defective medical device

Stryker Hip Recall Suit Spurs New FDA Regulations

In late September, spurred by the massive Stryker hip recall earlier this year, “the U.S. Food and Drug Administration (FDA) is launching a new system for identifying high-risk medical devices… that is says will target product problems more quickly and improve patient safety,”according to Newsday.
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New Study: Over 250,000 Patients Die from Hospital Mistakes Each Year

A new study published in the Journal of Patient Safety has concluded that the number of patients who die from medical mistakes in hospitals is significantly higher than past studies have revealed. In 1999, a report titled “To Err is Human,” which was published by the Institute of Medicine, put that number at 98,000. At the time the report was published, the medical community balked that number but in time accepted it as factual.
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Consumer Advocacy Group Wants Warranties on Medical Devices

The business of hip and knee implants is growing.  It’s not just baby boomers who need these implants, but the under 65 market is expanding as well.  Estimates are that by 2030 when 4 million replacements will be put in, half of all patients will be under 65.  Since people are getting replacements at a younger age, they will have th
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Johnson & Johnson Poised To Consider Settlement

The world’s largest provider of products in the health care field is considering the benefits of settling a huge case regarding hip implant recalls. There are approximately 11,500 lawsuits pending around the country with regard to the defective medical devices, with numerous plaintiffs alleging serious medical conditions and side effects after their hip implants were installed.
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Troubled Hip Implant Maker Faces Class I Spine Plate Recall

The U.S. Food and Drug Administration (FDA) has issued a Class I recall on the Stryker Spine OASYS Midline Occiput Plate. The device is used as an implant in spinal surgeries. The products affected were distributed between April 23, 2010 and February 12, 2013. The plate is designed to stabilize the junction between the occipital bone and vertebrae in the cervical spine.
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Legal Preemption in Medical Device Lawsuits

Having an attorney in defective medical devices cases is important, and having the right attorney can mean the difference between a successful and unsuccessful case. Medical device lawsuits are complicated and highly technical. Moreover, defendants in these cases are usually large medical device manufacturers who have high profile attorneys on retainer. Plaintiffs, thus, have to be careful in choosing an attorney. They must ensure that the attorney not only understands the complexities of medical device lawsuits, but he or she also is experienced in federal and state litigation.
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When Strips Malfunction

Nova Diabetes Care engaged in an aggressive campaign to recall blood sugar test strips because of a potential defect that causes the strips to provide incorrect readings. The devices were sold in the United States as well as in 13 other countries and Puerto Rico, and the recall applies to strips marketed under the name of Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits.
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FDA Issues Class I Recall of Drug Infusion Pumps

The US Food and Drug Administration (FDA) recently announced a Class I recall of Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL