Parker Waichman LLP

St. Jude Served with FDA Warning Letter

Faulty manufacturing practices blamed on St. Jude. The U.S. Food and Drug Administration (FDA) sent a warning letter this week to St. Jude Medical Inc. because of faulty manufacturing practices at its catheter manufacturing plant in Minnetonka, Minnesota. The letter was released in a regulatory filing with the U.S. Securities and Exchange Commission (SEC), said BizJournal. […]

St. Jude

Faulty manufacturing practices blamed on St. Jude. The U.S. Food and Drug Administration (FDA) sent a warning letter this week to St. Jude Medical Inc. because of faulty manufacturing practices at its catheter manufacturing plant in Minnetonka, Minnesota. The letter was released in a regulatory filing with the U.S. Securities and Exchange Commission (SEC), said BizJournal.

The filing stated that the FDA inspected St. Jude Medical’s Atrial Fibrillation (AF) Division’s catheter facility on a number of occasions from December 8 and December 19 and notified St. Jude Medical on December 19 that it observed issues with the manufacture and assembly of its Safire ablation catheter, reported BizJournal, which fix irregular heartbeats and destroy damaged and diseased tissue with heat, explained the Associated Press (AP). The warning letter was issued last Friday, said the AP.

FDA would not approve new devices for manufacture

The FDA said it would not approve new devices for manufacture at the St. Jude Medical plant until the firm corrects the outstanding problems, said the AP, noting that faulty record keeping was among the problems cited.

Typically, catheter systems consist of an energy generator and an attachable catheter, which is used on the patient’s tissue, said the AP.

This is not the first time St. Jude Medical has been the subject of controversy over its products. The St. Jude Symmetry Bypass Aortic Connector has been associated with a high occurrence of heart attacks, respiratory failure, and has been linked to several deaths, with adverse effects that include graft narrowing, valve leakage, failed deployment, and occlusion.

The St. Jude Symmetry is commonly used in “beating heart” or “off machine” heart bypass surgery, which has gained in popularity because it eliminates the need for the patient to be connected to a lung machine during bypass surgery and enables thoracic surgeons to attach saphenous (leg) vein grafts to the aorta without sutures and without clamping the aorta during the procedure.

Thousands of the devices have since been implanted in patients

The St. Jude Medical Symmetry device was approved in 2001 after an abbreviated approval process; thousands of the devices have since been implanted in patients. Despite adverse reports, St. Jude Medical neither conducted clinical trials or testing of a larger segment of the post-cardiac bypass population, nor has it made any alterations in design or manufacture to lessen the great danger the connector poses to patients.

Also, St. Jude Medical said it identified a memory chip problem in some of its older implantable cardioverter defibrillators (ICDs) devices, which stems from a memory chip St. Jude Medical used through 2002 that is susceptible to background radiation.

St. Jude Medical notified doctors and federal regulators of a software problem in some models of its ICDs that could cause the heart-shocking device to malfunction. About 39,000 patients are affected by this news.

ICDs are implanted devices the size of a stopwatch that are placed in the upper chest and shock or pace an irregular heart beat back into rhythm. In ICDs past their mid-life, a series of shocks might be skipped as the device delivers its routine of multiple shocks to revitalize the heart.

The first shock would be delivered, but the device might deliver fewer than the maximum of six shocks per episode. A second problem could cause a temporary increase in the device’s pacing rate. In addition to its shocking therapy, some patients need an ICD that can pace their heart, as well.

Need Legal Help Regarding St. Jude?

The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

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 for the process I am receiving from my Parker Waichman lawyers, thanks to Jorge and Dawn for all their help, very good service, I am very happy, I recommend them to my family and friends.
July Marrero
2 months ago
5 Star Reviews 150
Josephine Burgess-Zephrine guided me with patience and respect to the process regarding the process of preparing documents, submitting motions and finally testifying. Due do Josephine's professionalism and patience, I am very comfortable with speaking to all parties regarding my case. Thank you Josephine Burgess-Zephrine.
Denice Briggs
5 years ago
5 Star Reviews 150
Thank you Michelle Josama at Parker and waichman for being so great from day one with my family and myself! It was a pleasure meeting and working with you! Thank you for your care and professionalism.
bfst6611 st
4 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