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Articles Posted in Product Liability

breast-implants-300x199After Allergan’s textured breast implants were linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), the FDA asked Allergan to voluntarily recall the implants in July 2019. BIA-ALCL is a rare form of Non-Hodgkin’s lymphoma that appears almost exclusively in women who have textured breast implants, Allergan’s Biocell implants in particular.

BIA-ALCL is typically found in the scar tissue and fluid surrounding the implants, and if left untreated, can spread to other parts of the body. The symptoms of the cancer include pain or swelling near the implant, a lump in the breast, or a hardening of the breast. So far, 481 women with Allergan textured breast implants have been diagnosed with BIA-ALCL, and 33 have died.

Since the recall, women have been consulting with their doctors about the best course forward for them, including discussing whether removing the implants and replacing them with a safer type of breast implant is the best option. Many women, with the advice of their doctor, have decided to go this route.

Treadmill-300x179Peloton is recalling its Tread+ and Tread treadmills, less than a month after fighting with the U.S. Consumer Product Safety Commission (CPSC) over the agency’s “urgent warning” about the potential dangers of the treadmills and request for a recall of the machines.  The warning urged consumers to stop using the treadmills after they were linked to the death of one child and the injuries of 29 others.

On Wednesday, the company said that it will offer full refunds for the treadmills, which cost $4,295, and will stop selling them. The recall comes with an apology from Peloton CEO, John Foley, who said that the company “made a mistake” in fighting the commission’s request for a recall.

The commission issued the warning and recall request because it had received 72 reports of children, pets, and other objects being pulled under the treadmill. Twenty-nine of those reports involved children who were injured by the treadmill, including children with broken bones, brain injuries, and cuts. One six-year-old child died from his injuries. The potential dangers of the exercise machines were highlighted in a video showing a child being pulled under a Pelton treadmill which was posted to YouTube.

Treadmill-300x179On April 17, 2021, the Consumer Product Safety Commission (CPSC) issued a warning advising consumers to stop using Peloton treadmills,  after the Peloton Tread+ allegedly left one child dead. The commission is additionally concerned because of multiple reports of victims, mostly children, being pulled under the machine and suffering serious injuries as a result.

According to an official at the CPSC, this is not an accident that happens with other treadmills. The agency is asking Peloton to recall the treadmill while CPSC continues its investigation into the death of the child.

Peloton is fighting the recall and the investigation, claiming the CPSC warning is “inaccurate and misleading”. They insist their treadmills are safe for use as long as the warnings and safety instructions are followed. They do admit, however, that it’s important for consumers to keep children, pets, and other objects clear of the treadmill at all times. This, as any parent knows, is impossible unless you keep your treadmill in a locked room, as the CPSC is recommending. Moreover, parental supervision may not even prevent an accident. In one incident a child was allegedly pulled under the treadmill while the parent was running on it.

toddler-with-toys-2-300x200Keeping children safe and protected from hazards is a top priority for parents. Unfortunately, many toys on the market pose a danger to children. As a result, every three minutes in the U.S., a child is brought to an emergency room with a toy-related injury. Regardless of the severity of the risk they pose–from minor to serious injury or even death–it is unacceptable that dangerous toys are being sold and marketed to children. Playtime should be a safe time for all children. Luckily, there is a non-profit that is solely focused on keeping children safe and educating the public about toy safety. W.A.T.C.H., World Against Toys Causing Harm Inc., releases a yearly list of the most dangerous toys. The toys included on the list this year may pose a choking hazard or cause lacerations, impact injuries, eye injuries, or other injuries, so it is best to avoid them. Below you will find the ten toys that made the list and why W.A.T.C.H. considers them unsafe:

  1. Calico Critters Nursery Friends from Epoch Co. This toy poses a choking hazard due to its small parts.
  2. Missile Launcher from Toysmith. This toy can cause eye and facial injuries.

newborn-220142_1280-1024x682Graco has issued a recall of approximately 51,000 of their infant inclined sleepers because they pose a suffocation risk. While no deaths have occurred with the Graco infant inclined sleepers, there have been a number of infant deaths linked to other, very similar products. The inclined sleepers that are being recalled by Graco have been sold as accessories to the following Graco playards:

  • Pack ‘n Play Day2Dream Playard with Bedside Sleeper
  • Pack ‘n Play Everest Playard

If you are putting your infant to sleep in an inclined sleeper, you should stop using it and find an alternative.

Fischer-Price-Rock-n-Play-Sleeeper-227x300

Photo courtesy of the Consumer Product Safety Commission

On April 12th, Fisher-Price recalled 4.7 million of their inclined Rock ‘N Play Sleepers and advised parents to stop using the product immediately. The American Academy of Pediatrics had previously urged the Consumer Product Safety Commission to recall the Fisher-Price Sleeper after a Consumer Reports investigation revealed that it was tied to 32 infant deaths.

building-2560843_1920.jpgApparently, once a medical device gets approved by the FDA to go on the market, it is almost impossible to take it back off, even if the device has proven to be dangerous or even deadly, according to Michael Carome from the public watchdog group Public Citizen. In fact, the FDA has only withdrawn a total of two products from the market, ever.

This incomprehensible situation is proving injurious and even fatal for some women. One group of these women, known as E-Sisters, are women who have been implanted with the permanent contraceptive device called Essure. In 2017 alone, the FDA received 12,000 reports of adverse effects from women with Essure, ranging from bleeding, bloating, and pelvic pain to rashes, tooth loss, joint pain, and fatigue associated with an allergic or autoimmune reaction. Madris Tomes, a former FDA analyst, tracked more than 26,000 total adverse reports about Essure, including eight deaths. In addition, there may be as many as 32,000 more complaints made to the manufacturer of Essure that were never officially reported to the FDA.

Shortly after Essure went on the market, independent research began challenging the safety and efficacy of the device. One study found that women who had Essure needed follow-up surgery ten times as often as women who had their tubes tied. And the surgery to fix the problem is not a simple one. In fact most surgeons recommend a hysterectomy as the best way to remove Essure.

Last week a jury in Philadelphia found Johnson & Johnson guilty of designing dangerous pelvic mesh and hit the company with a $20 million verdict for injuries blamed on the dangerous pelvic mesh implant. Transvaginal mesh has also been the subject of lawsuits across the country as these mesh implants have caused pain, bleeding, and significant injuries.

What is Surgical Mesh?

Surgical mesh is a medical device that is used to provide extra support when repairing weakened or damaged tissue. Most surgical mesh devices are made from synthetic materials or animal tissue.

boy-1252771_1920.jpgIs your child mesmerized by the new “fidget spinners” being sold almost everywhere as a “stress reliever”?

I must admit that I don’t understand how these gadgets actually reduce stress, but a report out of Texas warns us that the fidget spinners may also be dangerous. More specifically, they may be a choking hazard for children.

Recently, the mother of 10-year-old Britton noticed her daughter choking in the back seat of the family’s car. Mom’s quick work to help her daughter, plus the efforts of ER docs at the local hospital, identified the culprit as a bearing from the fidget spinner with which Britton had been playing. The bearing had lodged itself in young Britton’s esophagus.

A St. Louis jury just ordered Johnson & Johnson to pay $120 million to a woman who claimed her ovarian cancer had been caused by her 40+ years of the company’s talcum powder products. The most significant part of the award is the $110 million in punitive damages the jury assessed. Obviously, the jury believed the plaintiff’s claims that J&J knew of the cancer risks of its products, but continued to make and sell them anyway, without warning to users.

Many in the public will focus on this part of the award, and decry the “runaway” jury system, believing this kind of money to be a “windfall” to the plaintiff. But a punitive damages award of this size says that the jury–which by law defines what is reasonable, and reckless, behavior in society–was mad at J&J, and wanted to tell the company, and other companies like it, that you cannot treat people this way. You cannot know that your products create serious health risks for your customers, but keep them in the dark about it. And so the jury sent its message in the only terms that J&J and companies like it understand: money. A lot of money.

Will J&J now think twice before it puts a dangerous product on the market? If so, then the jury and its huge punitive damages award has saved lives and done its job.

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