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PA Courts to Rule on Strict Liability for Medical Devices

The U.S. Court of Appeals for the Third Circuit was recently asked to determine if strict liability should be extended for prescription medical devices in Pennsylvania. Strict liability holds a party legally responsible for the damages or injuries of another party, even in the absence of negligence or intent to harm. Pennsylvania is not the » Read More

Insulin Pumps Recalled

The Food and Drug Administration (FDA) recently alerted consumers that Medtronic was recalling their MiniMed™ 508 insulin pump and MiniMed™ Paradigm™ Series insulin pump models. They discovered that the pumps were vulnerable to being hacked and could not be updated to correct the issue. The recalled Medtronic pumps could connect wirelessly to equipment, such as monitoring systems and » Read More

What is the Difference Between FDA-Approved and FDA-Cleared Medical Devices?

The types of products that are subject to Food and Drug Administration (FDA) approval are more extensive than one might think. In addition to prescription drugs and foods, the FDA evaluates cosmetics, vaccines, over-the-counter-drugs, infant formula, surgical implants, and medical devices. Although this testing is essential for public health and safety, the system is not » Read More

FDA Ends Program Hiding Reports on Faulty Devices

Roughly 20 years ago, the Food and Drug Administration (FDA) created a controversial program for medical device manufacturers to submit alternative summary reports regarding known risks involving their devices. This program allowed device manufacturers to hide reports from the general public; reports containing information of malfunctions and physical harm. The FDA recently announced that it » Read More

Drug-Coated Stents

When plaque builds up in an artery, it may cause the artery to narrow, which reduces blood flow. This may cause an increased risk of a heart attack. For this, a stent is used to reopen the narrowed artery, reducing the risk of a heart attack. For most people, the placement of a stent results » Read More

FDA Cautions Against Unapproved Tools for Diagnosing Head Injuries

Earlier this month, the U.S. Food and Drug Administration (FDA) warned against using unapproved devices to diagnose concussions and other types of head injuries. In a press release issued on April 10, the FDA cautioned against smartphone and tablet-based applications marketed to coaches, parents, and trainers used to assess changes in brain function. They claim » Read More

2018 Medical Device Recalls

The U.S. Food and Drug Administration (FDA) recently released its list of recalled medical products for 2018. When malfunctioning and dangerous medical products are used by consumers, permanent disabilities can occur. The complete list of recalled medical devices is posted online in the FDA’s Medical Device Recall Database. Some commonly used medical devices that were » Read More

Illnesses Due to Breast Implants

Millions of women worldwide have breast implants for cosmetic reasons and undergo this procedure for surgical reconstruction following mastectomies. Yet, the Food and Drug Administration (FDA) issued a stark new warning to two implant manufacturers as part of a larger federal review of the safety and long-term effects of medical devices. Women have alleged for » Read More

FDA Regulatory Requirement Changes

Implanted medical devices can save lives or restore mobility, but many of them have proven to have unforeseen consequences long after implantation. While medications must go through a human testing process prior to approval by the U.S. Food and Drug Administration (FDA), that is not the case with many medical devices. Currently, manufacturers going through » Read More

Hip Implant Lawsuit Agreements

Attorneys general for 46 states recently came to an agreement for a multi-million-dollar settlement from Johnson & Johnson (J&J) for deceptive advertising about the durability of hip implants. The states sued the hip implant manufacturer alleging that they knowingly made false statements in promoting the longevity of two of their widely used hip replacement systems. » Read More

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