Medical Devices Deemed Unsafe in Other Countries Still Sold in America

By Drazin & Warshaw | November 28th, 2018

Medical Devices Deemed Unsafe in Other Countries Still Sold in America

If a product is defective and potentially dangerous to consumers, and that safety risk is recognized by authorities in a foreign country, it is hard to imagine why prompt recalls or at least warnings are not provided to consumers worldwide. Unfortunately, it appears federal regulators in the United States have not embraced this simple truth. In fact, multiple consumer products, including medical devices, are deemed unsafe by other countries, yet still sold to consumers in the United States.

International Safety Warnings Fall on Deaf Ears in the U.S.

An investigation conducted by NBC News discovered multiple medical devices that were the subject of safety warnings in other countries, yet the Food and Drug Administration (FDA), the U.S. federal agency in charge of such oversight, did not. Some examples of the types of devices discovered by NBC News that were the subject of safety warnings internationally include the following:

  •        Knee implant devices that routinely failed and required replacement;
  •        Pregnancy tests that were defective and gave consumers false positive or negative results;
  •        Dental drills that were found to potentially damage the nerves in a consumer’s mouth.

If that was not bad enough, the FDA was found to have dragged its feet for months after other countries issued warnings concerning specific consumer products. A prime example is the Essure birth control device. Essure was advertised by Bayer (a massive drug and medical device manufacturer) as a minimally invasive way for a woman to be sterilized. The device received FDA approval in 2002. Shortly thereafter, reports began trickling in that women were suffering an array of serious side effects, including:

  •        Unintended pregnancies
  •        Laceration of the uterus and/or fallopian tubes
  •        Infections
  •        Severe abdominal pain
  •        Damage to the bladder

As more and more women reported adverse reactions to the Essure device, multiple countries took swift action. For example, France launched an investigation in 2015, which was followed in short order by Italy and Singapore in 2016. By the end of 2017, Essure was removed from public markets in Brazil, the European Union, Canada, Australia, etc. Did this list include the United States? No. In fact, the Essure device has never been formally recalled in America.

Injured by a Defective Medical Device or Consumer Product? Contact an Experienced Red Bank Personal Injury Lawyer to Discuss Your Potential Case Today

If you or a family member suffered a serious injury due to a defective consumer product or medical device, now is the time to take action by contacting an experienced personal injury attorney in Red Bank, New Jersey. Do not let the medical expenses pile up while you wait to determine if you should file a lawsuit against the manufacturer of the product. Most large product manufacturers have large teams of defense lawyers who will do all they can to try and minimize or avoid liability. This is why you need an aggressive New Jersey personal injury lawyer on your side to help level the playing field. Contact the lawyers at Drazin & Warshaw today. For over 70 years the firm has enjoyed a top-notch reputation and has handled thousands of cases involving personal injury cases and has won landmark decisions in the field of product liability. The firm is proud to represent clients throughout Monmouth, Ocean, and Middlesex counties. We have offices in Red Bank, Hazlet, and Brick. We serve clients from nearby towns such as Middletown, Howell, Marlboro and Manalapan, Toms River, Lakewood and Edison, New Brunswick and throughout New Jersey. Call us today at (732) 576 8860 or email us at info@drazinandwarshaw.com to schedule a free consultation. Our main office is located at 25 Reckless Place, Red Bank, NJ 07701, and we also have conveniently located offices in Hazlet and Brick

The articles on this blog are for informative purposes only and are no substitute for legal advice or an attorney-client relationship. If you are seeking legal advice, please contact our law firm directly.

Contact Drazin & Warshaw for a Free Consultation

When you've been injured in an accident, you deserve justice. We have a winning track record, and we'll demand maximum compensation for your injuries. There are no upfront legal fees and we don't get paid unless you get paid.

When you've been injured in an accident, you deserve justice. We have a winning track record, and we'll demand maximum compensation for your injuries. There are no upfront legal fees and we don't get paid unless you get paid.

* Indicates required field

VISIT ONE OF OUR THREE CONVENIENT
OFFICE LOCATIONS