Articles Posted in Product Liability Cases

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A 48-year old mother of seven recently passed away after taking the dietary supplement, OxyElite Pro, for several weeks. In fact, over the past 6 months, OxyElite Pro has been linked to 24 reported cases of acute hepatitis and liver failure in Hawaii. As a result, on October 10, 2013, the Hawaii Department of Health issued a request that OxyElite Pro be voluntarily removed from stores across Hawaii. That same day, the U.S. Centers for Disease Control and Prevention (CDC) requested the product be removed from stores. According to the CDC, the most commonly reported symptoms reported include loss of appetite, fever, nausea, light-colored stools, dark urine, and jaundice.

Shortly after the Hawaii Department of Health’s request, USP Labs, LLC, the manufacturer of OxyElite Pro products based in Dallas, Texas, reported that it would cease the nationwide manufacturer and distribution of the products associated with liver failure cases. Unfortunately, that does not mean the product, meant to increase energy, concentration, and metabolism, will be pulled from shelves nationwide. Rather, it is up to the retailers who purchased the products from USP Labs whether to pull the products from the shelves.

This is not USP Labs and OxyElite Pro’s first warning from the government. In 2012, the U.S. Food and Drug Administration (FDA) warned companies, including USP Labs, to stop using the geranium extract known as DMAA after it was linked to cases of increased blood pressure, shortness of breath, chest tightening, cardiovascular problems and even heart attacks. More specifically, the FDA concluded that DMAA is not a dietary ingredient and, as such, is not eligible to be used as an active ingredient in a dietary supplement. In early 2013, USP Labs agreed to settle a DMAA class action lawsuit for $2 million. Then in April 2013, USP Labs agreed to phase out products containing DMAA.

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Every year thousands of infants sustain injuries or are wrongfully killed by dangerous and defective products. In addition, deaths, injuries and property damage from consumer product incidents in general cost the nation more than $900 billion annually. Unfortunately, many of these injuries are caused by the negligence or recklessness of manufacturers and distributors, meaning that many of these injuries and deaths could be avoided.

Infants are particularly vulnerable to dangerous and defective products, including but not limited to toys, clothing, and even drugs. According to a 2011 report produced by the U.S. Consumer Product Safety Commission (CPSIA), among children younger than 5 years of age, there were an estimated 74,100 emergency department-treated injuries, associated with, though not necessarily caused by, nursery products in 2011. In addition, for the 3-year period from 2007 through 2009, the Consumer Product Safety Commission (CPSC) received reports of 341 deaths, associated with, but not necessarily caused by, nursery products among children younger than age 5. Several recalls relating to products used by infants have been reported in the past few months, including but not limited to the following:

HALO SleepSacks Recalled

On August 21, 2013, the CPSC issued a recall of approximately 27,000 HALO SleepSacks Wearable Blankets sold exclusively at Babies R Us and babiesrus.com from December 2011 through July 2013. Citing a risk of a choking hazard to infants, the CPSC advised consumers to stop using the product immediately. The recall was issued after the CPSC received six separate reports of a pink satin flower on the blankets becoming detached from the blankets. In one case, the report complained that an infant was discovered gagging on the detached petal.

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According to the U.S. Food and Drug Administration’s (“FDA”) Center for Drug Evaluation and Research, a generic drug is a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. Although generic drugs are generally cheaper, since the FDA requires that the warning labels of generic drugs be identical to their brand-name counterparts, generic drugs have essentially been granted immunity to civil action resulting from the use of their drugs.

Unfortunately for consumers of generic drugs, a recent U.S. Supreme Court decision furthered strengthened this generic drug manufacturers’ immunity, finding that design defect law claims in state courts based on the adequacy of a drug’s warning are pre-empted by federal law. As explained below, the ruling not only creates an inconsistency in product defect law, but it also all but ensures that generic drug makers will not be held accountable for product defects, marking a victory for both drug industry and the FDA.

In Mutual Pharmaceutical Co. Inc. v. Bartlett, Ms. Bartlett suffered a severe reaction to the generic pain reliever drug, sulindac, made by Mutual Pharmaceutical Co. Inc. (“Mutual”). Even though Ms. Bartlett’s doctor prescribed her the brand name of the non-steroidal anti-inflammatory drug (NSAID), Clinoril, for shoulder pain, her pharmacist dispensed the generic form of the pain reliever instead. The drug caused her to develop toxic epidermal necrolysis (TENS), which led to 60 to 65% of her skin to either burning off or becoming an open sore. The condition left Bartlett disfigured, disabled and nearly blind.

Bartlett thereafter filed suit against Mutual in federal court in New Hampshire alleging that the generic drug, sulindac, had a design that made it dangerous for use. Like Texas law, New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe. A drug’s safety is evaluated in part by the adequacy of its warnings. Notably, at the time that Bartlett was prescribed the drug, sulindac’s label did not specifically refer to TENS or Stevens-Johnson Syndrome, another form of TENS.

The New Hampshire state court agreed with Bartlett, finding the generic drug was unreasonably dangerous and awarded Bartlett $21 million in damages. The Court of Appeals for the First Circuit affirmed. Nonetheless, focusing on the fact that Bartlett was provided the generic version of the drug, the U.S. Supreme Court held that the Federal Food, Drug and Cosmetic Act preempts state-law design defect claims against manufacturers of generic drugs. As a result, the U.S. Supreme Court reversed the decision of the Court of Appeals. If, however, Bartlett had been dispensed the brand name version of the drug, she would have had a cause of action against the brand name drug manufacturer, and would have been able to recover damages for her injuries.

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In 2012, about 16.2 million car and truck owners received notification that their vehicles had safety problems and were being recalled. However, despite the high number of recalls, according to the Center for Auto Safety, changed auto recall accounting methods are raising questions about the productivity of defect investigations. Additionally, according to John Claybrook, former head of the National Highway Traffic Safety Administration (“NHTSA”), investigations by the agency are taking longer than they should, meaning many drivers could be driving unsafe vehicles without being aware of it.

The Department of Transportation’s NHTSA has the authority to issue vehicle safety standards and to require manufacturers to recall vehicles that have safety-related defects or do not meet Federal safety standards. Recalls are necessary when a vehicle or vehicle equipment (including tires) does not comply with a Federal Motor Vehicle Safety Standard or when there is a safety-related defect in the vehicle or equipment.

While manufacturers voluntarily initiate many recalls, auto companies are required to tell the NHTSA about claims they receive about serious injuries and deaths in their vehicles, so that NHTSA can then investigate the claims. Owners may also submit complaints to the NHTSA, prompting investigations.

Recall Accounting Methods Raises Safety Concerns

Due to budget issues, 28 NHTSA investigators handle every inquiry and complaint brought to the agency–meaning 28 individuals are responsible for investigating every automaker, truck maker or parts supplier.

In a recent New York Times article, David Strickland, current NHTSA administrator, argues that the limited number of investigators are sufficient due to new tools for data analysis, which allow the investigators to work more efficiently. Strickland added that NHTSA investigations resulted in 134 vehicle recalls in 2012, the second highest number since 1966.

According to the executive director of the Center for Auto Safety, Clarence Ditlow, however, the total number of recalls does not accurately measure the agency’s productivity since one inquiry can generate dozens of recalls. Specifically, federal auto safety regulators are counting what used to be considered multiple recalls as one recall. For example, 61 of the 131 recalls reported in 2011 resulted from one investigation involving aftermarket sunroofs–any car dealership or business that installed a sunroof was listed as a separate recall. As a result, the number of investigations actually being carried out is far fewer than expected based on the number of recalls.

Defect Investigations Taking Too Long and Kept Secret

In 2011, the U.S. Transportation Department reported that not all investigations were being completely in a timely fashion. At that time, the Transportation Department reported that 40% of those cases investigated missed the deadline by an average of six months. More recently, however, NHTSA’s investigations into possible defects and safety issues have been taking much longer than the agency’s own 12 months guideline. According to Claybrook, a safety investigation into 2002-2005 Ford Explorers and Mercury Mountaineers took 42 months–well over the agency guidelines of 12 months.

Perhaps even more concerning, is the fact that information about the investigations is only available to the public and news media through a Freedom of Information Act request. Even then, carmakers can still request the information they submit to the NHTSA be kept confidential. This means that car buyers may not learn the vehicles they own or are thinking about buying have raised safety concerns at NHTSA and among auto manufacturers.

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Easter can be a time for fun, great food, candy, little toys, and Easter egg hunts. However, certain safety issues arise each Easter. Specifically, from a food safety standpoint, Easter can be the single most dangerous holiday. To help ensure a safe Easter for all Texans this year, follow the safety tips provided below.

Candy & Toy Safety

Easter baskets are a big part of Easter. However, certain gifts inside these baskets may create safety hazards. To prevent choking, the University of Texas at San Antonio Police Department recommends refraining from putting the following candy and food in Easter baskets: (1) hard, round candy; (2) thick and/or sticky candy; (3) candy with nuts; (4) caramel; (5) sour candy; and (6) jaw breakers. Since children’s airways are higher and narrower than an adult’s, these candies can create a choking hazard.

Along those same lines, make sure that all Easter toys and dolls are free of choking hazards before placing them inside any Easter basket. In addition, as the fake grass often used in Easter baskets is not easily digestible, it is important to keep it away from young children. Finally, some children have nut allergies that are very serious, so be sure to check with parents before offering chocolate bunnies or other candies that may contain nuts. To protect those children with peanut allergies, be careful to read the label of contents of any chocolate included in the baskets. Even though many packages read “pure chocolate,” the chocolate may have been in contact with nuts or peanuts during their preparation or packaging.

Egg Safety

Many Easter celebrations involve Easter egg hunts. Although eggs are nutritious and a big part of this holiday celebration, it is important to remember that unbroken, clean, fresh shell eggs may contain Salmonella Enteritidis (SE) bacteria that can cause foodborne illness. In order to ensure that your children remain safe this Easter there are some important safe handling methods to remember when preparing, decorating, cooking or hiding Easter eggs.

First, when purchasing your eggs, always purchase from a refrigerated case. In addition, don’t buy out-of-date eggs and be sure to choose eggs with clean and uncracked shells. Eggs should be refrigerated as soon as possible after purchase. Once you bring your eggs home, they should be kept in their carton and placed in the coldest part of the refrigerator, not in the door. Raw in-shell eggs can be kept in the refrigerator a maximum of three to five weeks.

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Almost ten years after a young girl suffered a life-threatening reaction to the children’s pain reliever, Motrin, that caused her to lose most of her skin and left her legally blind, Johnson & Johnson was ordered to pay $63 million to the girl and her parents.

In 2003, when the then-7-year-old girl from Plymouth, Massachusetts, had a fever, her parents gave her Children’s Motrin. The girl had previously taken Motrin without suffering any side effects. However, this time, instead of her condition improving, she got worse, and ended up in the hospital for months. More specifically, the disease inflamed the girl’s throat, mouth, eyes, esophagus, intestinal tract, respiratory system, and reproductive system, forcing physicians to put her in a coma. Unbeknownst to her parents, ibuprofen, a common painkiller found in Motrin, can cause a rare, and potentially fatal, skin disease known as toxic epidermal necrolysis or “TEN” that eats away at your skin.

The young girl was not only forced to undergo surgery to drill through her skull to relieve some pressure, but she also lost 90% of her skin and is now legally blind. In addition, the girl suffered severe permanent lung and liver damage, and now has only 20% lung capacity. Although she also suffered brain damage, it caused only short-term memory loss.

Following this grueling experience, in 2007, the girl’s parents sued Johnson & Johnson, the maker of Motrin, and its subsidiary, McNeil PPC, Inc., for failing to provide proper warning of the possible side effects. The key issue in the lawsuit was the warning label Johnson & Johnson used for Children’s Motrin, made by McNeil-PPC, Inc. Notably, even though the prescription version of adult Motrin briefly mentions Stevens-Johnson Syndrome, a more common version of TEN, the over-the-counter children’s version of Motrin that was provided to the young girl, contained no such warning at all.

A manufacturer can be sued under one of three theories for injuries caused by a product or drug, including: (1) defective design, (2) defective manufacturing, or (3) defective warning and labeling. Here, the family sued the health care company under the third theory, alleging that the company failed to meet its labeling requirement. When dealing with warning labels, courts can find a product defective because of an inaccurate or inadequate warning label. Importantly, by law, the manufacturer is required to warn consumers of hidden dangers, and instruct users how to use a product in a way that will avoid the dangers.

In this case, the jury agreed that Johnson & Johnson failed to provide adequate warnings about ibuprofen’s potential side effects and awarded the girl, now 16, $50 million, and awarded an additional $6.5 million to each of her parents. With interest, the award totals $109 million.

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One key product liability issue to watch for in 2013 is reportedly the continued adoption of the learned intermediary doctrine by states. In June 2012, Texas joined 35 other states in holding that a sufficient warning to a treating doctor (the “learned intermediary”) satisfies a manufacturer’s duty to warn in product liability cases involving medicine and medical devices. Adoption of this rule essentially means that pharmaceutical manufacturers are not responsible for conveying drug risks to patients, even when the drug makers advertise their products directly to consumers.

With the Texas Supreme Court’s decision in Centocor, Inc. v. Hamilton, Texas became the largest remaining state where the Supreme Court had not adopted the learned intermediary rule, which requires warnings only to prescribing physicians–not to any health care provider with which the plaintiff may happen to come into contact. Unfortunately for future victims of negligent misbranding, negligent marketing, and fraud in drug/medical device product liability cases, the court all but did away with the direct-to-consumer exception to the rule, making it more difficult for plaintiffs to successfully bring suit against drug manufacturers.

In Centocor, Inc. v. Hamilton, the product at issue was Remicade, a prescription drug manufactured by Centocor, Inc. Patricia Hamilton suffered from Crohn’s disease and sought treatment from her physician, who informed her that her only treatment options were steroids or Remicade intravenous infusions. After her physician informed her of the risks and benefits of each approach, Patricia opted for the Remicade infusions. Following the treatment, Patricia claimed that the Remicade infusions caused her to suffer a serious drug-induced side effect called lupus-like syndrome.

Patricia and Thomas Hamilton brought suit, contending that the informational video shown to Hamilton by her physician in the course of her prescribed treatments provided “inadequate and inappropriate warnings and instruction for use” of its prescription drug Remicade, which made Remicade “defective and unreasonably dangerous.” More specifically, the couple alleged that Centocor’s video over-emphasized the benefits of Remicade and intentionally omitted warnings about the potential side effect of lupus-like syndrome. They argued that the video bypassed the physician-patient relationship and required Centocor to warn Patricia directly of Remicade’s potential risks and side effects, thereby making Centocor liable for Patricia’s injuries.

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The Toyota Motor Company has agreed to settle one of its “sudden accelerator” product liability cases in Utah that killed two people and injured two other family members. The case was set to go to trial in February. Details of the terms of the settlement were not disclosed.

In December, Toyota agreed to settle hundreds of claims in a class action for individuals who declared that they suffered economic losses due to a recall of millions of its cars because of sudden acceleration issues. That settlement was reported to be for more than $1 billion.

However, hundreds of other plaintiffs who are suing for serious personal injuries and wrongful death were not included in that massive deal. Those cases are pending and the Utah case was one of the bellwether cases set to go to trial first. Typically, bellwether cases are large cases based on the same theories of recovery, which judges and lawyers use as guidelines for evaluating cases that follow.

The Utah settlement was reached for an accident that involved Paul Van Alfen, his wife, son and his son’s fiancee, Charlene Jones Lloyd. Their accident occurred on November 5, 2010, on I-80 close to Wendover, Utah. As they were traveling on the interstate, their Toyota Camry suddenly accelerated, went through a stop sign at the bottom of an exit ramp and struck a wall. Skids evidenced Van Alfen’s attempt to stop the vehicle as it left I-80.

The accident resulted in two fatalities, Van Alfen and Lloyd. Van Alfen’s wife and son received injuries.

An investigation conducted by the Utah Highway Patrol revealed that the collision occurred because the accelerator was stuck, causing the Camry to suddenly accelerate.

Other settlements have recently been reported, including one involving a retired Los Angeles police officer and another involving a California Highway Patrol officer. In the latter case, the patrol officer and his entire family were killed near San Diego in 2009 when their Lexus suddenly accelerated, hit speeds of over 120 miles per hour, flipped and burst into flames. Investigation revealed that the accelerator had been mashed down by an improperly sized floor mat.

Toyota issued a statement that the recent settlements should not be an indication of what’s to come for other pending lawsuits. In other words, Toyota is going to pick and choose the weaker cases that they take to trial and settle the larger, stronger headline cases.

The company continues to stand behind the safety and integrity of their cars, while blaming these tragic accidents on driver error, faulty floor mats and faulty accelerator pedals.

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