Cosmetic surgery laws often aren't enough

Early last year, Irma Carabajal LeCroy was a successful Dallas real estate broker who owned two homes, a luxury car, an SUV and a small office building. Today, she is out of work, uses a walker and wheelchair to get around and says she has nothing left to her name.

And it's because of what she thought was a minor cosmetic surgery procedure.

LeCroy is one of a growing number of women who have had liposuction, sometimes combined with fat-transfer surgery, in doctors' offices or med spas — salon-like medical facilities that have doctors on the premises and offer skin care treatments, such as Botox injections, facials and laser resurfacing.

Some patients have found themselves disfigured or disabled. Others have died. Critics say the victims may not know that the rules that govern hospitals do not necessarily apply to the medical offices or spas popping up across the country. That's where a new breed of cosmetic surgeon now practices, often down the hall from where they do routine physicals, perform gynecological exams or pull wisdom teeth, according to state regulators, lawyers and plastic surgeons.

USA TODAY reported last year that only half of states require licensing or accreditation of medical offices where surgery is performed. But even when there are office-based surgery rules or laws in place, they often aren't enough, critics say. For example, most accreditation or licensing rules cover surgeries only if the patient is fully anesthetized. Some rules apply only if private insurance or Medicare is billed, which typically isn't the case in cosmetic procedures.

There are now about 4,500 med spas in the United States, up from about 800 five years ago, says Allan Share, executive director of the International Medical Spa Association. The growth of med spas has states scrambling to figure out how much legal oversight is needed. The Federation of State Medical Boards recently hosted a workshop for medical board attorneys that covered the regulatory oversight of med spas and office-based cosmetic surgery.

State medical boards and the laws regulating the practice of medicine were "created 100 years ago when cosmetic procedures or surgeries weren't anything that anyone had contemplated," says Mari Robinson, executive director of the Texas Medical Board. "It was about treating illness and disease — not this idea of people personally pursuing medical procedures solely based on improving their appearance."

In September, Maryland's health department shut down the Monarch Medspa in Timonium after three women contracted Group A Streptococcus infections during liposuction and one died. The department cited "deviations from standard infection control practices."

The Group A Streptococci bacteria, which can cause strep throat, are often found in the throat and on the skin and are spread through direct contact with mucus from infected people or contaminated surfaces, according to the health department. Most of these infections are relatively mild, such as with strep throat, but they can cause serious and even life-threatening complications.

Protecting consumers

Joshua Sharfstein, Maryland's secretary of Health and a pediatrician, sent a letter to three committee chairmen in the Maryland legislature last month asking them to tighten laws governing outpatient surgery. The existing law doesn't apply to outpatient surgery centers unless insurance companies are involved, according to a department press release. Health insurance typically covers only medically necessary or reconstructive plastic surgery after cancer. He also asked that the state Board of Physicians database include information on whether doctors perform cosmetic surgery and whether their facility is accredited.

"We asked ourselves if more needs to be done to protect consumers from unsafe cosmetic surgery," says Sharfstein. "There are some protections that exist for bigger surgical centers, but gaps in regulation might put consumers at risk" because smaller operations, including med spas, can take advantage of loopholes.

In Texas, doctors with office-based surgery centers or med spas that aren't accredited by one of three outside entities or licensed as ambulatory surgery centers, can register them for any level of anesthesia used that is above local anesthesia.

It wasn't the anesthesia that harmed LeCroy, however. It was the surgery itself, according to a lawsuit filed on her behalf against internal medicine doctor Hector Molina and the company that sold him the liposuction machine. The suit charges that Sound Surgical Technologies should have known of the risks of a non-surgeon who was not adequately trained in liposuction using the machine. In its response to the suit, Sound Surgical denied the allegations and says it was not to blame for any of LeCroy's injuries. In a statement provided to USA TODAY, the company said LeCroy's attorneys aren't suggesting the liposuction machine was defective, so it "is confident that it will be dismissed from this lawsuit either before or during trial." LeCroy's attorney, Jim Mitchell, says it wasn't that the machine was defective, it was that "Dr. Molina simply didn't know how to use the system."

When they prohibited Molina from performing cosmetic surgery in April, a Texas Medical Board disciplinary panel found his "entire knowledge" of the procedure he performed on LeCroy (who it did not name) "consisted of reading a book provided by the manufacturer of the liposuction equipment, completing an online program over two weeks, passing an online exam and completing one procedure under the direct supervision of another surgeon."

Texas-size problems

LeCroy was left permanently disabled by Molina due to problems including massive infection and the nerve and muscle condition known as "compartment syndrome," which causes body tissue to die, according to her lawsuit and an expert witness report by Miami plastic surgeon Alberto Gallerani. Molina denied the allegations in an answer to the lawsuit, and his lawyer declined to comment.

After LeCroy's more-than-nine-hour liposuction and fat-transfer surgery, Molina and a doctor assisting him abandoned her in his office "without any medical supervision or monitoring," according to Gallerani's report. Her friend, Marilyn Walker, found her "short of breath, unable to stand" and in severe pain in her legs and feet, the report said. She was rushed to the emergency room and transferred to a trauma center. So much fat was injected into the muscles in her buttocks, it caused the compartment syndrome, which Molina failed to diagnose, according to Gallerani's report. LeCroy needed 27 more surgeries to treat the compartment syndrome and related complications, according to Gallerani's statement. She spent a month and a half in the hospital.

LeCroy, 49, now has a home health aide coming to her house three times a week. The money she earned selling real estate, which she did starting at age 25, went to pay medical bills, because complications from cosmetic surgery aren't covered by insurance. She says she is unable to walk without a walker and needs a wheelchair for long distances. "I have nothing," says LeCroy. "I'm down to $698 a month in disability benefits."

Harlan Pollock, a Dallas plastic surgeon and past president of the American Association for Accreditation of Ambulatory Surgery Facilities, says Texas' law doesn't go far enough to protect patients.

When offices register with the state of Texas, certain requirements kick in for the safe administration of anesthesia, according to Texas Medical Board spokeswoman Leigh Hopper. These include the presence of a doctor and another person certified in treating cardiac arrest and a "crash cart" containing life-saving equipment. But Pollock says these requirements apply only to anesthesia and have little to do with the safety of the surgery itself. Accreditation, on the other hand, would require sterile procedures, physical requirements for the operating room, safety equipment and thorough record-keeping procedures, Pollock says. Sterile procedures are key for infection control, which was what Maryland officials found lacking at Monarch Medspa, medical experts say.

This kind of "an out," in Pollock's words, means "The public has no real assurance that the facility is an adequate facility, and that is disturbing and a real concern," he says.

On Nov. 30, the Texas Medical Board barred Molina from ever performing surgery or dispensing controlled substances, a category that includes some pain medications, such as those with codeine. But Texas has done little to crack down on the offices and med spas where doctors like Molina practice cosmetic surgery, say plaintiff attorneys and plastic surgeons.

Hopper emphasizes that Texas' medical board "rigorously screens" doctors who apply for medical licenses. And once they have these licenses, doctors are required to meet what's known as the generally accepted standard of care no matter what area they practice in, she says.

Still, if Texas' state Legislature wanted to address office-based surgery, Robinson says, the board would "be happy" to implement any new rules.

LeCroy isn't the only Texas patient to suffer after cosmetic surgery in a doctor's office or med spa. The Texas Medical Board also found OB/GYN Barbara Marino didn't meet the "standard of care," have emergency procedures in place or maintain a sterile operative facility during liposuction on patients at Medspa 21 in Houston. One died two days after his liposuction, and an autopsy report said the cause of death was "acute toxicity" from the combined effects of four medications, including a patch for the pain medication Fentanyl, according to the medical board's records. Another patient had excessive levels of pain medicine, the board said.

Late last month, Marino was ordered to observe at least 30 hours of cosmetic surgery by a board-certified plastic surgeon and document other procedures for treating at-risk patients and dealing with emergencies. She did not respond to calls seeking comment.

In November 2011, Laura Bennack, an emergency room doctor who owns Radiance MedSpa in San Antonio, had her practice put under the supervision of another physician by the Texas Medical Board. It had investigated the treatment of 10 cosmetic surgery patients and found she didn't meet what it considers the appropriate "standard of care" or keep adequate surgery records. According to the board's disciplinary order, Bennack performs tummy tucks, liposuction and breast augmentation while patients are awake. The board said in an order in February 2010 that Bennack acknowledged her medical record keeping was "sparse at best." Bennack did not respond to calls seeking comment.

Little regulation

Med spas typically offer only procedures without anesthesia or under local anesthesia, which isn't regulated in Texas or many other states. "There is absolutely no regulation of med spas," Pollock says. "That's something that to me is very frightening."

Some doctors, including Marino and Molina, register their facilities for higher levels of anesthesia. Several states require accreditation for offices intending to use deep sedation or general anesthesia, since it is the type used for the most serious procedures, says Tampa anesthesiologist Hector Vila. But doctors can get around the law by registering for a lower level of anesthesia or using large volumes of local anesthesia, says Vila.

Vila says existing laws need to be more strictly enforced to ensure people don't continue to skirt them. Performing surprise inspections and more frequent inspections could be one way to accomplish this, he says.

Some of the toughest laws:

Florida. The state changed its law early this year to authorize the state to inspect any facility, including med spas, that remove more than 1,000 cc's of fat during liposuction. That would cover all but the most minor procedures, says Democratic state Sen. Eleanor Sobel, who introduced the bill. Previously, the inspection authority existed only for facilities that accepted Medicare or other insurance. The law was passed after two women died of an overdose of lidocaine, a local anesthetic similar to novocaine, after liposuction.

California. Under a law passed in January, California's medical board keeps a list of accredited outpatient surgery settings. The board approved four accreditation agencies that inspect and accredit outpatient surgery settings, including medical offices and spas. These agencies can reject, revoke, or otherwise restrict a facility's accreditation. If that happens, the medical board is notified and alerts the public on its website.

New York. Any office-based surgery facility that removes more than 500 cc's of fat during liposuction or uses anything more than minimal sedation must be accredited. Still, even though New York has some of the most stringent regulation of office-based surgery, any licensed physician can perform cosmetic surgery under a local anesthetic in an unaccredited facility, says Manhattan plastic surgeon Adam Schaffner. "My hope is that they will require that physicians who perform such procedures perform them in accredited facilities (and) that they have hospital privileges for any procedure they perform outside the hospital," says Schaffner.

The issue of med-spa regulation is "absolutely rising to a national level ... everyone is really looking at it right now," says Robinson.

"Every single person needs to pay attention to the training of the person who's doing the procedure and the status of the facility — whether it's accredited or not," says Sharfstein. "What you find out can make the difference between life and death."

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Source: US Today (O'Donnell, 12/10)

More DPS workers testing blood to ease backlog

AUSTIN, Texas — The Texas Department of Public Safety has reassigned about 15 crime lab workers to blood testing to help trim a backlog in drunken driving cases.

The Austin American-Statesman and KVUE-TV reported Thursday that the number of blood samples sent to DPS rose 500 percent in six years as police increasingly use such evidence in DWI cases.

DPS increased the number of blood testing analysts by 20 percent by temporarily moving employees from areas without as many samples. Spokesman Tom Vinger says DPS in 2009 added nine blood testing positions but no additional workers in 2011 due to state budget constraints.

Sen. John Whitmire of Houston, who chairs the Senate Criminal Justice Committee, says it's a glaring example of not having enough resources to do the job.

Legislators convene in January.

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Source: Lubbock Avalanche Journal (AP, 12/7)

Seven injured in Texas State bus, SUV collision

Seven people were injured in an accident involving a Texas State University bus and an SUV.

The accident happened around 3 p.m. at 5th Street and Trinity.

Investigators say the bus collided with the SUV and then hit and uprooted a tree.

"The bus driver was out cold unfortunately and he was one of the first people to be pulled off. There was a lot of people who had hit their face on the seat in front of them. So there was some people like I guess bleeding on themselves and things but they were ok," Matt, a Texas State student said.

Six people were taken to UMC Brackenridge, and another person was taken to Saint David's. The driver of the bus was one of the injured.

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Source: My Fox 7 (11/28)

Man accused of driving wrong way on I-20 charged with intoxication manslaughter

A man involved in a fatal car accident Friday was arrested late last week by the Texas Department of Public Safety for intoxication manslaughter, said a spokesman for the agency.

Gustavo Cervantes, 36, of Wichita Falls, was driving a 2002 Dodge Ram eastbound in the westbound passing lane of Interstate 20 at 2:40 a.m. Friday, said Sparky Dean, DPS spokesman. His vehicle collided nine miles west of Sweetwater with a vehicle driven by Cory Lynn Carlile, 41, of Rowlett.

Carlile was pronounced dead at the scene.

Cervantes was taken to Hendrick Medical Center on Friday with "incapacitating injuries" but was released later that day; afterward he was arrested and charged, Dean said.

Cervantes posted a bond of $20,000 and was released from the Nolan County Jail.

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Source: Reporter News (Collins, 11/28)

Deaths at Texas railroad crossings rising, despite state safety plan

DALLAS — Deaths at railroad crossings in Texas have doubled in the last year, renewing questions about whether the thousands of miles of track in the state is being safely maintained and monitored, figures compiled by The Associated Press show.

The spike in fatalities comes after a four-year period in which Texas had lowered its death toll significantly and with the state in the midst of implementing a federally mandated plan aimed at improving rail-crossing safety.

They include not only the Nov. 15 accident in Midland that claimed the lives of four military veterans on a parade float, but an equally horrific accident that killed three generations of one family in the East Texas town of Diboll last March.

Critics of the railroads believe they deserve much of the blame for increasing the speed of trains without adjusting the timing of crossing gates, while state authorities contend that motorists are ultimately responsible for their own safety.

"In 2012, we can do all kinds of exploration in space, and yet, with all that technology, people are still getting killed at railroad crossings," said Sally Tingle, executive director for the Texas chapter of Operation Lifesaver, a nonprofit organization dedicated to eliminating railroad crossing accidents.

The AP found 32 people died this year at railroad crossings in Texas, based on federal data, news accounts and statements from the Texas Department of Transportation. For the previous four years, the state had averaged just 20 deaths a year. That followed two years in which the death toll reached 34 and 44.

The 2012 Texas death toll contrasts with the national statistics, which show railroad crossing deaths have generally decreased in the last five years and could be headed for a further drop-off this year. Data compiled by the Federal Railroad Administration through the end of August shows 168 deaths nationally, 10 less than what was reported for the same period in last year.

Experts said the spike in deaths in Texas merits evaluation, but they cautioned that it may simply be a statistical anomaly. The best measure is what the numbers show over several years, they said.

"Every accident is important, particularly to the family and community that experienced it," said Bob Chipkevich, former director of the National Transportation Safety Board's railroad accident investigation division. "But when you look for trends, you have to look at the longer term."

Texas, with nearly 11,000 miles of track, was one of 10 states required to develop a railroad crossing safety action as a result of a federal law enacted in 2008. The states were selected on the basis of the number of incidents at crossings reported for the previous three years.

The Texas plan, developed by the state's Department of Transportation, lists dozens of strategies, including evaluating crossings with multiple accidents and developing outreach programs to better educate the public and law enforcement.

In an email, TxDOT spokeswoman Veronica Beyer said the plan, which won't be fully implemented until 2014, has already led to crossing upgrades and improved education.

However, she noted that motorists "hold the key" to safety.

"We will continue to work with federal partners and railroad companies to ensure safety devices are working at railroad crossings, but, similar to roadway safety, we need the help from Texas drivers to enhance safety at these crossings as well," Beyer wrote.

Bob Pottroff, a Manhattan, Kan., attorney whose practice focuses on railroad crossing accident cases, said it's misguided to put the onus on motorists. The real issue is how the railroads are increasing the speeds of their trains without adjusting mechanical devices at crossings to provide longer intervals between initial warnings and the trains' arrival, he said.

Pottroff, who has filed a lawsuit on behalf of two veterans injured in the Midland accident, said the problem is particularly acute in Texas, a key corridor for moving freight to and from the West Coast.

"They are flying trains through Texas faster than they ever have," he said.

The four veterans killed in Midland were part of a parade honoring wounded vets when the flatbed truck carrying them collided with a Union Pacific train traveling 62 mph. The driver of the truck ventured onto the track after the warning signals had begun to flash and before the arms had descended, according to the National Transportation Safety Board.

The NTSB said the device was activated within 20 seconds of the train's arrival, the minimum standard required by federal regulations. However, TxDOT documents made public last week indicate that the device was designed to activate at 30 seconds.

Darin Kosmak, director of TxDOT's rail-highway section, wrote in an email that trains are traveling along the rail line at a maximum speed of 70 mph even though the crossing's design was based on speeds of no more than 25 mph.

The Diboll collision also involved a Union Pacific train and a crossing set for a 20-second warning time.

The train slammed into a Jeep Wrangler that had stopped on the track soon after the arms descended, causing the deaths of the 19-year-old driver, her 54-year-old grandmother and her 18-month-old nephew.

The conductor told police he thought it was a suicide because the vehicle never moved even though it was on the track for 10 seconds. But Jerry Easley, a lawyer who represented the family in a lawsuit against Union Pacific that was settled out of court, said evidence suggests the vehicle stalled and that the two women struggled to remove the toddler from a car seat.

Easley said video showed the vehicle entered the crossing 26 seconds before impact, but that wasn't enough time to escape the approaching train, which was traveling about 50 mph. The train's operators sounded the horn and backed off the throttle but didn't use the emergency brake until only a few seconds before the crash, he said.

Had the brake been set earlier, the women might have been able to save themselves and the child, Easley said.

"It certainly would have bought them more time, but the railroad can say, 'We don't put on the emergency brake because that might cause a derailment,'" he said.

Union Pacific spokeswoman Raquel Espinoza-Williams said the engineer complied with federal regulations by sounding the horn 21 seconds before the train reached the crossing.

"It is important to remember that trains cannot stop quickly," she wrote in an email to the AP, adding that a train going 55 mph can travel more than a mile before coming to a complete stop.

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Source: Dallas News (AP, 12/01)

After Dozens of Deaths, Inquiry Into Bed Rails

In November 2006, when Clara Marshall began suffering from the effects of dementia, her family moved her into the Waterford at Fairway Village, an assisted living home in Vancouver, Wash. The facility offered round-the-clock care for Ms. Marshall, who had wandered away from home several times. Her husband, Dan, 80 years old at the time, felt he could no longer care for her alone.

But just five months into her stay, Ms. Marshall, 81, was found dead in her room apparently strangled after getting her neck caught in side rails used to prevent her from rolling out of bed.

After Ms. Marshall’s death, her daughter Gloria Black, who lives in Portland, Ore., began writing to the Consumer Product Safety Commission and the Food and Drug Administration. What she discovered was that both agencies had known for more than a decade about deaths from bed rails but had done little to crack down on the companies that make them. Ms. Black conducted her own research and exchanged letters with local and state officials. Finally, a letter she wrote in 2010 to the federal consumer safety commission helped prompt a review of bed rail deaths.

Ms. Black applauds the decision to study the issue. “But I wish it was done years ago,” she said. “Maybe my mother would still be alive.” Now the government is studying a problem it has known about for years.

Data compiled by the consumer agency from death certificates and hospital emergency room visits from 2003 through May 2012 shows that 150 mostly older adults died after they became trapped in bed rails. Over nearly the same time period, 36,000 mostly older adults — about 4,000 a year — were treated in emergency rooms with bed rail injuries. Officials at the F.D.A. and the commission said the data probably understated the problem since bed rails are not always listed as a cause of death by nursing homes and coroners, or as a cause of injury by emergency room doctors.

Experts who have studied the deaths say they are avoidable. While the F.D.A. issued safety warnings about the devices in 1995, it shied away from requiring manufacturers to put safety labels on them because of industry resistance and because the mood in Congress then was for less regulation. Instead only “voluntary guidelines” were adopted in 2006.

More warnings are needed, experts say, but there is a technical question over which regulator is responsible for some bed rails. Are they medical devices under the purview of the F.D.A., or are they consumer products regulated by the commission?

“This is an entirely preventable problem,” said Dr. Steven Miles, a professor at the Center for Bioethics at the University of Minnesota, who first alerted federal regulators to deaths involving bed rails in 1995. The government at the time declined to recall any bed rails and opted instead for a safety alert to nursing homes and home health care agencies.

Forcing the industry to improve designs and replace older models could have potentially cost bed rail makers and health care facilities hundreds of million of dollars, said Larry Kessler, a former F.D.A. official who headed its medical device office. “Quite frankly, none of the bed rails in use at that time would have passed the suggested design standards in the guidelines if we had made them mandatory,” he said. No analysis has been done to determine how much it would cost the manufacturers to reduce the hazards.

Bed rails are metal bars used on hospital beds and in home care to assist patients in pulling themselves up or helping them out of bed. They can also prevent people from rolling out of bed. But sometimes patients — particularly those suffering from Alzheimer’s — can get confused and trapped between a bed rail and a mattress, which can lead to serious injury or even death.

While the use of the devices by hospitals and nursing homes has declined as professional caregivers have grown aware of the dangers, experts say dozens of older adults continue to die each year as more rails are used in home care and many health care facilities continue to use older rail models.

Since those first warnings in 1995, about 550 bed rail-related deaths have occurred, a review by The New York Times of F.D.A. data, lawsuits, state nursing home inspection reports and interviews, found. Last year alone, the F.D.A. data shows, 27 people died.

As deaths continued after the F.D.A. warning, a working group put together in 1999 and made up of medical device makers, researchers, patient advocates and F.D.A. officials considered requiring bed rail makers to add warning labels.

But the F.D.A. decided against it after manufacturers resisted, citing legal issues. The agency said added cost to small manufacturers and difficulties of getting regulations through layers of government approval, were factors against tougher standards, according to a meeting log of the group in 2000 and interviews.

Instead, in 2006, the F.D.A. issued voluntary guidelines, instructing hospitals and nursing homes on the use of bed rails. They recommended size limits for the gaps and openings in the rails and identified body parts most at risk for getting stuck.

Lara L. Mahoney, a spokeswoman for Invacare, a manufacturer of medical beds and rails in Elyria, Ohio, said newer hospital beds with side rails and stand-alone bed rails are better designed today and come with features like safety straps to prevent patients from sliding between parallel bars.

“The guidance has certainly had an impact on the industry,” she said.

In an interview, Mr. Kessler, the former F.D.A. medical device official who is now a professor at the University of Washington School of Public Health, acknowledged that the manufacturers’ resistance was a factor in not pursuing mandatory rules for bed rails.

But Mr. Kessler said a bigger factor in the F.D.A.’s decision was Congress.

“You have to remember that a few years before we began working on this issue, they had passed legislation telling us to ease the regulatory burden on companies,” Mr. Kessler said. “It would have been impossible to get a set of regulations through in that environment.”

One issue is that hundreds of stand-alone bed rail devices and beds for home use offered at medical supply stores or discount retailers may or may not be considered medical devices, depending on whether the manufacturer makes specific claims, saying, for example, the device will keep a dementia or Alzheimer’s patient from falling out of bed. Without such claims, it may be viewed as a consumer product, the F.D.A. said.

The F.D.A. said consumer safety devices were regulated by the Consumer Product Safety Commission, but the commission has long maintained that bed rails are medical devices and outside its mandate.

But that may be changing. Recently, the agency said it had begun reviewing death and injuries attributed to bed rails and will consider what actions it should take after the study is complete possibly by the end of this month. The commission said it was also coordinating with the F.D.A. to find a way to close the regulatory gap between the two agencies.

“As the elderly population increases we’re going to see more and more people cared for in their homes and assisted living facilities,” said Robert S. Adler, a commissioner with the consumer safety agency, who has made elderly safety a priority at the agency. “Bed rails are widely used in both of these settings and it’s something we need to get a handle on.”

Industry officials say despite the deaths and injuries reported from the use of bed rails, the devices can be an effective way of keeping frail older patients safe. The problem, they say, is when the bed parts — such as the mattress, rails and frame — come from different manufactures.

“This is when you get dangerous gaps in the assembly of the bed which allows a person to slip out between the mattress and rails and get injured,” said Lance Lockwood, an industry consultant and former employee of Hill-Rom in Batesville, Ind., a medical device company that makes hospital beds and bed rails. “This is something that should be explained to nursing homes and family members before they go out and buy these devices.”

In court filings, Ms. Black, whose mother died in a bed rail accident, claimed the staff at the Waterford home suggested the family buy a bed rail to keep her mother from rolling out of bed after she had been injured in a fall, and that no one warned her father when he bought bed rails for her mother. Washington state nursing home regulators said the nursing facility also never told Ms. Black and her father about the dangers of bed rails. Waterford did not respond to requests for comment.

Mr. Adler, the commissioner at the safety agency, credits Ms. Black’s advocacy with prompting the study of bed rail deaths and injuries, a point she plays down.

“Families need to be told about the possible dangers of bed rails,” said Ms. Black, who has since documented hundreds of deaths associated with the devices. “Dangerous bed rails with poor design should not be allowed to stay on the market.”

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Source: The New York Times (Nixon, 11/25)

UPDATE: Texas highway with nation's fastest speed limit records first fatal crash

Mustang Ridge, Texas  - On Sunday afternoon, the driver of a Honda Civic died after a crash with a Chevy Tahoe in the south bound lanes of State Highway 130.

Mustang Ridge Police tell KXAN the accident happened in the newly opened section of SH130 Toll, where the speed limit is 85 mph.

Police are still investigating the cause of the accident and did not say how fast the cars were traveling. But they did confirm that wild hogs were not a factor in the crash. Four accidents involved wild hogs the first night the toll road opened.

The driver and the passenger of the Tahoe suffered minor injuries. The driver in the Civic, Martha Harris, 60, from Lockhart died at the scene.

Police said the accident happened when one of the vehicle's was coming onto the on-ramp at Old Lockhart Road when the two vehicles collided.

The 41 mile toll road opened Oct. 24. The road has the highest posted speed limit in the U.S. at 85 mph.

Today was the first day drivers paid tolls on the road. Prior the road had been free to drivers wanting to try out the new road.

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Source: KXAN (Roberts, 11/12)

Many hospital patients get too much acetaminophen

NEW YORK- In a new study from two Boston hospitals, one in every 15 patients treated with acetaminophen got more than the maximum daily recommended dose at least once.

Acetaminophen - sold as Tylenol - is a common painkiller on its own, but also an ingredient in stronger narcotics such as Percocet and Vicodin. So without careful monitoring, it's not always obvious how much a patient has taken.

To protect against liver damage from an acetaminophen overdose, the U.S. Food and Drug Administration sets the maximum daily dose at 4 grams for most people or 3 grams for people 65 and older and those with liver disease.

Dr. Robert Fontana, a liver specialist from the University of Michigan Health System in Ann Arbor, called the new findings "a bit alarming."

"On the flip side, it doesn't look like there was any toxicity in these patients," Fontana, who wasn't involved in the new research, told Reuters Health.

"I certainly don't want people thinking, if I go to the hospital I'm going to get acetaminophen toxicity.'"

Researchers led by Dr. Li Zhou from Partners HealthCare System Inc in Wellesley, Massachusetts, reviewed the electronic health records of 23,750 adults treated at two hospitals during the summer of 2010. That included 14,411 people who took any acetaminophen during their stay.

Based on calculations from the electronic records, Zhou's team determined that 955 of those patients were given over 4 grams of acetaminophen in a 24-hour period, most on more than one occasion.

More than 20 percent of elderly people, and close to that many patients with liver disease, were given over 3 grams in a day.

People in the surgical and intensive care units were especially likely to be over-administered acetaminophen, as were those who took multiple different products containing the drug, according to findings published in the Archives of Internal Medicine.

Nobody developed liver failure due to acetaminophen during the study period. Patients given more than the recommended limit had higher levels of one liver-related enzyme in their blood - but it's not clear that would have any health consequences.

Fontana said the likelihood of doctors and nurses over-administering acetaminophen will probably drop in the future as the FDA cracks down on high doses of acetaminophen in narcotics.

There's also a need for more advanced health information technology systems that can track aggregate doses of ingredients that, like acetaminophen, are in multiple medications given to a single patient, according to Zhou.

"This is what we want to see," she told Reuters Health. "I really think it's doable."

As it is, she said, the technology that doctors and nurses use doesn't make acetaminophen limits obvious. And it's very difficult for them to calculate by hand exactly how much a patient has received if it's from different sources.

"It's so easy to exceed the 4-gram limit," Zhou said.

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Source: The Baltimore Sun (Pittman, 11/13)

12 years ago, a deadly trend began on Texas roads

Twelve years is a long time, especially when you consider this little-known stunning fact: The last day there wasn't a single fatality on Texas roads was 12 years ago Wednesday, on Nov. 7, 2000.

The statistic puts a stark perspective on the 41,252 people who have died in fatal traffic accidents on state roads during that time frame.

Texas Department of Transportation officials on Wednesday said the majority of wrecks on 80,000 miles of state roads were caused by people not wearing seat belts, drinking and driving and distracted driving.

"One fatality on a Texas roadway is one too many, and to see as many as eight or 10 in a single day is unacceptable," said TxDOT executive director Phil Wilson.

The Houston area alone has more than 10,000 miles of state-run roadways. Experts have historically called the area the nation's leader in alcohol-related road fatalities among populous cities, citing its limited public transportation and urban sprawl that causes people to drive many miles.

Road safety advocates point to legislation as a possible solution to decreasing traffic fatalities.

Jonathan Adkins, a spokesman for the National Governor's Safety Administration, said Texas' independent anti-government intrusion culture could be detrimental in preventing traffic deaths. He said 39 states have passed distracted driving bans. In 2011, Gov. Rick Perry vetoed a texting while driving ban.

Adkins also pointed to the dangers of a new toll road near Austin that allows motorists to drive 85 miles per hour.

"We have to create a culture in Texas and across the country where traffic deaths are not acceptable," he said. "Traffic crashes continue to kill people every day, and they are preventable."

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Source: Beaumont Enterprise (Mulvaney, 11/8)

Congress subpoenas co-owner of meningitis-linked pharmacy

BOSTON- The chief pharmacist at the company linked to the deadly meningitis outbreak has received a subpoena to appear before a congressional committee after he declined to appear voluntarily.

The House of Representatives Energy and Commerce Committee issued the subpoena to Barry Cadden, co-owner of the Massachusetts-based New England Compounding Center and its chief pharmacist before the compounding pharmacy surrendered its license in the wake of the outbreak.

"With more than 400 people infected and 30 deaths, it is critical that we hear directly from the head of the facility linked to the outbreak," said Committee Chairman Fred Upton and Ranking Member Henry Waxman in a statement. "Since Mr. Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena."

James Coffey, Director of the Massachusetts Board of Registration in Pharmacy, which regulates pharmacists in Massachusetts, has also been invited to testify at a hearing scheduled for November 14.

A spokeswoman did not immediately respond to a question as to whether Coffey had agreed to attend.

Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration, is scheduled to testify.

Hamburg, Cadden and others, including officials from the U.S. Centers for Disease Control and Prevention, have also been invited to testify about the outbreak before the Senate Health, Education, Labor and Pensions Committee at a separate hearing scheduled for November 15.

Meanwhile, NECC's legal team has been busy in federal court defending the company against a mounting number of lawsuits.

NECC lawyers, for example, say NECC did nothing wrong and have been caught in a crossfire of conflicting federal and state laws concerning specialty pharmacies. In addition, NECC lawyers argue various states have themselves enacted differing and in some cases conflicting regulations on the practice of pharmacies.

"Permitted practices in some states may be arguably impermissible manufacturing by FDA and other states," NECC lawyers said Monday in documents filed in U.S. District Court in Massachusetts.

But Peter McGrath said NECC and its attorneys are just buying time to plan how to contend with looming lawsuits and investigations.

Last month, McGrath, a former federal prosecutor, filed suit in state court in Massachusetts seeking to freeze the assets of NECC and its owners, including Cadden. His attachment, filed on behalf of an unnamed New Hampshire man, seeks several million dollars.

NECC wants that case moved to U.S. District Court because of the federal questions involved over what makes a drug manufacturer.

NECC said it expects a Judicial Panel on Multidistrict Litigation to rule within the next two to four months on whether to consolidate a number of lawsuits in one court. The decision could come soon after a hearing is held January 31 in Orlando, Florida.

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Source: AP (Clarke, 11/7)

Is Texas ready for 85-mph speed limit?

LOCKHART, Texas — For drivers who feel the need for speed, Wednesday is a big day in Texas.

A new 40-mile stretch of Texas 130 toll road bypassing Austin's east side will open with an 85-mph speed limit -- highest in the United States.

"I think people will routinely pass me going 100. Regardless of the speed limit, there's always going to be people who want to go past it," said Jeff Gibeaux, a civil engineer in Lockhart who plans to take the high-speed road to Austin on occasion.

While most states have raised speed limits gradually in recent years, Texas is going at it full throttle.

Since 2002, the Texas Department of Transportation -- at the urging of state lawmakers -- has raised the speed limit to 75 or 80 mph on nearly 6,507 miles of road.

Most of the increases have occurred since 2011, when a new state law broadened which roads qualified for higher speeds.

The speeds are now posted not only in rural areas but also on major roads such as Interstate 20 and Interstate 35 just outside Dallas-Fort Worth and other major metro areas.

On about 1 in 12 miles of Texas roadway -- including interstates, small highways and farm-to-market roads -- motorists may now legally travel at speeds once considered excessive and dangerous.

Safety experts in the U.S. and Europe warn that fatalities and injury accidents are likely to rise. Texas' fatality rate is already higher than the national average, with 3,015 people killed on roads in 2011.

"You need to take measures to counteract an anticipated increase in deaths," said Veronique Feypell de la Beaumelle, an analyst with the International Transport Forum, which publishes a road safety annual report with crash data from the U.S. and 31 other countries.

But state officials say they don't necessarily expect more carnage. On the contrary, they point to statistics showing that fatalities are declining along some West Texas highways that were the first to get higher limits.

They say their methods of studying a road before raising a speed limit are scientifically sound, although they are applied differently in various parts of the state.

Less certain is whether motorists have the proper training, or the self-discipline, to drive safely on a high-speed road. State officials say they are developing ways to promote better driving habits.

Last week, the Transportation Department began installing 3,400 signs reading "Left lane for passing only" on highways with a speed limit of 75 mph or more. The same message was flashed on more than 700 electronic highway signs statewide.

"We're going to have to teach Texans how to drive these safer speeds," said Bill Meadows of Fort Worth, a Texas Transportation Commission member.

Meanwhile, as lawmakers encourage the Transportation Department to raise speed limits in one county after another, researchers at organizations such as the Insurance Institute for Highway Safety are taking issue with some of the state's guiding principles for determining when to raise a speed limit.

State officials have said they generally believe that motorists will drive at a comfortable speed, regardless of the posted limit, so it's important to set limits near the thresholds at which people are already traveling. But that philosophy can conflict with a belief held by critics who say drivers go whatever speed they think they can get away with and often exceed posted speeds because they perceive them to be conservative.

Economics are a factor, too.

The new section of Texas 130 toll road is being built by a private developer known as State Highway 130 Concession Co. Llc., which is led by the U.S. arm of Spain-based Cintra. Texas 130 is part of the Austin area's Central Texas Turnpike System.

The developer is spending $1.4 billion on the project for the right to collect tolls through Nov. 11, 2062. To protect its investment, the group is paying Texas an extra $100 million in return for setting an 85-mph limit, according to the contract.

The idea is to attract more motorists to the road with the promise of higher speeds, which in turn generates more toll revenue.

Speed studies

State law requires the Transportation Department to perform a speed study before raising the limit on a stretch of road but lets the agency decide how to go about it.

Two of the agency's top safety officials demonstrated the process for the Star-Telegram this month on a stretch of Texas 130 that is already open north of Austin. There, the limit was raised to 80 mph this year, and the road could be a candidate for 85 mph in the near future, they said.

The first step in the speed study was for the pair of state employees to conduct a "trial run" of the 19-mile stretch. Darren McDaniel, a speed zone engineer for the department's Austin district, was given the task of driving the length of the road in a department pickup. Carol Rawson, director of the state's traffic operations division, sat in a passenger seat and took notes on McDaniel's speed.

McDaniel purposefully avoided looking at his speedometer and focused instead on driving at a speed he felt comfortable with -- most of the time, he was going 80 to 82 mph. The two were helped in their work by a couple of gadgets installed in the truck: a digital instrument to help Rawson track the speed without having to continuously look at the dashboard and an inclinometer mounted on the dash that was programmed to sound an alarm if the truck took a curve with too much gravitational force.

The duo also took notes on factors such as visibility on the road and the amount of clear space available on the shoulders and in the median, in case a motorist has to take evasive action.

Texas highways are typically designed to accommodate speeds of at least 70 mph -- the state's default limit until a speed study can be conducted, six months or more after a road opens to the public.

But roads can be designed for higher or lower speeds.

For example, a small portion of the planned Chisholm Trail Parkway in southwest Fort Worth is being designed for 50 mph to ensure that traffic goes relatively slowly through some old neighborhoods.

And, as with the Texas 130 extension, roads can be designed to accommodate 85-mph limits from their first day open to traffic.

The next step in the speed study was taking a sample of at least 125 randomly selected cars to determine how fast people are traveling on the road -- typically known as an 85th percentile test.

McDaniel and Rawson parked their truck on an overpass in Pflugerville near Austin and, using a laser gun like what police use to issue traffic tickets, they determined that 85 percent of the vehicles on this stretch of Texas 130 were traveling 83 mph or less.

As a result, the road was a candidate for an 80- or 85-mph speed limit, they said.

The idea is to set a speed limit so that 85 percent of motorists are obeying the law. Rawson said it's a commonly accepted standard in traffic-engineering circles that 85 percent of drivers are traveling at a safe, comfortable speed -- regardless of the posted limit.

"Most people drive what's safe and prudent, because we know people aren't wanting to hurt themselves," she said.

"They're not wanting to get into a crash. Most importantly, they want to get where they're going, so generally they're going to drive a speed that's reasonable, and that's what we're looking for."

'A moving target'

A top official at the Insurance Institute for Highway Safety, a research organization that tracks collision data throughout the U.S., said placing so much weight on the 85th percentile standard is leading states such as Texas to raise speed limits beyond reasonable levels.

"The 85th percentile is a moving target," institute President Adrian Lund said. "People do pay attention to the speed limit: They use it as a guideline and figure out how much faster they can go without getting a ticket. Gradually, you end up with the same number of people exceeding the speed limit that you had before. There's an assumption that the government is always conservative, so if 85 is the speed limit, then 90 and 95 must be safe, right?"

Higher speed limits could hit Texans in the pocketbook, too. If accidents increase, the cost of auto insurance will go up, David Snyder, vice president of the American Insurance Association predicted in a 2011 column that ran in the Star-Telegram.

Texas' fatality rate is already higher than the national average, and Texans pay some of the highest insurance rates.

Lawmakers' mandate

In April 2011, a state House transportation committee approved a bill that gave the Transportation Department power to raise the speed limit to 75, 80 or 85 mph on thousands of miles of the highway system, as long as a speed study was conducted on at least one place in each segment of roadway.

The bill, which eventually became law, also eliminated lower speed limits for trucks and for all traffic at night.

The lone vote against the bill was from Rep. Yvonne Davis, D-Dallas.

"When you've got as many inexperienced drivers on our highways as we do, the last thing you want is people going 75, 80, 85 mph," Davis said this month in an interview. "I thought the whole notion of raising the speed limit that high was crazy."

The bill passed without comment, although Davis said it was clear in the Capitol hallways that the measure had plenty of support -- particularly among rural lawmakers who were hearing from constituents that they wanted to legally drive faster.

"It probably started with the rural representatives," Davis said. "But these speed limits are in urban centers, too."

Support for higher speeds tends to be particularly strong in cities that stand to benefit economically from the lure of traffic, although projects such as the Texas 130 extension can also brew controversy.

About 30 miles southeast of Austin, the new Texas 130 extension leads to Lockhart, a city of about 13,000 that is known for its barbecue joints.

Residents aren't too happy that the speed limit on the frontage roads of U.S. 183 running parallel to the Texas 130 extension has been lowered from 65 to 55 mph.

State officials have said the lower limit is needed because commercial development is springing up along the frontage roads, creating a safety issue for motorists pulling in and out of driveways.

But many residents say the real motivation is to force traffic onto the 85-mph toll road.

And on the toll road, there is little opposition to the 85-mph limit.

"We're thrilled about it," said Wendy Ramsey, owner of Wendy R Gift Shop on the town square. She regularly drives 80 mph on the portion of Texas 130 that's already open and, beginning Wednesday, she fully expects to drive 85 mph on the new part of the toll road.

"There's so few cars on 130 at this point," she said, "that right now it seems safe."

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Source: Star-Telegram (Dickson, 10/22)

TX Supreme Court Rejects Crash Victim's Case

The Supreme Court of Texas refused for a second time to hear the case of tragic accident victim Michelle Gaines on Friday.

Without any explanation, the high court denied her attorneys' request for reconsideration.

Gaines, of Palestine, suffered a traumatic brain injury at age 19 on June 11, 2006, when an 18-wheeler hauling an oil rig careened through a red light and crashed into her 2000 Buick.

Four years later, a jury awarded Gaines more than $8 million in damages. The truck’s driver, its owner and another businessman involved with the oil rig were held liable. Court documents show the truck lacked working brakes and a jury agreed with Gaines' attorneys that there was an attempt to cover up what happened.

The state’s 12th Court of Appeals overturned the verdict last year, ruling there was not enough proof that the businessman, Joseph Pritchett — the only defendant with the money to pay the damages — was liable in the accident.

Pritchett's lawyers have said that he had no role in the accident and that he vehemently disagrees with implications of a cover-up.

Gaines' attorneys appealed, and the case made its way to the Texas Supreme Court for the first time this summer. When the justices refused to hear it, Gaines' attorneys filed the motion to reconsider.

Gaines spent weeks after the wreck recovering from a broken pelvis and punctured lung, but she continues to suffer from the effects of the head injury. Her father, Mike Gaines, has said his daughter has the maturity of a 12-year-old.

Scott Clearman, Gaines' attorney, said the Supreme Court's refusal to hear the case likely means the end of the legal battle and that she will eventually be confined to a state facility when her father is no longer able to care for her.

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Source: The Texas Tribune (Rocha, 10/26)

Texas Animal Welfare Organization Sues State over Dog and Cat Breeder Act

SAN ANTONIO- Touted as a "Puppy Mill" Bill, HB 1451 was not written to regulate Texas dog and cat breeders; it was written to eliminate them! Humane Society of the U.S. and their Texas cohort Texas Humane Legislation Network wrote the bill which was rammed through the Legislature despite strong opposition. HB 1451 is a national "animal rights" legislative agenda to end all breeding of animals – whether bred for food, clothing, or pet ownership.

Purebred dogs and cats face extinction with a loss of gene pools for all those breeds that serve mankind so well. "RPOA" stands for Responsible Pet Owners Alliance. "This new law tramples on important constitutional rights," claims Executive Director Mary Beth Duerler, "and will have a negative impact on the state's economy; affecting veterinarians, pet supply stores, groomers, pet sitters, and sales taxes."

The words "commercial" or "puppy mill" are nowhere in HB 1451. A breeder is defined as having "possession of more than 10 intact dogs or cats AND selling or even offering to sell more than 20 dogs/cats." "Intact" does not translate to "bred." Two litters of Labrador Retrievers could easily exceed the 20 limit sold. The exemptions for "certain dogs" are vague and indefinable. Texas Department of Licensing and Regulation (TDLR) inspectors will make those decisions on a case by case basis. It will be per dog, per year; and not a general exemption for any breed of dog.

The 26 pages of "Rules" evolved during numerous contentious meetings held by TDLR this year and compound the issue.

HB 1451 mandates USDA regulations at a minimum which cannot be met in a home environment due to stringent requirements for drainage, cleaning and sterilization methods. The new law has resulted in an exodus of breeders moving out of state, reducing number of intact females, or quit breeding altogether which is the goal of the Animal Rights Movement.

Can the new law be revenue neutral as required by statute with only 103 breeders licensed to date? The Legislature's financial analysis predicted 1,000 breeders would be licensed. Senator John Carona, Chairman of the Senate Committee on Business and Commerce, has written TDLR expressing concern that the program is falling far short of sufficient funding due to few licenses being issued. He warned, "… it must be supported by licensing income in a manner that does not punish registrants or raise the appearance of potential bias. Reliance on donations for the program's survival to any degree is not acceptable." The senator referred to the unique statutory provision that allows HSUS and other national "animal rights" organizations to make donations to an enforcement fund. This law is fundamentally flawed and must be repealed in its entirety. It can't be "fixed."

RPOA Texas Outreach, Inc. formed to promote and preserve the human/animal bond and our historic working relationship with animals.

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Source: PR Newswire (Responsible Pet Owners Alliance, 10/15)

Gov't to warn motorists about counterfeit air bags

WASHINGTON (AP) — The Obama administration is preparing to warn car owners whose air bags have been replaced in the past three years that dangerous counterfeit bags may have been installed, according to auto industry officials who have been briefed by the government.

The National Highway Traffic Safety Administration alerted the industry in a series of telephone briefings Tuesday that tens of thousands of car owners may be driving vehicles with counterfeit air bags, industry officials said. NHTSA testing has shown some of the counterfeit bags don't inflate or fail to inflate properly, they said. In at least one case, a counterfeit bag fired shards of plastic and other projectiles on impact, they said.

The officials requested that their names not be used because NHTSA had asked them not to speak publicly about the problem until after an announcement scheduled for Wednesday.

NHTSA will ask car owners to check a government website, Safercar.gov, or call their manufacturer or local dealership to learn if their vehicle model is among those for which counterfeit air bags have been made, officials said.

No deaths or injuries have been tied to the counterfeit bags, but it's unclear whether police accident investigators would be able to identify a counterfeit bag from a genuine one, officials said.

The agency has compiled a draft list of dozens of vehicle makes and models for which counterfeit air bags may be available. NHTSA cautions at the top of the draft that the agency "expects this list to evolve over time."

If the car is on the list and has had its air bags replaced during the past three years by a repair shop other than a new car dealership owners will be asked to bring the vehicle into a dealership to determine whether the replaced air bags are counterfeit. Fees for checking out air bags could run $100 or more, industry officials said. Some types of cars have as many as eight air bags.

The counterfeit bags typically have been made to look like air bags made by automakers and usually include a manufacturer's logo. Government investigators believe many of the bags come from China, an industry official said.

The bags are marketed to auto body shops as the real deal, officials said. Auto dealerships that operate their own body shops are usually required by their franchise agreements to buy their parts, including air bags, directly from automakers and therefore are unlikely to have installed counterfeit bags, officials said.

But only 37 percent of auto dealers have their own body shops, according to information on the National Association of Automobile Dealers' website. Many consumers whose vehicles have been damaged are referred by their insurance companies to auto body shops that aren't affiliated with an automaker.

Consumers who bought replacement air bags online will also be urged to check NHTSA's list.

A wide variety of counterfeit auto parts has long been a well-known problem, industry officials said. But recent incidents have escalated concern by government officials. In August, federal agents confiscated nearly 1,600 counterfeit air bags and arrested a North Carolina auto mechanic, according to a report by the Charlotte Observer. The mechanic was tied by federal officials to another counterfeit air bag case last year in Tennessee, the report said.

Last February, Dai Zhensong, a Chinese citizen, pleaded guilty and was sentenced in federal court in Chattanooga, Tenn., to 37 months in prison for trafficking in counterfeit air bags, according to a statement made at the time by the U.S. Attorney's Office.

Zhensong was a part owner and manager of the international department of Guangzhou Auto Parts, which made a variety of auto parts, many of which were counterfeit, the statement said. In 2010, he traveled from China to Chattanooga to sell additional counterfeit air bags and other auto parts. The counterfeit air bags were manufactured by purchasing genuine auto air bags that were torn down and used to produce molds to manufacture the counterfeit bags. Trademark emblems were purchased through Honda, Toyota, Audi, BMW and other dealerships located in China and affixed to the counterfeit air bags. The air bags were advertised on the Guangzhou Auto Parts website and sold for approximately $50 to $70 each, far below the value of an authentic air bag, the statement said.

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source: Associated Press (Lowy, 10/10)

Meningitis due to tainted steroids

The meningitis outbreak that has sickened at least 119 people and killed 11 of them has laid bare a disturbing lack of regulatory oversight of pharmacies that mix drug compounds and ship them around the country. Unless Congress passes legislation to strengthen the hand of the Food and Drug Administration, the public will continue to be at risk from contaminated products.

The outbreak has been linked to a steroid made by the New England Compounding Center in Framingham, Mass., that was shipped to 23 states. The steroid was almost certainly contaminated by a fungus, although final laboratory results are not yet in. Some 13,000 patients may have had the tainted steroid injected near their spines to ease back or neck pain. The center has shut down, surrendered its license and recalled all of its products, not just the steroids, while state and federal investigations try to pin down exactly what went wrong.

How could this happen? As Denise Grady, Andrew Pollack and Sabrina Tavernise explained in The Times, these pharmacies fall into a legal no man’s land between the Food and Drug Administration and 50 state pharmacy boards, most of which have little expertise and limited resources to ensure the safety of these products.

Years ago, compounding pharmacies were small-scale operations that mixed ingredients to meet the special needs of patients who couldn’t take the standard drugs, perhaps because they were allergic to a particular ingredient or couldn’t swallow a pill and needed a liquid form instead. Such pharmacies still exist, often inside a hospital, where they custom-make mixtures in accord with prescriptions written by the patients’ doctors.

Over the past decade or more, however, some pharmacies have morphed into miniature drug companies that compete with big pharmaceutical firms and produce compounds that essentially mirror drugs already on the market. Doctors and hospitals have turned to these pharmacies because their prices are often much lower than those charged by major manufacturers or because the standard drugs are in short supply.

Therein lies an element of risk. Compounded drugs have not gone through the same rigorous tests for safety and effectiveness required of standard drugs and are not made in plants inspected by the F.D.A. to ensure good manufacturing practices. There have been several incidents in recent years in which compounded drugs have caused injury. Some critics complain that the F.D.A. and state regulators should have intervened in this case sooner and more forcefully, which may well be true. But conflicting court decisions have left unclear what powers the F.D.A. has to regulate these pharmacies.

Congress can and should clarify matters with legislation. The legislation ought to grant the F.D.A. any powers it thinks it needs to inspect compounding pharmacies, monitor their nationwide sales and judge the safety or effectiveness of their products. It should also empower the F.D.A. to block pharmacies from making drugs (such as injectable steroids) that require a higher degree of sterility than many of them can meet. The goal is to ensure that there are no further calamities in this lightly regulated market.

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Source: The New York Times (10/9)

Toyota Yaris ranked worst among injury claims in insurance study

If you drive the Toyota Yaris, be careful.

That's because you're more likely to get injured in the tiny subcompact than in any other vehicle in a crash, according to an insurance industry study released Thursday.

The Highway Loss Data Institute looked at insurance statistics for model years 2009-11 and found personal injury claims were filed 28.5 times for every 1,000 Yaris vehicles the industry insured.

The Suzuki SX4, a small crossover, had the second-highest risk of injury to its occupants, posting 26.6 claims per 1,000 of the vehicles insured.

Other vehicles that scored poorly by the institute's measurement included the Chevrolet Aveo, Mitsubishi Galant, Kia Rio, Nissan's Versa and Sentra, Hyundai Accent and the Dodge Avenger.

Not surprisingly, the institute said its research demonstrated that the vehicles with the highest injury claims tend to be small cars.

"Injury claims data show something that crash test results can't, and that's the role that vehicle size plays," said Kim Hazelbaker, the institute's senior vice president.

That data come as small-car sales have zoomed with rising gas prices. Sales of cars in the same segment as the Yaris rose 32% through the first eight months of this year to more than 260,000, according to Autodata Corp. That's more than double the sales growth rate of all cars this year.

The Yaris has done even better, posting a 60% sales increase over that time period compared with a year earlier.

Toyota defended its vehicle, noting how the Yaris was among the 2012 "top safety picks" by the Insurance Institute for Highway Safety.

"Toyota is committed to achieving the highest standards for safety and is proud of its industry-leading 18 Toyota, Lexus and Scion models," Toyota spokesman Brian Lyons said.

The institute said the injury claims data were an important supplement to the crash tests conducted by federal safety regulators and the insurance industry.

"In most crash tests, the advantage of greater size and weight is masked by using a fixed barrier [in a test]. As a result, crash test results are comparable only among similar vehicles," Hazelbaker said.

But the insurance statistics show which vehicles' occupants are the most likely to be injured when it comes to real crashes, he said.

"We know that in the real world, if all else is equal, a larger, heavier vehicle does a better job protecting occupants than a smaller, lighter one."

Nissan, which had two cars on the list of the worst 10, said it would carefully evaluate the study.

"There are many factors that can influence claim rate and we will study the results to determine if the data can provide us with useful information for future safety developments," Nissan said in a statement.

"Nissan has a long-standing commitment to safety and innovation and continues to explore enhancements to safety technology even beyond conventional safety technologies. We believe that the Nissan Sentra and Versa provide excellent crash protection and safety to its occupants in the real world," the automaker added in its statement.

Among the vehicles with the least number of personal injury claims was the Porsche 911, with the lowest rate of 4.5 claims per 1,000 vehicles.

Other vehicles with a low number of claims included the Chevrolet Corvette and Silverado, Jeep Grand Cherokee, Lexus LX 570, Mercedes-Benz SL-Class convertible, Ford F-150, Land Rover Range Rover and Cadillac Escalade.

The institute also looked at the vehicles that suffered the highest dollar amount of damage in a crash.

The $200,000 Ferrari California fared the worst with an average claim of $82,112. That was five times the second-worst vehicle, the Maserati Granturismo, which suffered an average of $16,150 in damage per claim.

Expensive cars topped the list, but the institute also looked at the results for vehicles that are priced under $30,000. The Mitsubishi Lancer ranked poorly both in claims frequency and in the amount of damage inflicted per incident. The Lancer averaged $6,221 per claim.

Other vehicles that had high claims and losses were the Hyundai Genesis coupe, the Suzuki Kizashi four-wheel-drive sedan and the Subaru Impreza WRX.

"For consumers concerned about insurance premiums, this information is key," Hazelbaker said. "A lot of things go into your premium — your age, place of residence, driving record, sometimes even your credit history. The kind of vehicle you buy is the one factor that a consumer can control in the short term."

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Source: Los Angeles Times (Hirsch, 9/21)