Articles Posted in Product Liability

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Federal preemption has long been a hot button issue in pharmaceutical drug cases, with consumer advocates arguing that drug companies should be held to the sometimes higher state standards. However, the U.S. Supreme Court appears to have reversed the federal preemption stance it took in Wyeth v. Levine. In Wyeth, the Court held that the negligence claim against the pharmaceutical company was not preempted by federal regulations and that the drug company was liable for its failure to provide adequate warning of its drug’s dangers.

However, in Pliva v. Mensing, No. 09-993, the Supreme Court ruled that a pharmaceutical manufacturer could not be sued under state law for failing to warn consumers about its drug’s risks. This decision seems to go against the Court’s ruling in Wyeth just two years ago; both lawsuits deal with federal preemption issues and involve states setting higher safety regulations than the Food and Drug Administration (FDA). Yet in Wyeth, the Court held the drug company responsible, while in Pliva, the Court ruled the pharmaceutical lawsuit was barred under federal preemption.

Yet on closer inspection, there appear to be some key differences between the facts surrounding the drug warning labels in Wyeth and Pliva. The main issue in both the Wyeth and the Pliva pharmaceutical cases involved an FDA regulation referred to as “changes being effected” (CBE). Under the CBE regulation, a drug manufacturer may modify its warning label without prior FDA approval if the modifications will improve the drug’s safety. Under CBE regulations, the FDA approval comes after the warning changes, not before; however, the assumption is that the warning changes in such matters are so important to consumer safety that the FDA will eventually approve those changes.

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Jeep Grand Cherokees might face a recall due to a product defect that causes the increased risk for fuel fires following rear-end collisions. The auto recall would affect 1993 to 2004 Grand Cherokee models; however, Chrysler denies the need for a Jeep recall and the National HIghway Traffic Safety Administration (NHTSA) has not yet instituted one. Yet there are at least different three crash tests showing that Grand Cherokees are more likely to catch on fire following rear end collisions that similar SUVs manufactured during the same time period.

The various crash tests were conducted by Karco Engineering and The Federal Outdoor Impact Laboratory; Karco has previously performed crash testing for the NHTSA. One test conducted on 1995, 1996, and 1999 Grand Cherokees resulted in significant gasoline leaks following rear-impact crashes. These gasoline leaks not only put the Jeep passengers at risk, but could also pose a fire threat to the occupants of the striking vehicle.

Likewise, another investigation of Grand Cherokeesfrom 1993-2004 was conducted because of over 254 deaths resulting from “172 fatal fire crashes” involving those Grand Cherokees models. The majority of these investigations are focusing on the Grand Cherokee because of similar results showing that the Grand Cherokee’s fuel system is much more likely to pose a fire threat than those used in similar vehicles. For example, comparable Ford Explorer models were much less likely to catch fire following a rear-end collision; in crash tests, Ford Explorers’ fuel system typically remained intact following these collisions.

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The first case to go to trial in the series of Cook County pharmaceutical negligence lawsuits against Baxter International received a $625,000 verdict against the pharmaceutical manufacturer. The Illinois lawsuit of Estate of Johansen v. Baxter International, Inc., et al., 09 L 11175, was filed after the plaintiff, Steven Johansen, died as a result of receiving contaminated Heparin distributed by the defense.

Hundreds of lawsuits have been filed against Deerfield-based Baxter International, Inc. and Scientific Protein Laboratories, its supplier, after the Food and Drug Administration (FDA) discovered that the companies had been selling contaminated Heparin. The tainted Heparin was discovered to contain oversulfated chondroitin sulfate, which is a synthetic chemical created from animal cartilage that is typically distributed as a dietary supplement. According to tests run by the FDA, the false chemical mimics the real drug, Heparin.

However, not only does the oversulfated chondroitin sulfate not have the same blood thinning effects of Heparin, but can actually cause adverse reactions in patients taking it. The synthetic chemical has been found to cause vomiting, difficulty breathing, a drop in blood pressure, and other severe reactions. The plaintiff, Steven Johansen, first received low doses of the contaminated Heparin during dialysis treatment in December 2007, with no obvious reaction. However, Johansen later received a second, much higher dose of the contaminated Heparin, which resulted in his death five days later.

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Crib bumper pads have been the topic of debate for several years. While some claim that they are perfectly safe and harmless, others claim that crib bumper pads put infants at risk for suffocating in their cribs. A recent report that the Consumer Product Safety Commission (CPSC) has not taken adequate steps to investigate crib bumper pads calls into question the product’s safety.

Over the years, the CPSC has investigated allegations of babies’ dying as a result of suffocating in their crib bumpers. However, it now seems that at least 17 of those cases were not fully investigated by the CPSC. While the agency did look into the infant deaths, it determined that in at least 12 of the 17 cases it was difficult to clearly implicate the crib bumper pads in the infants’ deaths. The CPSC instead suggested that the deaths were caused not by the defective bumper pad design, but instead were the result of infants suffocating from pillows or blankets that were also in the cribs.

The American Academy of Pediatrics has taken a much firmer stance than the CPSC, going so far as to urge parents not to use crib bumper pads because of the risk of suffocation. These claims have been supported in autopsy reports conducted by medical examiners and coroners, who have affirmed that bumper pads were involved in the infant suffocations. In light of all this evidence, the CPSC must now decide whether it is safe for parents to continue using this crib product.

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An Illinois court denied defendant’s motion for summary judgment in Brandon Stollings v. Ryobi Technologies, 2011 WL 211008 (N.D. Ill.). The court disagreed with the defendant manufacturer that the Illinois product defect claim did not satisfy the requirements for strict liability or negligence claims and allowed the product defect case to continue.

Stollings involved claims that the Ryobi Technologies manufactured a table saw that was unreasonably dangerous due to several design defects. The Illinois product liability lawsuit was filed after the plaintiff, Brandon Stollings, lost two fingers while he was maneuvering the table saw. Stollings was cutting a piece of wood when it was kicked back at him by the blade, causing his fingers to push forward into the rotating blade. Stollings’s product liability lawsuit claimed that Ryobi Technologies’s table saw was unreasonable dangerous because its anti-kickback device was attached to the saw’s blade guard instead of being an independent system, it lacked flesh-detection technology, and sawdust tended to accumulate in the blade guards and obstruct the view of the operators.

However, the defense filed a motion for summary judgment to dismiss both Stollings’s strict product liability counts and his negligence counts, citing evidence that Stollings had removed the blade guard prior to operating the table saw and that the plaintiff admitted to never reading the safety manual. The defense argued that if the plaintiff failed to utilize the safety features it had included then he was over 50% liable for his own injuries.

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A recent Illinois personal injury lawsuit involving the injury of a seven year-old girl at a local playground brought up issues of tort immunity in Illinois. Tort immunity laws are meant to determine to what degree a municipality, in this case the park district responsible for maintaining the playground, is immune from its actions. In Steven Tagliere, etc. v. Western Springs Park District, No. 1-09-2633, the plaintiff alleged that the Western Springs Park District was negligent in its maintenance of a seesaw at its park.

Seven year-old Taiylor Tagliere was playing on a seesaw at a park owned by the Western Springs Park District with five other girls when her ankle became lodged in the middle section of the seesaw, resulting in a broken ankle. Steven Tagliere, Taiylo’rs father, testified that when he later went to inspect the seesaw it was missing several bolts, which was evidence that the seesaw contained an “obvious defect.” Under Illinois tort immunity laws, the alleged defect needs to be obvious in order to satisfy one of the requirements for the municipality’s liability.

However, the other factor that the plaintiff must prove is that the failure to maintain the seesaw constituted “willful and wanton misconduct” on behalf of the park district. It was the plaintiff’s failure to prove this that led to the trial court’s dismissal of the plaintiff’s claim, despite the presence of an obvious defect. The plaintiff appealed to the Illinois Appellate Court, stating that the lower court had erred in dismissing the case and asking the court to reconsider the evidence.

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The Illinois Appellate Court has affirmed a ruling by a Cook County associate judge who denied a forum non conveniens challenge brought by Motorola in Joseph Erwin, Jr., et al. v. Motorola, Inc., No. 1-09-2847. The Illinois birth injury lawsuit involved allegations that the plaintiffs’ children suffered birth defects as a result of their parents’ exposure to hazardous chemicals in the course of their employment in Motorola’s semiconductor industry “clean rooms”.

Motorola’s motion involved a request of a change of venue, citing forum non conveniens rules to support its motion in the birth defect lawsuit. Forum non conveniens is Latin for “inconvenient forum” and are applicable when a lawsuit is filed in a location that is inconvenient for parties or witnesses. Under this principle, a judge is allowed to change a case’s venue if a party can make a substantial case for its inconvenience.

Erwin was filed in a Circuit Court of Cook County court on the basis that Motorola’s headquarters are in Schaumburg, Illinois. However, Motorola argued that a more appropriate venue was Travis County, Texas, on the basis that much of the plaintiffs’ exposure to the hazardous chemicals took place in that county. It submitted a motion to dismiss the birth injury lawsuit on the basis of forum non conveniens, which the circuit court judge denied. Motorola then appealed this decision to the Illinois Appellate Court.

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In August 2010, the Federal Drug Administration (FDA) posted a letter it sent to a medical device manufacturer regarding the safety of its metal hip implants. The letter informed the medical device manufacturer that the FDA had become aware that it had not obtained marketing approval before releasing its metal-on-metal hip implant device for sale and that the company should stop marketing this device immediately.

The medical device manufacturer, DePuy Orthopaedics, Inc., had not received FDA approval for its TruMatch™ Personalized Solutions System prior to releasing it for sale. Therefore, the FDA was warning the medical device manufacturer that it needed to cease production of this product while it went through the proper channels of obtaining the FDA’s approval.

In addition, while DePuy had been cleared by the FDA to market its Corail® Hip System, which was intended to be used for a total hip arthroplasty. However, DePuy had made several changes to its Corail Hip System that were not approved or tested by the FDA and therefore could not legally be marketed or used.

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The United States Supreme Court has ruled that a family is allowed to pursue its lawsuit in California against Mazda Motors of American, Inc. in the case of The Estate of Thanh Williamson v. Mazda, 08-1314. The product liability lawsuit deals with claims that the auto company’s 1993 Mazda MPV minivan were unsafe because the middle seat of the vehicle’s second row was only equipped with lap seat belts.

The wrongful death lawsuit was filed after Thanh Williamson, a Utah mother, died in a 2002 auto crash. Mrs. Williamson was seatbelted into the back middle seat of the family’s Mazda minivan at the time of the car crash. According to eyewitnesses of the car accident, the impact of the car crash caused Mrs. Williamsons’s body to jackknife around the lap seat belt, which resulted in her fatal internal injuries.

Again, central to the estate’s product liability claim was that the seatbelt the late Mrs. Williamson was using was not equipped with a harness or shoulder belt. However, this option is not required by federal regulations. While federal law does require that a vehicle’s front and rear outer seats come equipped with both lap and shoulder belts, car manufacturers may decide whether or not to also provide this option in their middle or aisle seats.

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An Illinois product defect lawsuit recently received a $2 million jury verdict award for her severely injured right hand in Rita Thakore v. Universal Machine Co. of Pottstown, Inc. d/b/a Universal Machine & Engineering Corp., 05 C-5262. The Illinois product liability lawsuit involved allegations of a defective design of an automated packing line machine manufactured by the defendant, Universal Machine Co. of Pottstown, Inc.

The Illinois product liability lawsuit sprung from a work place injury that the plaintiff, Rita Thakore, experienced while employed as a production technician at Ciba Vision’s contact lens factory in Des Plaines, Illinois. The 47 year-old technician was wiping melted plastic residue off of the upper plate of the heat seal press of the packing line machine. Ms. Thakore was responsible for handling the heat seal press, which was designed to seal foil lids onto plastic containers.

The machine was stopped at the time, but the 200 lb. plate suddenly dropped from the machine and landed on top of her right hand. Her hand became trapped under the 450 degrees Fahrenheit plate for several minutes, until the high temperatures burned through her heat-resistant glove.

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