Articles Posted in Products liability

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halloween safety

Trick-or-Treat: The Scary Truth About Halloween Injuries

Many Halloween traditions involve pumpkins, apple cider, and even a scary hayride, but we are going to bet there will be some neighborhood trick-or-treating involved too. And for the more than 41.1 million trick-or-treaters, the majority children ages 5 to 14, who hit U.S. doorsteps in 2017 requesting a Halloween treat, many injuries followed. This year, the attorneys at Levin & Perconti, especially those with young families of their own including Mike Bonamarte, Margaret Battersby Black, Marvet Sweis Drnovsek, Colleen Mixan Mikaitis, AJ Thut, Jaime Koziol Delaney, and Pam Dimo thought it would be helpful to share a few easy ways our blog readers can protect children from injury while trick-or-treating this Halloween night.

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pollution in chicago

Willowbrook Sterigenics Investigated for Emitting Invisible Cancer-Causing Gas to Residents and Workers

The U.S. Environmental Protection Agency (EPA) is headed to the neighborhood of one of Levin & Perconti’s founding partners, John Perconti, to perform “ambient air testing” at the Willowbrook Sterigenics facility in DuPage County. Sterigenics is a global company which runs contract business for sterilization services. The Willowbrook facility, currently at the center of a toxic emissions review, sterilizes medical devices such as syringes and surgical procedure kits. The emission in question, Ethylene Oxide (EtO), is a known carcinogen and airborne substance identified as troublesome and cancer-causing for residents and workers who are ongoingly exposed. In 2007, the EPA issued standards to reduce emissions of EtO from hospital and medical device sterilizers to protect workers and community residents from damaging air pollutants.

An August 2018 public report prepared by the U.S. Department of Health and Human Services, Agency for Toxic Substances and Disease Registry (ATSDR) titled “Evaluation of Potential Health Impacts for Ethylene Oxide Emissions” showed workers and residents who live nearby Sterigenics have been exposed to elevated airborne EtO concentrations. The ATSDR further concluded that “an elevated cancer risk exists for residents and off-site workers in the Willowbrook community surrounding the Sterigenics facility,” and that “these elevated risks present a public health hazard.” ATSDR officials have put forth the recommendation that Sterigenics “take immediate action to reduce EtO emissions at this facility.”

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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.

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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:

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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

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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

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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.

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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.

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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’

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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.