Friday, December 28, 2012

TxDOT's "Holiday P.A.S.S." campaign continues to promote planning ahead this New Year's

AUSTIN-- New Year's Eve is a night of celebration and hope for a happier, healthier future, but if your celebration doesn't include having a sober ride home, your new year could begin on a much different note.

In their efforts to reduce drinking and driving, the Texas Department of Transportation is reminding Texans that having a sober ride home may be the most important part of their New Year's celebrations. TxDOT's Holiday P.A.S.S. (Person Appointed to Stay Sober) campaign has spent the month of December encouraging Texans to always take a sober ride home.

"New Year's Eve is a festive occasion, but no one wants to begin their new year with a DWI. Instead, we are encouraging Texans to plan ahead for a sober ride home before attending New Year's Eve parties," said John Barton, TxDOT deputy executive director.

During last year's holiday season (Dec. 1, 2011, through Jan. 1, 2012) there were 2,462 alcohol-related traffic crashes in Texas, resulting in 842 serious injuries and 78 fatalities (TxDOT, 2012). This holiday season, law enforcement officers throughout the state will work thousands of additional hours to crack down on drunk driving. Many cities and towns in Texas will implement "no refusal" programs over the New Year holiday period.

During the month of December, the Texas Hospitality Association has assisted TxDOT in spreading the important message about having your Holiday P.A.S.S. The association distributed customizable sober driver "gift certificates" and other materials in stores across the state where alcohol is sold. Additionally, award-winning mixologist, Rob Pate, owner of restaurants Peche and Cherry Street in Austin, created four signature non-alcoholic drinks that will be perfect for New Year's Eve parties.

For tips on planning for sober rides home after New Year's Eve celebrations, visit the Holiday P.A.S.S. Facebook page or the Pinterest page . You will also find recipes for our original non-alcoholic drinks there.


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Source: Herald Online (TxDOT, 12/27)

Wednesday, December 26, 2012

5 Key Steps To Staying Safe In Winter Driving

1. Make sure you and your car are properly equipped before you leave.

Do a quick check of your vehicle before you hit the road. Make sure that your car has ample antifreeze, the windshield is clean and you have plenty of windshield washer fluid, the headlights are clean and in working order and the tires have tread and are properly inflated. Also, make sure to have your battery tested, to avoid being stranded in the cold with a car that won't start.

In addition to your vehicle's mechanical equipment, it's important to keep some extra items in the trunk or glove box in case of emergency. Equip your car with a flashlight and extra batteries, a first aid kit, warm clothes, and a blanket. Remember to have sunglasses in the car as well. Its amazing how many people drive in the winter without them. The glare of the sun off of snow and ice can be more intense in the winter than it is in the summer.

One last thing to remember, perhaps the most important of all: Your cell phone.

2. Slow down and drive smoothly.

This may seem like a no-brainer, but even if you're driving an SUV or a four-wheel-drive truck, you cannot safely do 80 mph during a snowstorm. Four-wheel-drive may help your vehicle get going in the slushy stuff, but it's of no use when you're trying to steer or safely stop on a slippery road surface.

It is also important to avoid abrupt acceleration, braking and turns. Doing so can cause your vehicle to lose traction and can launch you into an uncontrollable skid, leading to a collision.

Driving too quickly is the main cause of accidents in winter conditions. Just be patient and accept the fact that it is going to take longer to arrive at your destination.

3. Do not tailgate.

It is important to remember that it takes a much longer distance to stop your vehicle in the snow or ice due to the greatly reduced traction, even with just a light covering on the road. You may think that the driver in front of you doing 35 mph on the freeway is going too slow and needs a reminder in the form of you riding their bumper, but doing so is dangerous. Be patient and stay back until it's safe to pass.

Tailgating often leads to accidents, especially if you are driving in stop-and-go traffic. If the car in front of you stops abruptly and you are following too closely, you can reflexively slam on the brakes and end up sliding into it. The resulting accident may be no more than a fender-bender, but having to deal with it on a busy road in the snow is certainly something that you want to avoid, especially if other cars are sliding around as well. Many serious accident injuries come from a second impact from another car after a seemingly trivial collision.

4. Do not use cruise control.

For some, driving with cruise control has become almost second nature. Sure, it prevents you from getting leg fatigue, keeps you from unwittingly speeding and is great on long trips, but driving with it on in winter conditions can be unsafe. Thus, if cruise control has become a staple of your driving habits, make a conscious effort to ensure that you are not using it in winter weather.

Using cruise control in the snow, ice or even rain is dangerous because if your car hydroplanes or skids, it will accelerate and rapidly spin the wheels since it will be trying to maintain a constant speed. If this happens, it will be more likely that you lose control of your vehicle.

5. Pull over or stay home.

If at any point during your trip -- or before you even leave -- you feel that the weather is too bad to continue driving, simply stay put. If you're out on the road, find a safe spot to pull over and wait until the weather passes or calms to the point where you feel comfortable driving again. If you haven't left yet, stay home and off the roads.

Remember, there is no shame in making the logical decision to stay in when the conditions are bad. You may be late arriving to your destination, but arriving late in one piece is much better than the alternative. Your boss or significant other will understand.

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Source: Aol Autos (Zak, 12/21)

Wednesday, December 19, 2012

Safety Agency Widens Inquiry on Ford Floor Mats

The National Highway Traffic Safety Administration has intensified an investigation into whether 480,000 Ford, Lincoln and Mercury vehicles have floors designed so that floor mats – if not properly secured – are nudged forward to snag the gas pedal and possibly cause unintended acceleration.

In a report posted on the agency’s Web site over the weekend, the agency says its investigation covers 2008-10 Ford Fusions, Mercury Milans and Lincoln MKZ models.

The agency says it is aware of 52 complaints from drivers who said floor mats prevented the accelerator pedal from returning to idle. But no accidents were reported.

Consumers who complained to the agency often said the unintended acceleration typically occurred after the driver pushed hard on the accelerator, as when merging onto a highway. But when the driver eased off the gas, the engine speed didn’t decrease. Drivers solved the problem by shifting into neutral or turning the engine off.

It seems possible, the agency report said, that the design of the floor pan can lift an unsecured floor mat so that it reaches the gas pedal.

The report noted mechanics who checked vehicles after owners complained of the problem blamed unsecured floor mats.

Ford changed the design of the pedals early in the 2010 model year, government investigators found. And, the “elevated rates of pedal entrapment” were found in the 2008 -10 model years before that change was made.

The agency began investigating the issue in May 2010 after receiving three complaints.

In a letter to the agency dated Sept. 9, 2011, Ford’s global director of automotive safety, Steven M. Kenner, wrote that problems with the gas pedal could occur only if the floor mat was not properly secured.

It is not a serious issue because the driver can move the floor mat with a foot or by tapping the accelerator pedal, Mr. Kenner wrote. Consequently, he said, Ford does not see a safety defect or “unreasonable risk” to safety.

More than two years is an unusually long time for the agency to go from a “preliminary evaluation” to the engineering analysis now under way. A spokeswoman for the safety agency could not immediately be reached for comment.

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Source: The New York Times (Jensen, 12/17)

Friday, December 14, 2012

Bad to the bone: A medical horror story

FORTUNE -- On Nov. 16, 2011, Georgia Baddley, a 70-year-old woman living near Salt Lake City, received a shocking call from a special agent at the U.S. Department of Health and Human Services. The agent told her that the government had come across new information about her mother's death.

Baddley was speechless. Eight years before, her 83-year-old mother, Barbara Marcelino, had unexpectedly died during spine surgery. At the time, Baddley didn't question what had happened; surgery was always risky for a woman of that age. She was horrified when the agent told her that the surgeon had injected bone cement into her mother's spine and that the product -- which was not approved for that use -- may have played a role in her death.

The agent explained that the government had filed criminal charges against the maker of the cement, a company called Synthes, and four of its executives. After hanging up the phone, Baddley sat in stunned silence. "I was taken aback," she says. "I had no idea that anything like that had happened."

Most people have never heard of Synthes, a medical device maker headquartered in West Chester, Pa. But the company became part of one of the most recognizable names in health care in June when Johnson & Johnson (JNJ) completed the purchase of it for nearly $20 billion -- the largest acquisition in J&J's history. Market watchers cheered the deal, which will expand the company's stable of high-margin orthopedic products. J&J, which has endured a series of reputation-sullying recalls and lawsuits in recent years, specifically cited Synthes's "culture" and "values" as evidence of its appeal, even as former Synthes executives awaited sentencing on charges of grievous conduct.

In 2009 the U.S. attorney in Philadelphia accused the company of running illegal clinical trials -- essentially, experimenting on humans. Between 2002 and 2004, Synthes had tested a product called Norian XR, a cement that has a unique capacity to turn into bone when injected into the human skeleton. The Food and Drug Administration explicitly told Synthes not to promote Norian for certain spine surgeries, but the company pushed forward anyway. At least five patients who had Norian injected into their spines died on the operating-room table. One was Barbara Marcelino.

The indictment of Synthes and its executives shook the health care industry. What occurred is a classic example of corporate malfeasance, but set inside an insular corporation run by a reclusive and autocratic Swiss multibillionaire, the provider of the largest individual gift in the history of Harvard University. The case offers a rare, sometimes disturbing, glimpse inside the shrouded world of medical devices, where surgeons occasionally turn for advice during operations to twenty something sales representatives.

Most of all, this is a story about a company that repeatedly ignored evidence of potential lethal consequences. Interviews with more than 20 former employees and surgeons involved in the Norian project, hundreds of pages of court transcripts, and company documents submitted in the case reveal that Synthes not only disregarded multiple warnings that it was flouting the rules, but also brushed off scientists' cautions that the cement could cause fatal blood clots.VV The Department of Justice targeted four high-ranking executives, all of whom pleaded guilty to a misdemeanor under an unusual provision of health care law called the Responsible Corporate Officer Doctrine. They accepted responsibility for the company's crime of running unauthorized clinical trials and for engaging in off-label marketing, or promoting products for unapproved uses, without conceding that they were involved in the crime. At the time, no executive had ever gone to prison for such a charge.

(Lawyers for the four executives declined to make their clients available for interviews or to comment on the facts of the case.)

Off-label marketing is so common among drug and device makers that it's often dismissed as the equivalent of driving slightly over the speed limit. During the past decade, pharmaceutical behemoths such as Merck (MRK), Pfizer (PFE), Abbott Labs (ABT), and GlaxoSmithKline (GSK) have paid billions in fines to settle charges that they engaged in off-label drug promotion. Yet cases continue to happen, in part because the potential profits often exceed the fines.

But this wasn't the typical off-label marketing case. Nor was it typical of trials for medical devices or drugs. Patients sometimes die during such clinical trials -- but only after being advised of the risks and then granting their consent. In hiding the unapproved status of the cement, prosecutors argued, Synthes denied patients the right to choose whether they wanted to be test subjects.

For the Justice Department, the Synthes case posed an unprecedented opportunity. It could finally hold individual businessmen accountable for their actions. Mary Crawley, the assistant U.S. attorney who led the prosecution, urged the court to send the executives to jail for their "venal crime." The "callous disregard of patient safety," she argued, "warrants the highest sentence the law will allow."

Read the entire story at CNN’s website.

Tuesday, December 4, 2012

One Dead, One Injured In Head-On Crash On Central Texas Highway

PRAIRIE HILL--A Riesel man was killed and a Mexia man was injured Tuesday night in a head-on crash just west of Prairie Hill on U.S. Highway 84.

A Texas Department of Public Safety trooper who investigated the accident said Barton Smith, 42, died just after 6:10 p.m. Tuesday after the 2000 Oldsmobile Alero he was driving collided with a 2007 Chevrolet Sliverado pickup truck.

Cesar Riojas, 37, of Mexia, was taken to Hillcrest Baptist Medical Center, in Waco where Wednesday he was listed in stable condition.

Trooper James Willis said Smith was westbound in the eastbound lane of U.S. 84 near Prairie Hill when his car and the eastbound pick up truck collided.

Willis did not mention any other victims.

Smith's body was taken to Blair-Stubbs Funeral Home, in Mexia, where arrangements were pending Wednesday.

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Source: KWTX (Gately, 11/28)

Monday, December 3, 2012

Federal investigation says state hospital failed in care of patient who died

When Brandy Bell was committed to Rusk State Hospital on May 14, there was little doubt she was a complicated patient with a long history of psychiatric problems. But one of her current struggles was painfully obvious.

“She was starving herself,” said Bell’s mother, Rita. “She wanted to die.”

During the Conroe woman’s 16 days at the state hospital, Bell virtually stopped eating. She lost 9 pounds in nine days, according to her medical records, grew dehydrated and lost strength. She began using a wheelchair.

On May 30, she died. She was 33.

Officially, Bell’s autopsy said she died from blood clots in her lungs. But a subsequent examination of her case by a federal Medicare investigator also concluded the hospital made crucial mistakes by neglecting Bell’s self-starvation and providing substandard nursing care.

Bell’s case is one of three cases involving state hospital patients with eating disorders being investigated by Disability Rights Texas, a federally funded protection and advocacy group. The other two patients — one is in Austin State Hospital, the other in Big Spring — are still alive.

For clinicians, eating disorders can further complicate treatment of patients who already have serious psychiatric problems. Experts say the circumstances surrounding Bell’s death while in state care pose a host of medical and legal questions on how best to monitor and treat patients who endanger themselves by refusing to eat — and when to force-feed them, if necessary.

“The question is whether or not the patient was engaging in behavior that was posing a significant risk to his life,” said Floyd Jennings, a clinical psychologist and attorney who advises the Harris County Public Defender’s Office. He stressed that while he had no direct knowledge of Bell’s case, “clinicians have a duty to begin intervening before it becomes a matter of life and death.”

The are currently 85 patients with diagnosed eating disorders at the state psychiatric hospitals, said Carrie Williams, spokeswoman for the Department of State Health Services, which oversees the facilities. That doesn’t include people without such diagnoses who temporarily refuse food for other reasons, such as paranoia.

The state psychiatric hospitals have no set protocol for treating patients with eating problems, Williams said. People whose primary illness is an eating disorder generally aren’t admitted to state psychiatric hospitals. But when they are, she said, treatment is determined on a case-by-case basis and might include extra attention to a patient’s physical condition, food intake and hydration.

According to medical records obtained by the Statesman, that never happened with Bell — even though Rusk State Hospital staffers knew from the start that she had struggled with eating problems.

Bell “was a known patient at Rusk with an identified eating disorder,” said Robin Thorner, a Disability Rights attorney. “Her death raises many questions about how the state hospitals identify and treat patients with eating disorders. It remains to be seen whether staff have sufficient expertise to provide quality care to patients with a co-occurring eating disorder.”

Williams said quality treatment is a priority at all the hospitals.

“The goal is to meet the needs of every single one of our patients and provide good, quality care,” she said. “We’re constantly evaluating how we’re doing. There is always room for improvement, and we learn from our experiences.”

Rusk State Hospital has figured in previous reporting by the Statesman this year. In February, a psychiatrist who had been sanctioned for having sexual relationships with his patients resigned after the hospital began disciplinary action against him because he appeared to be under the influence of drugs or alcohol at work. He was one of two psychiatrists at Rusk with a history of sexual misconduct, the Statesman reported. And in April the state opened an investigation into the case of a patient at Rusk who overdosed on illicit drugs at the facility. Records showed the patient claimed he obtained the drugs from a hospital employee.

‘She was sick’

According to her mother, Bell had struggled in the weeks before her admission to Rusk State Hospital. Embroiled in a Child Protective Services case involving her three young children, she refused to take her psychiatric medicine. At one point, she tried to jump out of a moving vehicle.

Already diagnosed with schizophrenia, bipolar and borderline personality disorders, Bell had been admitted to Rusk State Hospital two other times, Rita Bell said. By May, Brandy Bell was living at her parents’ home, refusing to eat and lying on the couch all day.

“She couldn’t help it,” Rita Bell said. “She was sick.” After several days in a local mental health center, Brandy Bell was committed by a court to Rusk State Hospital, a 335-bed inpatient facility about 130 miles southeast of Dallas.

Texas’s 10 state-run psychiatric hospitals provide medication and treatment programs for people with profound mental illnesses. About 2,500 patients reside in those hospitals at any day, and 14,400 people are admitted each year. The facilities provide routine medical care, such as basic physicals and monitoring of stable patients with disorders such as high blood pressure or diabetes, Williams said.

She added that, for those with serious eating issues, doctors might order diagnostic tests, consultations with dietitians and regular assessments of nutritional status by registered nurses. Patients may be placed on special precautions, with increased monitoring of weight, food and fluid intake.

A May 15 chart entry observed that Bell hadn’t been eating much in the three weeks preceding her admission and that she had once been diagnosed with bulimia. A nutritional assessment two days later noted that she had an “eating disorder” but offered no specific diagnosis, such as bulimia or anorexia.

Complicating Bell’s food history was that at 5’4” and 151 pounds, she was borderline obese, Rusk records said. A nutritional assessment in her chart noted that she had been counseled on “the importance of a healthy diet, limiting sugar and making healthy food choices.” She was also encouraged to exercise regularly.

In the early days of her admission, Bell was monitored closely to ensure she didn’t hurt herself, the documents show. After she showed no signs of obvious self-abuse, she was placed on routine supervision. When Bell continued to reject medication, staffers got a court order requiring her to take the drugs.

Food was another matter. More than a dozen entries in Bell’s records document her self-starvation, noting that she “has not eaten in days,” was “refusing most meals,” and “refused to eat lunch.”

It is not uncommon for psychiatric patients to refuse food in the hospital — and not easy to decide when to intervene, said Dr. Susan Stone, a Bastrop County psychiatrist and lawyer. Some medications are appetite suppressants. Rejecting food can also be related to paranoia or other conditions. Whether seeking legal permission to force nutrition or medication on a patient, the grounds are similar, Jennings said: “It is subjective, but would be tested by reasonableness and evidence. For example, even if a person hadn’t been eating for a while, had he been drinking? Do blood tests show an electrolyte imbalance that puts his health at risk?”

If so, the treating physician can ask a judge to order feeding, which at Rusk would require transfer to another medical facility for tube feeding.

But her medical records indicate that was never done, even as Bell kept refusing to eat, and her condition continued to deteriorate. One chart entry states that she appeared depressed, wouldn’t participate in activities and often refused to speak. “She is spending most of her time on the ward just sitting and staring with little to no interaction with her peers,” her social worker wrote.

‘Unresponsive’

One week before Bell’s death, a psychiatrist wrote in her medical chart that she had lost 9 pounds in nine days. The doctor suggested giving her liquids with electrolytes, such as Pedialyte or Gatorade.

“Otherwise, the role of non-psychiatric health care intervention is very limited at this time,” he wrote. “Ms. Bell’s refusal to eat, like her refusal to speak, appears to be psychogenic in origin, exactly why she was admitted to (Rusk State Hospital) in the first place.”

Bell had become paranoid, suspicious and depressed, records state. One day, she pulled off all her clothes and sat on a dayroom couch. On May 26, after nine days without a shower, staffers convinced her to bathe.

“Staff reported that she was in tears the whole time she showered and would not tell her what was wrong or talk to her,” medical document note.

By May 29, Bell was very pale and had thrown up twice that morning, her medical records show. That day, a nurse wrote in Bell’s medical records “Med clinic referral put in for c/o sore throat and not eating for days.”

“The night before she died, they tried to give her two cans of Ensure,” recalled Lea Miller, a fellow patient in Bell’s unit who has since been discharged. “She took one can and gave it away. The other can, she drank about half of it and poured the rest down the drain.”

Shortly after 6 a.m. on May 30, a nurse found Bell asleep on a dayroom couch and told her that she needed to have some blood drawn. Bell walked to the lab room, but was unsteady on her feet, records state.

“She sat in the chair and I turned to get the supplies,” the nurse wrote. “When I turned back to Brandy, she was slumped over forward and I thought she was doing something with her shoe. I asked her to sit up for me and she did not move. I touched her to help her sit up and realized she was unresponsive.”

Bell was revived and taken to East Texas Medical Center, where she was diagnosed with dehydration, low potassium and low blood pressure. “While at the emergency room, the decedent requested to use the restroom and during transfer to the restroom she became acutely unresponsive,” states the autopsy report by Forensic Medical Management Services of Texas.

Bell was declared dead at 10:52 a.m. A Rusk staffer called Rita Bell to give her the news.

“I just started slamming my hand on the table and screaming,” Rita Bell said.

The official cause of death was bilateral pulmonary emboli — blood clots — which can be caused by prolonged immobilization or bed rest. But the autopsy also found that Brandy Bell had starvation ketosis, a condition in which the body burns fat instead of carbohydrates and can lead to coma, seizures or death.

In August, an investigator with the Centers for Medicare and Medicaid Services — which funds treatment for some state hospital patients — made an unannounced visit to Rusk in response to a complaint about the circumstances surrounding Bell’s death. While the investigator didn’t single out any one staffer, she determined that that Rusk had given Bell substandard nursing care by failing to document everything she ate and drank, failing to regularly monitor her weight and failing to assess her care needs and medical status.

Rusk’s quality director, whose job is to improve patient care, responded by saying that the hospital’s “focus was on the psychiatric issues and not the possibility of medical issues,” according the report. She told the investigator that “the patient’s weight was slightly over the weight range for her age and height and that there were no visible signs that the patient was not eating or drinking.”

The federal inspector didn’t fine or penalize the hospital for its failings. In response to the report, Rusk State Hospital said it would make sure registered nurses “evaluate patient care needs, patient health status and patient response to interventions.” It also agreed to develop patient documentation requirements for its nurses, train nurses on how to deal with changes in patients’ eating habits and regularly sample its medical records to ensure proper documentation.

That’s small consolation to Rita Bell, whose grandchildren are now living with relatives. “She should have been in the hospital, and she should have been treated with IVs,” she said.

The family wanted to bury Brandy Bell in a nice coffin, but they couldn’t afford it, Rita Bell said. So they had her cremated, wrapped the plastic box in black velvet, decorated it with a silver bow and buried it.

Now her family is trying to make sense of why she died. “We don’t know what happened,” Rita Bell said. “She went there for help.”

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Source: The Statesman (Ball/Dexheimer, 12/01)

1 person killed in shuttle bus accident

HOUSTON - One person was pinned to a pole and killed and 11 others were taken to the hospital after a bus accident in the Texas Medical Center.

It happened shortly before 6 p.m. at the intersection of South Braeswood and Holcombe.

Somehow the driver of the bus lost control moments before the crash happened. Investigators told KPRC Local 2 a passenger on the bus ran from the back to the front and tried to take hold of the wheel but the bus crashed.

"It is very possible the driver had a medical condition," said Deputy Chief Fernando Herrera with the Houston Fire Department." But that is not definitive yet."

"Somebody inside the shuttle told me she thought the driver may have passed out," said Alexis Perez. She saw the whole thing happen and was one of the first on the scene.

"I ran over there and there was about 10 of us trying to push the shuttle off the lady," Perez said. "I think she died on impact. I know somebody checked for a pulse and she didn't have one."

Deputy Chief Herrera said there were 17 people on the bus and 11 of them were taken to area hospitals to be treated for their injuries.

The most serious ,he said, was some abdominal bleeding on the driver and one patient was going in and out of consciousness.

"Almost everybody inside the shuttle was injured," said Perez. "Everyone was disoriented and we had one guy with a broken arm and gashes on his forehead. People were throwing up and one lady passed out completely."

The woman who was hit and killed in the crash hasn't been identified yet. The shuttle bus is used by Medical Center employees to get around the large campus. The crash remains under investigation.

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Source: Click2Houston (Bauer, 11/28)

Wednesday, November 28, 2012

Suit over doctor’s note is a “health care liability claim,” 5th Court of Appeals rules

The list of disputes that qualify as a “heath care liability claim” under Texas Civil Practice & Remedies Code Chapter 74 just got a little longer. Chapter 74 requires a plaintiff litigating such a claim to file an expert report early in the proceedings. This time, the dispute at issue involves a doctor’s note, according to a Nov. 21 decision by Dallas’ 5th Court of Appeals.

The background in Crystal Monson v. Allen Family First Clinic, et al. is as follows, according to the 5th Court: In 2009, Monson saw Dr. Chandana Reddy at the Allen Family First Clinic for treatment. When Monson left the office, she received a note regarding her ability to return to work. That note stated that Monson could return to work five days later.

Reddy’s office manager, Candace Gauntt, later sent a letter to Monson’s employer that noted that Monson left the office “with no work limitation” and explained that previous note was filled out by a new employee who “misunderstood” what the doctor wanted. Monson was subsequently terminated by her employer, and the letter was an alleged direct and proximate cause of her termination.

In 2011, Monson sued Reddy, Gauntt and the clinic, alleging invasion of privacy and intentional infliction of emotional distress against the defendants, among other things. The defendants moved to dismiss Monson’s case because she failed to file an expert report 120 days after she filed her petition. Monson later amended her petition to omit the invasion of privacy claim, but a trial court dismissed her case for failure to file an expert report.

On appeal, Monson claimed that the trial court erred in dismissing her case because it was not a health-care liability claim and no expert report was needed, but the 5th Court disagreed.

“A physician or health care provider’s note recommending that a patient have time off from work or modified working conditions is ‘health care’ when the time off or modified working conditions are part of the patient’s medical care or treatment,” wrote Justice Lana Myers in an opinion joined by Justices Jim Moseley and Robert Fillmore that affirmed the trial court’s decision.

Robert D. Ranen, a partner in Gunter’s Ranen & Netzer who represents Monson, declines comment about the decision.

Russell G. Thornton , a partner in Dallas’ Stinnett Thiebaud & Remington who represents the defendants in the case, is pleased with the decision. Notes Thornton, “The courts just apply what the Legislature’s definition of what a health care liability claim is. The way the statute is, it’s pretty broad.”

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Source: Texparte Blog (Council, 11/27)

Tuesday, November 20, 2012

Meningitis victims try to freeze nearly $500 million in assets

A federal judge in Boston on Tuesday is expected to hear arguments on whether to freeze nearly $500 million in assets, including luxury homes, related to New England Compounding Center, the pharmacy linked to a deadly U.S. meningitis outbreak.

U.S. District Judge Dennis Saylor has ordered an expedited hearing to determine whether to freeze at least $461 million in assets belonging to NECC, its owners and two related companies, court records show. Saylor granted the request after plaintiffs' attorneys argued that NECC and its owners could conceal assets in order to avoid judgment in a growing number of cases being filed in the federal court system.

The Centers for Disease Control and Prevention said 34 people have died and 490 have been injured after Framingham, Massachusetts-based NECC shipped thousands of fungus-tainted vials of methylprednisolone acetate to medical facilities throughout the United States. The steroid was typically used to ease back pain.

NECC and sister company Ameridose have been shut down as U.S. regulators and law enforcement investigate what happened.

"There are so many unknowns in this case that we need to take this step to safeguard our clients` interests and the interests of the hundreds of people we believe were injured by the negligence of NECC and its owners," said Thomas Sobol, a Boston-based lawyer representing plaintiffs in the case before Judge Saylor.

Meanwhile, lawyers for NECC and the family that launched the specialty pharmacy are asking Saylor to stay all proceedings pending a ruling on whether to consolidate a number of lawsuits via the Judicial Panel on Multidistrict Litigation.

"There are at least 43 such cases currently pending in numerous federal courts around the country," NECC lawyers argued in a recent motion. "All of these actions seek recovery for injuries allegedly caused by the injection of methylprednisolone acetate compounded and distributed by NECC."

Barry Cadden, who was NECC's top pharmacist, launched the pharmacy with the help of his brother-in-law Gregory Conigliaro, a recycling entrepreneur. Sobol said in court papers the two men seemed to thrive financially.

In 2010, Conigliaro bought a $3.5 million home in Southborough, Massachusetts, with six bedrooms, nine bathrooms and more than 11,000 square feet of space, according to court papers filed by Sobol. Barry Cadden and his wife, Lisa, bought a beach home about three years ago that recently was featured in Rhode Island Monthly magazine.

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Source: Reuters (McLaughlin, 11/20)

Monday, November 12, 2012

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)

Monday, November 5, 2012

Hyundai kia repaying buyers for false mileage claims

Bye-bye 40 mpg: Hyundai and Kia are lowering the fuel economy ratings of some 900,000 vehicles due to a “procedural error” made during the Environmental Protection Agency’s testing cycle. Seven different 2013 Hyundai models and different 2013 Kia models will see their ratings drop by anywhere from one to six mpg.

We’ve actually heard about this before: in July, a class-action lawsuit was filed in California against Hyundai for misleading customers by advertising cars’ high highway mpg ratings, not the combined number, which was closer to real-world fuel-economy (and much lower than what was advertised). Now, following an official investigation by the EPA, Hyundai and Kia are adjusting fuel economy figures on the following cars: 2011 Hyundai Elantra and Sonata Hybrid; 2012 Hyundai Accent, Azera, Elantra, Sonata Hybrid, Tucson, and Veloster; 2012 Kia Optima Hybrid, Rio, Sorento, Soul, and Sportage; 2013 Hyundai Accent, Azera, Elantra, Elantra GT, Elantra Coupe, Genesis, Santa Fe, Tucson, and Veloster; and the 2013 Kia Rio, Sorento, Soul, and Sportage.

The decrease in the fuel economy numbers varies pending on the engine, transmission, and driveline. Some of the biggest losers include the 2013 Kia Soul equipped with the 2.0-liter I-4 and automatic, now rated at 23/28 mpg city/highway (down from 26/34 mpg); the 2013 Kia Rio automatic, down from 30/40 mpg to 28/36; the 2013 Hyundai Santa Fe Sport 2.4 with front-wheel drive is down to 21/29 mpg from 22/33 mpg; and the 2013 Hyundai Accent, which now achieves 28/37 mpg instead of 30/40 mpg.

This is a hard hit for Hyundai and Kia, as both companies (especially Hyundai) heavily advertised having numerous 40-mpg models in its lineup. As a compensation for the error, the automakers will be providing current and former owners with debit cards that cover the cost of fuel calculated by the difference in the new and old EPA combined cycles, the price of gas in the owner’s area, and the amount the owner drives.

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Source: Automobile (Nordlicht, 11/2)

Thursday, November 1, 2012

Texas Cities Differ on Texting-While-Driving Bans

Barbara Graff, an Odessa city councilwoman, knows the dangers of distracted driving. But that does not mean she wants to pass a law against it.

“I won’t even answer my phone anymore while I’m driving,” Graff said. But last October she voiced opposition to a ban on texting while driving in Odessa, saying the measure was not enforceable.

Although Odessa did not adopt the law, bans on cellphone use while driving are on the rise in cities across Texas, which is one of just 11 states without a statewide law. Austin and San Antonio are among 28 cities that have banned some degree of cellphone use while driving. Penalties include fines of up to $500.

The bans come as increasing evidence shows the dangers of distracted driving. Studies by the Texas Department of Transportation show traffic fatalities linked to some form of cellphone use increased almost 50 percent from 2006 to 2010.

In September, Amarillo banned the use of all mobile devices while driving. According to Mayor Paul Harpole, polls showed 65 percent of residents in Amarillo supported the law.

“To me, it comes down to common sense,” Harpole said. “A lot of people may be able to drive with a phone in their ear, but we have some who can’t.”

Harpole said some Amarillo residents who opposed the ban saw it as an issue of freedom. To Harpole, though, the question of safety was more important. “Today, none of us would think of getting into a car without airbags or seatbelts,” he said. “To me, it’s that kind of issue.”

In June 2011, Gov. Rick Perry vetoed a bill written by state Rep. Tom Craddick, R-Midland, that would have banned texting while driving statewide. In a statement, Perry called the bill “a government effort to micromanage the behavior of adults.” A representative for Craddick said he would try again to pass the bill in the 2013 legislative session.

While Perry and others call such bans government overreach, some object to texting-while-driving laws for practical reasons.

“If you talk to law enforcement,” Graff said, “they ask, ‘How can we enforce this?’” She said enforcing a ban on texting while driving is not feasible because it is often very difficult for officers to know if someone is actually texting.

In Amarillo, the police say catching violators will be easier. Sgt. Brent Barbee of the Amarillo Police Department said the city’s ban on all cellphone use “removes a lot of the challenge” of enforcement. “Any device in the driver’s hands will be a violation,” he said.

Graff said education on the dangers of distracted driving would be more effective in Odessa. A law, she said, could make the situation worse, causing some drivers to take their eyes off the road while trying to hide their texting.

“We could pass an ordinance, pat ourselves on the back, and say we took care of it. But did we?” she said. “We need to use education to stop this.”

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Source: The Texas Tribune (Swartsell, 10/29)

Wednesday, October 31, 2012

Ruling Raises Questions About List of Unsafe Consumer Products

Consumer groups said Tuesday that a federal court decision could threaten the effectiveness of saferproducts.gov, a relatively new federal database of unsafe products.

The ruling, by Judge Alexander Williams Jr. of United States District Court in Maryland, sided with a manufacturer who sued to keep its name out of the database, arguing that the complaint against it was confusing and contradictory and therefore should not be published.

The manufacturer, whose name and product remain anonymous, submitted medical data to the Consumer Product Safety Commission, which maintains the database, showing that the information in the database was “materially misleading.” The commission staff agreed, but the manufacturer argued that the corrected reports perpetuated the errors, and it filed a lawsuit.

Judge Williams, in a decision dated July 31 but made public on Monday, ruled that the safety commission’s decision to publish the complaint was “arbitrary and capricious” and that it could influence a consumer’s behavior, despite a disclaimer stating that the safety commission doesn’t endorse the findings.

On Tuesday, several consumer groups filed an appeal of the judge’s decision to keep some files sealed, as well as parts of the judge’s ruling. They also contested the judge’s decision to allow the manufacturer to proceed under the pseudonym “Company Doe.”

“The price that we pay for secrecy in cases like this is it can open the door to lots of litigants,” said Scott Michelman, an attorney for Public Citizen, one of the groups filing the appeal. “I do not expect this to be the last time that a company tries to keep a report of one of its products out of the database.”

In a prepared statement, the safety commission said, “The decision published yesterday concerning one incident reported to the saferproducts.gov consumer database does nothing to change the agency’s statutory mandate and enduring commitment to provide the public with a timely and searchable database of incidents involving consumer products. Consistent with the decision, the Commission did not post the individual report.” Judge Williams dismissed allegations that the decision would set off a flood of lawsuits by companies trying to stay off the database. “The prospect of successful challenges to the database does not threaten to categorically compromise the Commission’s consumer safety mission,” the judge wrote. “In sum, there is ample middle ground between the foundation this opinion lays and the apocalypse the Commission predicts.”

The database is the result of 2008 legislation that gave the safety commission more money and authority after numerous product recalls, including children’s toys from China.

The database, which went online in March, allows consumers, and others, to file complaints of injury, or potential harm, for all types of products except for food, drugs, cosmetics, cars and guns. More than 11,000 reports have been filed to the database so far. Before incident reports are posted, manufacturers are given a chance to respond, and if they can show that the entire report or part of it is not accurate, the report is supposed to be redacted or not posted on the database.

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Source: The New York Times (Martin, 10/24)

Monday, October 29, 2012

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)

Monday, October 22, 2012

FDA: More drugs may be linked to meningitis outbreak

Federal regulators broadened their warning to doctors Monday, raising questions about the potential risk of infection from other injectable drugs made by the specialty pharmacy in Massachusetts linked to the burgeoning fungal-meningitis outbreak.

The Food and Drug Administration initially said it received reports of three new cases of infections tied to two additional products made by the New England Compounding Center (NECC). It later corrected its statement, saying it had reports of two cases.

One involves the steroid triamcinolone acetonide, which is different from the steroid implicated in the existing meningitis cases. A patient who may now have meningitis received an epidural of the medication, the FDA said.

The other case involves a medication that is injected into the coronary arteries to temporarily paralyze the heart during open-heart and transplant surgery. Two patients who received the medication, called cardioplegic solution, during heart-transplant surgery, subsequently developed fungal infections, the agency said.

As a result of the cases, the sterility of any injectable drugs made by the NECC, including ones used in eye and heart surgery, “are of significant concern and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection,” the agency said in a statement posted on its Web site.

Steven Immergut, an FDA spokesman, said the agency didn’t know how many additional patients are affected and how many will need to be notified. The agency is working with the now-shuttered company to “get more information on the distribution of their products,” he said in an e-mail.

Until now, the meningitis infections have been linked to contaminated vials of one NECC steroid drug — methylprednisolone acetate. About 14,000 people received injections of that medication. As of Monday, 212 people have been received diagnoses of fungal meningitis linked to the tainted drug, two others have ankle infections and 15 have died, according to the Centers for Disease Control and Prevention.

The FDA has not confirmed that the two additional products were contaminated or that the three infections were caused by NECC products, according to its statement. The agency said it was possible there may be other explanations for the patients with fungal infections.

But the FDA said it is advising doctors to follow up with any patient who received “any injectable product” made by the NECC, including drugs used in eye surgery or cardioplegic solution bought from or produced by the company.

Doctors should inform patients who received the NECC products about symptoms of possible infection and tell them to contact a health-care provider immediately if they experience symptoms.

All of the company’s products have been under a voluntary recall by the company on Oct. 6. As part of that effort, the company attempted to contact all health-care providers and facilities that received its products, the FDA said. The agency had previously advised health-care providers and facilities to check their purchase records to see whether they bought any products from NECC and urged them not to use any products from the company.

In a statement issued Monday, the NECC said it was reviewing the FDA’s expanded advice to health-care practitioners. The company, which is a compounding pharmacy, said it was continuing to cooperate with officials from the FDA, the CDC and the Massachusetts pharmacy board.

“As we have said, we will respect those public agencies’ processes for investigations and will not comment while they are underway,” the company said.

Federal regulators said they are working with company officials to produce a specific list of injectable drugs that could be posted as soon as possible.

“A large portion of NECC’s products were injectables,” said the FDA’s Immergut. The company, which had a 71-page product list, makes more than 2,000 products, from pain medications such as fentanyl to such commonplace items as mouthwash to all-purpose nipple ointment to treat soreness and infection in nursing mothers.

The FDA said the company’s topical products, such as lotions, creams and eyedrops not used in surgery, pose lower risks and don’t require patient follow-up. The firm’s annual revenue is about $8 million, according to company spokesman Andrew Parven.

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Source: The Washington Post (Sun, 10/15)

Monday, October 15, 2012

Company linked to meningitis scare besieged as deaths rise

CHICAGO (Reuters) - The company that produced contaminated medications linked to an unprecedented fungal meningitis outbreak faced mounting scrutiny on Saturday over whether it illegally sold drugs to medical facilities, as the death toll from the disease grew to 15.

The Centers for Disease Control and Prevention (CDC) said another person died from meningitis, the second death in Indiana. The number of cases of the disease reported reached 201 in 14 states, according to the CDC and state officials.

Illinois reported its first case of meningitis from a steroid injection and New Hampshire officials reported that state's first four confirmed cases from the outbreak, which showed no signs of abating.

Tennessee is the worst affected state with six deaths and 52 cases followed by Michigan with three deaths and 41 cases, including one case of an infection that has not been confirmed as meningitis.

As federal and state authorities scrambled to contain the outbreak, investigators were trying to determine how the medication produced by New England Compounding Center was contaminated and whether its sprawling drug supply business complied with licensing laws.

A series of emails between the company and a clinic in Mississippi reviewed by Reuters show that NECC sold drugs without requiring physicians to supply individual patient prescriptions. The customer confirmed that NECC supplied the clinic with drugs without patient names or prescriptions, which are required by a number of states including Massachusetts, where the company is based.

The emails also indicate that NECC referred business to a sister company, Ameridose LLC, despite a statement by Ameridose earlier this week that the two operated separately.

NECC has recalled the suspect product, surrendered its license to operate in Massachusetts and suspended operations. Ameridose also has temporarily suspended operations.

"NECC's intent has always been to operate in compliance with our licenses in the states where we do business," the company said in a statement.

FEDERAL CRITICISM

The U.S. Food and Drug Administration is investigating NECC and there have been calls from some in Congress for a criminal investigation of the company.

"FDA considers this to be one of our top priorities and we are dedicating many resources to this investigation," the agency said in a statement late on Friday. Federal regulators have come under criticism for failing to prevent the outbreak by closely regulating drug compounding companies such as NECC, which prepare medications for clinics and doctors largely outside federal oversight. The FDA has said the law does not give it adequate authority to do so, leaving regulation largely to the states. "This outbreak began at a compounding pharmacy and the Food and Drug Administration has very limited authority over what these facilities produce," said a spokesman for the Health and Human Services Department in Washington. "We urge Congress to give FDA the authority it needs to ensure these kinds of outbreaks do not happen again."

NECC faces mounting threats from states as well. Several states are investigating the company and at least two - Michigan and Massachusetts - have said the company violated their regulations, according to a Reuters survey.

Some 14,000 patients received the suspect steroid medications, which were shipped to 76 facilities in 23 states as long ago as May.

Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea. Fungal meningitis is a rare form and is not contagious.

Cases of meningitis have been reported in Tennessee, Michigan, Florida, Idaho, Illinois, Indiana, Maryland, Minnesota, New Jersey, North Carolina, Ohio, Texas, Virginia and New Hampshire.

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Source: Yahoo News (McCune, 10/15)

Wednesday, October 10, 2012

When implanted medical devices go wrong, who pays?

Cole Legal Group | Texas Medical Malpracitce Lawyer
Insurance companies, often stuck with the tab for health services when a medical device fails, are ready to share the pain.

As the number of costly, high-profile recalls rises, along with pressure to cut their own spending, insurers are starting to pin more of the responsibility on manufacturers.

If they succeed, medical device makers - already worried about weaker global demand for many of their products and the impact of a new U.S. tax on their profits - will have even more costs in the wake of product recalls, the biggest of which can already lead to billions of dollars in expenses.

"The (insurance) plans are being more aggressive. The reason it gets so much more focus now is because there are so many cases," said Mark Fischer, chairman of Rawlings & Associates, a unit of the Rawlings Group that helps insurance companies recoup payments from the party that was deemed at fault for claims, a legal service known as subrogation.

In recent years, more than a hundred medical devices were recalled out of concern they could cause serious injury or death.

Rawlings is one of the largest firms providing claims recovery services for the healthcare industry, along with Trover Solutions Group, both based in Louisville, Kentucky. Others include HealthCare Subrogation Group and Meridian Resource Company.

Rawlings is currently retained to pursue more than 30 mass tort cases related to healthcare, compared with an average of about three in a given year just a decade ago, Fischer said.

"There has been a drastic increase in the number of cases being pursued," he said. Insurers tend to hire Rawlings when there are enough cases being filed over a product to warrant multi-district litigation status.

Fischer helped recover funds for insurers from claims on Sulzer Medica's defective hip implants in 2000 and Medtronic Inc's faulty Fidelis defibrillator leads in 2007.

In the Fidelis case, Medtronic settled U.S. lawsuits covering more than 9,000 individual personal injury cases for $221 million, according to their regulatory filings.

Fischer then pursued Medtronic to recover money for clients like WellPoint Inc that had paid doctors and hospitals for treatment relating to the defective leads, or wires that connect an implantable defibrillator to the heart.

He expects a settlement - the first collected from a medical device maker - to be signed by year's end, but would not give a dollar amount.

WellPoint spokeswoman Lori McLaughlin said the insurer routinely tries to collect from manufacturers on recall-related health claims.

Aetna Inc, the nation's third largest insurer, said it has managed to wrest reimbursement from drug and device markers, and has negotiated payments to patients for costs from defective or recalled products, without providing details.

Trover Solutions Chief Executive Robert Bader reckons that about 80 percent of health insurers turn to firms like his to pursue manufacturers in recall cases.

"It's the fiduciary responsibility of the insurer to recover members' premiums from the manufacturer. It's a highly specialized process and so a lot of them outsource," Bader said.

The government's Medicare health plan for the elderly recovers part of the money it paid for recall-related medical services once a settlement is reached, said spokeswoman Kathryn Ceja. She would not give details on how it pursues those funds.

FALLOUT OVER THE RIATA RECALL

A 2010 recall of Riata defibrillator leads by St. Jude Medical could become the next tug-of-war between insurers and medical device makers over who picks up the tab.

Some 79,000 U.S. heart patients still have the lead implanted in a blood vessel leading to the heart. Deciding on how to proceed is tricky since removing the leads may be riskier than leaving them in.

The Food and Drug Administration in August said all Riata patients should receive medical imaging tests to see whether the insulation covering the thin wires eroded, exposing the cables and making them more prone to short-circuit, as well as making the surrounding tissue vulnerable to heat damage.

The agency did not say how often imaging tests should be performed. But ordering just one test per patient will add millions of dollars to the cost of their care.

A single fluoroscopy - which shows a real-time, continuous X-ray image on a monitor - for each Riata patient could cost between $7.9 million and $45.3 million overall, based on a Reuters review of the procedure's cost at different hospitals.

Doctors say more than one X-ray would be needed to monitor the leads, which can remain in a patient's body for many years. Dr. Bruce Lindsay, section head of Cardiovascular Medicine at the Cleveland Clinic, said doing an annual imaging study would probably be sufficient.

Even before the FDA guidelines, Medicare covered the extra cost of imaging studies in almost every instance, doctors say. But some private insurers had balked.

"I've had to call (insurers) constantly and justify it," said Dr. Martin Burke, director of the Heart Rhythm Center at the University of Chicago Medicine.

"We're definitely finding more problems (with Riata leads), but surveillance has gone up. We're finding more because we're looking more," he said.

St. Jude spokeswoman Amy Jo Meyer said the company has expanded its regular warranty to include a baseline fluoroscopic or X-ray screening if a patient's insurer does not cover it. Paying for additional imaging would be reviewed on a case-by-case basis.

"It would not be in device makers' best interest to balk at paying these costs. In the end, they do have to stand behind their products and these products do sometimes fail," said Debbie Wang, an analyst with Morningstar.

TALLYING THE COSTS

Burke and colleagues estimate that Medtronic's Fidelis recall cost Medicare some $287 million over five years for monitoring or replacing the leads, according to a study published in the Heart Rhythm Journal.

Medtronic spokesman Chris Garland said the company gave a credit to patients for its recalled Fidelis leads, plus $1,200 for "reasonable unreimbursed medical expenses." He would not say how many people received the replacement and additional funds.

The Fidelis case was just one out of 113 medical device recalls between 2005 and 2009 classified as serious enough to cause significant health problems or death, according to an analysis published in the Archives of Internal Medicine last year. Most involved devices that correct heart problems.

The study found that 24,000 patients underwent procedures in 2005 related to problems with devices from Medtronic or from Guidant, now part of Boston Scientific Corp.

"We expect manufacturers to take reasonable responsibility for costs associated with a recall of their products to prevent the healthcare system from absorbing the impact," said Aetna spokeswoman Tammy Arnold.

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Source: Reuters (Sherman, 10/8)