Parker Waichman LLP

Rep. Mike Fitzpatrick Calls for Congressional Medical Device Hearing

Representative Mike Fitzpatrick, who has been calling for stricter medical device regulations, has asked the Committee on Energy and Commerce to hold a medical device hearing in order to update laws. This is not the first time Fitzpatrick has taken action in pursuit of tougher medical device regulations. He recently helped draft and introduce two […]

Representative Mike Fitzpatrick, who has been calling for stricter medical device regulations, has asked the Committee on Energy and Commerce to hold a medical device hearing in order to update laws. This is not the first time Fitzpatrick has taken action in pursuit of tougher medical device regulations. He recently helped draft and introduce two bills that aim to change how medical device injuries are reported.

Fitzpatrick introduced the Medical Device Guardians Act, a law that would require physicians to report medical devices injuries. Current regulations already require them to report adverse events with drugs, but the law only orders hospitals and manufacturers to report medical device issues. The proposed regulation would also protect doctors from civil liability, meaning that material in the reports cannot be used against them.

The Medical Device Guardians Act was launched in light of delayed safety risks surrounding power morcellators, devices used to cut up tissue into smaller pieces during laparoscopic gynecologic procedures. These tools are often used during a minimally invasive hysterectomy or myomectomy, removal of uterine fibroids. The problem is that sometimes, a presumed fibroid is actually an undetected uterine cancer that cannot be reliably detected before surgery. Using a power morcellator on cancerous tissue can spray malignant cells throughout the pelvic cavity and greatly worsen, or “upstage” the cancer.

Power morcellator risks were brought to light by husband-and-wife physicians who experienced the issue personally. At the time Dr. Amy Reed underwent a hysterectomy with a power morcellator, it was believed that the chances of a hidden uterine cancer masquerading as a fibroid were very rare. After a review of literature however, it was discovered that 1 in 350 women undergoing these procedures are at risk. The U.S. Food and Drug Administration (FDA) issued a safety alert in 2014 and placed a black box warning on morcellators.

Mike Fitzpatrick and fellow representative Louise Slaughter introduced the bill in light of these issues. They say it should not have fallen on patients to bring these problems to the public sphere.

Fitzpatrick also introduced Ariel Grace’s Law, which was prompted by Bayer’s Essure permanent birth control device. The legislation seeks to take Essure off the market and hold Bayer liable for alleged complications. Essure is composed of two metal springs inserted into the fallopian tubes to block fertilization. Women have complained of abdominal pain, menstrual irregularity, headaches, fatigue and pregnancy despite implantation.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I am very grateful to the Waichman LLP law firm for all their help throughout the process. In my case, they were very kind, especially my friend Jorge Peniche, who was very attentive to my case. I am more satisfied with the final decision in my case. Thank you very much.
Silverwolf Romano
a year ago
5 Star Reviews 150
Mindy Gallagher
a year ago
5 Star Reviews 150
My daughter was in a bad car accident and I was so overwhelmed by everything happening. Ms. Josama and Gillian made me feel at ease during that process and worked their best on my daughter's case. I would surely work with Parker Waichman again. Thanks guys.
Marjorie Rene
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038