Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip, said two lawyers briefed on the plan.

The tentative plan, which must win court approval, represents one of the largest payouts for product liability claims involving a medical device.

A spokeswoman for the company’s DePuy Orthopaedics unit declined to comment on the possibility of a settlement. An announcement about the plan is expected in the coming days, the lawyers said.

The agreement will include those patients who have already been forced to have the device, known as the Articular Surface Replacement, or A.S.R., removed and replaced with another artificial hip, said the lawyers who spoke about the agreement only on the condition of anonymity.

Under the deal, each patient would receive about $350,000 on average in compensation, though that figure will vary depending on factors like a patient’s age and medical condition.

The precise value of the settlement is unclear because lawyers for patients are still trying to estimate how many of the 12,000 related lawsuits involve patients who had a replacement. Lawyers believe that number may be 7,000 to 8,000 cases.

The final cost of the deal to Johnson & Johnson could rise, depending on how many claimants who received the device undergo replacement operations in the future, the lawyers said. Under the plan, patients who have not had a replacement would not receive compensation, the lawyers said.

The A.S.R. hip was sold by DePuy until mid-2010, when the company recalled it amid sharply rising early failure rates. The device, which had a metal ball and a metal cup, sheds metallic debris as it wears, generating particles that have damaged tissue in some patients or caused crippling injuries.

DePuy officials have long insisted that they acted appropriately in recalling the device when they did. However, internal company documents disclosed during the trial of a patient lawsuit this year showed that DePuy officials were long aware that the hip had a flawed design and was failing prematurely at a high rate.

Many artificial hips last 15 years or more before they wear out and need to be replaced. But by 2008, data from orthopedic databases outside the United States also showed that the A.S.R. was failing at high rates in patients after just a few years.

Internal DePuy projections estimate that it will fail in 40 percent of those patients in five years, a rate eight times higher than for many other hip devices.

It had been long anticipated that DePuy would try to settle the case. Of the two lawsuits that have gone to trial, the company lost one lawsuit and won the other one.

However, it was facing the start of several new trials around the country with the prospect of large damage awards. The outlines of a settlement proposal were reported Tuesday by Bloomberg News.

The hip was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version for use here in standard hip replacements that used the same cup component as the resurfacing device. Only the standard version was sold in the United States; both were sold outside the country.

About 93,000 patients received an A.S.R., about one-third of them in the United States.

Problems with the design first came to light in Australia and England just a few years after its marketing began. But DePuy officials insisted for years to surgeons who complained about that device that patient problems reflected their surgical technique rather than the implant’s design.

Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant.

The agency also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.

DePuy never disclosed the F.D.A. ruling to regulators in other countries, where it was still marketing the resurfacing version of the implant.

The head of DePuy’s orthopedic unit, Andrew Ekdahl, oversaw the introduction of the hip and was warned by a company consultant in 2008 that the implant appeared to have a design flaw, according to internal DePuy documents disclosed during a trial earlier this year.

When DePuy recalled the hip in 2010, it announced a program in which it offered to pay the medical costs of a replacement procedure.

All-metal replacement hips like the A.S.R. were once highly popular with orthopedic surgeons who believed the devices would last longer than traditional replacement devices made of plastic and metal. But the metal devices are rarely used anymore because of their high early failure rates.

While the settlement, if approved, would resolve much of the litigation against DePuy involving that device, it continues to face thousands of lawsuits involving another all-metal hip that it no longer sells called the Pinnacle.

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Source: The New York Times (Meieir, 11/12)

Toyota Plaintiffs Target Vehicle Electronics

The sudden-acceleration litigation against Toyota shifts to Oklahoma on Monday, as plaintiffs attorneys for the first time blame vehicle electronics for a crash that injured the driver and killed a front-seat passenger.

The first major trial over sudden acceleration focused on Toyota's failure to install a brake override safety system, not the electronics. A Los Angeles jury began deliberations on October 2 following two months of testimony.

The plaintiff in the Oklahoma case is Jean Bookout, who suffered internal bleeding and a broken ankle when her 2005 Camry crashed six years ago. Her friend, Barbara Schwarz, who was in the front seat, was killed.

Toyota has so far managed to settle litigation over sudden-acceleration defects. A $1.6 billion settlement, approved in July, resolved claims by consumers that their vehicles lost value. Another $25.5 million settlement resolved claims that shareholders lost money from the recalls. But trials now under way could influence the outcome of hundreds of remaining lawsuits, all of which target Toyota for injuries and deaths associated with accidents. Bookout filed her lawsuit in 2008, one year before Toyota began recalling nearly 10 million vehicles for defective floor mats and accelerator pedals linked to sudden acceleration. The case is a an outlier: It's not part of a coordinated proceeding, and lawyers have not selected it as a bellwether trial, defined as one whose outcome could guide the resolution of other cases pending against Toyota across the nation.

"Ms. Bookout doesn't have much memory…but she remembers the onset of the incident and remembers pumping her brakes, and the car kept going when she was slowing to get off the exit ramp," said Bookout's lawyer, Graham Esdale, a shareholder at Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Ala.

But Toyota has brought in a significant legal team including Bowman and Brooke, its lead national counsel in the sudden-acceleration cases. The team also includes J. Randolph Bibb Jr. of Lewis, King, Krieg & Waldrop in Nashville, Tenn., and James Jennings and Derrick Teague, senior shareholders of Jennings Cook & Teague in Oklahoma City.

Toyota spokeswoman Carly Schaffner issued a formal statement: "Multiple independent evaluations have confirmed the safety of Toyota's electronic throttle control systems, which are equipped with numerous, robust failsafe systems."

Toyota faces a formidable foe. In addition to Esdale, Beasley Allen's trial team includes senior member Jere Beasley and products liability shareholders Ben­jamin Baker and J. Cole Portis. The firm also is working with Larry Tawwater and Darren Tawwater of The Tawwater Law Firm in Oklahoma City.

The trial is expected to last less than three weeks. "It'll be fairly extensive," Esdale said. "Right now, our trial team is bigger than anyone we've sent to a court."

Bookout and Schwarz's estate intend to claim that Toyota was negligent and that the design of its 2005 Camry was defective, Esdale said. They also plan to ask jurors for punitive damages.

Some 20 experts are on tap, many of whom appeared during the first bellwether case over sudden acceleration to testify about braking systems. Others plan to testify about alleged defects in the vehicle's electronics software. Toyota has moved to exclude a report by one such plaintiffs expert, Michael Barr, whom plaintiffs lawyers indicated has identified a potential software glitch that could cause sudden acceleration. "Mr. Barr testified in his deposition that the Toyota software is defective, which results in unintended acceleration," Larry Tawwater wrote.

FIGHT OVER EXPERT

Toyota's motion and Barr's report were filed under seal, but Toyota has made a similar request to exclude Barr's findings in a case scheduled to go to trial on November 5 in the multidistrict litigation over sudden-acceleration defects against Toyota pending before U.S. District Judge James Selna in Santa Ana, Calif.

Beasley Allen has asked that additional members of its team have access to Toyota's proprietary software, which is housed in a secured facility in Maryland. Only two lawyers at the firm — Esdale and Baker — now have access to the source-code database.

"We filed a motion to allow lawyers trying the case access to it," Esdale said. "Clearly, they'll see and hear about it during the trial." Toyota's attorneys have opposed that request; access to its source code is governed by a stipulated protective order in the multidistrict litigation.

Oklahoma County District Court Judge Patricia Parrish issued a letter order on September 24 denying Toyota's motion as to Barr, but hasn't ruled on the source-code request. On October 1, she denied the plaintiffs' request to put James Lentz, head of Toyota's North American region and Toyota's highest ranking U.S. executive, on the stand. Lentz was forced to testify in person before jurors during the first trial.

Parrish also rejected a motion by Toyota to prevent plaintiffs lawyers from disclosing to the news media all "extrajudicial statements," especially highly sensitive proprietary information, that could prejudice a prospective jury pool.

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Source: Law Journal (Brondstad, 10/07)

Heavy use of herbicide Roundup linked to health dangers: study

Heavy use of the world's most popular herbicide, Roundup, could be linked to a range of health problems and diseases, including Parkinson's, infertility and cancers, according to a new study.

The peer-reviewed report, published last week in the scientific journal Entropy, said evidence indicates that residues of "glyphosate," the chief ingredient in Roundup weed killer, which is sprayed over millions of acres of crops, has been found in food.

Those residues enhance the damaging effects of other food-borne chemical residues and toxins in the environment to disrupt normal body functions and induce disease, according to the report, authored by Stephanie Seneff, a research scientist at the Massachusetts Institute of Technology, and Anthony Samsel, a retired science consultant from Arthur D. Little, Inc. Samsel is a former private environmental government contractor as well as a member of the Union of Concerned Scientists.

"Negative impact on the body is insidious and manifests slowly over time as inflammation damages cellular systems throughout the body," the study says. We "have hit upon something very important that needs to be taken seriously and further investigated," Seneff said.

Environmentalists, consumer groups and plant scientists from several countries have warned that heavy use of glyphosate is causing problems for plants, people and animals.

The EPA is conducting a standard registration review of glyphosate and has set a deadline of 2015 for determining if glyphosate use should be limited. The study is among many comments submitted to the agency.

Monsanto is the developer of both Roundup herbicide and a suite of crops that are genetically altered to withstand being sprayed with the Roundup weed killer.

These biotech crops, including corn, soybeans, canola and sugarbeets, are planted on millions of acres in the United States annually. Farmers like them because they can spray Roundup weed killer directly on the crops to kill weeds in the fields without harming the crops.

Roundup is also popularly used on lawns, gardens and golf courses.

Monsanto and other leading industry experts have said for years that glyphosate is proven safe, and has a less damaging impact on the environment than other commonly used chemicals.

Jerry Steiner, Monsanto's executive vice president of sustainability, reiterated that in a recent interview when questioned about the study.

"We are very confident in the long track record that glyphosate has. It has been very, very extensively studied," he said.

Of the more than two dozen top herbicides on the market, glyphosate is the most popular. In 2007, as much as 185 million pounds of glyphosate was used by U.S. farmers, double the amount used six years ago, according to Environmental Protection Agency (EPA) data.

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Source: YahooNews (AP, 4/25)

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)

Michelin recalls 841,000 BFGoodrich and Uniroyal light commercial tires for tread separation

Michelin voluntarily recalled around 841,000 BFGoodrich and Uniroyal tires Thursday because the tread can separate, causing rapid air loss.

No deaths or injuries have been reported from the tires, which were made as replacement tires for commercial light trucks and full-sized heavy duty vans from April 2010 until early this year, according to the company.

Michelin North America Inc., based in Greenville, S.C., is beginning the recall immediately. Tires will be replaced at no charge. Websites and toll-free numbers have been set up with more information.

Quality-control workers started noticing an increase in reported problems with the tires this year. The company has noticed the separation in less than 150 tires, but decided the voluntary recall was needed to protect the safety of drivers, said Michelin’s technical director, Mike Wischhusen.

“We constantly monitor our products performance in the field and it was our own internal quality systems that caught this issue,” Wischhusen said. “We caught it very early, based on a very small number of returns.”

Michelin’s internal testing shows the problems with the tires have apparently been corrected for those manufactured more recently, Wischhusen said. “A tire is a complex thing. There is rarely one thing you can pinpoint to cause something like this,” he said.

The tires being recalled were BFGoodrich commercial tires LT 235/85 and LT245/75 and Uniroyal Laredo tires LT 235/85 and LT245/75. Michelin said anyone looking for more information can call 800-637-5527 or visit www.bfgoodrichtires.com/voluntarysafetyrecall or www.uniroyaltires.com/voluntarysafetyrecall .

“We’re taking this proactive action in order to protect our consumers and the driving public,” Wischhusen said.

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source: Washington Post (AP, 7/26)

1.3 Million BMW 5 and 6 Series Vehicles Recalled

German luxury-car maker BMW AG said on Monday that it is recalling about 1.3 million vehicles world-wide for repair due to potential problems with a battery-cable cover, one of the German luxury car maker’s largest recalls in recent years.

“In some remote cases, the battery cable cover inside the boot [trunk] of these vehicles may be incorrectly mounted,” BMW said. “This can result in the electrical system malfunctioning, the vehicle failing to start and, in some cases, to charring or fire.”

The recall covers all BMW 5 and 6 Series models built between 2003 and 2010. The company said it isn’t aware of any accident or injury that was triggered through the technical fault.

Vehicle owners will be notified in writing. Repairs will take approximately 30 minutes and will be free of charge to the customer. BMW didn’t elaborate on the anticipated costs it will face related to the recall.

A BMW spokesman said the recall is a precautionary safety measure as no accidents have been reported so far. Nine cases of related defects have been reported. BMW has filed a notification to the U.S. National Highway Traffic Safety Administration.

The recall comes a month after the auto maker agreed with U.S. safety regulators to pay $3 million in civil penalties for failing to report safety defects soon enough.

A review of 16 BMW recalls issued in 2010 found “a number of instances” in which the auto maker didn’t comply with U.S. law, the NHTSA said last month.

BMW denied that it violated federal law, but agreed to make internal changes to its recall decision-making process in order to “ensure timely reporting to consumers and the federal government in the future.”

The U.S. requires auto makers to report defects within five days and promptly issue a recall to correct the problem.

Many global auto makers have reported large-scale recalls in recent months and years, highlighting the potential risks of sharing certain components and technology through a wide range of different vehicles to reap economies of scale.

In 2009 and 2010, Japan’s Toyota Motor Corp. was hit by a huge global recall affecting roughly 9 million vehicles world-wide that dented its reputation for producing top-quality cars. NHTSA, however, didn’t find evidence of electronic defects in the Toyota vehicles.

The BMW recall disclosed on Monday is almost equivalent to the annual sales volume of the company’s namesake brand in 2011. The BMW brand achieved a new sales record last year with a 13% rise year-on-year to 1.38 million cars. The BMW 5- and 6-series accounted for 332,501 and 9,396 vehicle sales, respectively.

The recall, however, affects the cars from the previous model generation.

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source: Wall Street Journal Blog (3/26)

Chrysler Recalls Charger Police Cars

Chrysler Group LLC is recalling certain Dodge Charger police vehicles from the 2011 and 2012 model year to fix electrical problems that could lead to failure of their low-beam headlights or the loss of anti-lock braking.

In a document filed with the National Highway Traffic Safety Administration, the car maker said the possible headlight problem stems from overheating in the bulb harness connector. Overheating can also occur in a component called a power distribution module, which can result in the loss of anti-lock brake and electronic stability control functions.

Chrysler said it built the affected cars between July 5, 2010, and Dec. 20, 2011. The recall includes 9,688 vehicles. The company said it is not aware of any accidents or injuries resulting from the problems.

Under the recall Chrysler dealers will replace the headlamp jumper harnesses and relocate the anti-lock brake and electronic stability control fuse within the power distribution module. The service is free of charge. The recall is expected to begin next month. Customers can contact Chrysler at 800-853-1403.

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source: Wall Street Journal Blog (Welsh, 2/13)

Nissan Recalls 28,000 Jukes and 34,000 Sentras for Possible Stalling Problems

In two actions, Nissan is recalling about 62,000 vehicles for stalling problems, the automaker told the National Highway Traffic Safety Administration.

Nissan said that 28,000 Jukes from the 2011 model year were being recalled because a defective weld could allow the turbocharger boost-sensor bracket to break. That could cause an idling engine to stall. Nissan said the engine shouldn’t stall when the vehicle was under way.

The automaker told the safety agency that it first learned of the possible problem in November 2010, but its investigation and monitoring of what it called field data didn’t suggest that a recall was needed until earlier this month.

Meanwhile, almost 34,000 Sentras are being recalled because the zinc coating on the battery-cable harness is thicker than specified. This could cause a voltage drop that could damage the electronic control module, causing the engine to stall and making it impossible to restart, the automaker said.

Nissan told the agency that it began investigating the problem last February and recently concluded that a recall was necessary.

A Nissan spokesman could not be reached to confirm whether either condition had resulted in accidents.

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source: New York Times (Jensen, 12/16)