FDA to Overhaul Medical Device Review System

FDA to Overhaul Medical Device Review System

“Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices.”

On Monday, November 26, 2018, the Food and Drug Administration announced that it plans to modernize its current process, the 510(k) clearance pathway, which is how a majority of the medical devices are reviewed and approved by the FDA today.

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Lawsuit Claims Biomet Misleading Patients/Surgeons with Inaccurate Information

Lawsuit Claims Biomet Misleading Patients/Surgeons with Inaccurate Information

November 23, 2018. Recent news about Biomet’s Magnum hip replacement:  three California residents filed a lawsuit against Biomet Orthopaedics claiming:

  • Biomet sold defective Magnum metal-on-metal devices to these patients
  • Biomet has posted false and misleading data on its website as a way to reassure patients and surgeons that there is nothing wrong with the device

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RideSharing Safety Tips

RideSharing Safety Tips

The holidays are a busy time. We travel for family get-togethers, we gather for office or work celebrations, we go from store to store shopping for gifts. The down side is that parking can be a hassle and it can get expensive at places like the airport or event centers like stadiums. How can you enjoy the holidays yet keep driving frustrations on the down low?

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What Makes Driving at Night More Dangerous?

What Makes Driving at Night More Dangerous?

Night time driving is a must for anyone who works second and third shifts as well as for those who are taking care of day-to-day activities or who just want to enjoy the evening with family and friends.

Unfortunately, driving gets more dangerous as the light fades. While we only do one quarter of our driving at night, 50% of traffic deaths happen at night.

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The Dangers of Distracted Walking

The Dangers of Distracted Walking

Many communities are becoming more “walkable,” adding paths and traffic-calming measures to keep pedestrians safe; however, there are still many hazards for walkers to be aware of, such as blind intersections and high traffic areas. But are you familiar with distracted walking?

We hear a lot about the hazards of distracted driving – texting, emailing, talking and doing other things that take your hands off the wheel, eyes off the road and mind off driving. Distractions also can take a pedestrian’s attention away from his or her surroundings, leading to serious injuries from a fall or stepping into traffic.

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Is Hands-Free Risk-Free?

Is Hands-Free Risk-Free?

According to the National Safety Council, at any moment 7 % of drivers are using cell phones, which means they are driving distracted.

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Closing of Biomet Metal-on-Metal Hip MDL Does Not Mean No More Litigation

Closing of Biomet Metal-on-Metal Hip MDL Does Not Mean No More Litigation

The Multi-District Litigation (MDL 2391) for the Biomet metal-on-metal hip closed September 1, 2018 to any new cases. However, this does not mean that potential Biomet Magnum and M2a clients should be turned away.

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Are These Medical Devices Safe?

Are These Medical Devices Safe?

The documentary, The Bleeding Edge, has focused some much-needed attention on the medical device industry and the process to bring these devices to market.

The film documents the following four medical devices, raising the question as to how well our system is working in regulating medical devices.

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State Farm: $250 Million Agreement to Settle Federal Lawsuit

State Farm: $250 Million Agreement to Settle Federal Lawsuit

September 4, 2018. Insurance giant, State Farm, agreed to pay $250 million to settle a federal lawsuit alleging that the company broke federal racketeering laws by secretly funneling money to help elect an Illinois high court justice [Supreme Court Chief Justice Lloyd A. Karmeier who was a candidate for the high court in 2004] to help overturn a billion-dollar judgment against the company.

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Zimmer Biomet Faces More Magnum Hip Replacement Lawsuits

Zimmer Biomet Faces More Magnum Hip Replacement Lawsuits

August 28, 2018. More lawsuits have been filed against Zimmer Biomet on behalf of patients who had to undergo a traumatic second revision surgery to remove the Biomet Magnum metal-on-metal hip implants.

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