Vested Interest - News and Notes - March 2006 Issue

Error Rate Greatest in Hospital Radiology

One of the most dangerous times in the hospital for patients is when they are wheeled out of their rooms and taken to the radiology department for a test or a procedure. Medication errors that harm patients are seven times more frequent in the course of radiological services than in other hospital settings, according to an analysis by United States Pharmacopeia, a non-profit group that sets standards for the drug industry. (ATLA Law News Digest – January 20, 2006)

Nursing Home Inspections Miss Violations

State inspectors often overlook serious deficiencies, including life-threatening conditions, in the nation’s nursing homes, Congressional investigators say in a new report. Investigators, from the GAO, questioned data used by the Bush administration in arguing that its policies have fostered "significant improvements" in the nation’s nursing homes. Nursing homes must meet federal standards to participate in Medicaid and Medicare. Homes are inspected by state employees working under contract to the federal government. Much of the apparent improvement has resulted from the fact that those state inspectors "missed serious deficiencies" or understated their severity. (ATLA Law News Digest – January 20, 2006)

Ford Touts Volvo Safety Link in Ads but Not in Trials

Ford Motor is trying to more closely align itself in advertising with Volvo, which it acquired in 1999. But in product liability trials, Ford tries to distance itself from safety-conscious Volvo. A Ford advertising campaign launched in October touts the safety innovation achieved in part by "Ford and our Volvo division working together." Meanwhile, a law firm has filed a legal challenge to a Florida court order barring the release of Volvo crashed-tested documents used in a case against Ford. Ford asked to have the trial exhibits sealed last spring after it lost a personal-injury case involving a Ford Explorer rollover accident. (ATLA Law News Digest – January 20, 2006)

EPA Asks Companies to Prevent Release of Chemical in Teflon

In a rare move against a widely used industrial compound, the EPA is asking U.S. companies to virtually eliminate public exposure to a toxic chemical used to make Teflon and thousands of other products. Although the effort is voluntary, the federal government has rarely taken such a sweeping, accelerated action against an industrial compound. The eight companies that use perfluorooctanoic acid to make an array of nonstick and stain-resistant products are expected to comply, cutting releases from their plants and products by 95 percent over the next four years and completely soon after that. (ATLA Law New Digest – January 27, 2006)

Guidant Says Failure Rate for Pacemakers Doubled

Medical device maker Guidant has said that the failure rate from a faulty hermetic seal in some of its recalled pacemakers has increased from summer projections. The company told doctors that 145 cases have been reported of 16,000 pacemakers that remain implanted in patients’ chests, raising the failure rate from July’s range of 0.17 to 0.51 to a new range of 0.31 to 0.88 percent. Guidant also acknowledged another batch of 54,000 pacemakers might have a similar problem, after a manufacturing mix-up included faulty components with those that worked correctly. Of that group, about 19,300 pacemakers remain implanted. (ATLA Law New Digest – January 27, 2006)

Prescription Drug Traces Found in Recycled Water

Water quality officials have found traces of resilient prescription drugs in waste water that has been filtered and recycled into a Southern California aquifer for eventual use as drinking water, but the amounts are so small that the health effects are unclear. Drugs, including antibiotics, antipsychotics, birth-control hormones, Viagra and Valium routinely turn up in wastewater all over the world because people flush them down their toilets. But medications have also ended up in Los Angeles County’s water supplies because of the region’s aggressive efforts to turn treated sewage into drinking water. (ATLA Law News Digest – February 3, 2006)

Regulating Home Renovations

In an effort to reduce lead poisoning in children, the EPA is proposing a broad rule requiring contractors working on homes built before 1978 to use lead-safe work practices. The proposal would create the first nationwide requirements covering the way contractors perform routine renovations and clean up afterwards. For any work that could disturb lead-based paint – including removing paint, taking down wallpaper or replacing windows- contractors would have to take various steps to minimize clients’ exposure including using special vacuums, sealing off work areas and posting warning signs. (ATLA Law News Digest – February 3, 2006)

FDA Rule Asserts Federal Preemption

The new prescription drug labeling rule from the FDA asserts that if a label meets the agency’s requirements, state law failure-to-warn suits over the drug’s risks are preempted. The rule states that the "FDA believes that under existing preemption principles, FDA approval of labeling under [federal law], whether it be in the old or new format, preempts conflicting or contrary state law." Some attorneys said that courts are likely to give deference to this position and find drug makers’ warnings to be sufficient if they meet the FDA’s requirements. (ATLA Law News Digest – February 17, 2006)

Liability Law Blocks Federally Insured Doctors from Disasters

Dozens of federally insured medical providers have been blocked from helping the Gulf Coast recover from Hurricane Katrina because their medical liability protection doesn’t apply outside their own states. Doctors and nurses from community health centers across the county, who encountered the insurance problem after Sept. 11, 2001, and found it most devastating after Katrina, hope a change can be made before another major medical emergency. (ATLA Law News Digest – February 17, 2006)

Device Won FDA Approval Though Staff Objected

A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, a Senate committee reported. The device, the surgically implanted vagus nerve stimulator, had not proved effective against depression in its only clinical trial for treatment of that illness. As a result, scientists at the FDA repeatedly and unanimously recommended rejecting the application of its maker, Cyberonics Inc., to sell it as such a treatment. But the director of the Center for Devices and Radiological Health at the agency kept moving the application along and eventually decided to approve it. (ATLA Law News Digest – February 24, 2006