Articles Posted in Products liability

Published on:

by

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.

Continue reading
Published on:

by

The FDA is often criticized for the amount of time it takes to test and approve a drug, a required step before a medication is able to be marketed and sold to the public. But behind the scenes, more and more pharmaceuticals are being quickly approved, bypassing the traditionally-required clinical trials that ensure a drug’s safety while providing the benefits they claim.

The Drug Approval Process

According to FDA.gov, the standard drug approval process is 3 phases:

Continue reading
Published on:

by

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

Continue reading
Published on:

by

This month, the New York Times online and print editions both ran a piece on the surprisingly unregulated medical device industry. Although now under the purview of the Food and Drug Administration, devices only became their responsibility in 1976. Bogged down with prescription drug approvals, the government organization made the decision to allow all previously marketed medical devices to continue to be sold under something called a 510(k) provision. A secondary provision called a PMA Supplement (Premarket Approval) gives companies the ability to pay a fee for an ‘FDA review’ of a new product that promises to be similar to a company’s previously marketed device. By calling it a supplement and not a new product, they are able to bypass already lax rules for medical devices. Again, no studies or testing required. It seems unbelievable that devices implanted in hips, hearts, knees, eyes, uteri, and just about every other part of the body are able to exist with such minimal supervision and regulation. Unfortunately it’s the truth.

Perhaps it is worth noting that there are devices that have indeed saved lives. Many heart attack patients are enjoying healthy lives thanks to stent placements. Millions of those who struggled to walk and move around are now freely mobile due to hip, knee, and other joint replacements. But what about those devices that haven’t lived up to their intended purpose?

Doctors and Patients Left in the Dark About Known Complications

Continue reading
Published on:

by

In late October, Senate Republicans voted to overturn a rule that would prevent banks and big financial institutions from blocking class action lawsuits. The rule, set to go into effect in 2019, would’ve forced banks and credit card companies to do away with arbitration clauses embedded in lengthy agreements between a financial institution and the consumer.

Wells Fargo Scandal: Why Class Actions Are Necessary

With last year’s Wells Fargo scandal still fresh in Americans’ minds, overturning the block on class action lawsuits is unwelcome news. Wells Fargo employees were discovered to have opened over 3.5 million fake accounts and to have enrolled consumers in their auto bill-pay program without their consent. Close to 200,000 customers also paid fines on these fake accounts.  As part of a class action settlement, Wells Fargo must pay $142,000,000 back to consumers whose names were used to open fake bank and credit card accounts.

Continue reading
Published on:

by

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.

Continue reading
Published on:

by

Last year, Johnson & Johnson made constant headlines over their talc powder, sold for over 100 years and used by millions of women to keep undergarments and their body fresh and dry. When it was revealed that Johnson & Johnson knew that their product caused cancer and engaged in a decades-long cover up, many women suffering from ovarian cancer decided to sue the company, resulting in several large verdicts.

While the Johnson and Johnson crisis has blown the lid off the lengths manufacturers will go to sell a product (even with evidence indicating danger), they are hardly the first company to engage in such deceptive practices. The American Association of Justice (AAJ) recently released a report entitled “From Accutane to Zonite: A History of Dangerous Drugs and Devices Marketed to Women,” a thorough look into the ways women have been deceived by large corporations, paying big companies with their health and even their lives. The report comes at a time when the House is peddling the Protecting Access to Care Act (also known as H.R. 1215), a bill that would give significant legal protection to companies that are sued by those injured by faulty medical devices, dangerous drugs, negligent medical care, and abuse and neglect in nursing homes.

140 Years of Deceit & Claims of Curing ‘Women’s Problems’

Continue reading
Published on:

by

The FDA just issued strongly-worded letters to 14 U.S. companies that have been marketing and selling products that claim to prevent and/or treat cancer. The 14 companies sell 65 different cancer-related products that are available for purchase on various websites, including through social media.

According to the FDA news release, the companies that received the warning letters made products such as ‘pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices).’

The letters request that each company notify the FDA of their plans to cease production and sale of the products or to seek product approval from the FDA. Failure to react appropriately will be met with legal consequences.

Continue reading
Published on:

by

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.

Continue reading
Published on:

by

As any parent knows, teething feels like a phase that might never end. The constant irritability and tears have led many parents to turn to what feels like a safe, natural solution: homeopathic teething tablets. Amazon, CVS, Target, Walgreens and most major retailers used to carry at least one brand of the tablets, which claim to give parents and babies relief from the agony of teething. The Food & Drug Administration recently carried out their own laboratory studies on the tablets and found that many had high levels of belladonna, levels far surpassing what the label described. According to the FDA’s report, belladonna is a toxic substance that affects the central nervous system with inconsistent results that puts infants and children at unnecessary risk.

FDA Not as Strict on Homeopathic Medication Regulation 

It’s important to know that the FDA does have a say over homeopathic medications. The labeling, distribution, and sale of homeopathic medications is largely up to the manufacturer, distributor, and retailer and although the FDA has the ability to step in and oversee the labeling of these products, it rarely has done so. While it is unclear why the FDA finally decided to intervene, they made a strong point by urging all parents to avoid teething tablets. So strong that the products have become relatively hard to find in recent weeks. It is unclear as to whether or not news of 10 deaths and 400 teething-tablet reactions reported to the FDA were before or after the message the Administration released in late January.

Continue reading