pharma law

The pharmaceutical industry is asking Congress to exempt drug patents from an administrative procedure that allows patent challenges without having to go to federal court, The Wall Street Journal's Joseph Walker reports. But the Congressional Budget Office has found that enacting the exemption would delay the entry of new generic medicines to the market and would cost federal healthcare programs $1.3 billion over 10 years.

Jacob S. Sherkow, an associate law professor at New York Law School, told the WSJ that challenges to technology patents have been successful through the administrative procedure, but most pharma cases haven't been decided yet.

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.

The U.S. Supreme Court has agreed to take up a case involving Teva Pharmaceutical Industries Ltd.'s top selling drug, Copaxone, The Philadelphia Inquirer reports. The case could impact patent litigation, including because Teva asked the Supreme Court to require the Federal Circuit to be more deferential to lower court ruings.

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."

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: http://cdn.ca9.uscourts.gov/datastore/opinions/2013/09/24/1356310_opn&di...