High Court urged to limit reach of Alien Tort Statute.

In an op-ed for the Wall Street Journal (2/28, Subscription Publication), David B. Rivkin and Lee A. Casey, who served in the Justice Department under Presidents Reagan and George H.W. Bush, argue that the Supreme Court should rule against corporate liability in two cases involving the Alien Tort Statute. Noting that the court is scheduled to hear arguments today in two cases involving the statute, Rivkin and Casey write that the law is being used in ways that far exceed its original intent.

FDA issues recall of perinatal pediatric hospital bed.

MedPage Today (2/25, Petrochko) reported, "The FDA has issued a class I recall of" the Perinatal Pediatric Hospital Bed, because its "doors and drawers... may open inadvertently while the device is being moved and the wheels may not swivel properly, which may result in serious injury or death."

Lawmaker introduces bill to limit state drug, device inspections

The Hill (2/23, Kasperowicz) "Floor Action" blog reported, "Rep. Brian Bilbray (R-CA) this week introduced legislation that would prevent any state from requiring drug or medical device inspections that are duplicative to inspections already required at the federal level by the US Food and Drug Administration (FDA)." The lawmaker said "his bill, the Science and Technology Regulatory Relief Act, is needed in his state because the California Food and Drug Branch is now running inspections that are mostly similar to FDA inspections, which he said is hurting job creation." The measure (H.R. 4056) "would amend the Food, Drug and Cosmetic Act so that duplicative state-level inspections would be eliminated."

Whistle blowers key in efforts to curb healthcare fraud

USA Today (2/23, Kennedy) reports, ." USA continues, "A bipartisan coalition backed strengthening the False Claims Act in 2009, and the Obama administration pushed for more money and tougher fraud-fighting provisions in the 2010 health care law, said Tony West, an assistant attorney general in the Justice Department's civil division. The health care law 'allows us to use it more effectively,' West said of the False Claims Act." West said that whistle-blower suits are one of the primary tools the department uses to fight fraud

Tennessee tort-reform advocates press for "losers pays."

The Tennessean (2/19, Gee) reported, "Unsatisfied with landmark tort reform legislation that Gov. Bill Haslam and Republican lawmakers successfully enacted last year, business, insurance and health-care interests continue to push for laws that will reduce their exposure to civil lawsuits." The Tennessee Civil Justice Act of 2011 capped non-economic damages at $750,000, punitive damages at $500,000 (with some exceptions), and curbed claims under the state's Consumer Protection Act. Tennesseans for Economic Growth, the business coalition that worked for that law, backs several "loser-pays" bills targeting civil case litigants who reject proposed settlements. These would make parties losing motions to dismiss pay opposing parties' litigation costs, and make plaintiffs pay defendants' costs if they spurn a settlement offer, then at trail win less than 75% of the offer, and likewise make defendants pay when plaintiffs win over 125% of a rejected settlement amount. Another proposal would shield employers from punitive damages when employees act without their knowledge.

Doctors say defective heart device exposes failure of safety monitoring.

Doctors say defective heart device exposes failure of safety monitoring.
Bloomberg News (2/15, Cortez) reports, "St. Jude Medical Inc. (STJ)'s Riata, a cable used in heart defibrillators, is the latest example of a defective medical device that wasn't spotted quickly enough because US surveillance systems are lacking," according to an article published in the New England Journal of Medicine. "St. Jude and US regulators aren't conducting studies needed to guide treatment for patients with Riata leads, though technology is available to do so, the researcher said." Robert Hauser, a Minneapolis Heart Institute cardiologist who wrote the article said, "Patients in the United States continue to be exposed to underperforming and potentially hazardous medical devices after they have been approved by the Food and Drug Administration, despite multiple recalls and some tragic adverse events."