847-797-8000. " /> Defective medical device lawyer

121 S. Wilke Road, Suite 301, Arlington Heights, IL 60005

Home and Hospital Visits for Your Convenience

Call for a FREE Consultation

847-797-8000

Subscribe to this list via RSS Blog posts tagged in Defective medical device lawyer

The benefits and risks of mammography screening have long been debated in the scientific community. According to the National Cancer Institute, while screening may be effective in reducing the number of deaths from breast cancer through early detection of a cancerous tumor, it can, at the same time, cause harm to the woman who is participating. The most common limitations of breast cancer screening can include false-positives, overdiagnosis, false-negatives, discomfort, radiation risk, and anxiety.

Yet a new medical device approved in February by the U.S. Food and Drug Administration, may alleviate some of the risks posed by mammograms, according to the University of Rochester Medical Center (URMC). The device, which passed the FDA's most stringent premarket approval process, was developed by a URMC startup company, Koning.

The Koning Breast CT system is intended to diagnose cancer in women who have signs or symptoms of the disease, and those who have abnormal findings after a standard mammogram. As of right now, it is not intended to replace annual screenings, yet the use of the new device may help to alleviate the risks of overdiagnosis or false-positives. Because it is also the first breast imaging device that allows for a readable picture without compression of the breast tissue, the Koning Breast CT system is also a more comfortable procedure for patients undergoing treatment.

...

In mid-January the U.S. Food and Drug Administration approved a first-of-its-kind device to treat obesity, according to a FDA press release. The device, known as the Maestro Rechargeable System, realigns nerve pathways between the brain and the stomach. It's the first FDA-approved device to fight obesity since 2007, and is approved for patients who have a body mass index of 35 to 45, with at least one other obesity-related condition. One such condition would be Type 2 diabetes. The system consists of a rechargeable electrical pulse generator, leads, and electrodes that are implanted surgically into the abdomen. Safety trials consisted of 233 patients, in which 157 received the device and 76 in a control group who did not. Though there were some adverse effects observed, the FDA sponsored a survey that found that patients with severe obesity would be willing to accept the dangers for the weight loss it promised.

There are several devices to help fight obesity that have been on the market for years, including those that tie off the passageways to the stomach. Some of these devices require that the patient eat very slowly, or that he takes very small bites. Many of these devices came under fire by the FDA for safety concerns. One well-publicized event was the discontinuation of the manufacture of one of these devices for teenagers after two percent of patients who were using them experienced severe side effects. According to the National Institutes of Health, a significant number of patients surveyed in a trial of obesity-reducing devices experienced negative side effects.

Only time will tell if the recently approved device will have a similarly bad track record. If you or someone you know has experienced negative side effects or long-term health problems because of an obesity device, you may be eligible for compensation. Do not go through it alone. Contact an experienced Chicago defective medical device attorney today.

Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan. The system was first introduced as a prototype more than five years ago, but only received approval from the U.S. Food and Drug Administration (FDA) last year.

The first da Vinci Intuitive surgical robot was introduced more than a decade ago. When the company first went public, 15 years ago, it posted $10 million in annual sales, though the robot had only been used on 600 patients worldwide. The machine was thought by the medical professional community to be a great symbol of technological surgical advance, and, according to ModernHealthcare.com, “one of the most coveted status symbols of 21st-century medicine.” Yet the $2.3 million machine caused serious side effects and even injury in several patients, due to a disregard for patient safety on the part of the manufacturer and aggressive marketing tactics that often preceded patient testing.

As of 2013, according to ModernHealthcare.com, da Vinci was facing 25 product liability lawsuits. Many of the lawsuits allege that the manufacturer failed to properly train surgeons on how to use the innovative machine, and instead pushed through patents and marketing efforts before hospitals were equipped enough to handle the new technology.

...

Last year, a Supreme Court ruling came down that will affect thousands of Americans, even if they were not aware of the ruling. Building on a ruling that declared manufacturers of medical devices could, in some cases, enjoy immunity status if the device turned out to be defective, last year's case determined that no patient could challenge a manufacturer in state court if it had been approved at the federal level. According to Forbes, the ruling is a big win for medical product manufacturers and a loss for American consumers.

The ruling, which, according to Forbes, outlines that “state lawsuits claiming drugmakers failed to adequately design their medicines cannot proceed because they are pre-empted by federal law,” was based on a 2004 incident in which a New Hampshire woman was left unable to see, work, or eat without a feeding tube. The woman had taken a generic non-steroidal anti-inflammatory, but later developed Stevens-Johnson Syndrome and toxic epidermal necrolysis. A lower court ruling awarded her $21 million in damages. The manufacturer of the drug, Mutual Pharmaceutical, argued that the decision should be overturned because the FDA had already approved the drug.

Mutual pointed to a 2011 ruling which determined that generic drugs were not required to change product labeling if alerted to side effects of which they were not previously aware.

...

With cancer rates at an all-time high and cancer remaining a leading cause of death in the United States, the word biopsy has become a household term. A biopsy, according to WebMD, is the examination of a contaminated tissue that was removed from the body to determine what disease—or to what extent the disease is present—is afflicting a patient. A patient will undergo a biopsy if he or she has abnormal test results or if a medical practitioner suspects that it could identify an unidentified condition. There are several types of biopsies, according to WebMD. A surgical biopsy is one of the most common, and one of the most dangerous. In a surgical biopsy, a surgeon will either remove a part of tissue or a whole lump of tissue.

Because of the sensitive nature of biopsies, especially in cases in which a patient may already be ill or injured, equipment used in the procedure must be painstakingly considered. When biopsy medical devices are recalled, it can be a very serious issue for any patient involved. One such recall issued in 2011 just recently expired, but not before implicating thousands of patients. In 2011, DeRoyal Industries, based in Tennessee, issued a recall of their Geomed Biopsy Tray, an all-inclusive tool kit used by surgeons to perform the invasive procedure. According to the U.S. Food and Drug Administration, there were several products included in the tray that were potentially contaminated, including triad lubricating jelly, alcohol prep pads, and alcohol swabs.

According to the Committee to Reduce Infection Deaths (RID), Center for Disease Control data suggests that 1.7 million people contract infections in U.S. hospitals every year. The RID posits that number is actually seven times higher than that. Contamination from faulty medical equipment, such as the recalled biopsy tray, is one major culprit of such infection. Medical equipment that is not sterilized properly can not only transmit infection borne at the manufacturing site, but also obtained at the hospital itself.

...
Elite Lawyer Badge Illinois State Bar Association Illinois Trial Lawyers Asscociation NACBA Manta Member BBB North western suburban bar association 10 Best Personal Injury Law Firms
Back to Top