Lax Regulations for Medical Devices

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Lax Regulations for Medical Devices

New Jersey Medical Product Liability Lawyers discuss lax regulations for medical devices. Medical devices come in all shapes, sizes, and functionalities, and they can be lifesavers to people with certain conditions. Often, medical devices remain inside the body to prevent a debilitating condition from developing or worsening. With regulatory processes becoming less strict, however, dangerous products are making their way into the market. When these defective medical devices fail, the consequences can be devastating.

Such was the case for a Georgia woman who nearly died due to a defective filter. The patient had an IVC filter placed in her bloodstream to prevent blood clots; years later, she discovered that the device had fractured and debris was clogging her arteries and on its way to her heart. The debris was discovered when she went to the emergency room with arm pain and lightheadedness. Most of the debris was subsequently removed via surgery. However, a piece remains in the artery leading to her lungs. She and more than 3,000 others are suing the maker of the filter, Bard.

Many Devices Exempted from Human Testing

The IVC filter did not have to undergo a clinical trial before it was released. The Food and Drug Administration (FDA) oversees regulation for new and existing medical devices. By law, the agency must make the approval process the least burdensome it can, so many products are only tested on animals or machines before being made available. For some products, this approach makes sense – things like Q-tips and bandages are considered medical devices – but for other, riskier products such as replacement joints and mesh implants, these relatively lax regulations could put patients in danger.

Most medical devices have to go through a pre-market notification phase known as the 501(k) process before being put on the market. This allows new products to bypass the clinical trial phase by demonstrating that they are substantially equivalent to other products that are already available. Essentially, new devices can be made available for use without independently establishing their effectiveness, which can result in substandard products reaching the market.

Some products do not have to go through a premarket notification phase at all. Products that are considered less risky are often exempted from the 501(k) process. As an alternative, the FDA collects data from patients using the devices to determine if there is a safety risk. Medical records may not tell the full story, however, as doctors are not required to report incidents the same way hospitals are, and manufacturers can influence the data relating to their devices. Meanwhile, dozens of patients may be injured or killed before the agency realizes there is an issue.

There are currently more than 190,000 medical devices in use in the U.S., with more being released every day. The first quarter of 2018 saw more new devices approved than any other quarter since 2005. Without thorough regulation, patients may be exposed to defective products that can result in deadly injuries.

New Jersey Medical Product Liability Lawyers at Eichen Crutchlow Zaslow, LLP Obtain Compensation for Victims of Defective Medical Devices

If you or a loved one has been harmed by a defective medical device, call the New Jersey medical product liability lawyers at Eichen Crutchlow Zaslow, LLP. Our knowledgeable, experienced lawyers will investigate who is responsible for your injury and determine whether medical malpractice was a factor. We are committed to recovering the maximum compensation for your suffering. With offices conveniently located in Edison, Red Bank, and Toms River, we serve clients throughout New Jersey. Call us today at 732-384-1331 or contact us online for a free consultation with a New Jersey medical product liability lawyer.

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Testimonials

I also WON lifelong FRIENDS!

"The list is LONG of the wonderful things that I can say about Barry, Maria (his assistant) & the rest of the folks that I had the HONOR of spending time with during my case. I brought my case to another lawyer that told me that I have no case, yet Barry was not only able to WIN, but he WON a substantial amount! Lawyers have awful reputations, but Barry defies every single one of them! Barry Eichen genuinely CARES about his clients!! NOTHING was too much to ask for – there was no such thing as too many phone calls! Without a doubt, I was in the BEST HANDS with Barry as my attorney! I not only WON my lawsuit, but I also WON lifelong FRIENDS!"

~ Client

Eichen Crutchlow Zaslow, LLP
5.0
2018-10-22T00:29:45+00:00

~ Client

"The list is LONG of the wonderful things that I can say about Barry, Maria (his assistant) & the rest of the folks that I had the HONOR of spending time with during my case. I brought my case to another lawyer that told me that I have no case, yet Barry was not only able to WIN, but he WON a substantial amount! Lawyers have awful reputations, but Barry defies every single one of them! Barry Eichen genuinely CARES about his clients!! NOTHING was too much to ask for – there was no such thing as too many phone calls! Without a doubt, I was in the BEST HANDS with Barry as my attorney! I not only WON my lawsuit, but I also WON lifelong FRIENDS!"

I have to say he is a great person.

"I had a bad accident back in June of 2015. My dad knows Barry. I have to say he is a great person. I was unsatisfied with some things that were happening with a previous lawyer and he made sure everything was fixed and I was satisfied. My lawyer Edward McElroy is great he answers emails in a timely matter even on weekends. I know they probably used to get annoyed with me calling all the time Lol. But I was just curious to what is going on with my case. Nicole, Ed’s secretary is great. She always responds back to my emails in a timely matter as well and even checks up on things with me from time to time. Barry recently became my mother and cousins Lawyer do to a bad accident they were involved in as well. I would highly recommend this firm. Thanks guys 🙂"

~ Client

Eichen Crutchlow Zaslow, LLP
5.0
2018-10-31T17:42:12+00:00

~ Client

"I had a bad accident back in June of 2015. My dad knows Barry. I have to say he is a great person. I was unsatisfied with some things that were happening with a previous lawyer and he made sure everything was fixed and I was satisfied. My lawyer Edward McElroy is great he answers emails in a timely matter even on weekends. I know they probably used to get annoyed with me calling all the time Lol. But I was just curious to what is going on with my case. Nicole, Ed’s secretary is great. She always responds back to my emails in a timely matter as well and even checks up on things with me from time to time. Barry recently became my mother and cousins Lawyer do to a bad accident they were involved in as well. I would highly recommend this firm. Thanks guys 🙂"

Mr. Zaslow is truly the best.

"The loss of my husband due to malpractice was and is devastating, Daryl took on our case and said, “Unfortunately I can’t bring your husband back but I can make sure that you will be ok financially,” and that is what he did , with compassion and dedication and always made feel like he had time for me, I never felt rushed or unimportant, I cannot say enough about how professional yet caring this office has treated me . Mr. Zaslow is truly the best at what he does and I can’t say enough about his secretary who not only kept me informed but listened to me during the most painful time of my life , all I can say is what a great team . Thank you Daryl for helping me . Thank you Heather for listening."

~ C.C.

Eichen Crutchlow Zaslow, LLP
5.0
2018-10-31T17:44:24+00:00

~ C.C.

"The loss of my husband due to malpractice was and is devastating, Daryl took on our case and said, “Unfortunately I can’t bring your husband back but I can make sure that you will be ok financially,” and that is what he did , with compassion and dedication and always made feel like he had time for me, I never felt rushed or unimportant, I cannot say enough about how professional yet caring this office has treated me . Mr. Zaslow is truly the best at what he does and I can’t say enough about his secretary who not only kept me informed but listened to me during the most painful time of my life , all I can say is what a great team . Thank you Daryl for helping me . Thank you Heather for listening."

Daryl Zaslow went to bat for him

"When, at age 44 my son suffered a massive Ischemic stroke, my greatest concern was how he would be able to live a normal life without the use of his speech and his arm. Daryl Zaslow went to bat for him and through his tireless efforts, his medical knowledge and his sincere concern for my son, Mr. Zaslow secured for my son a future not only without financial worries, but with hope and happiness. There are no words to express the thanks of our family to a great lawyer."

~ Client

Eichen Crutchlow Zaslow, LLP
5.0
2018-10-31T17:48:36+00:00

~ Client

"When, at age 44 my son suffered a massive Ischemic stroke, my greatest concern was how he would be able to live a normal life without the use of his speech and his arm. Daryl Zaslow went to bat for him and through his tireless efforts, his medical knowledge and his sincere concern for my son, Mr. Zaslow secured for my son a future not only without financial worries, but with hope and happiness. There are no words to express the thanks of our family to a great lawyer."

Very very pleased with the service and professionalism.

"Very very pleased with the service and professionalism of this law firm. I really felt that my case was very important to them and went to every length to achieve the best outcome possible. Or attorney really went to bat for me and his staff was very professional and courteous. Highly recommended. Thank you again for a great outcome !!"

~ M.M.

Eichen Crutchlow Zaslow, LLP
5.0
2018-10-31T17:51:39+00:00

~ M.M.

"Very very pleased with the service and professionalism of this law firm. I really felt that my case was very important to them and went to every length to achieve the best outcome possible. Or attorney really went to bat for me and his staff was very professional and courteous. Highly recommended. Thank you again for a great outcome !!"

This is a 5 star firm.

"Great firm took me right in and sat with me and understood my case, unlike other attorneys I had seen. This is a 5 star firm."

~ Client

Eichen Crutchlow Zaslow, LLP
5.0
2018-10-31T18:04:32+00:00

~ Client

"Great firm took me right in and sat with me and understood my case, unlike other attorneys I had seen. This is a 5 star firm."

I would highly recommend his firm.

"Mr. Eichen handled a motorcycle accident for me in 2002, as well as various other cases since that time. I have permanent injuries from that accident and he was able to resolve my case for the full policy limits and get me compensation as quickly as possible. I would highly recommend his firm."

~ Client

Eichen Crutchlow Zaslow, LLP
5.0
2018-10-31T18:07:23+00:00

~ Client

"Mr. Eichen handled a motorcycle accident for me in 2002, as well as various other cases since that time. I have permanent injuries from that accident and he was able to resolve my case for the full policy limits and get me compensation as quickly as possible. I would highly recommend his firm."
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