Product Recalls

Medical Device Risks Finally Revealed By FDA

Published on: July 2, 2019 | Levin & Perconti

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FDA Releases 20 Years of “Hidden” Data Related to Medical Device Injuries and Deaths

Serious medical complications and lifelong injuries, and even death, can result from a risky or wrong medical device. But a March 8, 2019 Kaiser Health News investigative report has led to the recent Food and Drug Administration (FDA) release of two decades worth of previously hidden data containing millions of malfunctions by medical devices and allowed some manufacturers to keep potential safety issues quiet.

Some of the FDA’s public reporting of adverse device outcomes were previously filed as an “alternative summary,” and included more than 5.7 million incidents hidden from the American people. This is risk information that could have been (and now will be) helpful for device prescribing doctors, medical researchers and life-saving knowledge for consumers and patients.

Companies Behaving Badly Part 4: General Motors Refusing Takata Recall

Published on: February 14, 2019 | Levin & Perconti

On Monday, we began a week long feature on our blog about major companies and organizations that engaged in poor corporate conduct. The list of these companies and their bad deeds are courtesy of the American Association for Justice (AAJ), a group committed to preserving Americans right to a trial by jury. The list, officially titled “Worst Corporate Conduct of 2018” can be found here.

Today’s focus is on General Motors and their refusal to recall their newer model cars equipped with Takata airbags. According to the National Highway Traffic Safety Administration (NHTSA), “Roughly 37 million vehicles equipped with 50 million defective Takata air bags are under recall. Long-term exposure to high heat and humidity can cause these air bags to explode when deployed. Such explosions have caused injuries and deaths.” NHTSA also says that an additional 15-20 million airbags will be recalled by December of this year.

To date, at least 24 people have died from defective Takata airbags and nearly 300 have been injured.

FDA to Finally Examine Safety of Cosmetics and Beauty Products

Published on: August 14, 2018 | Levin & Perconti

For the first time in history, the Food and Drug Administration is set to conduct a survey examining safety and production practices of cosmetics and beauty products. On July 2, the FDA officially announced its intention to investigate the beauty industry and gave 60 days (by 8/31/18) for the public to comment.

Beauty Industry is Largely Unregulated

Most people are surprised to learn that the FDA has very little regulatory authority over the $100 billion cosmetics industry. Cosmetics, including shampoos, lotions, deodorants, nail polish, and other personal care products, do not require FDA approval before being sold to the public, nor does the FDA have the ability to force a company to recall a product.

Stroller Maker Britax Sued by Consumer Product Safety Commission for Failure to Recall Dangerous B.O.B. Strollers

Published on: March 2, 2018 | Levin & Perconti

Popular stroller maker Britax was sued on February 16th by the Consumer Product Safety Commission (CPSC) for failure to issue a recall of models of their B.O.B. jogging strollers that have been reported to cause injuries to both adults and children. According to claims by owners, the front wheel of the 3 wheel strollers is unable to be properly secured to the frame, causing the wheel to become lodged in the ground and the stroller to tip over. The CPSC complaint cites 200 consumer complaints involving a B.O.B. stroller’s front wheel since January 2012, resulting in injuries to at least 50 children and 47 adults.

According to the consumer complaints, B.O.B. jogging strollers have caused the injuries described below.

Infant/Child Injuries

Ford Explorers Sickening Drivers and Passengers with Carbon Monoxide

Published on: August 31, 2017 | Levin & Perconti

Those who ride in a Ford Explorer as a passenger or a driver are putting themselves at risk for carbon monoxide poisoning. Despite nearly 2,100 complaints to Ford and another 791 to the National Highway Transportation Safety Administration (NHTSA), Ford has yet to issue a recall of 1.33 million 2011-2017 Ford Explorer sport utility vehicles.

“Please help us. I have three kids and no other vehicle”

The Ford Explorer Interceptor is the most widely used police vehicle in this country, causing concern over the potential consequences police officers may suffer while operating the car. Among the complaints are a strong smell similar to burning hair that causes nausea, vomiting, headaches, light headedness, and even fainting. In July, a Massachusetts police office became disoriented and rear ended another car. He and the interior of his Ford Explorer Interceptor both tested positive for carbon monoxide. In an attempt to smooth over issues with police departments and taxpayers, Ford has sent investigators out to examine Explorer Interceptors and fix them at no cost to police departments. According to the engineer of the Explorer, post-production changes to the vehicle that involve drilling holes and other entryways for lights, sirens and electronic equipment are allowing carbon monoxide to leak into the car’s interior. Following that theory, the engineer says that civilians don’t have any reason to worry.

Samsung & Others Guilty of Hiding Binding Arbitration Clauses in Terms & Conditions

Published on: March 1, 2017 | Levin & Perconti

Late last year, stories began flooding the news about Samsung’s Galaxy Note7 phone, a device that bears more resemblance to a small tablet than a smartphone. Released just last August, by October so many complaints of spontaneously exploding phones had been thrown at the company that they decided to stop all sales of the Galaxy Note7 until they could determine the cause of the fires. In the same press release, Samsung implored all users to immediately turn off their phone and send back for either a refund or for an entirely different model. What many Galaxy Note7 users likely didn’t notice was that buried at the bottom of the phone’s box was a small 16 page booklet containing a paragraph stating that users could not sue Samsung. Instead, they were agreeing to binding arbitration as a means to settle any claim of injury or death arising from use of their product.

Teen Among Many Injured By Galaxy Note7

In Illinois, Michael Taylor, 19, went to sleep with his Samsung Galaxy Note7 on the charger next to his bedside. He woke up hours later to excruciating pain in his leg and to his smartphone on fire. The phone had exploded while charging, causing severe burns to the teen’s leg. When he consulted with an attorney in an attempt to sue Samsung for his injuries, it was discovered that hidden deep in a booklet seldom read by users, Taylor had unknowingly agreed to arbitration. Without knowing it, Taylor had waived his right to a jury trial, agreed to use an arbitrator chosen by Samsung to settle his dispute, and to pay Samsung’s legal fees if the arbitrator determined Samsung was not at fault. While that same part of the booklet also states that consumers can opt out within 30 days of purchase, it is hardly likely that most consumers would read a 16 page booklet of terms and conditions. Users assume that the products they purchase are safe and that they are protected by law should an injury occur from its use. Instead of taking true ownership for the burns suffered by Mr. Taylor, Samsung hid behind the agreement they placed in the product packaging, stating that he agreed to abide by their arbitration process to settle any grievances.

FDA Recalls Saline Syringes Manufactured by Nurse Assist Inc.

Published on: February 2, 2017 | Levin & Perconti

In January, the Food & Drug Administration (FDA) issued a Class I Recall for Normal Saline Flush syringes made by Nurse Assist Inc. The syringes have shown a direct link to an antibiotic-resistant bacterial infection known as Burkholderia Cepacia (B. Cepacia). According to the Centers for Disease Control, B. Cepacia is not threatening when otherwise healthy patients are infected. For those patients with compromised immune systems, the infection can develop into a severe respiratory illness, making it particularly dangerous for those who have lung diseases such as cystic fibrosis. The infection arises from soil and water exposed to B. Cepacia and spreads through person-to-person contact, making it hard to contain in healthcare environments such as hospitals and nursing homes.

Saline flush syringes are used after medication is delivered through an IV in order to keep the entry point sterile and prevent infection. The introduction of an infection such as B. Cepacia can have serious consequences.

Recall Specifics

Greatbatch Medical Hip Joint Replacement Recall

Published on: January 18, 2017 | Levin & Perconti

The Food & Drug Administration has recently issued a Class I recall for Standard Offset Cup Impactors with POM-C Handle, a device used during hip replacement surgeries and manufactured by Greatbatch Medical. These devices, used in hip replacement operations in the United States between July 30, 2004 and December 22, 2015, were found to have non-sterile parts, which can lead to serious infection and even death. Greatbatch reported to the FDA that there were nearly 3,000 patients who had a hip replacement using one of their cup impactor devices. To view the model numbers that are listed under the FDA’s recall notice, please click here.

How to Know If You Have a Case

As anyone who has experienced a major surgery knows, you hope for the best possible outcome and to wake up better off than when you entered the operating room. If a medical product or device fails to meet basic safety standards in a surgical environment, the impact can be life threatening.

Ikea to Pay $50 Million for Deaths Caused by Unsafe Furniture

Published on: January 7, 2017 | Levin & Perconti

Ikea, the Swedish home retail giant, has agreed to pay $50 million to 3 families whose children were killed after being crushed by toppled dressers. To these families, money will never be able to replace what they have lost, but the settlement is expected to send a strong message to legislators and furniture manufacturers that parents are demanding better quality, safer furniture.

An Unsettling Statistic

According to the United States Consumer Product Safety Commission, a child dies once every 2 weeks from falling furniture or televisions. While there is no federal law requiring specific safety measures be followed in furniture production, there are voluntary national safety standards that manufacturers should follow. According to the lawsuit filed by the victims’ families, Ikea consistently refused to meet those standards and their negligence directly resulted in the death of 3 children, each 2 years old.

Listeria Outbreak Prompts Recall of Blue Bell Creameries Ice Cream

Published on: April 28, 2015 | Levin & Perconti

Now that the weather is getting warmer and spring is hitting Chicago, it’s about that time of year for a warm-weather favorite treat: ice cream. Soon lines will start forming on hot summer nights at neighborhood ice joint favorites. Ice cream trucks will start driving through town with their catchy jingles to alert you of their delicious treats for sale. Unfortunately a recent recall draws attention to potential food poisoning risks associated with one popular store bought ice cream brand.

According to a recent article by the New York Post. Blue Bell Creameries has issued an all-product recall for potential listeria contamination. They issued this recall after two samples of chocolate chip cookie dough ice cream tested positive for listeria, which is a potentially deadly bacteria. The recall includes ice cream, frozen yogurt, sherbet, and frozen snacks. The recall affects 23 states and international locations, including Illinois. The illness was eventually tracked to two different company locations in two different states.

The article elaborates about a rather unsettling fact: the company cannot even say how the bacteria was introduced into the facilities. This begs the question about quality of the safety regulations and oversight within the company and its production area. The most recent contamination was discovered only after a testing program was initiated by the company after the first recall. It is interesting to ponder why this testing was not already in place. Last month the U.S. Centers for Disease Control and Prevention linked the contaminated ice cream to three deaths and five illnesses occurring in more than one state. This is a serious and widespread case of foodborne illness. However, this is the first recall in the company’s 108 years of operation. Blue Bell is now implementing a new process to test all of its products before releasing them to the market. However, under product liability law, it is already the legal duty of companies and manufacturers to inspect their products to discover dangers.
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