Articles Posted in Product Defects

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Yesterday Toyota announced its largest recall ever when it announced its plan to recall 3.8 million vehicles due to a product defect. According to the auto manufacturer, the vehicles in question are equipped with a floor mat that causes the accelerator pedal to become stuck.

As a temporary solution, the federal government and Toyota are encouraging vehicle owners to simply remove the driver’s side floor mat. Toyota advised that until the manufacturer comes up with a solution regarding the defective product, owners should simply remove the mats rather than bringing the vehicle to the dealership.

An alert has been issued by The National Highway Traffic Safety Administration regarding the Toyota floor mats warning drivers that stuck accelerator pedals could lead to high speeds and deadly crashes. Secretary of Transportation, Ray LaHood, reinforced this message in a recent statement, in which he “strongly urge[d] owners of these vehicles to remove mats or other obstacles that could lead to unintended accelerations”.

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Increased reports of medical problems associated with certain nutritional supplements has prompted The Food and Drug Administration (FDA) to issue a public health advisory on body building supplements. These supplements may contain steroids or steroid-like substances and may be associated with kidney failure and liver failure in men.

While the FDA has not specified exactly how many products fall into this category, it advised that consumers not to purchase and use products labeled with words such as “anabolic” or “tren” or phrases like “blocks estrogen” and “minimizes gyno”. In addition, the FDA cautions consumers to be wary of body-building products claiming to enhance or diminish the effects of hormones like testosterone, estrogen or progestin.

Of those products that the FDA did specifically name, those included MASS Xtreme, TREN-Xtreme, ESTRO Xtreme, HMG Xtreme, AH-89-Xtreme, MMA-3 Xtreme, TT-40-Xtreme, and VNS-9 Xtreme, all of which contained hidden and potentially dangerous steroids. The FDA has taken action in the form of sending a warning letter to these drugs’ manufacturer, Americell-Labs, stating that the company should produce products that are in compliance with federal regulations.

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The U.S. government has struck a deal with General Motors (GM) that requires the car manufacturer to assume responsibility for any automobile product liability lawsuits filed after GM emerges from bankruptcy as a new, government-owned company. This requirement even applies to claims regarding vehicles manufactured by the old GM.

This agreement is much better for the general public than GM’s original plan, which would have barred any new product liability lawsuits being filed against the new company. However, lawmakers had a problem with leaving the American public without any legal recourse for personal injuries resulting from car and truck product defects. The deal that resulted in the present requirement resolved this problem that could have stalled GM’s plan for a quick restructuring program.

And while future vehicle product liability claims are protected, it appears that previously filed product liability claims will likely remained tied to the old GM and therefore be tied to its bankruptcy proceedings. Typically, after a company files for bankruptcy the courts and bankruptcy protection allow that company to leave any legal claims behind so that they can emerge from bankruptcy with a clean slate.

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The U.S. Food and Drug Administration (FDA) advised consumers that products sold under the Hydroxycut branded name could cause liver and heart problems. The FDA Hydroxycut advisory stated that “although liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risks.” The results were that its products were recalled.

Chicago and Illinois residents have reported symptoms of adverse affects from taking Hydroxycut, which range from stomach and abdominal pain, excessive fatigue, recurring headaches, excessive weakness, vomiting, loss of appetite, to kidney failure and liver damage severe enough to require a liver transplant.

Hydroxycut products are dietary supplements that were marketed for weight loss as fat burners, energy-enhancers, low carbohydrate diet aides, and for water loss. The brand names are marketed by Iovate Health Sciences, Inc., Iovate Health Sciences USA, Inc., Muscle Tech, among other brand names.

The FDA has asked that healthcare professionals and consumers report any serious adverse or side effects from the taking of these products.

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Medtronic, the maker of Sprint Fidelis, a heart defibrillator cable, has taken its product off the market. But the problem with it still being used by some 150,000 people around Illinois and the country has resulted in several deaths in removing the defective cable.

Medtronic estimates that the cable has failed in a little more than 5% of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.

Already 4 patients have died during extractions. It is feared that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers that have performed many of these operations.

“I think we are seeing the tip of the iceberg,” said Dr. Charles J. Love, a cardiologist at who specializes in cable extractions. For many patients around Illinois, the big issue is who is skilled enough to remove these defective heart implants. It is thought that some surgeons removing the cables do not have the required skill level.

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In a recent Chicago product defect case, the pace of settlement negotiations were perhaps hastened because in November 2008 the Illinois Supreme Court ruled that defendants in negligence suits who settle prior to trial, should not be named on jury verdict forms for the purpose of apportioning liability (Ready v. United/Goedecke Services, Inc., et al., WL 5046833).

The recent Illinois product liability case involved involving a punch press operator and settled for over $5 million. Both of the worker’s arms were amputated after a punch press malfunctioned and part of the machine crushed both arms.

Seven years ago a U.S. District Court judge approved a $1.1 million settlement in this same Illinois product defect case, which released one of the manufacturers of the machine that caused the injury. However, the case wasn’t over as there two remaining manufacturer parties still involved in the Illinois product liability case.

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Car and truck manufacturers have largely ignored the product defects causing insufficient occupant protection and rollover crashes until recently, relying instead on inadequate minimum government standards. However, this is changing in light of increased pressure from a consumer-friendly government coupled with years of having to compensate victims of rollover deaths and personal injuries. These manufacturers are now taking steps to protect the public.

In 2005, the National Highway Traffic Safety Administration (NHTSA) proposed an upgrade to the 1973 version of the federal roof crush standard for automobile manufacturers. At that time, the standard was so weak that most occupants in a rollover would be severely injured or killed. That standard merely requires a vehicle roof resist a static force of 1.5 times the empty weight of the vehicle or 5,000 lbs., whichever is less. This kind of standard does not reflect the dynamic forces that a vehicle typically experiences in an actual rollover. In virtually every rollover, the roof makes contact with the ground on one side or then the other.

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The Illinois Supreme Court reversed a $27 million jury verdict award and ordered a new trial after applying the risk-utility test of Illinois product design liability in favor of the defendant. This is a new application of the risk-utility test, which typically falls in favor of the plaintiff.

Illinois’ strict design defect theory applies one of two tests to determine whether a product is unreasonably dangerous. The first test is the “consumer expectation” test, under which the plaintiff must show that the product is more unreasonably dangerous than a typical consumer would realize when purchasing it.

The other test is the “risk-utility”, or “risk-benefit” test. Under the risk-utility test the consumer must prove that the danger associated with a product outweighs the product’s benefits. Under the risk-utility design the product manufacturer may also prove that the product’s benefits outweigh the risk of danger inherent in the product’s design.

In Mikolajczyk v Ford Motor Co, 2008 W.L. 4603565 (Ill.Supp.Ct. 2008) , the Supreme Court applied the risk-utility test to determine whether the product was defective under Illinois law. In Mikolajczyk, the plaintiff died of injuries sustained when another vehicle crashed into the rear end of his Ford Escort. His widow brought a claim regarding the defective design of the driver’s seat against the Ford Motor Company and Mazda Motor Corporation.

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Last week Illinois Attorney General Lisa Madigan filed a lawsuit against SFCA, Inc., a distributor of baby cribs, bassinets and playpens, claiming that SFCA continues to sell and distribute the subject bassinet, even after voluntarily recalling 1,000,000 of the products in 2007.

The bassinet allegedly has design flaws. Federal regulators warned consumers that the bassinet caused the death of two infants. The bassinets are equipped with sides that drop down for easy access to the baby. Unfortunately the design creates a gap that the baby can slide through. The two infants that died did slide through and hung to death.

SFCA is not taking responsibility regarding the product liability claim for the defective bassinet, which is manufactured and marketed through Simplicity, Inc., a subsidiary company of SFCA, Inc. SFCA maintains that it wasn’t responsible for the items produced by Simplicity because it only just bought the Simplicity brand in August 2008. Yet closer examination reveals that SFCA bought the Simplicity brand bassinets, but then shipped them from its own facility using the same design of the products that killed the 2 infants.

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The U.S. Food and Drug Association is responsible for ensuring that new medical devices are safe enough to be put on the market. As a federal agency, the FDA controls regulation nationwide and within Illinois and Chicago. But what most consumers don’t know is that the process for approving these medical devices doesn’t always ensure that they are effective alternatives to already established medical treatments.

The majority of newly approved medical devices undergo a 501(k) review. Under this review process the manufacturer needs to prove that their device is substantially similar to another device that has already been approved for the market. Once they have done that, the manufacturer just needs to show that the device does what it claims. Yet in the field of medicine, just performing a function is different than guaranteeing the supposed outcome.

For example, let’s suppose that Elaine, an Illinois woman, was trying to decide between which type of radiation she should get to treat her breast cancer. Her options range from conventional radiation, which would irradiate her whole breast five times per week for a total of five weeks, to a newly-FDA approved radiation therapy method called MammoSite brachytherapy. This new method only requires radiation for five days and uses radioactive ‘seeds’ to treat the cancer.

All things being equal, the MammoSite option is much more appealing because it gets the job done in a fraction of the time and is Elaine’s first choice. Her doctor recommends it and she decides to go with the newer treatment option. However, what Elaine doesn’t know is that even though MammoSite is FDA-approved, the long-term effectiveness of the treatment is not yet proven. While early studies have come back with promising results, it will be years before there is enough data to determine whether it is as effective as conventional radiation. Yet many of the women undergoing this form of treatment are unaware that it is still in an experimental state and are trusting the FDA-approval and their doctors’ recommendation.

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