Air bag sensor problem causes Kia to recall nearly 73,000 vehicles

Kia Motors is recalling 72,568 Rio small cars in the United States to address a potential sensor problem that could lead to the front passenger airbag deploying unnecessarily.

Kia, an affiliate of Hyundai Motor, is recalling the cars from model years 2006 through 2008 because of possible cracking of a printed circuit in the front passenger seat sensor mat that could lead to the system not being able to detect whether a child passenger is in the seat, according to documents filed with the National Highway Traffic Safety Administration.

In that case, the airbag would deploy during a crash when normally the sensor would tell it not to, increasing the risk of injury.

[If you've been in an accident due in part to an automotive defect, contact The Cole Legal Group]

If enough cracking in the circuit occurs, the airbag warning light on the car's instrument panel will illuminate, according to NHTSA documents.

No undesired airbag deployments or injuries related to the issue were reported, according to NHTSA documents.

The recall to replace the sensor mat is expected to begin in July, according to NHTSA documents.

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source: Reuters (Klayman, 6/5)

Johnson & Johnson settles Texas Risperdal case for $158 million

In the state's largest-ever Medicaid fraud recovery, Johnson & Johnson agreed Thursday to pay Texas $158 million to settle a lawsuit over its efforts to get the schizophrenia drug Risperdal on an approved list for the state's poorest patients.

Texas Attorney General Greg Abbott and a Pennsylvania whistleblower sued Janssen, a subsidiary of Johnson & Johnson, in 2004 over allegations the drug company used faulty research and trips, meals and other perks to convince Texas health officials to put Risperdal on the state's medication algorithm, which determined which drugs were dispensed at state-run hospitals and institutions.

“Today’s agreement sends a strong message that the state will pursue those who defraud Texas taxpayers,” Abbott said in a statement. “Johnson & Johnson’s scheme to profit from the Medicaid program by overstating the safety and effectiveness of an expensive drug and improperly influencing officials ended up costing taxpayers millions of dollars.”

In preceding medical trials, Risperdal — a drug which can lead to diabetes and excessive weight gain, especially for children — was found to be no better or safer than other generic versions, despite its significantly higher price tag.

Attorneys for the state of Texas argued Janssen marketed the powerful antipsychotic drug for use in children, even though the medication was approved only for the very narrow purpose of treating adult schizophrenia. The lawsuit also alleged the company offered trips and kickbacks to state health officials.

The whistleblower, Allen Jones, uncovered the details while working as an investigator at the Pennsylvania Office of the Inspector General. He was represented by Dallas attorney Tom Melsheimer and Austin attorney Tommy Jacks, both part of the firm Fish & Richardson.

“We are proud to have aided the courageous efforts of Allen Jones, a man who helped shine a light on the dark and corrupt practices that impacted taxpayers across Texas,” Melsheimer said. “He uncovered a terrible effort to push a mind-altering drug on children at the most vulnerable time in their lives.”

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source: Texas Tribune (Rich, 1/19)

Texas court begins trail of $1b Risperdal marketing suit

AUSTIN, Texas — Texas prosecutors want jurors to award the state $1 billion in a lawsuit that accuses Johnson & Johnson of overstating the safety of an anti-psychotic drug and influencing its use in the state's Medicaid program. The company, facing similar claims in other states, is promising to vigorously defend itself when both sides lay out their cases during opening statements Tuesday.

The lawsuit accuses Johnson & Johnson and several of its subsidiaries of fraud by making false or misleading statements about Risperdal and the drug's safety, cost effectiveness and superiority in the 1990s. Risperdal is a pill for schizophrenia and bipolar disorder.

The trial is expected to last two weeks.

The suit was originally filed in 2004 by whistle-blower Allen Jones, a former employee with the Office of Inspector General in Pennsylvania, and Texas later joined the case. Jones has said he learned of Johnson & Johnson's actions in Texas while investigating similar claims in Pennsylvania.

The suit is among dozens of pending state and federal cases alleging illegal marketing practices and kickbacks in an effort to boost Risperdal over competing drugs. And a verdict against the company wouldn't be the first.

Last year, a South Carolina judge ruled that Johnson & Johnson must pay a $327 million civil penalty after a jury found it guilty of overstating the safety and effectiveness of Risperdal. In 2010, a jury found that the company violated Louisiana's Medicaid Fraud Act and was fined about $258 million in damages.

Johnson & Johnson has denied the claims in Texas's lawsuit and said it follows U.S. Food and Drug Administration rules.

"We are committed to ethical business practices, and have policies in place to ensure that our products are only promoted for their FDA-approved indication. If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action," the New Brunswick, N.J.-based company and its subsidiaries said in a statement.

Jones' attorney and Texas Attorney General Greg Abbott's office, which is representing the state, declined comment before the trial began.

Risperdal and similar antipsychotic drugs have been linked to increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar.

Jones accuses several doctors who were state officials in Texas' mental health department of giving Risperdal preference over other antipsychotic drugs. One is accused of accepting honoraria from Johnson & Johnson to urge doctors in other states' Medicaid and mental health programs to use Risperdal.

The drug company and its subsidiaries are also accused of promoting misleading interpretations of research studies and paying millions of dollars - much of it to decision-makers - to influence the creation of state mental health medication guidelines favoring Risperdal.

The company also is accused of falsely saying the drug was safe to use with children and other populations when federal regulators had not approved its use with those groups.

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source: Seattle Times (AP, 1/10)

Earlier, more comprehensive Honda recall could have avoided near fatal injury

TOKYO — Georgia college student Kristy Williams was almost killed when a metal piece flew out of an air bag in her 2001 Honda Civic — a traumatic accident her lawyer says might have been avoided had there been an earlier, more comprehensive recall.

Williams had even arranged to get her air bag fixed. But the appointment was a week too late.

The recalls at Honda Motor Co. for defective air bags that may inflate with too much pressure and send pieces of metal and plastic flying now affect some 2 million vehicles around the world.

Tragically for Williams, although recalls for air bags began in November 2008, her vehicle wasn’t included until last year’s batch.

The Tokyo-based automaker has now issued five recalls for defective air bags — the latest just this month for 304,000 vehicles globally, including the popular Accord, Civic, Odyssey, Pilot, CR-V and other models manufactured in 2001 and 2002.

There have been 20 accidents related to the problems, including two deaths in the U.S. in 2009, according to Honda.

“This is a serious, basic problem,” Williams’ attorney Leigh May said in a telephone interview.

Honda should have made the recalls encompassing, and her client might not have gotten hurt if it had, she said.

“It’s so terrible. Air bags are supposed to be there to protect you. And, if the air bag is a mechanism of your injury, that’s just not right,” May told The Associated Press.

Honda and Williams settled for an amount that cannot be disclosed as a condition of their agreement, May said.

On April 2 last year, Williams was stopped at a traffic light when the driver and passenger air bags deployed without there being a crash.

Flying shrapnel severed her neck artery. She was in intensive care for two weeks, required several surgeries and suffered strokes. Luckily, she survived.

“It was really hard to get things together when I was released from the hospital. However, I am a determined individual and put my mind to finishing school,” Williams, 25, said in an email.

“I want others to be aware of the consequences of not getting the recall seen about ASAP,” she said.

Atlanta-based Butler, Wooten & Fryhofer, where May is a partner, is among a handful of U.S. law firms that won in suing Honda over the air bags.

May said it was unclear what Honda knew when, and why all the vehicles weren’t recalled the first time as the problem air bags came from one supplier, Takata Corp.

Honda spokesman Hajime Kaneko confirmed the recalled air bags came from the one supplier. Takata declined comment.

As it played out, the recalls grew almost piecemeal, from the first recall in 2008, to include more models in two separate recalls in 2009, and again last year, and then this month.

Kaneko said Honda had earlier thought the causes were different, such as the use of incorrect material in the chemical used to deploy the air bags and excessive moisture in the inflator propellant, which is part of what inflates the air bag.

But Honda found, under its fourth recall, that the cause was a defect during the production of the chemical, which had led to all the problems, Kaneko said. The latest recall came about because the company had not fully accounted for all the vehicles requiring recall, he said.

Honda, a reputed pioneer in air-bag technology, had expanded the recall to account for a possibly defective stamping machine during production.

“I can only say we are extremely sorry,” said Kaneko. “It is our responsibility we failed to identify a problem part in our products.”

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source: Washington Post (Kageyama, 12/20)

Texas' tort law has failed to reduce health costs, attract doctors

A national report released Wednesday says the 2003 Texas law that limited damage awards in malpractice suits has caused health care spending to rise and has not significantly increased the number of doctors in Texas.

The report comes as Gov. Rick Perry has touted the benefits of the law on the presidential campaign trail, boasting that it has added 21,000 Texas doctors — a claim the report disputes. Supporters of the law also urged Congress to enact a similar provision for the nation as part of the federal health care law that passed in March 2010. That provision was not included.

The 24-page report by Public Citizen, "A Failed Experiment," says that using Texas as a model would benefit doctors and insurers — not residents.

The report claims that Medicare spending in Texas has risen faster than the national average, and so have private health insurance premiums. It also says that, contrary to Perry's claims, the per capita increase in the number of doctors practicing in the state has been much slower since the state passed the so-called tort reform law than it was before the law.

Organizations that support the 2003 law — the Texas Medical Association and the Texas Alliance for Patient Access — disputed the report's assertions on the number of physicians who have come to the state. As for health care costs, "we never said consumer costs would go down," Jon Opelt, the alliance's executive director, said Wednesday.

Before the state limited damage awards that patients and their families could collect in malpractice cases, doctors were leaving the state in droves, and malpractice insurance rates were about double what they are today for most doctors, said Dr. Howard Marcus, an internist at Austin Regional Clinic. Marcus, a member of the medical association and chairman of the alliance, said that it took several years for tort reform to have an effect and that since 2007, Texas has licensed 60 percent more new doctors each year than it did before tort reform.

The report by Public Citizen, a nonprofit consumer advocacy group, examines the number of direct patient care and primary care doctors in Texas between 1996 and 2010. It says that in the seven years before the lawsuit limits, the per capita number of doctors increased by 9.3 percent. In the seven subsequent years, the increase was 4.2 percent.

Perry's 21,000 figure was disputed by a PolitiFact check, which Public Citizen cited. PolitiFact said that Perry was counting all physicians licensed in Texas — the number actually practicing was 12,788 — since 2003. Experts said most of that increase was due to population growth, not tort reform.

Marcus said that Public Citizen erred by using a seven-year range before and after the 2003 law took effect. He said that it took until about 2007 for the law's effects to be felt, adding that it would be better to examine 2007 to 2011 and compare those years with the period before the tort changes.

Perry spokeswoman Allison Castle said Wednesday that tort reform has greatly expanded access to care, especially in underserved rural areas. For example, she said, the number of obstetricians in rural areas of Texas has grown by 27 percent.

Castle added that from 2003 to 2009, Texas premiums for employer-sponsored health coverage increased at a lower rate than the national average and 27 other states.

The Public Citizen report counters that doctors in rural areas of Texas have decreased by 1 percent since tort reform after increasing by 23.9 percent in the seven years before the 2003 law.

It also says that health care coverage is unaffordable to more Texans since the law took effect. In 2010, 24.6 percent of Texans were uninsured — the highest rate in the nation — compared with 23.6 percent in 2003.

Regarding Medicare costs, the Public Citizen report says that proponents of lawsuit limits say that doctors would order fewer tests and practice less "defensive medicine" if they didn't have to fear as many lawsuits. "In fact," the report says, "Medicare diagnostic testing expenditures in Texas not only increased during this time frame (2003 to 2007), but rose 25.6 percent faster than the national average."

Marcus and Opelt said many factors drive such costs and that they have no bearing on changes in the medical malpractice law.

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source: www.statesman.com (Roser, 10/12)

Houston-based firm pleads guilty over Oklahoma acid spill in 2007

Integrated Production Services, a Houston-based oil field services contractor, pleaded guilty Tuesday in federal court in Muskogee, Okla., to violating the Clean Water Act by negligently spilling 400 to 700 gallons of hydrochloric acid -- used in "fracking" of wells -- into a creek in eastern Oklahoma in 2007.

IPS agreed to pay a $140,000 fine and make a $22,000 payment to the Oklahoma Department of Wildlife Conservation for ecological studies and remediation of Boggy Creek in Atoka County, according to federal officials.

IPS will also serve two years' probation, perform an environmental compliance program at a cost of $38,000, and train employees in hazardous-waste handling and spill-response procedures.

IPS was working at a natural gas well site on May 24, 2007, when a tank leaked corrosive hydrochloric acid onto the bermed surface of the well site, which was already flooded after heavy rainfall. Rather than properly removing the acid-polluted rainwater, IPS supervisor Gabriel Henson drove a company truck through the earthen berm, discharging the rainwater and the acid into Dry Creek, a tributary of Boggy Creek, the statement said.

On July 20, Henson pleaded guilty to a misdemeanor violation of the Clean Water Act and is awaiting sentencing. He faces up to one year in prison and a $100,000 fine.

"As hydraulic fracturing occurs with increasing frequency across the country, companies and individuals involved in those operations must adhere to the laws that protect human health and the environment and level the playing field for responsible businesses," said Ignacia S. Moreno, an assistant attorney general for the Justice Department.


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source: Ft. Worth Star-Telegram (Smith, 10/11)

Study: Over Half of Adverse Drug Reactions in Hospitals Are Preventable

More than one-half of all adverse drug reactions treated in hospitals and emergency care are preventable, according to a new study.

In addition, prior research has shown that many preventable drug reactions -- which include drug overdoses and internal bleeding associated with the improper use of blood thinners and painkillers -- are life-threatening, said the Swedish researchers. This widespread problem, which is even more common among the elderly, has important implications for health care systems, they said.

There are many reasons for the high numbers of preventable adverse drug reactions, according to Katja Hakkarainen, a pharmacist from the Nordic School of Public Health, Gothenburg. These may include "poor coordination of care, lack of time and knowledge among health professionals, and lack of patient education," she said in an International Pharmaceutical Federation news release. "Unfortunately there is no consensus today on what to do" to prevent adverse drug reactions, she said.

"But our finding that they are so common means that it is imperative to create a climate in which they are not hidden, and that there is no 'blame and shame' involved," Hakkarainen added. Human error is inevitable, she said, "thus, safety measures need to be incorporated into the health system."

The findings were slated for presentation Thursday at the annual conference of the International Pharmaceutical Federation in Hyderabad, India.

In conducting the meta-analysis, in which evidence from a number of studies is combined with the aim of getting results with more statistical power, researchers examined the results of 22 previous studies. Among adult outpatients, the frequency of preventable adverse drug reactions that resulted in hospitalization or emergency treatment was 2 percent, they found. Of these, 51 percent were preventable.

Researchers also found that among the elderly, a full 71 percent of drug reactions could have been avoided.

Among hospitalized patients, the frequency of harmful drug reactions was 1.6 percent, and 45 percent of them were preventable.

The researchers added that as more drugs become available for people of all ages, the number of adverse drug reactions is likely to increase. They said it's important to know which could have been prevented since they are typically much more severe than those that were unavoidable.

In a different study, they noted, researchers found that nearly a third of preventable adverse drug reactions were life-threatening, compared to those that were unavoidable as part of treatment.

The Swedish researchers also cautioned that patients should not stop taking their medications for fear of an adverse reaction.

"Although it is clearly important to carry out such studies, we would like to emphasize that for most of the time, medications do much more good than harm," said Hakkarainen. "We would not like to think of people discontinuing therapy as a result of our conclusions."

Experts say that information presented at medical meetings should be considered preliminary because it has not been subjected to the rigorous scrutiny required for publication in a peer-reviewed medical journal.

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source: Health Day (Dallas, 9/9)
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Two 18-Wheelers Collide; One Driver Injured

RIESEL,TX — An 18-wheeler rear-ended a second tractor-trailer rig Monday morning in Riesel and the driver of the second truck was flown to a Waco hospital for treatment of his injuries.

Riesel police Chief Danny Krumnow said at around 8 a.m. Monday, the driver of the first truck was stopped at a signal light at Texas Highway 6 and FM 1860 when the second rig whose driver failed to see the light struck the rear of the rig.

Krumnow said B. J. Newton, of Fort Worth, was flown by Air Evac helicopter to Hillcrest Baptist Medical Center.

Information about his injuries and his condition wasn’t immediately available.

The other driver was not injured.

Krumnow said traffic along both roadways was diverted for a short time.

Riesel police and fire units, along with an East Texas Medical Center ambulance, responded to the accident.

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source: www.kwtx.com (Gately, 7/11)