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First Amendment Protects Off-Label Promotion, Judge Rules

A federal judge ruled earlier this month that the Food and Drug Administration can't bar a drug company from promoting an unapproved use for its pills derived from fish oil, The Washington Post's Carolyn Johnson reports. U.S. District Judge Paul Engelmayer ruled that the First Amendment protects Amarin Corp. "'truthful and non-misleading speech'" in promoting a use of its pills that has not been approved by federal regulators.

GSK Faces Lawsuit Over Generic Drug After 7th Circuit Ruling

The Wall Street Journal's Ed Silverman reports on a rare ruling: brand-name drug manufacturer GlaxoSmithKline must face a Paxil lawsuit from a plaintiff who took the generic version of the drug.

The U.S. Supreme Court has held that generic drugmakers can't be held liable for failing to warn consumers of the risk of their products because they have no authority to change the label approved by federal regulators for the brand-name version.

But the Seventh Circuit denied a bid by GSK to dismiss the lawsuit even though the plaintiff took a generic version of Paxil, WSJ reports. GSK's liability stems from designing and labeling the drug, WSJ further reports.



Actos Defendants Sanctioned in Las Vegas Case

A Las Vegas judge has sanctioned defense attorneys in a trial over Actos for disobeying court orders and disrupting court proceedings, The National Law Journal's Amanda Bronstad (and my colleague) reports: the lawyers, according to the trial judge's opinion, have "'“repeatedly engaged in disruptive and disrespectful behavior towards the court.'" The jury will be told of the sanctions and the judge plans to fine the lawyers $5,000 for each future violation.

Court Rules Federal Law Bars State Ban on Pain Drug

A federal judge ruled that a Massachusetts state ban on the sale of prescription painkiller Zohydro violates federal law, Reuters reports. Governor Deval Patrick had banned the drug when declaring a public health emergency about the abuse of opoids in his state. But Judge Rya Zobel ruled that the ban interferes with the Food and Drug Administration's "constitutionally mandated" regulatory authority, Reuters also reports.

Drug Companies Scaling Back Payments to Doctors for Drug Talks

Drug and medical-device companies are scaling back payments to doctors for promotional talks "as transparency increases and blockbuster drugs lose patent protection," ProPublica reports: "Eli Lilly and Co.’s payments to speakers dropped by 55 percent, from $47.9 million in 2011 to $21.6 million in 2012. Pfizer’s speaking payments fell 62 percent over the same period, from nearly $22 million to $8.3 million. And Novartis, the largest U.S. drug maker as measured by 2012 sales, spent 40 percent less on speakers that year than it did between October 2010 and September 2011, reducing payments from $24.8 million to $14.8 million."

The Physician Payment Sunshine Act, going to effect this year, is going to require all pharmaceutical and medical-device companies to publicly report payments to physicians, ProPublica reports.

U.S. Supreme Court Rejects Appeal of $142 Mil. Award Over Pfizer's Illegal Marketing

The U.S. Supreme Court has decided against granting Pfizer's appeal of a $142 million award in favor of Kaiser Foundation's health plan and hospitals regarding the off-label marketing of the Neurontin epilepsy drug, Bloomberg Businessweek reports. The Supreme Court's action also means that a national class action can proceed in which insurance companies, union funds and employers are suing for paying for coverage of "ineffective dosages of Neurontin" on the basis of aggregate data showing a correlation between Pfizer's off-label marketing and the number of off-label prescriptions, Bloomberg Businessweek further reports.

Sixth Circuit Rules Generic Drug Claims Preempted Under U.S. Supreme Court Precedent

The Sixth Circuit has ruled that state-law tort claims against generic drugmakers are federally pre-empted, according to Squire Sanders' Sixth Circuit blog. The Sixth Circuit majority cited Supreme Court precedent: PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett.  The majority also "reads those cases as broadly holding that state law failure-to-warn claims based on generic drugs are preempted by the FDA’s requirement that the labels on generic drugs conform to the labels on the brand-name drugs," according to the blog.

Philadelphia's Lull in Mass Torts Continues (But Out-of-State Drug Plaintiffs Tick Up 5%)

The Legal Intelligencer (my journalism alma mater) reports on the continuing trend of the reduction in mass torts in the Philadelphia court system. Court leaders, however, have seen a 5% uptick in filings by out-of-state plaintiffs suing over the pharmaceutical drugs they took.

One attorney told The Legal that more vigorous regulation by the Obama administration may have led to fewer tort lawsuits. "Obama has been more proactive in putting out more label changes, warning physicians about the side effects of prescription drugs. That takes away a lot of the failure-to-warn claims," plaintiffs attorney Sol Weiss said.

Johnson & Johnson Reaches $2.2 Billion Settlement for Physician Kickbacks, Marketing Off-Label Uses of Prescription Drugs

According to a transcript of a press conference given by Attorney General Eric Holder, Johnson & Johnson and three of its subsidaries will pay $2.2 billion to resolve claims of off-label marketing of prescription drugs and paying kickbacks to physicians and pharmacies:

"We are here to announce that Johnson & Johnson and three of its subsidiaries have agreed to pay more than $2.2 billion to resolve criminal and civil claims that they marketed prescription drugs for uses that were never approved as safe and effective – and that they paid kickbacks to both physicians and pharmacies for prescribing and promoting these drugs.  Through these alleged actions, these companies lined their pockets at the expense of American taxpayers, patients, and the private insurance industry.  They drove up costs for everyone in the health care system and negatively impacted the long-term solvency of essential health care programs like Medicare. This global settlement resolves multiple investigations involving the antipsychotic drugs Risperdal and Invega – as well as the heart drug Natrecor and other Johnson & Johnson products.  The settlement also addresses allegations of conduct that recklessly put at risk the health of some of the most vulnerable members of our society – including young children, the elderly, and the disabled."

Circuit Split Set Up Over Mass-Torts First Impression Issue?

The Philadelphia Inquirer reports that a Ninth Circuit opinion "is the latest in a debate about whether multiple lawsuits alleging harm to patients from the same pharmaceutical product should be heard in state courts or federal courts."

According to the opinion in Romo v. Teva Pharmaceuticals, at issue was whether it was appropriate to remove mass torts to federal court under the Class Action Fairness Act's provisions for federal removal of "mass actions" when the claims of a 100 or more plaintiffs involve common questions of law or fact that the plaintiffs propose to try jointly.

The district court remanded to state court involving plaintiffs who say they were injured by the ingestion of propoxyphene, "an ingredient found in the Darvocet and Darvon pain medications, as well as in the generic brand counterparts," the majority opinion said. The Ninth Circuit majority agreed with the district court the plaintiffs' petition for coordination wasn't a proposal to try the cases jointly, only for coordination of discovery and other pretrial matters.

In contrast on the same issue of first impression, the Seventh Circuit in In re Abbott Laboratories involved plaintiffs seeking consolidation through trial, the Ninth Circuit majority said.

The majority also said in a footnote that a three-judge panel doesn't have the authority to revisit circuit precedent decided in 2009 case of Tanoh v. Dow Chemical Corp. that there is a presumption against removal to federal court, that any uncertainty should be construed in favor of remand, and that the proposal to try claims jointly must come from the plaintiffs. The Chamber of Commerce and others argued as amici, the majority's opinion said, that "we should revisit Tanoh and that it has lost its precedential value, urging that plaintiffs should not be able to structure their complaints to avoid federal jurisdiction in light of the purposes of CAFA to curb class action and mass action abuses that have occurred in state courts," the footnote in the opinion said. But the majority also said it approves of Tanoh and that other circuits, including the Seventh Circuit in Abbott, have cited it.

In contrast, the dissent said that the majority "creates a circuit split, for practical purposes, with the Seventh Circuit's decison in Abbott."

"If plaintiffs are masters of their complaints and can plead in a way to avoid federal jurisdiction, they remain free to 'game' the system to some degree, including by joining less than one hundred plaintiffs in many suits in state court, so long as those cases are separate," the dissent said. "... That leads me to recognize that the issue here, stated more precisely, is whether when plaintiffs seek to coordinate under California law many state actions, and urge the state court that coordination is necessary to avoid inconsistent judgments, that is a proposal for joint trial within the meaning of CAFA."

The full Ninth Circuit opinion is here:



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