Products liability

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.

Marketing Continues Despite Talc Powder Cancer Concerns

Published on: May 3, 2019 | Levin & Perconti

product liability

Johnson & Johnson’s Talc Powder Product Marketing Still Aimed at Minority Groups Despite Cancer Claims

Decades of questioning the use and dangers of cosmetic talc powder in health and personal hygiene products finally came to light in 2006, when the World Health Organization began classifying cosmetic talc as “possibly carcinogenic.” At the head of the issue was well-known consumer product company, Johnson & Johnson along with its signature Baby Powder products. Despite tests revealing that the talc J&J uses is possibly harmful to humans and its related health risks, the company continues to focus on selling the product focusing on its longtime consumers. These groups include African-Americans, fitness enthusiasts and overweight women who use the products as a genital antiperspirant and deodorant. The inexpensive products are being explicitly marketed to improve the livelihood of a group of innocent consumers misinformed from a company undeterred by the concern about the health effects and cancer risks of talc.

Consequently, these same minority and overweight women audiences are being struck with ovarian cancer or mesothelioma and now make up a large number of the plaintiffs alleging that J&J’s Baby Powder and Shower to Shower products were the cause. And in July of 2018, J&J was ordered to pay $4.69 billion to 22 women who had claimed that asbestos in the company’s talcum powder products caused them to develop ovarian cancer and failed to warn consumers about the risks associated with its use.

Surgical Mesh Injuries To Women

Published on: April 22, 2019 | Levin & Perconti

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FDA Says Surgical Mesh Manufacturers Must Stop Selling Unsafe Devices

On April 16, 2019, The U.S. Food and Drug Administration (FDA) ordered two manufacturers of three different vaginal mesh products to immediately stop selling and distributing their products for not meeting U.S. premarket standards for high risk devices. The FDA also said there was insufficient evidence that the mesh worked better than surgery to repair pelvic organ prolapse (POP).

The three vaginal mesh devices are:

Illinois Cancer Trends Identified From Ethylene Oxide Exposure

Published on: April 22, 2019 | Levin & Perconti

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Department of Public Health Says Cancer Risk Studies Will Continue Southwest of Chicago

On March 29, 2019, the Illinois Department of Public Health (IDPH) released news that the Willowbrook Cancer Incidence Assessment study involving the area surrounding the Sterigenics facility in DuPage County found that cancers were indeed elevated. The increased cancer risk presents a public health hazard, prompting IDPH to investigate the implications associated with ethylene oxide (EtO) emissions in the Willowbrook area and recommend for further research.

According to the U.S. Environmental Protection Agency (EPA), EtO is a colorless gas commonly used to sterilize some types of medical equipment and in fact carcinogenic to humans. The Sterigenics plant was ordered in February of 2019 by the Illinois EPA to seal its containers of the chemical and stop using EtO to sterilize devices.

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.

Baby Powder, Asbestos And Cancer Risk: Johnson & Johnson in Trouble

Published on: December 21, 2018 | Levin & Perconti

talcum powder risk

New Evidence Shows Johnson & Johnson Execs Likely Knew Talc Found in Baby Powder Was Not Safe

For decades, claims of cancer-causing talc found in popular American household brand Johnson & Johnson’s Baby Powder have stayed alive through more than 11,700 plaintiffs and hundreds of personal injury reviews, successful lawsuits, and dozens of intense investigative reports. Most recently, under the close watch of a Reuters published review, thousands of court released internal and confidential documents uncover the company’s knowingly talc and asbestos risk could have been responsible for causing horrible diseases, such as ovarian cancer. Worse, it’s believed many Johnson & Johnson executives and scientists may have known about the issue since the early 1970s and chose to do nothing about it.

Within the Reuters review of these now unshielded Johnson & Johnson documents, as well as trial testimony and scientific research reviews, several conclusions were made as noted by Reuters in a December 14, 2018 NBC news special report.

Trick-or-Treating Accidents and 8 Ways to Avoid Them

Published on: October 30, 2018 | Levin & Perconti

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.

Be Seen

EPA To Test Toxins In Air In Dupage County Neighborhood

Published on: October 2, 2018 | Levin & Perconti

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.”

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.

FDA Fast Tracking Approvals for Dangerous Drugs

Published on: July 17, 2018 | Levin & Perconti

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: