Medical Products Liability Posts in March, 2014

HeartMate II Pocket Controller Responsible for Four Deaths

Sometimes the medical devices meant to keep you alive are more dangerous than the condition they are meant to alleviate. When Thoratec introduced its HeartMate II monitor with pocket control, patients across the U.S. lauded the introduction as an easier way to deal with a debilitating condition....
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Sexual Enhancement Drug Weekend Warrior Contains Harmful Ingredient

The U.S. Food and Drug Administration (FDA) regulates that drugs are on the market and enforces recalls when enough substandard performance, undeclared ingredient, or adverse side effect reports are received. According to the FDA, “recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.” There are three types of FDA recalls—Class I, II, and III. A Class I recall is the most severe, and issued when a product or device is likely to have severe adverse health effects....
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The Risk of Artificial Joints

Artificial joints fail 10 percent of the time, according to the Consumer Reports Safe Patient Project. Surgical mistakes, complications, and product defects can all make a patient’s life more difficult....
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Is Mirena Dangerous?

The FDA-approved warning label for Mirena, an intrauterine system used by thousands across the country, lists critical side effects including perforation, embedment, expulsion, ovarian cysts and breast cancer. Additionally, women who become pregnant while using Mirena could miscarry. Mirena patients have reported a wide range of minor and major side effects, leading to defective medical device lawsuits....
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Nonprofit Group Calls for Body Part Warranties

Consumers are likely familiar with warranties offered any time a purchase is made for a new appliance or electronic. But what about surgeries for replacement body parts? Although one million individuals receive hip or knee implants every year, only one manufacturer offers a warranty, and this warranty is only on a partial knee implant....
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Testosterone Therapy Linked to Heart Issues

More research has come out recently that links testosterone therapy to heart conditions. A study published in early January of this year found that men taking testosterone drugs faced a higher risk of heart attack for men over the age of 65. Men younger than 65 but with a history of heart problems also had higher risks for heart attacks, according to the study tracking 56,000 men....
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Essure Problems Being Reported to FDA

In recent months, the FDA has begun reviewing more information regarding Essure, a transcervical sterilization procedure for women. Essure is a Class III medical device that, according to the FDA, received a high level of review prior to marketing. The procedure had to be vetted through the pre-market approval process used by the FDA. This process includes reviewing data about product labeling materials and a scientific and regulatory review....
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The Dangerous Link: Antidepressants and Birth Defects

Around the world, selective serotonin reuptake inhibitors (often called SSRIs) are some of the most commonly prescribed depression medications. In the United States, one of the most popular SSRIs given to patients with depression is Zoloft, which has been linked to dangerous birth defects when taken by pregnant mothers. A new study from the British Medical Journal is the latest authority to lend credence to the risks posed by antidepressants....
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Defective Medical Devices to Be Under Inspection Scrutiny

The federal government’s Office of the Inspector General has released their 2014 work plan, and medical device scrutiny features heavily in the goals of the organization. The work plan details all of the hospital-related practices and policies, including quality of care, billing and payments, emergency preparedness, and medical device security....
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL