April 2011

Apr 26, 2011 10:04 AM

CBS: Baby's death prompts war against hospital errors

CBS’s “The Early Show” reported on the all too common story of preventable medical errors, and the victim this time was newborn Genesis Burkett. Genesis was given 60 times the normal dose of sodium during a routine procedure, but despite a blood test detecting these extremely high sodium levels, and a doctor’s orders, eight hours passed before any action was taken.

 

 

The Civil Justice System and Auto Safety

I authored an opinion piece in The Washington Post this weekend about the importance of the civil justice system in improving auto safety. I was inspired by a new report from the National Highway Traffic Safety Administration that found traffic deaths have dropped to their lowest level since 1949.  AAJ released a report last year that showed how litigation has spurred automakers to make safety innovations, creating a safer climate for both drivers and passengers.

The full op-ed is here, and and a short excerpt of my column is after the jump:

By Employing Safety Measures, VA Hospitals Significantly Reduced Deadly Infections

Kevin Sack with The New York Times reports that a new VA study will "likely to step up pressure by further undercutting the notion, prevalent at many hospitals not long ago, that infections are an unavoidable cost of doing business." Sack points to the larger implications this could have on the safety of all Americans while in hospitals.

An aggressive four-year effort to reduce the spread of deadly bacterial infections at veterans’ hospitals is showing impressive results and may have broad implications at medical centers across the country, according to the first comprehensive assessment of the program, which was released Wednesday afternoon.

The study of 153 Veterans Affairs hospitals nationwide found a 62 percent drop in the rate of infections caused by methicillin-resistant Staphylococcus aureus, or MRSA, in intensive care units over a 32-month period. There was a 45 percent drop in MRSA prevalence in other hospital wards, like surgical and rehabilitation units.

The Veterans Affairs strategy employs a “bundle” of measures that include screening all patients with nasal swabs, isolating those who test positive for MRSA, requiring that staff treating those patients wear gloves and gowns and take other contact precautions and encouraging rigorous hand washing. The results may not be easily replicated in the private sector, but they are likely to step up pressure by further undercutting the notion, prevalent at many hospitals not long ago, that infections are an unavoidable cost of doing business.

US Government: FDA Allows High-Risk Devices to be Sold without Strenuous Testing

The Government Accountability Office has found that high-risk medical devices are often approved for sale by the FDA without sufficient proof of safety. Bloomberg reported on the findings today and pointed out that many high-risk devices are cleared with minimal tests.

High-risk medical devices are approved for sale without sufficient proof of safety by U.S. regulators who don’t monitor recalls when concerns arise during marketing, the Government Accountability Office found.

The Food and Drug Administration has given expedited reviews to at least 67 devices such as pacemakers and hip joints since the GAO called in January 2009 for “immediate steps” to increase standards or reclassify the potential risks, according to Marcia Crosse, the GAO’s director of health care. The Senate Special Committee on Aging discussed the findings at a hearing today in Washington.

A series of device recalls led by Johnson & Johnson (JNJ)’s decision last year to pull 93,000 artificial hips from the market spurred lawmakers to scrutinize the agency’s approval process. The FDA has been slow to implement a 1976 law requiring that all high-risk devices undergo a strict review. Many are still cleared with minimal tests under the so-called 510(k) program if companies prove they’re similar to existing products, said the GAO, the investigative arm of Congress.

Big Announcement Today from HHS on Patient Safety Initiative

Great announcement from HHS today. The Obama Administration has launched the Partnership for Patients: Better Care, Lower Costs, a new public-private partnership that will help improve the quality, safety, and affordability of health care for all Americans. This is a big step for consumers and will also help to lower costs by reducing medical errors.

National Law Journal Op-Ed on LARA

The National Law Journal published a great Op-Ed by Gregory Joseph on the most recent attack on the civil justice system - the Lawsuit Abuse Reduction Act of 2011. Joseph argues that a previous mandatory-sanctions regime under Rule 11, in effect 1983 to 1993, was eliminated because it did not work. Why would we go back to a system that was already proven to not work?

Legislation has been introduced in ConĀ­gress to reinstate, in a more aggressive form, the 1983 version of Federal Rule of Civil Procedure 11, under which sanctions were mandatory, not discretionary. The House held hearings on H.R. 966, the Lawsuit Abuse Reduction Act (LARA), in March. This article analyzes this legislation.

LARA would amend Rule 11(c) to accomplish four things: make Rule 11 sanctions mandatory; eliminate the safe harbor of Rule 11(c)(2), which affords the alleged offender 21 days to withdraw the challenged position before a Rule 11 motion may be filed; convert the purpose of the rule from one of deterrence, alone, to add a compensatory dimension; and mandate an award of attorney fees, in addition to any other sanctions the court deems appropriate.

1 in 3 Patients Experience Adverse Event

ABC World News reports on the new study released by Health Affairs on patient safety.