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2018

Essure Device: FDA Safety Oversight after Discontinuation of US Sales

Essure FDA Oversight

December 20, 2018. FDA Commissioner, Scott Gottlieb, issued a statement on the new steps the FDA will take to strengthen the long-term safety oversight of Essure.  In his statement, Gottlieb said the FDA will continue to evaluate the product’s long-term safety profile even after it has been discontinued in the US market.

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Recognition & Honors for Brian S. Franciskato

Brian S Franciskato, Recognition & Honors

We are proud to say that our team is involved in the community and charitable activities, working to improve its well-being. The Nash & Franciskato Law Firm would like to recognize Brian S. Franciskato for his contributions.

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Franciskato and James Selected for Super Lawyers 2018

Super Lawyer Logo

The Nash & Franciskato Law Firm congratulates Brian S. Franciskato and Randy W. James for once again making the Super Lawyers List.

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NBC News Investigation into Biomet Hip Implants

ball and socket

November 27, 2018. An NBC News investigation focused on medical device dangers, specifically the Biomet M2a Magnum Hip Implants, came out this week asking the question, “how can a medical device deemed unsafe in another country still be sold in the US?”

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FDA to Overhaul Medical Device Review System

FDA Overhaul of 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

Biomet Magnum Lawsuit

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

RideShare 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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Holiday Accidents & Injuries

Holiday Accidents Injuries

The holidays are here. Time for holiday cheer and celebration. It’s also a time when the risks for having an accident increase. Knowing what some of the potential injuries and accidents are may help you avoid serious injury this holiday season.

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What Makes Driving at Night More Dangerous?

Night Driving

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. In fact, more than 40,000 people were killed in car crashes in 2016 (according to Injury Facts).

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The Dangers of Distracted Walking

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.

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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