News and Press Releases

FOR IMMEDIATE RELEASE:

MONDAY - February 23, 2009

EMPLOYEES OF PRE-FILLED SYRINGE MANUFACTURE SENTENCED FOR MISBRANDING THE MEDICAL DEVICES

RALEIGH - United States Attorney George E.B. Holding announced that in federal court here today United States District Judge Terrence W. Boyle sentenced RAVINDRA KUMAR SHARMA, age 54, of Richmond, Virginia and ANIRUDDHA PATEL, age 43, of Carpentersville, Illinois. Both received 54 months’ imprisonment.

Both SHARMA and PATEL pleaded guilty to Criminal Complaints filed on April 3, 2008, and April 23, 2008, respectively, charging conspiring to commit a number of federal offenses including mail fraud, submitting false statements in a matter within the jurisdiction of the executive branch of the United States Government, and knowingly sending misbranded medical devices into interstate commerce with the intent to defraud. Both SHARMA and PATEL pleaded guilty pursuant to plea agreements and are cooperating in this ongoing investigation.

These crimes relate to SHARMA’s work as quality control director, and PATEL’s work as plant manager for a company called AM2PAT, Inc., which manufactured syringes pre-filled with saline and heparin, a commonly used anti-coagulant. Members of the conspiracy sent syringes, pre-filled with heparin and saline, from a business facility in Angier, North Carolina, into interstate commerce for public use, using a private and commercial interstate carrier. These syringes were misbranded as “sterile,” when, in fact, the requisite sterility testing on these products had not been completed prior to their shipment into interstate commerce. Additionally, after shipment, Device History Reports (“DHR”), reports detailing the testing conducted on a given lot of syringes, would be falsely backdated so as to appear that sterility testing took place on these syringes before they were shipped into interstate commerce for public use. On some occasions, shipping records were forward-dated to give the appearance that syringes remained at the facility to undergo testing, when in fact they did not. On other occasions, the production date of syringes were backdated to give the same false impression.

As a result of this scheme between 200 and 300 medical patients around the country developed bacterial infections after having been injected with syringes from AM2PAT, Inc. Some of these infections resulted in serious illness such as spinal meningitis and permanent brain damages, while other infections led to death.

Relatedly, on February 19, 2009, a Federal Grand Jury sitting in the Eastern District of North Carolina returned a ten-count Indictment against both AM2PAT, Inc., and its former President, Dushyant Patel. This indictment charges both the company and Dushyant Patel with conspiracy, multiple mail fraud counts, and the release of misbranded and adulterated medical deices into interstate commerce for the scheme detailed above. The Indictment also charges both AM2PAT, Inc. and Dushyant Patel with making materially false statements to the Food and Drug Administration in the company’s 2003 Notification to the Food and Drug Administration of its intent to market syringes pre-filled with heparin.

Commenting on this case, United States Attorney George E.B. Holding stated: “The crimes committed by Mr. Sharma and Mr. Anu Patel, and the related crimes alleged in the Indictment against AM2PAT and Dushyant Patel constitute the most fundamental breach of the public’s trust. Citizens in this country trust that producers of medical devices aren’t lying when they say that have adequately tested a given product. As we’ve seen in this case, such lies can literally mean the difference between life and death. I hope this case sends a message to medical device makers everywhere: If you cut corners, and violate the public’s trust, we’ll bring you to justice.”

“The FDA-Office of Criminal Investigations is fully committed to investigating and supporting the prosecution of those who may endanger the public’s health and safety by manufacturing and selling unsafe products to be used on an unsuspecting public. We continue to look forward to working with our law enforcement partners and commend the US Attorney's Office for their diligence," said David Bourne, Special Agent in Charge, FDA-Office of Criminal Investigations, Miami Field Office

Investigation of the case was conducted by the Office of Criminal Investigations of the Food and Drug Administration and the United States Postal Inspectors. Assistant United States Attorney Jason H. Cowley served as prosecutor for the government.

 

News releases are available on the U. S. Attorney’s web page at www.usdoj.gov/usao/nce within 48 hours of release.

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