Vested Interest - News and Notes - July 2005 Issue

4th Patient on M.S. Drug May Have Brain Infection

Shares of Biogen Idec and Elan fell on news that a fourth patient may have developed the life-threatening brain infection that prompted the companies to halt sales of their multiple sclerosis drug Tysabri earlier this year. If the fourth case of the normally extremely rare infection is confirmed, it would make it more difficult for the drug to return to the market, doctors and analysts say. The new case might indicate the drug is more dangerous than previously thought because it appears the fourth patient might have taken the drug for a substantially shorter time than the other three. (ATLA Law News Digest – June 9, 2005)

Med Mal Returns to Profitability

According to a new study by Conning Research and Consulting Inc., despite the dismal performance of the medical malpractice line over the last few years, the line will again be profitable in 2006. "The medical malpractice line has demonstrated periods of high profitability as well as periods of crisis with severe losses," said Stephan Christiansen, director of research at Conning. "While we have certainly been in the loss and crisis segment of the cycle for the past few years, we see clear indications of progress toward profitability." (Insurance Journal – June 9, 2005)

Surgical Tools Washed in Hydraulic Fluid

About 3,800 patients at two hospitals run by Duke University Health System were operated on last November and December with instruments that were washed in hydraulic fluid instead of detergent, hospital regulators said. The hospitals did not detect the problem for weeks, despite complaints from staff members about slick tools, putting patients in "immediate jeopardy," according to a report by the Centers for Medicare and Medicaid Services. (AP – June 12, 2005)

State to Post Surgery Prices

A new law signed by Governor Blagojevich will allow patients to shop around for more health care providers before choosing where to have outpatient surgery in Illinois. The law will require hospitals and surgery centers to report to the state the cost of outpatient procedures, as well as their success rates in performing them. The state will post the information on the Internet beginning in January 2007. (Chicago Tribune – June 15, 2005)

Scooters Sending Kids to Hospitals

According to a new government report by the Consumer Product Safety Commission, from July 2003 to June 2004, about 10,000 children entered emergency rooms due to accidents involving gasoline or electric powered scooters. About two-thirds of the injured were younger than 15. Sixty percent were male. Razor USA recalled about 246,000 electric scooters in June after receiving 261 reports of handlebar welds breaking or bending, which resulted in at least 16 injuries, including three broken arms. (Chicago Sun-Times – June 15, 2005)

Safer Auto Windows for Kids

Power windows are being redesigned to pinch fewer fingers as more auto makers in the U.S. adopt designs that automatically reverse if there’s an obstacle in the path. The main beneficiary: kids (or pets) who might otherwise bump the buttons and get their hands, heads or paws caught in the window. Common in Europe and Asia for more than a decade, the auto-reverse designs first showed up in the U.S. in luxury models and now are spreading to more mainstream models. (ATLA Law News Digest – June 16, 2005)

Airline Inspections Inadequate

The Federal Aviation Administration is failing to effectively oversee new safety risks posed by sharp cost-cutting in the airline industry and rapid growth of budget carriers, a government report concludes. U.S. airlines, many of which continue to struggle financially, are looking for new ways to cut costs by outsourcing maintenance and reducing the time that planes are parked at gates. At the same time, new low-fare carriers are expanding to dozens of cities. Both trends have created safety concerns that the FAA has not adequately addressed in its inspection program, according to a report issued by the Transportation Department inspector general. (ATLA Law News Digest – June 16, 2005)

Drug Safety - System Broken

A top federal drug official told a medical advisory board that the nation’s drug safety system had "pretty much broken down" and there was room for "a lot of improvement" in the government’s approach to uncovering dangers in drugs already on the market. Dr. Janet Woodcock, deputy commissioner of operations at the FDA, made her remarks before a committee of experts at the Institute of Medicine, who had been asked by the agency to suggest safety improvements after a year of well-publicized trouble, including the withdrawal of two big-selling painkillers. (ATLA Law News Digest – June 16, 2005)

Are Report Cards for Doctors a Good Idea?

Issuing "report cards" to evaluate doctors who perform angioplasty, the surgical reconstruction of a blood vessel to improve blood flow, may have unintended results, researchers have found. It is widely believed that such evaluations give consumers an accurate measure of a doctor’s skill. The research, however, suggested that the evaluations might cause doctors to avoid operating on the sickest patients in order to improve their scores. (ATLA Law News Digest – June 16, 2005)

Police Vests May Not be Bullet Proof

The nation’s largest supplier of bullet-resistant vests to law enforcement agencies is urging its customers to replace vests containing the fiber Zylon, saying they may not be safe. Second Chance Body Armor said it sent notices to police agencies nationwide. The warning affects about 98,000 vests. New research shows that vests made even partially with Zylon "may fail to perform and result in serious injury or death." Lawsuits have been filed in at least nine states, and federal and state investigations have been started. (AP – June 22, 2005)

Public Citizen, Bridgestone Join to Fight Tire Rule

Public Citizen, along with Bridgestone/Firestone, three other tire companies and a trade group representing the tire industry took regulators at the National Highway Traffic Safety Administration to court asking for a tougher tire-pressure monitoring rule. This rule is mandated under the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act that Congress passed in the aftermath of the Firestone debacle. It called for more stringent reporting and documentation of vehicle and tire problems with NHTSA. Vehicle manufacturers will have to start complying with the rule to install a system on one or more of the vehicle’s tires to warn when they are 25 percent or more below the recommended tire pressure. (ATLA Law News Digest – June 23, 2005)

Drug Trials on Children Broke Rules

Federal officials have found that a Columbia University Medical Center committee that oversees the use of patients as subjects in medical research violated federal regulations in the 1990s in the case of four research projects. In the projects, experimental drugs were tested in children, including four foster children, with AIDS or who were HIV positive. The office for Human Research Protections informed Columbia in a letter last month that the medical center’s institutional review board had "failed to obtain sufficient information" concerning the selection of foster children as subjects, the process for getting their parents’ or guardians’ permission. (ATLA Law News Digest – June 23, 2005)

Anesthesiologists Change Their Ways

Many doctors may be paying more for medical malpractice insurance, but anesthesiologists are paying less today, in constant dollars, than they did 20 years ago. That’s mainly because some anesthesiologists chose a path many doctors in other specialties did not. Rather that pushing for laws that would protect them against patient lawsuits, these anesthesiologists focused on improving patient safety. Their theory: less harm to patients would mean fewer lawsuits. They have advocated the use of devices that alert doctors to potentially fatal problems in the operating room. They have helped develop computerized mannequins that simulate real-life surgical crises. And they have pressed for procedures that protect unconscious patients from potential carbon monoxide poisoning. (The Wall Street Journal – June 21, 2005)

AMA: U.S. Faces Doctor Shortage

At their annual meeting in Chicago, the AMA warned that a doctor shortage is looming, and overbooked physicians already have begun turning away patients. The number of medical students has remained roughly constant for 20 years, while the patient population has increased. Many doctors are nearing retirement age, just as aging baby boomers are requiring more care. The shortage is compounded by the unwillingness of many younger doctors to work long hours. According to an AMA report, specialists that are experiencing shortages or are expected to in the future include critical care, dermatology, radiology, endocrinology, allergy and immunology, psychiatry, cardiology and geriatrics. The Council on Graduate Medical Education, which predicts a shortage of about 90,000 doctors by 2020, has proposed a 15 percent increase in medical school enrollment. (Chicago Sun-Times – June 22, 2005)

Judicial Conference to Mull Unpublished Opinions

The U.S. Judicial Conference this fall will take up the controversy over whether lawyers should be allowed to cite unpublished opinions, following a unanimous vote by a lower committee. Most federal circuits already allow citation of unpublished opinions. Only the 9th U.S. Circuit Court of Appeals and three others currently prohibit citation. The new rule, 32.1, would bring all federal circuits in line. (ATLA Law News Digest – June 23, 2005)

CPSC Imposes Penalty For Failing to Report Hazard

The U.S. Consumer Product Safety Commission announced a provisional settlement with a toy and art materials manufacturer for failing to report important product safety information to the Commission. The settlement will impose a $300,000 penalty against Rose Art Industries Inc., of Livingston, N.J., for failing to inform the government in a timely manner about a defect in soap making kits that led to injuries to young children. Rose Art made and sold about 125,000 Glamour Gear Soap Making Kits nationwide. The kits, which are intended for children eight years of age and older, include bars of soap, molds and a plastic cup to melt soap chunks. A defect in the plastic cup, which is used to heat the soap in a microwave, can cause it to deform or develop a hole in the bottom and pose a serious burn hazard to children. Rose Art received 10 reports of children who were burned by hot soap while removing the plastic cup from the microwave. The majority of the children suffered second and third degree burns. The firm did not inform CPSC about the defect, injuries and the resulting civil litigation against the company until February 2002. According to federal law, manufacturers, distributors, and retailers are required to report to CPSC immediately (within 24 hours) after obtaining information which reasonably supports the conclusion that a product contains a defect which could create a substantial risk of injury to the public, presents an unreasonable risk of serious injury or death, or violates a federal safety standard. (CPSC Press Release - June 28, 2005)