Parker Waichman LLP

Synthes Inc. Warned over Handling of Medical Device Complaints

Medical device maker Synthes Inc. has been officially warned by federal regulators over procedures by which it receives complaints on defective medical devices. The West Chester, Pa., company has just over two weeks to correct those issues and report how it plans to implement better procedure to the Food and Drug Administration (FDA) or the […]

Medical device maker Synthes Inc. has been officially warned by federal regulators over procedures by which it receives complaints on defective medical devices.

The West Chester, Pa., company has just over two weeks to correct those issues and report how it plans to implement better procedure to the Food and Drug Administration (FDA) or the agency could be compelled to take further action against the company.

Synthes manufactures plates and rods used in reconstructing bones, most often used in trauma situations like following major traffic accidents. In its warning letter received from the FDA in February, Synthes is accused of failing to properly follow-up on complaints about certain rods it manufactures. The company also failed multiple times at reporting device malfunctions to the FDA within the 30-day window it has.

Synthes recently made headlines late last year when a judge in Pennsylvania sentenced four of its former executives to prison terms for their role in illegally promoting Norian bone cement. Three deaths have been attributed to the use of Norian when used in back surgeries.

The company, and its executives, were found guilty of conducting their own “clinical trial” of Norian for use in back surgeries without clearance from the FDA. The judge in the case accused the Synthes execs of conducting “human experimentation” in the pursuit of profit for their company. Each received prison sentences because of their direct involvement with the experimentation.

Norian was approved for use in arms but not in the spine. The company was accused of including more than 50 surgeons to be part of its illegal marketing campaign of the bone cement.

According to a Dow Jones report, the medical trauma segment of the devices industry is one of the fastest-growing. Synthes is in the process of being purchased by industry giant Johnson & Johnson for $21.3 billion.

The same report indicates Synthes received its warning letter on Feb. 16, meaning the 15-day time frame it had to report back to the FDA with its changes to the complaint procedures has passed.

Medical device makers are required to report any complications or complaints about its products to the FDA in a timely manner. It is also required to follow-up with every credible complaint waged against one of its products. A failure to do so can result in untold serious injuries and deaths to future recipients of a potentially dangerous medical device.

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 would like to thank everyone at Parker waichman who worked so hard on my case especially Jerrod Ryan my wonderful attorney who was very professional knowledgeable and very patient. SINCERE THANKS GOD BLESS YOU ALWAYS
Betty Pershae
a year ago
5 Star Reviews 150
Positive: Professionalism , Quality , Value I want to say thank you to Kathy Snedecore for her awesome work ethics. She’s amazing and I appreciate her always providing updates and being on top of my Mother’s case. Thank you for everything! Me & Leyla are beyond grateful.
Gabriela Fernandez
3 years ago
5 Star Reviews 150
I’m really satisfied with my experience dealing with Parker and Waichman and especially my attorney, Mathew Hinrichs, along with the support staff (Jacqueline & Theresa). My attorney is very professional and thorough but very approachable. He always returns calls/emails even in the early evening if necessary. His support staff of Paralegals are professional and thorough as well. This law firm gets things done! My confidence in Parker Waichman is very high, and I have been recommending this law firm to others here in Milwaukee by word of mouth. This recommendation will continue.
Daniel Kasten
3 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