Navigation Links
Pennsylvania Law Firm Urges FDA Action On Power Morcellators
Date:7/16/2014

Philadelphia, PA (PRWEB) July 16, 2014

The law firm of Levy, Baldante, Finney, Rubenstein, Cohen & Chizmar, P.C. recognizes the deep-seated concerns shared by many in regard to laparoscopic power morcellator devices intended for use in various types of uterine surgeries, including hysterectomies and myomectomies, and on the heels of a Food and Drug Administration advisory panel meeting, it's asking the FDA to do the same. The hearings concerned a device currently being assessed for its propensity to spread uterine cancer to other portions of the body.

This past April, the FDA warned doctors against using these morcellator devices to conduct an operation, at the time requesting new labels that would delineate the potential risk to patients (FDA NEWS RELEASE, 4/17/14). Johnson & Johnson’s Ethicon unit subsequently halted the sale and distribution of the morcellators.

The FDA panel (NEJM Journal Watch, "FDA Advisers Call for Black-Box Warning or All-Out Ban on Morcellators in Fibroid Removal," 7/14/14) was intended to give the agency a clearer idea of the risks of the device and the best course of action. While the advisory panel failed to reach a consensus, there were signals from many participants that a future halt on usage might be in the offing, with the majority opinion that morcellators should be banned or at the very least limited. This insight came after a set of hearings in which doctors spoke on the matter and people affected by a surgery gone wrong shared their plight.

Levy Baldante Finney Baldante Rubenstein & Cohen is asking the FDA to follow the lead of those advisory panel members who recognized the inherent danger posed by these uterine surgery devices. They ask that the FDA ban the further sale and usage of morcellators for uterine surgery.

The New Jersey and Pennsylvania personal injury law firm’s medical device liability branch has taken an active interest in the subject and is working to assist people who have been negatively impacted by these products. Martin G. Rubenstein, the firm’s lead on Drug and Medical Device litigation, had this to say:

“Early word out of the morcellator advisory panel is encouraging,” said Mr. Rubenstein, “but in the past, I’ve seen various instances where the FDA’s final decision does not align with what concerned panel members have urged. It’s more important than ever that the FDA take a look at the facts and come to a wise decision regarding the usage of these devices.

“In order to offer the highest degree of protection to citizens, the FDA should move to put an end to the sale of morcellators and initiate an immediate recall on the items. At the very least, new usage guidelines must be put in place that prevent the products’ continued usage except in extreme cases where immediate medical intervention is necessary and a doctor has been able to rule out the presence of uterine sarcomas. In such instances, a patient must be made well aware of the potential dangers.”

“It’s my sincere hope that the FDA acts at once so that no one else has to be put at risk by these devices.”

The law firm of Levy, Baldante, Finney, Rubenstein, Cohen & Chizmar, P.C. has been fighting for the rights of injured parties since its founding in the 1960s. Recognized by such organizations as Super Lawyers, the American Association for Justice, and the Trial Lawyers Associations of both Pennsylvania and New Jersey, Levy Baldante is dedicated to assisting persons injured by medical malpractice, automobile accidents, defective products, premises liability, and other instances of personal injury. A host of personal injury resources and a free consultation are available via the firm’s Laparoscopic Power Morcellator Uterine Surgery Lawsuit webpage.

Read the full story at http://www.prweb.com/releases/2014/07/prweb12017413.htm.


'/>"/>
Source: PRWeb
Copyright©2014 Vocus, Inc.
All rights reserved

Related medicine news :

1. SeniorQuote Insurance Services Expands Coverage to Pennsylvania
2. As Risperdal Lawsuits Move Forward, Wright & Schulte LLC Learns of Bid to Keep Clinical Studies Sealed in Pennsylvania Risperdal Litigation
3. Pennsylvania Athletic Trainers’ Society (PATS) and Pennsylvania Society of Physician Assistants Meet: Discuss Issues to Improve Quality of Healthcare for Athletes
4. National Conservative Group Begins Pennsylvania Ad Blitz -- Starts Ads on the Heels of Failed Obamacare Rollout, Tax Increase Push
5. Workers’ Compensation Costs Per Claim Moderating In Pennsylvania After Years of Growth, New Study Reports
6. Risperdal Lawsuit News: Bernstein Liebhard LLP Notes Mounting Claims Involving Risperdal Gynecomastia Allegations in Pennsylvania Litigation
7. Pradaxa Lawsuits Continue to Mount, With Filing of New Pradaxa Wrongful Death Claim in Pennsylvania by Wright & Schulte LLC
8. What Does the New Breast Density Bill Mean for Pennsylvania Women?
9. American Banker Honors Patti Husic, Centric Bank CEO and Chair of Pennsylvania Bankers Association, as One of The 25 Women to Watch in U.S. Banking
10. New Risperdal Lawsuit Filed in Pennsylvania Litigation; Alleges Male Breast Growth Injuries Caused by Anti-Psychotic Medication, Bernstein Liebhard LLP Reports
11. Pennsylvanians Want Full Liquor Privatization; Survey Shows Strong Bipartisan Support, Including Among Union Households
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... 2016 , ... Those who have experienced traumatic events may suffer from a ... such as drug or alcohol abuse, as a coping mechanism. To avoid this pain ... following a traumatic event. , Trauma sufferers tend to feel a range of emotions, ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
(Date:6/24/2016)... ... 2016 , ... Comfort Keepers® of San Diego, CA is excited to announce ... program to drive cancer patients to and from their cancer treatments. Comfort Keepers ... of life and ongoing independence. Getting to and from medical treatments is one ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their ... Award, an essay contest in which patients and their families pay tribute to a ... the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... BEVERLY HILLS, Calif. , June 23, 2016 ... faced the many challenges of the current process. Many of ... option because of the technical difficulties and high laboratory costs ... would have to offer it at such a high cost ... to afford it. Dr. Parsa Zadeh , ...
(Date:6/23/2016)... ANGELES , June 23, 2016 ... CAPR ), a biotechnology company focused ... therapeutics, today announced that patient enrollment in its ... in Duchenne) has exceeded 50% of its 24-patient ... enrollment in the third quarter of 2016, and ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology: