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The U.S. Food and Drug Administration (FDA) issued its largest recall of medical products ever in 2014, according to the Regulatory Affairs Professional Society (RAPS). The recall, posted to the FDA's website in August, was of 233 Class I products manufactured by Puerto Rico-based Customed.

The FDA classifies medical devices and products into three categories: Class I have the least potential to harm a user—Class III products are usually those that sustain life. Class I examples can include bandages, enema kits, and any medical product not necessary to keep a person's vital organs functioning. Nearly half of all medical products on the market are classified into Class I, according to the FDA.

The devices recalled by Customed were recalled because of packaging flaws. The products were primarily sterile convenience packs; the recall was initiated because of “adhesion in the sterile packaging,” according to RAPS. If the product was used on a patient, it had the potential to not be sterile and lead to infection, though as of September, no cases had been discovered of a person suffering an infection or side effects because of Customed products. The FDA generally does not wait until a case of injury has been discovered to recall medical products; once the manufacturer is aware of the problem, it is responsible to initiate a recall immediately.


In August, two U.S. senators began pressing the Food and Drug Administration (FDA) to take power morcellators off the American medical device market. According to the FDA, laparoscopic power morcellators are used to help remove tissue through small incision sites, and are most commonly used in hysterectomies or during the surgical removal of uterine fibroids (myomectomy).

The FDA clearly states that when used for either purpose, the morcellators “poses a risk of spreading unsuspected cancerous tissue” beyond the uterus and into the bloodstream. As such, the agency discourages the use of morcellators but does not outright forbid their implementation. This is what New York Senators Chuck Schumer and Kirsten Gillibrand are attempting to quell.

According to an article in Modern Heathcare, in August Senators Schumer and Gillibrand wrote a letter to the FDA requesting that the agency to remove the morcellator devices from the market. The letter, reports Modern Healthcare, cites a recent survey done at Boston's Brigham and Women's Hospital which found that women who had morcellators implemented were at a nine times higher risk of having the cancer spread than what was communicated to them at the time of surgery.


When the antidepressant drug Paxil hit the consumer market in the early 1990s, it was hailed by the medical world as a wonder drug, able to relieve even the most severe cases of mental depression. Like most other antidepressants, Paxil is a selective serotonin reuptake inhibitor (SSRI). There have been widely-publicized side effects about SSRIs for the patient who takes them. However, not as much has been published about the effects SSRIs can have on babies born to women who are taking them.

According to the U.S. Food and Drug Administration (FDA), the first such warning was in fact issued as early as 2005, when the FDA advised the medical community to discontinue the practice of prescribing Paxil to pregnant women. In 2005, however, the FDA maintained that women who were already on Paxil may face a greater risk to the fetus by discontinuing the medication than by continuing to take it.

This has changed. According to a recent article in The New York Times, the risk of taking SSRIs during pregnancy could be far worse for the fetus than the risk of being depressed. Women, reports the The New York Times, go to great lengths to give their baby the best start to life: they often quit smoking, give up drinking, and decline foods like Brie cheese and swordfish. Yet these same women often do not give up SSRIs, “despite an increasing number of studies linking prenatal exposure to birth defects, complications after birth, and even developmental delays and autism.” A recent study out of John Hopkins University found that young boys with autism were more than 30 percent more likely to have been exposed to SSRIs via their mother during prenatal development.


Finding out that you or a loved one has suffered injuries or requires additional procedures to correct problems from a defective medical device is frustrating. There are certain steps you need to take to protect yourself and to have the best chance of getting the company to recall or fix defective devices.

The Corporate Whistleblower Center believes that defective medical devices are a problem more pervasive than many people realize. Recent reports from the Justice Department show that heart defibrillators made by Guidant post a serious risk to those using them. The company manufactured Prizm 2 and Renewal 1 and 2 devices that led to a problem known as arcing. The device will detect an irregular heartbeat and administer a shock, but then the electrical pulse will arc back to the device, too. When this happens, the device actually short circuits and becomes ineffective, leaving the user at high risk.

Recent government investigations reveal that some of these companies were aware of the defects in their products long before any of those details were made public. In this case, Guidant appeared to continue selling those same products even though some changes were made to the original model.


New data shows that a company manufacturing cochlear implants distributed defective products to adults and children for many years. Unfortunately, this is just one example of defective medical devices that cause injury to people all over the world.

The second largest manufacturer of cochlear implants across the globe, Advanced Bionics, knew that there were issues with their HiRes 90K implants from the beginning. Early users of the product discovered shocks and pain and excess moisture inside the implants. Sadly, some of those early users are still feeling the impacts of defects today.

One such patient is Grace Bagadiong. Grace has an undiagnosed medical condition that has taken away her ability to use her arms, walk, or breathe on her own. As a toddler, Grace became totally deaf. Her doctors recommended a cochlear implant surgery as the only route for Grace to ever hear again. In 2005, Grace received a HiRes 90K implant, but her parents received a surprising letter just a few months later. The letter explained that Grace's implant was being recalled after numerous failures were reported, including patients who were shocked in the head by the device.

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