Dangerous or Defective Products

Published on: July 17, 2013

Mutual Pharmaceutical Co. Inc. v. Bartlett. -U.S. Supreme Court Decision Shields Generic Drug Manufacturers from Liability in Product Defect Cases

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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Published on: April 25, 2013

As the Number of Emergency Visits Involving Energy Drinks Rises, Individuals and Groups Push the FDA for Increased Regulation

By Carabin Shaw

In March 2013, a group of doctors and researchers sent a letter to the Food and Drug Administration (“FDA”) urging it to take action to protect teens and children from the health risks associated with energy drink consumption. The letter specifically states that there is scientific evidence that the high level of caffeine in energy drinks–about 80 to more than 500 milligrams of caffeine, compared with amount 100 mg in a 5-ounce cup of coffee or 50 mg in a 12-ounce soda–have adverse health and safety consequences.

Indeed, in the eight years since energy drinks such as Monster, Red Bull, Rockstar, and 5-Hour Energy have been on the market, the FDA has reported six deaths and eighteen hospitalizations associated with the energy drink Monster alone. In addition, according to the FDA, 5-Hour Energy drinks have been cited in 13 deaths in the last four years. Moreover, federal data shows that the number of emergency department visits involving energy drinks doubled from 10,068 visits in 2007 to 20,783 visits in 2011.

According to the Drug Abuse Warning Network (DAWN), a public health surveillance system that monitors drug-related emergency department visits in the U.S., the majority of energy drink-related emergency department visits involved either adverse reactions or misuse or abuse of drugs. Although males make up two-thirds of the energy drink-related emergency room visits since 2007, emergency room visits doubled for both sexes from 2007 to 2011. Finally, of the 20,783 emergency room visits in 2011, 58% involved only energy drinks, while the remaining 42% involved other drugs as well.

Typical problems linked to excessive caffeine consumption can include anxiety, headaches, irregular heartbeats and heart attacks. Other possible side effects include:

Caffeine toxicity
High blood pressure
Withdrawal
Dehydration
Irritability
Insomnia
Death

Notably, effects of the energy drink are even more heightened in individuals that suffer from certain pre-existing or undiagnosed conditions, including heart problems, epilepsy, seizures, mood or behavioral disorders. Individuals who use certain medications or other supplements may also be at a higher risk of health complications.

Recent Lawsuits
These deaths and hospitalizations have led to an array of lawsuits against energy drink companies. Last year, the family of a 14-year old Maryland girl sued Monster Beverage, alleging that its energy drink was responsible for the girl’s death. The teenage girl went into cardiac arrest after drinking two, 24-ounce cans of Monster in a 24-hour period. Monster Beverage denies the allegations, stating that a team of physicians they hired to review the girl’s medical records found no evidence to show caffeine was a factor in the girl’s death, concluding that she likely died of natural causes.

In addition, a class action lawsuit was also filed against Monster Beverage by its shareholders, alleging that the company knowingly marketed, advertised, and sold the drink as a safe beverage despite its toxic mix of ingredients.

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Published on: March 24, 2013

How to Stay Safe this Easter

By Carabin Shaw

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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Published on: February 11, 2013

Texas Supreme Court Rules that a Manufacturer Satisfies its Duty to Warn by Providing Sufficient Warning to a Doctor: Centocor, Inc. v. Hamilton

By Carabin Shaw

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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Published on: October 21, 2012

23 Banana Boat Spray-On Sunscreen Products Recalled Over Fire Risks in Texas, Nationwide

By Carabin Shaw

The makers of Banana Boat sunscreen recently issued a voluntary recall of approximately 500,000 bottles of continuous spray-on canisters after at least five individuals allegedly caught fire while using the products. According to reports, Banana Boat UltraMist Sport, UltraMist Ultra Defense, and UltraMist Kids SPF 30 and SPF 50 may ignite if a consumer nears an open flame or other spark before the product fully dries. In response to safety concerns, the maker of Banana Boat products, Energizer Holdings Company, reportedly removed a total of 23 products from store shelves on October 19th. Additionally, the company urged anyone who has purchased the recalled products to immediately stop using them. The current recall does not apply to Banana Boat lotions which apparently contain fewer chemicals that may ignite when exposed to an open flame.

All five of the alleged consumer burn injuries occurred within the last year. Four Americans and one Canadian were reportedly injured as a result of using Banana Boat spray-on products. Following an internal investigation, Energizer Holdings purportedly discovered the company’s spray-on sunscreen applicator was delivering more sunscreen than the industry standard. As a result, the sunscreen allegedly became more likely to ignite because it took longer to dry. Banana Boat has reportedly sold in excess of 20 million spray-on sunscreen bottles since the company introduced the UltraMist line of products in 2010. The makers of Banana Boat stated the company expects to reintroduce modified spray-on sunscreen products again in the future.

According to Dan Dillard, the Executive Director at the Burn Prevention Network, the organization received two burn reports related to spray-on sunscreen products earlier this year. One man allegedly received second and third degree burns when he ignited while standing near a barbeque grill after applying a Banana Boat spray-on product. The other involved a woman who also received second and third degree burns when she reportedly ignited after using the products while working with welding equipment. Dillard stated the organization received no reports of sunscreen-related burn injuries prior to 2012.

Anyone who was injured by a Banana Boat spray-on sunscreen product is urged to file a MedWatch report with the nation’s Food and Drug Administration. Potential lawsuits against Banana Boat and other spray-on sunscreen manufacturers are currently being evaluated throughout the nation. If you or a family member was hurt after using a dangerous or defective product, it is a good idea to contact an experienced personal injury lawyer as soon as you are able.

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Published on: September 16, 2012

Ford Recalls Two SUV Models Over Potential Fire Hazards

By Carabin Shaw

Ford Motor Company has issued a recall for nearly 6,000 Ford Edge sport utility vehicles (SUVs) due to alleged safety hazards. According to the automaker, the SUVs pose a fire risk due to potential fuel leaks. 5,499 vehicles sold in the United States and 346 sold in Canada are reportedly part of the recall. The recall was issued after the company determined a metal housing on the fuel line pulse damper in 2012 Ford Edge SUVs manufactured with a 2.0-liter EcoBoost engine may crack and cause a steady leak that could ignite.

A Ford spokesperson, Susan Krusel, stated that the company used warranty claims data in order to identify 12 fuel leak claims. She also said no injuries or fires were reported as a result of potential leaks. Owners of the affected vehicles should receive recall notices in the mail after September 24th. Ford dealerships will reportedly replace faulty parts as well as provide Edge owners with a rental vehicle during repairs.

Meanwhile, Ford has also issued a second recall of approximately 7,600 Ford Escape SUVs over reported fire risks. 2013 Escape models built with a 1.6-liter EcoBoost engine may rapidly leak engine coolant if a cup plug in the cylinder head becomes dislodged. A chemical in the coolant can potentially ignite after coming into contact with an overheated engine. Although no customers have reported engine fires, one SUV was allegedly extinguished on a dealer’s lot in Nashville, Tennessee. About 6,150 vehicles in the United States and 1,300 vehicles in Canada are affected by the recall.

The recent Ford Escape recall followed closely behind another recall of the same model. In July, approximately 11,500 2013 Ford Escapes were recalled after three vehicle fires were reported. Ford Motor Company reportedly asked owners to immediately stop driving their new vehicle due to the dangers associated with the fire risk. Also in July, the automaker recalled nearly all 2013 Escape SUVs over a carpet padding safety issue. The carpet padding reportedly made it difficult for drivers to fully press the brake.

Thousands of consumers are injured or killed by defectively manufactured products every year. If you were hurt by a manufacturer or distributor’s unsafe product, you may be eligible to receive financial compensation for your medical costs, lost wages, suffering, pain, any resulting disability, and other damages. If you were injured by a defective or dangerous product, you should speak with an experienced Texas personal injury attorney who can help you protect your interests.

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Published on: August 19, 2012

More Than One-Quarter Million SUVs Recalled in North America Over Fire Hazard

By Carabin Shaw

Automobile manufacturers Isuzu and General Motors have issued a recall for more than one-quarter million sport utility vehicles (SUVs) in North America. Approximately 258,000 model year 2006 and 2007 SUVs sold or registered in 20 states, the District of Columbia, and Canada are being recalled over a power window and door lock switch defect that can potentially cause a fire in the vehicle. The recall includes the following models: Buick Rainier, Chevrolet Trailblazer, GMC Envoy, Isuzu Ascender, and Saab 97-X. Although several automobile brands are subject to the recall, each of the vehicles at issue was manufactured by General Motors.

According to documents published on the National Highway Traffic Safety Administration‘s (NHTSA) website, salt and chemical fluids used to clear icy winter roads may corrode the power window and lock circuit board located inside of the driver’s door. The power window switch in SUVs affected by the recall that are currently registered or were sold in Connecticut, Delaware, Illinois, Indiana, Iowa, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, West Virginia, and Wisconsin will be replaced by automobile dealerships at no cost to the owner. Additionally, General Motors spokesperson Alan Adler stated the company will replace the switch free of charge for anyone living in a state that is not subject to the current recall at the request of the owner.

According to General Motors, although the company has received reports of 28 vehicle fires caused by the faulty circuit boards no physical injuries resulted. The NHTSA has also received more than one dozen SUV fire complaints. The registered owner of any vehicle that is subject to the recall will reportedly receive a letter from General Motors requesting that an appointment be scheduled in order to replace the faulty switch.

Unfortunately, thousands of consumers are hurt or killed by dangerous or defectively manufactured products each year. Many such injuries are completely preventable. If you were the victim of an injury caused by a defective or dangerous product, you may be able to file a claim against the company that manufactured or distributed it. When a manufacturer or distributor fails to ensure their product is safe for consumer use, an individual who is injured may be eligible to receive financial compensation for medical expenses, lost wages, pain, suffering, and more. If you were hurt by a dangerous or defective product, you should contact a skilled Texas personal injury lawyer to discuss your right to recovery.

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