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The FDA Regulates the Marketing and Sales of Medical Devices Which Can Impact Outer Banks Residents among Others

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The Food & Drug Administration (FDA) regulates the marketing and sales of medical devices which can have an impact on the residents of the Outer Banks, North Carolina (NC) as well as all Americans. The safety and reliability of some medical devices, such as internal orthopedic hardware devices and heart pacemakers, are virtually critical to those receiving such implanted devices. Therefore, when critics claim the FDA is either improperly approving such medical devices, or lacks true manpower to provide oversight, it gets the attention of consumers and the press.

Also, state and federal courts have long struggled with complicated legal issues when a consumer suffers a serious injury or wrongful death due to a defective or failed medical device—should such suits be permitted if the FDA approved the medical device?

According to a recent NY Times article: The Supreme Court’s 2008 Riegel (Riegel v. Medtronic) decision turned on interpretation of laws and regulations governing Class III medical devices, which include products that sustain life, prevent major health problems or might pose unreasonable risks if they malfunction.

The majority of Class III devices submitted for F.D.A. consideration — hundreds each year — are variants on products like standard pacemakers that were already in the market when the main law covering devices was passed by Congress in 1976. While companies must notify the F.D.A. when introducing such products, the agency does not require extensive safety and effectiveness testing before allowing them to be sold.

But many of the industry’s most sophisticated and profitable Class III devices — implants like defibrillators, newer pacemakers that balance the heart rate in different chambers of the heart, drug-coated stents to prop open arteries, artificial hips, spinal disks, knees and stimulators that control pain — are seen as so different from pre-1976 devices that they must undergo a more thorough safety and effectiveness review.

As things stand now, lawyers expect injury lawsuits to leave design questions behind and focus on whether patients were harmed because a company did not make or handle the product according to the safety processes laid out in the documents approved by the F.D.A.

Another question may be whether injury lawsuits are barred in cases where manufacturers deceived the regulators by providing false data or withholding data on safety and effectiveness to get their marketing approval.

About the Editors: Shapiro, Cooper, Lewis & Appleton personal injury law firm (VA-NC law offices ) edits the injury law blogs Virginia Beach Injuryboard, Norfolk Injuryboard, as well as the Northeast North Carolina Injuryboard as a pro bono service to consumers. Lawyers licensed in: VA, NC, SC, WV, DC, KY, who handle car, truck, railroad, and medical negligence cases and more.