Mother of 12-year-old Tuscaloosa boy killed in wreck files lawsuit against tire manufacturer, car repair shop

BIRMINGHAM, Alabama - The mother of a 12-year-old Tuscaloosa boy killed in a wreck on Interstate 65 has filed a wrongful death lawsuit against the manufacturer and the local distributor of a recently replaced tire on her SUV.

12-year-old Octavious Chandler died in a March 25, 2011, wreck in north Jefferson County. The crash happened about 5:50 p.m. on interstate 65 north in Gardendale. His mother, Julia Chandler, was driving, and Octavious was in the front passenger seat.

The lawsuit was filed Tuesday afternoon in Jefferson County Circuit Court by Birmingham attorneys Jeremy Knowles and Amanda Luker on behalf of Julia Chandler. It claims that Michelin North America Inc. and Amigo Tires, a Tuscaloosa car repair shop, acted "negligently and wantonly" in regards to a tire that "detreaded" while Chandler was driving.

A jury trial is requested to decide whether to award compensatory and punitive damages from Amigo Tire and Michelin.

According to the suit, "defendant Michelin designed, manufactured, distributed and/or sold the Michelin XW4 tire made the basis of this lawsuit. Said tire failed and detreaded, thereby causing the fatal accident."

After the wreck, witnesses told investigators that it appeared the vehicle blew a tire, then lost control and flipped several times before landing in the middle of the interstate.

Octavious was pronounced dead at the scene. His mother and three other passengers - an 8-year-old girl, an 8-year-old boy and a 4-year-old girl - were treated for non-life-threatening injuries.

The lawsuit states that on March 15, 2011, Julia Chandler bought a used Michelin tire that Amigo Tire employees selected from the shop's inventory. The employees installed the tire on her 1997 Ford Explorer.

Ten days later, the tire's tread separated as Chandler was driving, "causing the vehicle to go out of control and rollover several times," the suit states.

It claims that Amigo Tire employees "negligently or wantonly selected" the Michelin tire, "which was over 15 years old, and informed Plaintiff that the tire was safe for travel. In fact, the tire was not fit for use."

When contacted by phone, a man who said he was the manager of Amigo Tire said he wasn't aware of the lawsuit and hung up.

The suit also claims breach of warranty against Michelin, which "impliedly warranted" that the tire "was reasonably fit and suitable for the purposes for which it was intended to be used. The Plaintiff avers that the Defendants breached said implied warranties in that the tire was not fit for the ordinary and expected purposes for which such tires are intended to be used; but to the contrary, said tire was in a dangerously defective and unsafe condition."


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Source: Alabama (Stein, 3/14)

Burned tot’s parents file lawsuit over toy tractor

An Athens County couple has sued the manufacturer of a battery-operated toy riding tractor that they say burst into flames, severely injuring their toddler son.

Wyatt Buckley, now 3, who lives outside Albany, was burned over more than 50 percent of his body when the toy tractor he was riding in his yard ignited on June 3, according to the lawsuit filed in U.S. District Court in Columbus.

The lawsuit against the toy’s manufacturer, Peg Perego USA Inc. — an Italian company with U.S. offices in Fort Wayne, Ind. — seeks unspecified damages for his parents, Marlon and Heather Buckley.

It says the fire was caused either by a defective product or a defective manufacturing process. The tractor was powered by a 12-volt battery.

“A toy given to a 2-year-old just can’t catch on fire; and if it does catch on fire, it should be designed and manufactured so it wouldn’t continue to burn so it would not cause catastrophic harm to the child,” said Andrew List, the attorney for the Buckley family.

Wyatt potentially faces a lifetime of surgeries and medical treatment, List said.

Mrs. Buckley said her son is improving every day, “but he still has a long way to go.”

Peg Perego could not be reached for comment. However, the company said in a statement at the time of the incident that “the materials of our toys cannot suddenly burst into flames. We are confident that other extraordinary external factors were involved to cause such a sudden fire.”

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Source: The Columbus Dispatch (Woods, 1/25)

Consumers warned to check Fisher-Price infant sleepers after mold reported, 16 infants treated

WASHINGTON — The government is warning consumers to inspect Fisher-Price Newborn Rock ‘N Play Sleepers due to risk of exposure to mold for infants who use them.

The Consumer Product Safety Commission said Tuesday that its warning applies to 800,000 infant recliner seats, called sleepers, that were sold at stores nationwide and online since September 2009, with prices ranging between $50 and $85. The seats, designed for babies up to 25 pounds, feature a soft plastic seat held in a tubular metal rocking frame. The product has a removable fabric cover.

Mold can develop between the removable seat cushion and the hard plastic frame if the sleeper remains wet or is infrequently cleaned, the agency said. Mold is associated with respiratory illnesses and other infections, the warning said. Fisher-Price has received 600 reports of mold and 16 infants have been treated for respiratory issues, coughs and hives after they were in the Fisher-Price sleepers.

The agency said consumers should check for dark brown, gray or black spots that can indicate the presence of mold under the removable seat cushion. If mold is found, they are advised to immediately stop using the product and to contact Fisher-Price for cleaning instructions or further assistance.

Units currently in retail stores are not affected by the warning, but mold growth can occur after use of the infant sleepers.

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Source: Washington Post (AP, 1/8)

Toyota to pay $1.1B in 'unintended acceleration' cases

LOS ANGELES — After years of litigation and probes, Toyota announced a $1.1 billion settlement Wednesday to resolve lawsuits alleging "unintended acceleration" in some Toyota and Lexus models.

Toyota recalled millions of vehicles in 2009 and 2010 related to charges that throttles could jam in the open position.

Toyota will create a fund for retrofitting 3.2 million Toyota and Lexus cars with technology that makes them easier to stop in a panic situation, as part of the settlement in a U.S. District Court case that sought class-action status. Owners of models that can't be retrofitted will receive cash payouts. And those who sold their vehicles in late 2009 and all of 2010 will be eligible for compensation due to lowered resale value due to the issue.

In all, the company says the agreement affects 16 million owners of vehicles with electronic throttle controls, whether or not they were part of the recalls.

Toyota maintains that the bulk of unintended acceleration cases were due to floor mats that slid underneath accelerators and became trapped — and not the result of electronic defects in the cars' engine computers.

"We felt we achieved our objective, to defend the safety of the product," says spokesman Mike Michels. That having been done, the settlement is "a business decision and we turn the page on a lot of this."

The settlement is expected to be approved Friday by U.S. District Court Judge James Selna.

"After two years of intense work, including deposing hundreds of engineers, poring over thousands of documents and examining millions of lines of software code, we are pleased that Toyota has agreed to a settlement that was both extraordinarily hard fought and is exceptionally far-reaching," says Steve Berman, co-lead counsel for plaintiffs in the cases.

At least one industry analyst says the settlement is proof that Toyota was culpable. "Automakers don't pay billions of dollars to get rid of litigation involving driver error," says Sean Kane of Safety Research & Strategies.

The settlement comes more than three years after the fatal crash of a Lexus that killed an off-duty California Highway Patrol officer and his family near San Diego erupted into a full-blown scandal for the automaker.

At first, Toyota answered the sudden acceleration charges by saying that floor mats could become trapped under acceleration pedals. Then later, Toyota announced a series of worldwide recalls involving millions of cars, including some for potentially defective accelerator assemblies.

Toyota executives appeared before congressional hearings and were questioned about the issue. The National Highway Traffic Safety Administration launched an engineering investigation that was never able to show any electronic bugs were the cause of unintended acceleration. But the agency never dropped the issue.

Last week, NHTSA levied a $17.35 million fine against Toyota — the maximum currently allowed for a single violation — for waiting too long to report the issue that led to just one of the series of recalls, involving the 2010 Lexus RX 350 and RX 450h crossover SUVs.

To settle the unintended acceleration cases, Toyota agreed to:

Install a brake-override system in non-hybrid vehicles that were subject to floor-mat entrapment recalls. The systems, which are now common in new Toyota and Lexus vehicles, cut power to the engine when they sense that the driver is trying to stop the vehicle as if in a panic, such as by repeatedly pushing the brake pedal. Toyota says its hybrids don't need the system.

Put $250 million into a fund for former owners who sold their cars between Sept. 1, 2009, and Dec. 31, 2010, or leased them during the period to compensate them for reduced value of their vehicles due to publicity around issues of Toyota's unintended acceleration. The actual amount that will go to any individual owner wasn't immediately disclosed. It may become more clear, says Berman spokesman Mark Firmani, after Friday's hearing.

Create a separate $250 million pool to compensate owners of non-hybrid cars that can't be retrofitted with the brake-override system. Toyota spokesman Michels says cars without the system are still safe because the brake-override system is "not a prevention or cure" for floor mats that can become trapped under pedals.

Establish a "customer care plan" for all 16 million affected Toyota customers to add another three to 10 years to the warranty period for parts that could be related to unintended acceleration.

Pay $30 million to issue grants for study of auto safety and enhanced driver education.

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Source: USA Today (Woodyard, 12/26)

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)

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.

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)

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)

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)

When implanted medical devices go wrong, who pays?

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)

Workers claim fast-food restaurant sold spoiled chicken to public

CONROE, Texas – A fast food restaurant in Conroe has re-opened after a week-long closure to retrain workers about food safety.

It comes after the KHOU 11 News I-Team uncovered allegations from ex-employees who said the restaurant was selling spoiled food to customers.

One of those former workers is Toisha Corpuz. She was grateful when the KFC on North Loop 336 West in Conroe hired her despite her criminal record. But Corpuz said one day she noticed something.

“It stinks really bad,” Corpuz recalled. She said the stench came from the restaurant’s kitchen and especially its walk-in cooler.

“It just smelled. When you walked in there, it took your breath away,” Corpuz said. She said the smell came from the raw chicken stored in boxes inside the restaurant’s cooler. She also claims things got worse when workers took the chicken out.

“I almost threw up back there when the cooks opened the bags,” Corpuz said.

She says the poultry was spoiled, but that it was still fried and made available for sale to the public.

“You’re a mother, would you want your kids eating that stuff?” the 11 News I-Team asked Corpuz.

“Absolutely not,” she replied.

Corpuz and other workers said despite a KFC policy that raw poultry must be used within 10 days of being killed, chicken as old as 16 days was still cooked and served.

“I had no choice,” explained Corpuz. “I had to take care of my children. I had to have a job.”

Eventually, she said she had her husband call in a complaint to Montgomery County Environment Health Services that the KFC was selling spoiled chicken. Records show it took five days before a health inspector showed up at the Conroe KFC.

“We had just sold the last two cases of spoiled chicken,” said Corpuz.

However, the inspector did confirm a “foul odor in back of kitchen and walk-in cooler.”

The 11 News I-Team spoke to other current and former workers at the KFC, including Robert Garrett.

“You knew it was unsafe?” asked the I-Team.

“I knew it was unsafe,” admitted Garrett.

Like Corpuz, he remembered the smell of the expired chicken, comparing it to “expired trash that hasn’t been taken out for awhile.”

Garrett also claimed that raw chicken 16 days past its kill date was cooked and sold anyway.

“There would be times I would know that food that was going out the window or to the public sitting down, that it wasn’t any good and it just makes you sick to your stomach,” said Garrett.

Food safety expert Sarah Klein with the Center for Science in the Public Interest reviewed the allegations.

”We rarely hear this kind of really egregious and deliberate misuse of product and putting public health at such risk,” said Klein.

She said there’s a good reason for KFC’s 10-day limit.

“Things like E. coli, salmonella, and campylobacter are very common in poultry,” explained Klein. “So the longer it sits in a refrigerator, the more the bacteria have time to grow and multiply.”

Klein said then not even cooking may make the expired meat safe to eat. She also pointed out something else.

“Whether or not you kill the bacteria through cooking, that meat is still rotting,” said Klein. “So consumers are basically eating fried, rotted meat.”

We took the workers’ allegations to Michael Batts, manager of the Conroe KFC. Batts referred our questions to the restaurant’s owner.

But did he know his restaurant was allegedly serving expired chicken? Corpuz claimed she taped a phone conversation with Batts, her manager, last March.

Manager: Yes?

Corpuz: Sorry to bother you. Hey, we got 22 cases of bad chicken back there.

Manager: Why?

Corpuz: Um, because they’re out of date. Some of them, I think nine of them, went out today and five of them went out yesterday.

Manager: Okay, well cook what you can of it. Change the date on it where it will all go out tomorrow or something, OK?

Corpuz: OK...Just cook as much as possible.

Manager: Cook as much as possible of it.

Corpuz: And change the dates on the rest, OK.

Manager: Don’t cook it OK?

Corpuz: Don’t cook too much, is what you’re saying?

Manager: Do what?

Corpuz: What did you just say?

Manager: I said of course if it’s bad, don’t cook it.

Corpuz: OK.

Manager: But if you can cook it...

Corpuz: OK, bye. Yes sir.

Manager: Don’t cook a whole bunch extra, but you can cook a little extra.

Tem-Kil, Inc. owns the Conroe KFC along with 33 other restaurants in Texas. An executive there declined an on-camera interview. In a statement, the company insisted they are committed to the highest standards of food safety and said Tem-Kil has taken action to ensure high quality and safety at the restaurant.

The national headquarters of KFC also declined to speak on-camera. But a spokesman said in a statement that nothing is more important to KFC than food safety. KFC also said that because of our report, the company started an investigation of the Conroe restaurant and shut down the restaurant for a week so the entire staff could receive additional food safety training.

The director of the Montgomery County Consumer Health Department also declined our repeated requests for an interview. In a statement, Michael Lindsey insisted that his department responded to the March complaint about the sale of spoiled chicken in a timely manner.

Health inspectors visited the restaurant last week after it reopened. They did not find any food safety violations.

Corpuz was fired from the KFC in June for not performing work to her employer’s standards. She contends the restaurant’s claim about her was unfounded, as was her dismissal.

As for Robert Garrett, he left his job at the KFC in late May. He said one of the reasons he quit was because of concerns about food safety.

The I-Team is not aware of any similar allegations against any other KFC in the Houston area.

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Source: WFAA (Noll, 9/11)

Texas high court hands victory to Austin architect in liability case

The Texas Supreme Court on Friday handed a legal victory to Austin architect Sinclair Black as the high court declined to hear the appeal of a McKinney woman who was partially paralyzed in a 2004 balcony collapse that she had alleged was partly Black's fault.

By declining to hear the case, the high court allowed to stand a July 2011 ruling by the 3rd Court of Appeals. That court had thrown out a jury's $410,000 verdict against Black, ruling that Black and his firm, Black + Vernooy, were not partially to blame for the balcony collapse at an Inks Lake home that left Lou Ann Smith paralyzed from the waist down.

Black and others in the architectural industry had argued that allowing the original jury's verdict to stand could have a chilling effect on the architectural profession.

Black's attorney, Bruce Bennett, declined to comment Friday. Attorneys for Smith and her family could not be reached for comment.

Smith's attorneys could ask the high court to reconsider its decision not to hear the case.

The original jury's verdict was issued in favor of Smith, who suffered spinal damage when she and a friend stepped onto the third-story balcony of an Inks Lake home they were visiting. The balcony broke away from the house and sent the women to the ground.

A subcontractor had attached the balcony using 3¼-inch nails, not the bolts specified by the architect's design, and deviated from other design specifications, photos and court testimony showed.

Black and his firm designed the house and had a contract with homeowners Robert and Katherine Maxfield that required the firm provide "administration of the construction contract." It also required that he "visit the site at intervals" and "endeavor to guard the owner against defects and deficiencies."

Black visited the construction site several times and took photos. He testified that he didn't report any problems with the balcony because he didn't notice any issues.

In 2010, a Travis County jury ruled that the general contractor, Nash Builders, was 70 percent to blame for the balcony collapse, that a subcontractor was 20 percent responsible and that Black and his firm were 10 percent liable.

Black and his lawyers had argued in their appeal that Black could not be held liable for the contractor's negligence, and that while he had a duty to report any defects and deficiencies of which he was aware, he had no duty to identify any and all defects. Black also argued that while he had a duty to the Maxfields, he had no duty to visitors to the home.

In reversing the original jury's decision, the 3rd Court of Appeals agreed with that argument.

Writing the opinion for the majority, Justice David Puryear said Smith and her family had asked the court "to do something that has never been done in the history of Texas jurisprudence; they request this court to transform and extend the contractual duty owed to the Maxfields into a common law duty owed to the Smiths as visitors to the Maxfields' home."

"Although our sympathies extend to the Smiths for the suffering they have unjustly been forced to endure, this court simply cannot create a new common law duty in order to uphold the relief that they sought against the architects," he wrote.

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Source: Statesman (Harrel, 8/31)

Patio bistro sets recalled

WASHINGTON, D.C. – Midas Lin is recalling about 16,400 patio bistro sets because when the chair support bar is not fully engaged, the chair poses a fall hazard to a consumer who sits in the partially engaged chair.

The sets were exclusively sold at Lowe's stores nationwide from August 2011 through February 2012 for about $98 for the set.

The firm has received thirteen reports of consumers who fell from partially opened chairs, resulting in reports of back injuries, contusions and scrapes.

This recall involves folding chairs sold with three-piece patio bistro sets. Each set contains two folding chairs and a folding table. The chairs have a black steel frame and dark stained wooden seats and backs. Model #S658-01, item # 0355053 and "Garden Treasures" is printed on the cover of the instruction manual sold with the patio bistro sets.

Consumers should immediately stop using the recalled chairs and contact Midas Lin for a new set of warning labels and supplemental instructions for the chairs. Do not return the product to the store.

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Source: KMTR (8/6)