays $280mln to Settle In-Store Promotion Antitrust Claims

News Corp said on Monday that it had agreed to pay $280 million to resolve claims that it monopolized the market for in-store promotions at more than 50,000 retail stores across the United States.


The settlement with Rupert Murdoch's company abruptly ended a trial that had begun earlier in the day, when jurors in Manhattan federal court heard opening arguments in what had been a $2 billion lawsuit.


As part of the settlement with the plaintiffs, who consist of consumer packaged goods companies including Dial Corp and Kraft Heinz Co, News Corp said it will pay $250 million to settle the case and another $30 million to resolve related claims.

Litigation
Legal Newsline |
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Irony? AAJ Accused of Trying to Compel Arbitration Against Member

Weeks before the head of a national trial lawyers group condemned a legal maneuver used by businesses in attempts to fight class action lawsuits, the group was accused of using the same move – by one of its own members.


The American Association for Justice – a lobbying group for plaintiffs lawyers that was formerly known as the Association of Trial Lawyers of America - was a defendant in a lawsuit filed by Miami attorney Timothy Blake, who alleged he’d received a fax that violated a federal telemarketing law.


Blake, who wrote in his 2014 complaint that he’s been a member of AAJ for more than three decades, alleged the AAJ benefited from faxes sent regarding a health insurance plan because it receives royalty payments from the insurer when AAJ members sign up.

Litigation
The Legal Intelligencer |

Judge: Wal-Mart Can’t Use Spoliation to Thwart Crib Death Claim

Parents who claim their infant son died in his crib after suffocating because of an allegedly defective bumper pad had no duty to preserve the other items in the crib at the time, a federal judge ruled in finding there was no spoliation of evidence.


The defendants in Micjan v. Wal-Mart Stores wanted the most severe sanction for what it claimed was spoliation of evidence, but U.S. Magistrate Judge Robert C. Mitchell of the Western District of Pennsylvania denied their request for summary judgment.


After their three-month-old son Dylan Micjan died in March 2012 from asphyxia, Travis and Stefanie Micjan sued Wal-Mart, which sold the bumper pad; Garan Services Corp., which licensed the product; and Triboro Quilt Manufacturing, which made the bumper pad. The three defendants argued the couple failed to preserve key evidence, including the crib, crib mattress, two blankets, a stuffed animal and a pillow, that were all in the crib at the time of their son's death.

Litigation
Law.com |
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Court: Trolls Can’t Hide Behind Anonymity in Defamation Claim

A New Jersey appeals court has ruled that an anonymous online commentator must reveal his or her identity to members of a church known for its proselytizing who claim the commentator defamed them.


Appellate Division Judges Carmen Messano and Harry Carroll ruled Feb. 26 that the comments made by a person known only as Carlos Doe on a website operated by the Intellectual Freedom Foundation are not protected by the First Amendment.


The plaintiffs are Davina Mazzuckis and her husband, John Mauro, and Arcesio Pereira and his wife, Sindy Quintero, all of whom are members of the World Mission Society Church of God. They allege in the lawsuit, which also names the foundation as a defendant, that Doe defamed them by posting that Mazzuckis and Pereira were engaged in an extramarital affair and that Mazzuckis used “sexual innuendo” to recruit new members to the church, according to the ruling.