Products Liability

Recall delay leads to $10 million fine for Graco

March 31, 2015 | Kraft Davies Olsson PLLC

Washington residents may be interested to learn that Graco, a major manufacturer of car seats, was hit with a $10 million fine for delaying the issuance of a recall for defective child car seats, potentially placing millions of children in danger. The fine follows the conclusion of the company’s completing the largest car seat recall in U.S. history.

According to the National Highway Safety Administration, the first $3 million is due from the company immediately. The remaining $7 million must either be paid in over the next five years or the company must spend an equal amount on safety improvements. The recall involved four million child and booster seats and two million rear-facing infant carrier seats, all of which had defective safety buckles.

Reportedly, the company had delayed the recall despite numerous parent complaints about defective safety buckles on the car seats. The recall was not conducted until NHTSA pressured the company into proceeding with it. A part of what the company will be required to do is come up with a strategy to encourage the return of a greater percentage of recalled seats. Although 75 percent of recalled vehicles are subsequently repaired, the agency indicated only 40 percent of the defective car seats have been.

Guilty plea for maker of adulterated children’s Tylenol

March 17, 2015 | Kraft Davies Olsson PLLC

Children’s Tylenol maker McNeil Consumer Healthcare pleaded guilty recently to a federal criminal charge that the company knowingly sold infants’ and children’s medicine containing metal particles. The Johnson & Johnson subsidiary admitted that it was aware of the manufacturing problem for almost a year before taking corrective action. This latest Tylenol case calls to mind the drug recalls and scares of the 1980’s, which included lethal tampering with Tylenol and later copycat tampering with Excedrin in Washington.

In this case, McNeil acknowledged that particles of nickel, iron, and chromium were introduced into liquid infants’ and children’s Tylenol and children’s Motrin during manufacturing at their plant near Philadelphia. Although the particles did not cause injury, the FDA advised families to stop using adulterated medicines.

An attorney for McNeil acknowledged that although the company launched an initial investigation of the problem after a consumer reported it in 2009, it did not follow through on all of the steps required in its own internal guidelines. The plant, which was linked to other Tylenol recalls, was closed in 2010 and completely rebuilt, though it has not yet reopened. Department of Justice prosecutors faulted McNeil for not following good manufacturing practices and promised continued aggressive oversight and punishment of any companies that disregard these practices and safeguards, particularly when the health of children is at stake.

FDA currently unable to limit sale of powdered caffeine

January 6, 2015 | Kraft Davies Olsson PLLC

Washington residents may be interested in learning more about the FDA’s limited ability to reduce the amount of powdered caffeine available for sale. The FDA claims that the consumption of caffeine powder has already resulted in two deaths. According to the Federal Substance Abuse Administration, almost 21,000 individuals attend the emergency room every year due to complications caused by the effects of caffeine. Recently, there have been consumer advocates claiming that caffeine in its pure powder form could be a cause of death that goes undetected.

Even though the FDA governs the amount of caffeine available in foods, beverages and medicine, the federal agency does not have jurisdiction over the substance in powder form when it’s considered to be a supplement, according to sources. The only recourse the FDA may have would be petitioning the U.S. Justice Department to remove the product from the market, but the process could take years. The FDA has already published a blog post online urging consumers to avoid powdered caffeine when possible.

One of the caffeine deaths reported involved an 18-year-old male in Ohio. The state has already admitted more than 200 individuals into healthcare facilities due to overdoses of caffeine. Specific numbers in Washington were not reported. The FDA is reportedly considering taking regulatory action that could result in banning the product outright or simply issuing warning letters to anyone distributing the product.

Massive airbag recall under pressure

November 4, 2014 | Kraft Davies Olsson PLLC

Motorists in Washington may be interested in a letter sent by the National Highway Traffic Safety Administration to a manufacturer on Oct. 29. So far, two deaths have been attributed to defective airbags manufactured by Takata, an automotive supplier. In the letter, NHTSA officials issue orders and inquire about the company’s ability to expedite the current recall involving airbags in 7.78 million vehicles. The NHTSA has already contacted auto manufacturers and expressed interest in enlisting other suppliers to expedite the process.

The pace of the recall depends on having enough replacement parts available. There have been reports of defective airbags propelling metal and plastic shrapnel at passengers as they deploy during a collision. In the letter, the NHTSA Deputy Administrator inquires about the number of replacement canisters Takata can produce, how much the rate of production can be increased and the quality of controls in place. The NHTSA also ordered Takata to improve their testing procedures for identifying defective airbags.

The NHTSA has already requested that auto manufacturers expedite their own recall notification campaigns. The NHTSA is requesting these manufactures develop innovative strategies for getting their customers to bring their vehicles into local dealers to get the defective airbag component replaced.

Lipitor lawsuits increase

August 21, 2014 | Kraft Davies Olsson PLLC

Residents of Washington may not be aware of the large number of lawsuits that have been filed recently against pharmaceutical company Pfizer. The suits claim that the statin drug Lipitor causes type 2 diabetes; the increase likely follows an FDA warning that the drugs may cause a small increase in risk of type 2 diabetes. Pfizer has reportedly denied the accusations and maintains that it plans to fight the cases.

Lipitor, a cholesterol-reducing drug, is reportedly the biggest-selling pharmaceutical in the United States. Statins typically decrease production of cholesterol which in turn lowers the risk of heart disease. The FDA has encouraged people to continue taking the drug, insisting that the benefits outweigh the risks. Nevertheless, enough suits have been filed for a federal court to consolidate cases. The first trial is expected to take place in July 2015. Pfizer will allegedly use the outcome of this case to plan for the other claims against the company.

Reports indicate that there are nearly 1,000 suits pending against Pfizer; the company has complied with the FDA’s mandate that they add a warning label. The company did not comment on whether funds had been put aside for future litigation.

World Cup inspires heightened coverage of header hazards

July 3, 2014 | Kraft Davies Olsson PLLC

The United States has been knocked out of the World Cup. However, the national team inspired a great deal of “soccer fever” before it lost to Belgium a few days ago. Soccer is a great sport for kids, amateurs and professionals alike, partially because it is such a physically active sport and promotes both athleticism and team work.

However, there is a darker side to soccer that has only recently been discussed in the media and among sports safety experts. While soccer is played primarily with the players’ feet, many also regularly use their heads to steer flying soccer balls in various directions. According to a local CBS station, many high-level players use their heads an average of 12 times each game.

While one wouldn’t normally associate soccer with preventable brain injuries, it is becoming increasingly apparent that heading the ball regularly and repeatedly can ultimately cause players brain damage. The excitement of the World Cup has thankfully inspired a discussion about this critical player safety issue.

Why consumers should be careful when buying sunscreen

May 30, 2014 | Kraft Davies Olsson PLLC

In our last post, we discussed several ways that our readers can better ensure that they remain safe while having fun this summer. One key ingredient for a safe summer that we have yet to mention is sunscreen. Failure to liberally apply sunscreen when you are out of doors can lead to otherwise preventable burns and a heightened risk of developing skin cancer.

It is therefore important to have a bottle of sunscreen at the ready any time you venture out of doors for more than a few moments during the summer months. It is worth noting that harmful UV rays can even penetrate dense Washington cloud cover. However, not all sunscreens are created equal and not all sunscreens will properly protect you from these rays.

You may be asking, “If certain sunscreens are ineffective, why are they not recalled as defective products?” This is an excellent question. The short answer is that while the Food and Drug Administration does have regulations in place in regards to sunscreen manufacturing, these regulations are sparse and very loosely enforced.

Think about installing window guards if you have kids

April 6, 2014 | Kraft Davies Olsson PLLC

Spring is finally here. As a result, the weather is warming significantly. However, it is not yet warm enough for most people to justify turning on their air conditioning units. During this time of year, most of us open our windows when our homes become uncomfortably warm. In springtime, few simple pleasures are as nice as a cool breeze blowing through the house.

However, it is important for parents of small children to take certain precautions before opening your home windows this season. Windows are a perfect illustration of the fact that not all dangerous products are those that are subject to recall. Certainly, if a particular model of window was uniquely dangerous or defective it would be recalled. However, most windows are dangerous simply because children can fall out of them without warning.

According to the Consumer Product Safety Commission, windows are among the top five everyday home hazards currently affecting American families. Young children who are curious about the world around them approach windows and often attempt to climb out of them simply because they can.

Pradaxa documents speak to widespread scandal

March 2, 2014 | Kraft Davies Olsson PLLC

The U.S. Food and Drug Administration (FDA) works hard to ensure that prescription medications are both reasonably safe and effective before they are made accessible to patients. In addition, the FDA makes significant efforts to revise warnings and/or recall any prescription medication that proves to be a truly dangerous drug after it hits the market. However, these efforts are only beneficial when drug manufacturers and researchers are forthcoming about information they learn about these drugs over time.

According to recently unsealed legal documentation, employees of the manufacturer of a popular prescription blood thinner not only pressured the author of an internal research paper on the drug to revise the study, some employees believed that the entire study should be quashed.

This scandal points to a fundamental challenge that exists within the drug manufacturing industry. If research indicates that one’s product is dangerous, defective or otherwise harms patients, the money and effort which have been poured into the drug’s research, manufacture and marketing must either be supplemented with additional funds aimed at fixing the problem or the drug must simply be pulled.

New study indicates that FDA drug approval process is flawed

February 15, 2014 | Kraft Davies Olsson PLLC

As many of our readers know, one of the primary missions of the Food and Drug Administration (FDA) is to ensure that prescription and certain non-prescription medications are both safe and effective for public use. When these medications are potentially unsafe, the FDA does its best to educate the public about possible dangers by requiring drug manufacturers to include this information on warning labels and on advertisements.

The American public counts on the FDA’s approach. Many trust that dangerous drugs will be properly labeled as such and that defective prescription drugs will either never made it to market or will quickly be recalled. However, a study recently published in the Journal of the American Medical Association indicates that the FDA’s approval process may not be as reliable as the American public has been led to believe.

According to the study, the quality of evidence that the FDA analyzes in order to determine whether specific drugs should be approved or denied for public use varies widely. Some drugs are approved for certain indications on the basis of numerous trials, while some are approved one the basis of a single trial. In addition, these trials vary widely in terms of completion rates, duration, comparators, patient size and endpoints.