Articles Posted in Product Liability

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The Food and Drug Administration (FDA) has reported that it has received 23 reports of adverse health effects in persons who have used the weight-loss product, Hydroxycut. Reported complications from using Hydroxycut include heart problems and a kind of muscle damage that could lead to kidney failure. One person suffering from severe side effects of Hydroxycut even required a liver transplant.

On May 1, 2009 the FDA issued a warning to consumers to stop using Hydroxycut. According to the FDA warning the manufacturer, Iovate Health Scientists of Oakville, Ontario, Canada and its American distributor, are recalling Hydroxycut. All in all, lovate is recalling 14 of its product line. This recall will not affect its products Hydroxycut Cleanse and Hoodia, which have different ingredients than the other products.

The Hydroxycut brand has been widely sold at national stores including Vitamin Shoppe and GNC. The product is sold in a form of pills, drinks and powders which is designed to increase energy, burn calories and fat, and control appetite. According to the FDA about nine millions units of the product were sold in 2008. Vitamin Shoppe and GNC reportedly are removing Hydroxycut products from their websites and stores.

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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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A February 2008 decision by the Supreme Court stands as a barrier to patients who desire to sue for medical device liability. The Supreme Court ruling in Riegel v. Medtronic, Inc. holds that patients or their surviving heirs would be barred from suing makers of complex medical devices like the Medtronic’s heart device product, if the Food and Drug Administration (FDA) approved its sale.

Since that ruling, judges nationwide have applied the Supreme Court decision to a wide range of cases where manufacturers was being sued. The most recent dismissal was just last week by the Wisconsin Supreme Court.

But now members of Congress want to change the law. Lawmakers and patient advocate groups say that that February 2008 Supreme Court decision left patients legally powerless against the FDA’s oversight of products.

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U.S. District Court Judge Virginia M. Kendell denied a Chicago woman’s medical device liability claim that her left knee injuries were caused by her knee replacement device. The complaint was removed to the federal court from Chicago’s Cook County Circuit Court and contained claims of negligence, strict liability and breach of warranty based on Illinois law.

Judge Kendall granted summary judgment in favor of the the manufacturers, Zimmer Holdings, Inc., Zimmer U.S., Inc., and Zimmer, Inc., in a lawsuit brought by the plaintiff, Joyce Link.

After reviewing the case facts, Judge Kendell held that Ms. Link’s claim against Zimmer for their manufacturing of the Natural Knee II was preempted under the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act. Per Judge Kendall’s ruling this act “imposed detailed federal oversight onto the introduction of new medical devices onto the introduction of new medical devices onto the market”. Judge Kendall credited her interpretation of Riegel v. Medtronic, 128 S.Ct. 999 (2008), as partial basis for her opinion.

In addition, Judge Kendall cited 21 U.S.C. § 360(c), which states that as part of the oversight states and their subdivisions are barred from implementing their own requirements concerning medical devices, such as the Natural Knee II. The federal act specifically preempts any state requirement regarding a medical device “which is different from, or in addition to” a requirement imposed by the MDA.

In Judge Kendall’s opinion, the state requirement is not preempted unless it also “relates to the safety or effectiveness of the device or to any other matter” covered by the MDA. Kendall held that Ms. Link’s claim was just the kind that Congress intended to preempt under the MDA.

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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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An Illinois federal judge upheld a jury verdict for a woman permanently disabled in a motorcycle crash even though her expert witness did not pinpoint the exact cause of the crash. McCloud v. Goodyear Dunlop Tires N. America, Ltd. WL 2323792 (C.D. Ill. June 2, 2008).

Trish McCloud was severely injured in 2002 when the rear tire blew out on her Honda Gold Wing motorcycle. Her expert witness narrowed down the tire defect to three possible manufacturing errors by defendant, Goodyear. Based on his testimony the jury awarded her damages under her Illinois product liability claim.

Goodyear asked for a new trial, in part because it felt that McCloud’s expert had not adequately proved that its product was defective. McCloud’s expert had testified that the blowout was the result of a nylon cord getting embedded in the tire’s innermost layer rather than the layers of rubber, which was where it belonged. This then caused a bubble to form in the sidewall layer of the tire, which eventually burst. Her expert posed three different ways this Illinois product defect could have occurred during the manufacturing process, but did not pinpoint which one specifically was the cause.

In response, Goodyear reasoned that the blowout was the result of the tire being overloaded and under-inflated. It argued that the motorcycle itself was overweight, which would have contributed to this blowout, and further cited inadequate checking of the tire pressure by the owner. Furthermore, the fact that none of its other customers had reported a similar problem was a factor to be considered.

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A California Appellate Court supported a trial court’s ruling that the Medical Device Amendments (MDA), Title 21 USC §360k(a), preempts any state law imposing safety requirements on manufacturers of a medical device. So even though the medical device did not pass all of the state’s safety requirements, in Blanco v. Baxter Healthcare Corp. the plaintiff’s claim was denied because the medical device in question met all the FDA requirements. As we see again and again, the MDA’s preemption claim is making it increasingly difficult to seek legal recourse for a faulty medical device. Of course, this would hold true for our cases in Chicago and around Illinois.

Claudia Blanco was diagnosed with mitral valve stenosis and needed to have her natural valve replaced with an artificial one. During surgery a bileaflet mitral heart valve manufactured by Baxter-Travenol Laboratories was inserted. A year after Blanco received the valve Baxter suspended marketing of its product due to reports of possible valve failures.

However, Blanco didn’t receive any notice of the valve problems for another five years. And while the notice advised her of the potential problems it did not advise her to have the valve removed or replaced. Less than ten years later Blanco’s artificial valve failed and she was rushed to the hospital for an emergency valve replacement, but died. After her death a representative from Baxter evaluated her valve and determined that the failure was in fact caused by a faulty valve.

But despite the evidence that the product was faulty Blanco’s claim was denied by both the trial and appellate courts. Because the medical device had passed a “rigorous” approval by the FDA it was protected from litigation for product liability. Also, because the device’s warnings were also approved by the FDA a claim cannot be brought for failure to warn.

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Consider the following scenario. You work at a Chicago manufacturing factory. One day the machine you operate becomes jammed. In order to try to remove the jammed material you remove the machine’s guard and place your hand inside. But as you do this the machine starts up and crushes your hand. You are now permanently disabled and unable to do your job. What are your legal options?
Because of Illinois worker’s compensation law you are limited to recover against your employer in the Illinois Industrial Commission and cannot bring a separate civil lawsuit directly against your employer. But if your injury at work involved a machine or product then you may be able to recover damages from the manufacturer in a product liability claim brought as a separate civil suit.

The most common product liability claim from work-related injuries is due to the product’s lack of safety features, such as a guard or an automatic shut-off that is activated when the guard was removed, or a release lever that kills the power instantly. When a product fails to include a reasonable safety feature that makes it unduly dangerous to its user then the manufacturer can be held liable for any injuries sustained while operating the machine.

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