Accident & Injury Law in Texas

Archive for the ‘Defective Products’ Category

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Hundreds of people taking the diabetes drug Avandia needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend that the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.

Avandia, intended to treat type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

“Rosiglitazone should be removed from the market,” one of the reports, written by Drs. David Graham and Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal FDA reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline.

Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients.

The battle has been brewing for years but has been brought to a head by a fierce disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the FDA to issue a warning, and sales plunged.

The bipartisan, multiyear Senate investigation — whose results are expected to be released publicly today but which werealso obtained by the Times — sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.

GlaxoSmithKline said Thursday it Will remove zinc from its denture cream after reports that excessive use over many years can cause neurological damage and blood problems in consumers.

The British manufacturer will stop making and marketing Super Poligrip Original, Ultra Fresh and Extra Care products in the U.S. The company plans to reformulate the creams without zinc.

The company said that the products are safe when used as directed but that some patients use extra cream to help with ill-fitting dentures. Zinc is believed to help with adhesion.

Denture creams containing zinc were first approved by the Food and Drug Administration 15 years ago.

In 2008, researchers at the University of Texas Southwestern Medical Center in Dallas described a possible link between denture cream zinc and nerve damage.

Glaxo’s voluntary action comes as hundreds of patient lawsuits are poised to go to trial, alleging that Poligrip caused nerve damage, leading to a loss of balance and loss of sensation in the hands and feet, leaving patients unable to walk.

“They made the right decision in the sense that it’s going to prevent the crippling of more people,” said attorney Andy Alonso of Waichman Alonso LLP. “But it’s too late for many of my clients, unfortunately.”

Alonso represents more than a hundred users of denture cream in Miami federal court, where several hundred lawsuits are being consolidated. He said about 30 million people in the U.S. wear dentures and use products like Poligrip

A day after Toyota Motor Corp. announced an indefinite suspension of U.S. sales on an unprecedented scale to fix faulty gas pedals, the automaker said late Wednesday that it will recall an additional 1.1 million vehicles in the United States over floor mat problems. Toyota said Thursday’s recall would affect five models: 2008-10 Highlander, 2009-10 Corolla, 2009-10 Venza, 2009-10 Matrix and 2009-10 Pontiac Vibe.

Toyota said late Tuesday that it would halt sales of some of its top-selling models to fix gas pedals that could stick and cause unintended acceleration. Last week, Toyota issued a recall for the same eight models, affecting 2.3 million vehicles.

The suspect accelerator parts are made by a U.S. supplier, but similar parts are also found in its European-made vehicles, an official with the Japanese automaker said Wednesday. Toyota said it hasn’t decided what to do there.

Tuesday’s announcement follows a larger U.S. recall last year of 4.2 million vehicles because of problems with gas pedals becoming trapped under floor mats, causing sudden acceleration.

That problem was the cause of several crashes, including some fatalities.

Toyota has said it was not aware of any accidents or injuries due to the pedal problems associated with last week’s recall. About 1.7 million vehicles fall under both recalls.

Toyota is also suspending production at six North American car-assembly plants beginning next week and gave no date on when production could restart.

The sales and production, halt involves several best-selling U.S. models, including the Camry and Corolla sedans, the Tundra truck and the RAV4 crossover, a blend of an SUV and a car.

Toyota said the sales suspension wouldn’t affect Lexus or Scion vehicles and that the Prius, Tacoma, Sienna, Venza, Solara, Yaris, 4Runner, FJ Cruiser, Land Cruiser and select Camry models, including all Camry hybrids, would remain for sale. Those vehicles contain gas pedals produced by a different North American supplier than the one whose parts are involved in the current sales halt, Toyota has said.

The supplier is CTS Corp., based in Elkhart, Ind., and.he suspect part was manufactured at its plant in Ontario, according to a report Toyota gave the U.S. National Highway Traffic Safety Administration last week. CTS said Toyota told it  about fewer than a dozen cases in which drivers struggled with pedals.

David Strickland, the administrator of the federal traffic safety agency, said that the Transportation Department had been in regular communication with Toyota about the recall. Strickland said Toyota’s decision to stop selling the vehicles was “an aggressive one and one that is the legal and morally Correct thing to do.” Rental car firms Avis Budget Group and Enterprise Holdings said they were pulling thousands of Toyota models covered by last week’s recall until a fix is available.

Avis Budget said the decision to idle 20,000 Toyotas was a precaution. Enterprise Holdings, which controls the Enterprise, National and Alamo brands, said it would pull an unspecified number of Toyota models from its fleet.

Toyota expects to sell 2.2 million vehicles in North America in 2010, up 11 percent from 2009, according to sales targets released Tuesday. Toyota said it was planning global sales of 8.3 million vehicles this year, up 6 percent from 2009, but those numbers do not account for the U.S. sales stoppage.

Two years ago, Toyota beat out General Motors Co. to become the world’s largest automaker. Now just weeks into 2010, it is halting some sales in the U.S., its biggest market.

Three large pickup trucks that serve as workhorses for construction crews, farmers and small-business owners are not providing good protection from side crashes, according to tests conducted by the insurance industry which struck the side of the vehicles with a barrier moving at 31 miles per hour to imitate the front end of a pickup truck or sports utility vehicle.

The Insurance Institute for Highway Safety gave low marks to the 2009 versions of the Chevrolet Silverado 1500, Dodge Ram 1500, and Nissan Titan in side crash tests.

The Ram, equipped with standard side air bags, earned the second-lowest score of “marginal.”  The Titan and Silverado received the lowest mark of “poor” when tested without optional side air bags.

When the trucks were tested with the optional safety equipment, the Titan’s rating improved to “marginal,” but the Silverado continued to receive a “poor” rating.  The institute said the Silverado’s test results also applied to its twin, the GMC Sierra 1500.

The institute attributed the Silverado’s low ratings to a combination of a poor side structure and a lack of side torso air bags.  The optional side curtain airbags worked well in protecting motorists’ heads, but a person’s upper body would remain unprotected even with the optional side curtain air bags.

According to David Zuby, the institute’s vice president, “The size, weight and height of these large pickups should help them ace the side tests just like the other large pickups we’ve tested.  Not these three.”  Zuby said that occupants of passenger cars typically are more vulnerable in a side crash because their bodies are in line with the fronts of vehicles.  But, he said, trucks faired poorly even with the higher seating positions.

GM spokeswoman Carolyn Markey said the Silverado and Sierra received top scores in the government’s front- and side-impact tests.

If you were injured in a side crash, regardles of the type of car you were driving, be sure to call our office at (512) 343-2572.

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it can’t be sued by women who claim that they were injured by the product, even though its old label inaccurately described the amount of estrogen it released!

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.  The Bush administration has argued strongly in favor of the doctrine, which holds that the FDA is the only agency with enough expertise to regulate drug makers and that courts should not second-guess its decisions. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.

Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent. This was done, it later said, to adjust for the different ways the body metabolizes hormones from pills and patches. This adjustment was never part of the ’study protocol, a plan filed with the FDA.

High doses of estrogen are known to raise the risk of blood clots that can cause heart attacks and strokes.

The FDA did not warn the public of the potential risks until November 2005, six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was Changed, and prescriptions fell 80 percent, to 187,000 by February from 900,000 in March 2004.

According to Janet Abaray, a plaintiff’s lawyer from Cincinnati, Johnson & Johnson took advantage of an agency overwhelmed by its many, responsibilities. “Johnson & Johnson knew that FDA does not have the funding or the manpower to police drug companies,” Abaray said.

A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew von Eschenbach, acknowledged the agency faces a crisis and might hot be “adequate to regulate the food and drugs of the 21st century.”
The FDA does not test experimental medicines but relies on drug makers to report the results of their own tests honestly.

Last month, at a trial over the schizophrenia drug Zyprexa, Dr. John Gueriguian, a former FDA scientist, testified that the agency did not always ask for strong warnings when it thought a drug was risky. Companies often oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Gueriguian said.

For years, agency leaders acknowledged that lawsuits could aid the agency’s oversight of safety. In the past decade, several lawsuits have shown that companies played down the risks of their medicines and failed to disclose clinical trials to the public.

Here is an excellent video of how insurance companies use ERISA to swoop in and take injury victim’s recovery money.

In August, the Atlanta Journal Constitution broke a story about
Progressive Insurance Company’s use of private investigators in a
shocking manner. The story, which is unfortunately no longer available
online, stated as follows:

When a new couple arrived at Southside Christian Fellowship
in August 2005, members welcomed them with open arms. Soon, the new
couple talked their way into private group support sessions…During
the private talks, church members confessed abortions, sexual
orientation issues, drug addictions and other dark secrets. No one knew
the couple wasn’t actually interested in joining the church. Instead,
they were private investigators hoping two church members…would spill
something they could use to discredit the pair in an ongoing lawsuit
over a traffic accident. The private eyes even tape-recorded the
sessions.

Immediately after the story broke, the Progressive CEO offered an apology, calling the situation “appalling.”

But Progressive is now singing a different tune. In a lawsuit filed
by the personal injury victims, Progressive is now asserting that the
conduct was “reasonable.”

It will be interesting to watch and see how this story plays out.

Technorati Tags: insurance company spying, progressive

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Here’s an awesome new video about the myths of tort reform perpetuated by the insurance industry!

Not being a lawyer, you may not be aware that the Texas rules of evidence prohibits a lawyer from mentioning insurance in a case where the insurance company is not the defendant.  In other words, if you find yourself on a jury hearing a claim for medical malpractice or a car accident, you won’t hear about insurance.

Lately, I have begun to question the wisdom of such a rule.

The theory is that the jury should make its decision based on the injury – how much was David hurt in the accident, how much time did he lose from work, what were his medical bills, and what is an appropriate compensation for his pain and suffering?  According to this theory, if the jury knew that Bobby had a $100,000 insurance policy when he drove his car into David’s, then they would be more likely to give him a large reward.  After all, it’s not coming out of Bobby’s pocket.  How much insurance Bobby has is not related to the injuries David suffered.  True…

But is this really a fair rule?  Why then, even when liability is not an issue, is the defendant put in front of the jury by the defense counsel and asked questions about himself to “humanize” him?  The answer is simple, the defense counsel knows that when they put a face to their client, the jury is more likely to return a lower verdict.

In other words, even if Bobby admits he blew the stop sign and rammed into David, he gets to tell the jury how sorry he is, how he has five kids to support, how he just lost his job, and how his wife ran off with his neighbor.  None of this, of course, is related to the injuries David suffered, but the defense gets to put it in front of the jury.  Is that fair?

While most jurors are aware that there is insurance available (I hope), fairness would justify letting them know all the facts.

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Technorati Tags: insurance, jury, court room, trial

Asbestos litigation in Texas just became a lot harder. The Texas Supreme Court recently overturned a Corpus Christi mechanic’s $169,000 damage award because he failed to quantify how much asbestos had been inhaled on the job.

Arturo Flores, working a mechanic for more than 30 years, was exposed to asbestos every time he ground brake pads (the pads contained anywhere from 7 to 28 percent asbestos). He developed asbestosis, an incurable and debilitating lung condition.

On appeal, Borg-Warner, who lost at trial, claimed that Mr. Flores could not quantify how much asbestos he had inhaled and how much were from their brakes. The court reasoned that Mr. Flores did not show how much asbestos could have been inhaled or whether the amounts were sufficient to cause asbestosis.

Since the testing required to prove this new, higher standard is expensive, victims will now have a much harder time winning in court.