Parker Waichman LLP

Tainted Syringe Maker Had History of Violations

Tainted Syringe Maker Eyed For Violations. The company that distributed tainted pre-filled syringes linked to five deaths received a warning letter in August 2005 from the Food & Drug Administration (FDA) regarding atrocious conditions at its Raleigh, North Carolina manufacturing facility.  According to an Associated Press report, that FDA warning letter discussed nine serious violations found […]

Tainted Syringe

Tainted Syringe Maker Eyed For Violations. The company that distributed tainted pre-filled syringes linked to five deaths received a warning letter in August 2005 from the Food & Drug Administration (FDA) regarding atrocious conditions at its Raleigh, North Carolina manufacturing facility.  According to an Associated Press report, that FDA warning letter discussed nine serious violations found at the AM2PAT plant in Raleigh.

Federal prosecutors have charged that AM2PAT knowingly shipped untested syringes that sickened hundreds and killed five people.  Many of those using the syringes were undergoing chemotherapy treatments which would have compromised their immune systems.

In December 2007 and January 2008, Sierra Pre-filled and B. Braun syringes were recalled by AM2PAT because of the contamination issues.

North Carolina facility was shut down because of the problems

The company’s Angier, North Carolina facility was shut down because the problems.  As we reported yesterday, the plant’s manager and quality control director  were each sentenced to 4 1/2 years in prison for fraud and allowing tainted drugs into the marketplace.  Both had pled guilty and had agreed to provide information about plant owner Dushyant Patel.

Patel, who may have fled to his home in India, was indicted last week on 10 charges that include fraud and selling adulterated medical device. Interpol is reportedly assisting in the international search for Patel.

According to the Associated Press, the problems cited by the 2005 FDA warning letter included poor documentation of sterility tests; insufficient efforts to maintain a sterile environment; and unqualified workers at its facility in Raleigh, North Carolina.

AM2PAT promised to fix those problems, and the FDA was apparently satisfied that it had done so when it inspected the facility again in 2006. Sometime after that, AM2PAT moved production from Raleigh to Angier, North Carolina, some 20 miles away.

FDA inspected the Angier plant in August 2007

According to the Associated Press, the FDA inspected the Angier plant in August 2007, and said it only found a problem with labeling.  But that was the same month it started receiving complaints that debris had been found in “muddy brown” AM2PAT syringes.

Despite these reports, the FDA did not go back to the plant until the Centers for Disease Control traced infections to the tainted AM2PAT syringes.

Need Legal Help Regarding Tainted Syringe?

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
Parker Waichman LLP helped my family with my father's 9/11 VCF Claim. My dad was in downtown Manhattan when 9/11 happened. Because of that he was diagnosed with COPD. Unfortunately, in early 2020 when COVID hit, he passed away. It was determined that his COPD from 9/11 was a contributing factor in his death. Working with Parker Waichman during such a difficult time was so helpful. Tina Morace was an absolute godsend in the process. Any questions I had, and there were many, were answered immediately. She always responded with a phone call and an email to follow so that I had everything in writing. I highly recommend their services to anyone who is in need.
Lisa Rooney
a month ago
5 Star Reviews 150
I am very happy with the experience that I had with Parker Waichman LLP. Both my Attorney, Brett Zekowski and Lynda Luckman were very professional, courteous and helpful. Mr. Zekowski and Mrs. Luckman personally called me with updates regarding my case, answered my questions promptly and were a comfort through a difficult time.
MARION MUSUMECI
5 years ago
5 Star Reviews 150
The attention that we got was very appreciated. We have been bounced around before and felt like we didn’t matter. Mathew and the entire Parker Waichman team made us feel like family.
Erika Houston
7 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