Dangerous or Defective Products

Published on: June 25, 2014

Japanese Automakers Preparing to Recall Three Million Vehicles Sold in Southern States, Including Texas

It appears as though General Motors is not the only major automaker to order recalls of thousands of its automobiles. Now Japanese automakers Mazda, Honda, and Nissan have ordered recalls as well. Between the three, more than three million vehicles were slated to be recalled, due to faulty airbags supplied by Takata Corporation, a parts manufacturer.

The recalls specifically targeted vehicles that were sold in states with high absolute humidity in the southern United States, including Texas. The reason was because the front air bag inflators contained a defect that could cause them to explode. If air bags deploy with too much pressure, they can rupture, resulting in a failure to protect the vehicle occupants from injury.

The three automakers decided to order recalls after receiving information about the issue from Takata Corporation. This recall supplements one that was enacted in 2013, which affected as many as six million vehicles, including those manufactured by Mazda, Honda, and Nissan. For the current recall, Honda estimates that more than two million vehicles sold in the United States are affected. Nissan and Mazda have previously recalled 750,000 and 160,000 vehicles respectively.

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Published on: June 5, 2014

Texas Court of Appeals Affirms Ruling Against Man Injured By Falling Air Compressor

By Carabin Shaw

The Texas Court of Appeals of the First District recently affirmed a trial court’s summary judgment motion against a plaintiff injured by an air compressor box at Lowe’s.

In Carpenter v. Campbell Hausfeld Company, Dwayne Carpenter was shopping for an air compressor at a nearby Lowe’s store in 2009. He tried to load a 1.2 HP 20-Gallon 125 PSI Electric Air Compressor, manufactured by Campbell Hausfeld, into his cart when the strap surrounding the compressor box suddenly broke. The box fell on Carpenter and sent him to the floor, causing him to injure his leg, left hip, arm, and shoulder.

Afterward, Carpenter filed a strict product liability lawsuit against the air compressor’s manufacturer, claiming that the strap was designed defectively, which made the air compressor unreasonably dangerous. In turn, Campbell Hausfeld filed for summary judgment, claiming that Carpenter had provided no evidence to support his lawsuit. Campbell Hausfeld put forth the elements of strict products liability, followed by the elements of a claim premised on a design defect and the statutory requirements for proving a “safer alternative design.” The manufacturer argued that Carpenter not only did not produce evidence of a product defect, but it also failed to produce evidence of a safer alternative design. Campbell Hausfeld argued further that Carpenter failed to argue that its actions were the cause of his injuries, or provide evidence of any damages.

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Published on: May 27, 2014

GM Issues Its Seventh Recall of Vehicles in a Week, Thirtieth This Year

By Carabin Shaw

General Motors has come under the spotlight due to its recall of 13.8 million vehicles in the United States, including those sold in Texas. This has included the most recent recall of 500 new pickup trucks and SUVs due to an airbag malfunction and 2.6 million vehicles due to a faulty ignition that has led to 13 deaths.

The most recent calamity to hit GM was the faulty ignition defect. The defect led to a situation where key rings holding more than one key could cause the ignition to switch to the accessory position or the off position. That could lead to the loss of power, including power steering and breaking, as well as preventing airbags from deploying in the event of a front-impact crash.

According to the National Highway Traffic Safety Administration, GM was aware of the defect prior to 2014, but chose to do something about it only this year. The agency criticized GM for waiting so long, noting that the families and friends of those killed as a result “deserve straight answers about what happened.” In response, GM claims that it has launched a new unit that will quickly uncover any safety defects and issue recall notices for the applicable vehicles. For delaying the recall of vehicles with ignition problems, GM will pay a fine to the National Highway Traffic Safety Administration of $35 million. That is unlikely to be the last time GM issues a payout, given that many families of those killed will probably file wrongful death lawsuits. Some believe that the lawsuits against GM could force the company to pay out as much as $10 billion.

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Published on: January 7, 2014

Texas Military Veteran Sues Medical Device Company After Plate in His Leg Breaks Twice

By Carabin Shaw

A Texas military veteran recently brought a lawsuit against a medical device company after the plate in his leg broke for the second time. Sergeant Don Gustafson, a veteran of the Marine Corp and Navy Reserve, sued Zimmer, Inc. in state court in Collin County, claiming that the medical device company created an unsafe product and lied about it. Zimmer, Inc. sells devices ranging from knee to hip devices and generates earnings of $4 billion per year worldwide.

The situation began back in 2007, when Gustafson broke both bones in his lower leg in a motorcycle accident. He had a plate installed to stabilize the leg that was manufactured by Zimmer, Inc. Sometime later, the plate broke and Gustafson was forced to have a new one installed. He contacted the company to let them know what happened, and was allegedly told that there was nothing wrong with the product. Gustafson believed the company’s claims, and so he had the same type of plate installed in his leg. One year later, after suffering pain in that location, Gustafson had an X-ray, which showed that that plate was broken as well.

Gustafson claims that as a result of the plate being broken, he suffered so much damage in his lower leg, his doctors discussed amputating it prior to his third surgery. His complaint came to the attention of the federal Food and Drug Administration (FDA), which requires that companies like Zimmer, Inc. report every device failure within 30 days of it taking place. Gustafson claims that Zimmer, Inc. was not reporting every device failure. Instead, the company allegedly sometimes waited months to report a problem (like Gustafson’s), and its employees operated under the belief that they did not need to report every problem, just the ones reported to them by a physician.

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Published on: October 27, 2013

Outbreak of Salmonella Infections Across the U.S., including Texas, Linked to Foster Farms Chicken

By Carabin Shaw

According to the U.S. Centers for Disease Control and Prevention (CDC), as of October 17, 2013, a total of 338 individuals from 20 states and Puerto Rico have been infected with seven outbreak strains of Salmonella Heidelberg linked to Foster Farm’s Chicken. Forty percent of those infected have been hospitalized, with approximately 75 percent of the victims residing in California. Nine ill persons have been identified in Texas. Salmonella Heidelberg is the country’s third most common strain of Salmonella, which can result in foodborne illness if not destroyed by proper cooking and safe handling. Notably, this is not the first time in recent months that the CDC has reported an outbreak strain of Salmonella Heidelberg. In July 2013, the CDC reported that 134 individuals had been infected with the same strain also linked to Foster Farm’s chicken.

Earlier this month, officials from the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) issued a public health alert due to concerns that illness caused by Salmonella Heidelberg was associated with chicken products produced at three Foster Farm’s facilities in California. The U.S. Department of Agriculture (USDA) thereafter threatened to shut down these facilities, citing a risk to public health. While Foster Farms has not initiated a recall, the company is complying with the USDA’s requests to mitigate issues at the facilities tied to the outbreak. The investigation by the USDA-FSIS is ongoing.

How to know if you’ve been infected

The symptoms of the illness caused by Salmonella include high fever, diarrhea and abdominal cramping. While most of all persons infected with Salmonella develop diarrhea, fever, and abdominal cramps (usually within 12 to 72 hours after infection) that require little medical treatment, if any, some elderly individuals, infants, and those with impaired immune systems can suffer severe illnesses or death. The outbreak strains involved in these cases are resistant to several commonly described antibiotics, which means there may be an increased risk of hospitalization or possible treatment failure in infected individuals.

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Published on: October 14, 2013

OxyElite Pro, a Dietary Supplement Manufactured in Dallas, Texas, Linked to Liver Failure, Death

By Carabin Shaw

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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Published on: August 16, 2013

Taylor Farms de Mexico Ceases Shipments of all Salad Mixes to the U.S. in Response to Recent Cyclospora Outbreak

By Carabin Shaw

On August 12, 2013, Taylor Farms de Mexico officially informed the U.S. Food and Drug Administration (“FDA”) that it had voluntarily suspended shipment of all salad mixes, including iceberg lettuce, romaine lettuce, green leaf lettuce, red cabbage, green cabbage, and carrots from its operations in Mexico to the United States, as of August 9, 2013. Taylor Farms de Mexico will not resume shipments or production of these products from its operations in Mexico until it receives FDA approval. In the meantime, officials from the FDA and Taylor Farms will conduct an environment assessment of the Taylor Farms processing facility in Mexico to determine the probable cause of the outbreak.

Taylor Farms de Mexico is a division of the California-based produce supplier Taylor Farms whose greens go to various restaurant chains, including Olive Garden and Red Lobster. Notably, it is believed that these products have not been sold directly to consumers. According to NBC News, Taylor Farms de Mexico is responsible for shipping salad mixes tainted with parasites that have sickened hundreds of individuals in Nebraska and Iowa. At this point, the FDA and Center for Disease Control (“CDC”) are still investigating whether Taylor Farms’ bagged salad is also tied to the cyclospora outbreak that sickened more than 535 individuals nationwide in 18 states, including Texas, over the past several months. In fact, as of August 12, 2013, there were 215 cyclospora outbreak cases reported in Texas alone. Unfortunately, unlike the outbreaks in Nebraska and Iowa for which health officials have traced the source of the outbreak, authorities in Texas have failed to find a common source for the sickness thus far.

According to the FDA, cyclospora is a parasite too small to be seen without a microscope that causes an intestinal infection called cyclosporiasis. The cyclospora parasite is acquired by the ingestion of food or water contaminated with the cyclospora parasite. Since cyclospora needs days, and sometimes even weeks, after being passed in a bowel movement to become infectious for another person, it is unlikely that it will be passed to individuals that have not directly ingested the parasite. Symptoms include watery diarrhea, fatigue, loss of appetite, abdominal cramps and fever.

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Published on: July 25, 2013

Legal Update on Transvaginal Mesh Cases Nationwide

By Carabin Shaw

Transvaginal mesh devices are designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). According to the Food and Drug Administration (FDA), in 2010, of the 300,000 women who had surgery for POP, 1 in 3 used transvaginal mesh devices. At the same time, of the 260,000 women who underwent surgery for SUI in 2010, 80% involved transvaginal mesh.

Unfortunately, many women have suffered an array of injuries as a result of the use of these devices. More specifically, there are more than 3,600 cases against transvaginal mesh manufacturer CR Bard, Inc.’s Avaulta alone in the United States. Notably, Bard is not the only transvaginal mesh company being sued. Other companies named as defendants in suits nationwide include American Medical Systems, Johnson & Johnson, and Boston Scientific Corp. In total, one judge has been assigned to manage nearly 23,000 cases involving these companies, among others. In these cases, women allege that erosion of the mesh products caused intense pain, infection, organ damage, made sexual intercourse painful and caused women to have to undergo additional surgical procedures to remove the mesh products.

Many of these cases have been consolidated in the Multidistrict Litigation Court in U.S. District Court in the Southern District of West Virginia. One such of these cases is Cisson v. Bard, Inc. In Cisson, the plaintiff alleges that Bard executives ignored warnings from the company that manufactured the plastic placed in the devices that the plastic should not be permanently implanted in people. The Cisson trial, however, which began in early July 2013, was declared a mistrial after only two days of trial after a witness disobeyed the court’s order and testified about the devices’ marketing.

Meanwhile, according to Reuters, in June 2013, Endo Health Solutions, which owns American Medical Systems, Inc., agreed to pay more than $54.5 million to settle thousands of lawsuits in North America alleging its vaginal-mesh implants eroded and caused women pain. In addition, two women have received sizable verdicts after suing mesh manufacturers for their injuries. First, in July 2012, a California woman and her husband who sued C.R. Bard were awarded $5.5 million by a jury after she was forced to undergo nine revision surgeries. Next, in February 2013, a New Jersey woman won $11.1 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its vaginal mesh product. In that case, the plaintiff underwent eleven surgeries.

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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

By Carabin Shaw

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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