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Articles Posted in Product Liability

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Earlier this month, the Food and Drug Administration (FDA) issued a warning regarding

FDA Warnings

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two breast implant manufacturers for their failure to comply with specific regulatory requirements. According to the official FDA press release, the FDA sent warning letters to Allergan and Ideal Implant Incorporated.

The Warning Letters

Under United States regulations, the manufacturers of silicone breast implants must conduct studies to ensure the continued safety of their products, even after the product has obtained FDA approval. According to the FDA, these post-approval studies are designed to “further evaluate the safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.”

Notably, the FDA requires this follow-up testing even if the manufacturer voluntarily recalls a product. These post-approval studies are crucial to evaluate the continued safety of recalled breast implants for those who already have had the devices implanted.

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In 2015, the International Agency for Research on Cancer, a division of the World Health Organization, classified glyphosate, the active ingredient in Roundup, as a possible carcinogen. While this is not the first product that presents a risk of cancer to users, the Roundup cases are unique because so many people have been exposed to the product. Since the discovery that Roundup may cause cancer, there have been thousands of product liability lawsuits filed against Bayer, the German manufacturing giant. Bayer purchased Monsanto, the company that initially created and marketed Roundup, in 2018.

Roundup

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These product liability claims seek to hold the company accountable for tragic effects caused by its herbicide, which the company did not disclose to consumers. Over the past few years, several of these cases went to trial, resulting in multi-million-dollar verdicts, totaling over $2 billion to date.

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Earlier this year, the manufacture of the popular herbicide, Roundup, was found to be liable in a series of product liability lawsuits and ordered to pay a total of $2 billion in punitive damages. In addition to these cases, there are approximately 13,400 others who are waiting for their case to be heard, all of whom claim that glyphosate, the chemical found in Roundup, is responsible for their cancer diagnoses.

Roundup in cereal

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Over the years, Roundup has been used to treat crops across the United States. It is also used as a desiccant, or a drying agent, that is sprayed onto crops – especially oats – just before they are harvested. Farmers use glyphosate to kill the crop so that it dries out faster, allowing manufacturers to process the oats more quickly. As a result, it has been suggested that high levels of glyphosate can be found in certain oat products. Thus, the dangerousness of Roundup may not only affect adults who used the product, but also anyone who consumes food containing glyphosate.

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The truth is that manufacturers are most interested in making a profit. Some manufacturers place dangerous products into the stream of commerce, putting millions of lives at risk. Often, there is something more that could be done to create a safer product; however, manufacturers may need encouragement to make their products safer. This encouragement frequently comes from a manufacturer’s fear of legal liability associated with a lawsuit, such as an Illinois product liability claim.

e-cigarette

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Take cigarettes, for example. For decades, there has been widespread agreement that smoking is hazardous to health. Indeed, tobacco companies are still facing lawsuits brought on behalf of those who have died due to complications caused by smoking. However, over the years, society has become more informed about the dangers of tobacco, and more recently the trend has shifted away from smoking traditional tobacco cigarettes and toward “vaping.”

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medical questionnaire

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Over the past decade, manufacturers of electronic cigarettes, or e-cigarettes, have marketed their product as a safe alternative to smoking. Indeed, their efforts have been largely successful, with an estimated 2 million adults and teens reporting they have used an e-cigarette within the past three days.

That being said, the federal Food and Drug Administration has not approved the use of e-cigarettes as a stop-smoking aid. The U.S. Preventative Services Task Force agrees, noting that there is insufficient evidence supporting the use of e-cigarettes for those who want to quit smoking. Part of the reason why e-cigarette use has not been approved is the lack of longitudinal studies following the health of those who use them on a routine basis.

In recent news, according to a study released by researchers out of New York University and published in Proceedings of the National Academy of Sciences, e-cigarettes may still pose a potential risk of lung cancer, bladder cancer and heart disease. Depending on the results of further research, users of e-cigarettes who develop lung cancer, bladder cancer or heart disease may be eligible for compensation through a product liability lawsuit against the manufacturers of these products.

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Earlier this month, a Missouri jury returned a verdict assessing $110 million in damages against household product maker Johnson & Johnson in a lawsuit regarding its talcum powder products. This litigation marked the fifth trial that the company has faced regarding whether or not these products lead to the development of ovarian cancer. The plaintiff in this lawsuit, a woman from Virginia, alleged that she used the company’s talc-based products for over four decades and developed ovarian cancer as a result. The plaintiff was required to undergo chemotherapy after she was diagnosed with cancer, which later spread to her liver. In her complaint, the plaintiff specifically identified Johnson & Johnson’s Shower Powder and Baby Powder products.

The talcum powder that Johnson & Johnson uses for its talc-based products is sourced from a company called Imerys Talc America. This company is owned by another company based in Paris.

Currently, there are over 2,000 lawsuits containing similar allegations pending against Johnson & Johnson. One of the primary causes of action asserted in the complaints is that Johnson & Johnson failed to provide adequate warnings regarding the potential risk of developing certain cancers from the use of its talc-based products, despite evidence available at the time the product was marketed suggesting a linkage. These lawsuits are mostly still pending in St. Louis, Missouri.

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Advancements in technology have made vast improvements in travel and transportation. Some of the biggest technological changes to how we get around are smartphones and other digital computer platforms. Nowadays, it is not uncommon for vehicles to be equipped with their own computer systems in the dashboard, which offer motorists a variety of assistance and luxury features. Now, developers are finding ways to put these technological advancements to use for driver safety.

A recent study from the National Highway Traffic Safety Agency (NHTSA) has identified some important questions regarding how smartphones and vehicles could interface in the future. The report could spur some smartphone makers to include vehicle safety technologies in their infotainment system applications. This feature would then lock out or prevent the driver from accessing certain features while he or she is operating the vehicle.

The NHTSA released another study in 2016 that discussed a safety proposal for smartphone manufacturers. It suggests that the smartphone operating systems be equipped with a Driver Mode that will prevent the driver from accessing certain features on the phone while in transit. Some of the features that would be off-limits during travel would be social media, video, web surfing, and manual text entry. The proposal also considered taking Driver Mode one step further and having it automatically activate if the driver has not engaged it prior to operating the vehicle or if the driver has not paired it with his or her vehicle.

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Breast implants are one of the most popular elective surgeries throughout the world. Although breast implants have been around for several decades, the U.S. Food and Drug Administration has recently identified a possible linkage between these medical devices and anaplastic large cell lymphoma (ALCL). This condition is categorized as an uncommon type of non-Hodgkin’s lymphoma. The FDA first identified the potential connection in 2011.

Now, in 2017, the FDA has indicated that it has collected additional evidence regarding this linkage. When it first started its investigation six years ago, the FDA was only able to identify a few cases involving the development of the disease in relationship to breast implants. This made it more difficult to identify the factors that would contribute to the disease’s onset. The agency prepared a report detailing its understanding of the potential linkage and calling for the assessment of additional information and identification of additional cases.

In partnership with the World Health Organization, the FDA has now obtained additional information and data regarding the potential link between ALCL and breast implants. The World Health Organization is an international agency dedicated to improving human health throughout the world, particularly when it comes to combating diseases. The FDA’s latest announcement describes ALCL as a rare T-cell lymphoma that may develop after an individual receives breast implants.

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Major retailer Target has announced a recall of over half a million toy eggs designed to absorb water after concerns that the toys could create a blockage in a child’s stomach if they are ingested. The toys were designed and packaged for Easter.

Since the toys are designed to absorb water, if a child accidentally ingests a toy, it will swell inside the body and create an intestinal obstruction. The reports also suggested that the toy may not show up on an x-ray, making a life-threatening condition even harder to identify and treat. This could lead to serious health consequences, including severe pain, discomfort, dehydration, nausea, vomiting, and even death.

Although there appear to be no reports of injuries associated with the toy at this time, the Consumer Product Safety Commission initiated a Fast Track Recall covering some 560,000 toys. They also alerted members of the medical community and instructed parents to take adequate precautions, including not giving the toy to children and returning the product immediately.

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E-cigarettes have emerged as a popular alternative to traditional cigarettes. Created by a pharmacist in China, they offer a less toxic method for ingesting nicotine, compared to traditional cigarettes. A liquid solution containing propylene glycol, water, flavoring, and nicotine is heated, producing the vapor.

Although the companies that manufacture e-cigarettes and the many available accessories claim that they are a safe alternative to smoking, the U.S. Food and Drug Administration has yet to back that claim. In fact, the federal agency has proposed banning the sale of e-cigarettes to minors and is in the process of requiring companies that make these products to place warning labels on them. Additionally, the Centers for Disease Control have stated that there should be more regulations limiting the sale and advertising of these products to minors.

Beyond the health implications, there are concerns regarding whether the devices are safe. A recent article described one incident in which an individual was using an e-cigarette when the battery inside it exploded, causing him to suffer third-degree burns. Although the incident occurred over one year ago, the individual is still experiencing damaging effects and requires daily treatments and care.

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