Remember all the news coverage about the deaths caused by a tainted anti-coagulant drug called heparin? There were lots of news stories, but I'll bet most of you forgot about it. I know I did. Perhaps the news about heparin stopped getting national coverage because of who got caught, and who got away.

A scandal involving an Indian CEO and at least several Indian employees has resulted in indictments in North Carolina. Dushyant Patel, who is the CEO of AM2PAT, masterminded the fraudulent scheme that involved shipping tainted syringes of heparin.

A criminal case was launched last spring after the falsified reports were discovered. The plant manager, Aniruddha Patel, and the quality control director, Ravindra Sharma, were sentenced to 4.5 years in
federal prison Monday for their participation. The Indian men, in the United States legally with work visas, said they feared they would lose their jobs and their U.S. residencies if they didn't go along with Dushyant Patel's scheme.

Dushyant Patel won't be serving any prison time unless India finds him and allows extradition. That's because Patel fled the U.S. before he could be arrested. Supposedly Interpol is involved in what is described as an international manhunt to find Patel. I have read dozens of news reports and a press release from the Dept. of Justice, but haven't seen a single explanation about how Patel escaped from the U.S. The silence on Patel looks like a cover-up by several branches of our government that have bungled the AM2PAT case for a very long time.

As an example of the bungling: the FDA received complaints in 2005 that the company's "chief microbiologist" was a teenager who dropped out of high school, and that labs were filthy, and yet nothing was done to correct the problems. My suspicion is that the FDA went easy on AM2PAT because the
company is considered to be a minority owned business. AM2PAT was based in Obamaland -- Chicago, Illinois, where Dr. Dushyant Patel practiced radiology.

Aniruddha Patel and Ravindra Sharma claimed that they went along with the fraud because they were afraid they would lose their H-1B status if they were fired. That seems like a weak excuse for being involved in a conspiracy that resulted in permanent physical damage and deaths of many innocent American patients. Both of these white collar mass murderers made plea agreements to fink on Dushyant Patel, which is the reason given for their light sentences. Keep in mind that these two, and probably others at AM2PAT were involved in the conspiracy.

These men are described as Indian nationals who are in the U.S. on legal work visas. I was not able to find information about the specific visas they had, but one thing for sure is that AM2PAT does hire H-1Bs. You can see LCAs filed by AM2PAT by searching the DOL database. Unfortunately there is no way to directly link the LCAs to specific individuals, but it is proof positive that the company wanted to hire H-1Bs.
http://www.flcdatacenter.com/CaseH1B.aspx

Here are a few results by year. As you can see, AM2PAT has been hiring H-1Bs for a long time.

10/01/2007, SENIOR PROCESS ENGINEER (MATERIALS ENGINEER), $52,998
02/28/2006, Materials Engineer, $55,307
07/29/2002, BUSINESS MANAGER, $45,000

Almost everything about Dushyant Patel has been wiped off the web, but I found a little blurb about his medical practice which you can read below. The drug scandal uncovered could be the tip of the iceberg. Dushyant Patel was involved with several different companies including a few based in India. It's truly a global conspiracy that involves both immigration and uncontrolled international trade. Hopefully the FDA is doing a better job of checking out Astral in India than they did with AM2PAT in North Carolina.

"Astral is rapidly establishing a global footprint," said Dushyant R. Patel, CEO, Astral Pharmaceutical Industries. "Collaborating with a partner of Sagent's caliber in the United States is a fantastic opportunity for Astral to quickly expand our science, quality and manufacturing expertise in injectable anti-infectives
to the U.S. market."

REFERENCES:
http://www.macraesbluebook.com/search/company.cfm?company=724827

AM2PAT business address
http://www.mripros.net/drpatel.htm

Dushyant Patel, M.D., FACR, short educational biography
http://www.usdoj.gov/usao/nce/press/2009-Feb-23_2.html

February 23, 2009, EMPLOYEES OF PRE-FILLED SYRINGE MANUFACTURE SENTENCED
FOR MISBRANDING THE MEDICAL DEVICES
http://www.orlandosentinel.com/topic/ny-hssyri2512490867feb25,0,1584126.story 

Hunt for mastermind who shipped tainted syringes
http://triangle.bizjournals.com/triangle/stories/2009/02/23/daily15.html

Prison time handed out in AM2PAT, Sierra Pre-Filled syringe
http://www.newser.com/article/d96i83q00/feds-launch-international-search-for
-ceo-in-case-of-tainted-syringes-blamed-for-5-deaths.html 

 
Feds launch international search for CEO in case of tainted syringes blamed
for 5 deaths
http://theoriginalgreenwichdiva.com/2009/02/24/us-attorney-is-looking-for-th
e-ceo-dushyant-patel-of-am2pat-inc-who-continuously-shipped-contaminated-syr
inges/
U.S. Attorney is looking for the CEO Dushyant Patel of AM2PAT Inc.
http://www.newsobserver.com/news/health_science/story/1418047-p2.html

FDA ignored debris in syringes
http://sev.prnewswire.com/health-care-hospitals/20071127/AQTU03227112007-1.html

  
Sagent Pharmaceuticals Inc. and Astral Pharmaceutical Industries Announce
Collaboration for Developing and Manufacturing Injectable Antibiotics
+++++++++++++++++++++++++++++++++++++++++++++++++++
http://www.macraesbluebook.com/search/company.cfm?company=724827 
Am2pat Inc
Chicago, IL,
60659-1400
Phone: 847-726-9443
+++++++++++++++++++++++++++++++++++++++++++++++++++

http://www.mripros.net/drpatel.htm 
Dushyant Patel, M.D., FACR
Staff Radiologist for Meridian Regional Imaging. A longstanding member of
the Chicago radiological community, Dr. Patel performed his diagnostic
radiology residency at Michael Reese Hospital, followed by a fellowship in
Neuroradiology at Northwestern Memorial Hospital. After holding several
academic appointments at both the University of Chicago, and the University
of Illinois, Dr. Patel became Medical Director at the Advanced Medical
Imaging Center, one of the first ourpatient imaging centers offering MRI in
Chicago, Illinois. Dr. Patel received his CAQ in Neuroradiology in 1995,
and established himself as an American College of Radiology Fellow in 1996.
Dr. Patel is a Board Certified by the American Board of Radiology.
+++++++++++++++++++++++++++++++++++++++++++++++++++

http://www.usdoj.gov/usao/nce/press/2009-Feb-23_2.html 
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 SHARMAs work as quality control director, and
PATELs 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
companys 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 publics trust. Citizens in
this country trust that producers of medical devices arent 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 publics trust, well
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
publics 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.
+++++++++++++++++++++++++++++++++++++++++++++++++++

http://www.orlandosentinel.com/topic/ny-hssyri2512490867feb25,0,1584126.story 

OrlandoSentinel.com
Hunt for mastermind who shipped tainted syringes

February 25, 2009
McClatchy Newspapers

RALEIGH, N.C. - Federal authorities are hunting the mastermind behind a
"horrific case" in which bacteria-laden syringes shipped from an Angier,
N.C., plant sickened hundreds of people and killed five.

Two men pleaded guilty Monday in U.S. District Court in Raleigh for their
roles in ignoring sterility standards at the former AM2PAT Inc. plant. The
court heard of conditions at the plant more consistent with a Third World
textile factory than a pharmaceutical facility.

The men - plant manager Aniruddha Patel and quality control director
Ravindra Kumar Sharma - were each sentenced to 41/2 years in prison for
fraud and allowing tainted drugs into the marketplace. They were rewarded
with a relatively light sentence in exchange for information about chief
executive Dushyant Patel, whose company sold $6.9 million worth of heparin
and saline syringes in 2006-07 that did not undergo proper sterility
testing.

Dushyant Patel, indicted late last week on 10 charges that include fraud
and selling adulterated medical devices, has not been arrested. Authorities
think he may have fled to his homeland in India and are seeking help from
Interpol.

Heparin is blood thinner, and saline is used for hydration. Both help flush
intravenous lines during cancer treatments, kidney dialysis and other
procedures.

Syringes from AM2PAT were pulled from the market early last year, and the
Angier plant shuttered after an outbreak of Serratia, a bacterial
infection, hit patients in Colorado, Texas, Illinois, Florida and other
states.

On Monday, prosecutors laid out a scheme before Judge Terrence Boyle in
which the plant's operators routinely failed to follow sterility rules to
keep production running faster. The drugs were not produced at the plant,
but were loaded into syringes there, then shipped.

The plant was subject to U.S. Food and Drug Administration requirements for
its production. The syringes were supposed to be loaded in a "clean room,"
with employees in caps and gowns and air carefully ventilated to keep germs
from spreading.

A photograph entered into evidence Monday shows a "clean room" refreshed
with a common window fan held together with duct tape. In another photo,
women work on an assembly line under lamps, surrounded by what look like
green plastic recycling bins.

Once the syringes were loaded with drugs, each batch was required to be
held for two weeks, while employees tested for bacteria and other
contaminants. If bacteria were cultured from the medicines, the whole batch
should have been held back. That wasn't happening, court documents show.

Batches of syringes went straight from the production line into the
marketplace, with Sharma falsifying manufacturing dates to make it appear
to regulators that requisite quality tests had been done. And when tests
were done, results were ignored.

Even then, the drugs were shipped. "This is a horrific case," said U.S.
Attorney George Holding. "They were preying on the weakest of the weak."
The scheme led to bacterial infections in 200 to 300 patients, some of them
resulting in spinal meningitis and permanent brain damages, prosecutors
said.

Dusty Martin, a single father from Independence, Va., nearly lost his son a
year ago after injecting him with the tainted heparin during a routine
treatment for the 8-year-old's hemophilia, a condition in which the blood
fails to clot. Michael Martin recovered, but until his father got a letter
last week from the U.S. attorney's office in Raleigh telling him the
infection was caused by a tainted syringe, Dusty Martin labored under the
belief he had been careless and caused his son's illness.
+++++++++++++++++++++++++++++++++++++++++++++++++++

http://triangle.bizjournals.com/triangle/stories/2009/02/23/daily15.html 
Monday, February 23, 2009 | Modified: Tuesday, February 24, 2009

Prison time handed out in AM2PAT, Sierra Pre-Filled syringe scandalTriangle
Business Journal - by Jeff Drew Associate Editor
TBJ file photo

This sign told the story at the AM2PAT facility in Angier last year.
View Larger Two former employees of AM2PAT Inc. were sentenced Monday in
Raleigh to 54 months in prison for their roles in sending out improperly
labeled syringes linked to hundreds of bacterial infections and some
deaths, according to a statement issued by U.S. Attorney George E.B.
Holding.

U.S. District Judge Terrence Boyle handed down the sentences against
Ravindra Kumar Sharma, 54, of Richmond, Va., and Aniruddha Patel, 43, of
Carpentersville, Ill. The two men pleaded guilty to a number of federal
charges, among them mail fraud and knowingly sending misbranded medical
devices into interstate commerce with the intent to defraud.

Sharma and Patel made the guilty pleas as part of an agreement with the
U.S. attorney in which they pledged their coorperation to the ongoing
investigation into AM2PAT, a Chicago-based company whose Angier office
operated under the name Sierra Pre-Filled until it was shuttered last year.
The news release from Holdings office says that the charges stem from
Sharmas work as quality control director and Patels job as plant
manager at the Angier facility, where AM2PAT manufactured syringes
pre-filled with saline and heparin, a commonly used anti-coagulant.

Holding alleges that "members of the conspiracy" sent out syringes
containing saline and heparin that were mislabeled as sterile when, in
fact, the required sterility tests had yet to be performed. After the
syringes were shipped, dates on records were changed to give the false
impression that the tests had been done, according to Holdings press
release.

The U.S. attorneys office alleges that "this scheme" led to between 200
and 300 cases of bacterial infections in patients injected with AM2PAT
syringes. Some of those infections resulted in spinal meningitis and
permanent brain damange, Holding says. Other infections led to death,
though the release does not give a specific number.

In a related development, a federal grand jury in the Raleigh-based Eastern
District of North Carolina indicted AM2PAT and its former president,
Dushyant Patel, on 10 charges including conspiracy, mail fraud, the release
of misbranded and adulterated medical devices into interstate commerce, and
making materially false statements about the syringes to the U.S. Food and
Drug Administration.

"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 publics trust," Holding
was quoted as saying in the news release. -"Citizens in this country trust
that producers of medical devices arent lying when they say that (they)
have adequately tested a given product. As weve seen in this case, such
lies can literally mean the difference between life and death."
Triangle Business Journal detailed the problems at the Sierra
Pre-Filled/AM2PAT facility in a print story that ran Feb. 8, 2008.
+++++++++++++++++++++++++++++++++++++++++++++++++++

http://www.newser.com/article/d96i83q00/feds-launch-international-search-for
-ceo-in-case-of-tainted-syringes-blamed-for-5-deaths.html 
Feds launch international search for CEO in case of tainted syringes blamed
for 5 deaths

By MIKE BAKER | Associated Press | Feb 24, 09 5:25 PM CST in Business
For months, prosecutors say, technicians in the gloom of a run-down North
Carolina plant prepared life-sustaining syringes and shipped them before
ensuring they were sterile.
 
Needles and Syringes
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An undated handout photo released by the U.S. Prosecutor's Office as part
of the government's evidence against Aniruddha Patel, plant manager for the
medical company AM2PAT, shows conditions in the drug... (Associated
Press) (1 of 4)+ Prev+ Prev | Next ;Next ; Slideshow Investigators
believe a rush to maximize profits led Dushyant Patel's AM2PAT Inc. to
produce heparin and saline syringes that killed five people and sickened
hundreds of others, some resulting in spinal meningitis and permanent brain
damage. Authorities are now on an international search for Patel after he
was indicted last week on 10 charges including fraud, false statements and
selling adulterated medical devices.

U.S. Attorney George Holding said Tuesday that authorities believe Patel
has fled to his native India and have turned to Interpol for cross-border
aid in catching up to him.

"Our office is committed to pursuing him and bringing him here to account
for his actions," Holding said.

Court documents portray a disturbing recklessness that allowed syringes to
ship before they were checked for contamination. Reports detailing the
testing were backdated to appear they passed procedure before shipping, and
some test results were manipulated or fabricated to deceive inspectors from
the U.S. Food and Drug Administration, prosecutors said.

Patel's company sold nearly $7 million worth of heparin, a blood thinner,
and saline syringes in 2006-07. The plant in Angier, about 20 miles south
of Raleigh, cut corners so it could maximize profit, including shipping
products quickly without checking on safety, according to court documents.
The syringes were recalled in December 2007 after an outbreak of illnesses.
Health inspectors identified bacterial infections in Colorado, Texas,
Illinois and Florida and traced the contamination to AM2PAT.

It's a similar disregard for consumer health that congressional leaders
portrayed in the salmonella outbreak traced to products from a Georgia
peanut plant that sickened 600 people and may have contributed to nine
deaths. Company e-mails released by a U.S. House committee showed Peanut
Corp. of America owner Stewart Parnell ordered products tainted with the
bacteria to be shipped because he was worried about lost sales. Parnell has
not been charged, but federal officials are investigating.

Ned Feder, a staff scientist at the Washington-based nonprofit Project On
Government Oversight, said the FDA must rely to some extent on the honesty
of plants, but that the agency also needs to verify the paperwork companies
produce. The FDA doesn't inspect often enough, largely because it is short
on staff, he said.

"You hardly turn around and the FDA is breaking news," Feder said. "If it
isn't peanuts in Georgia, it's syringes in North Carolina. They're
completely different (cases), but they can both be traced back to the fact
that the FDA doesn't have the manpower to do the policing it needs to do."
FDA spokeswoman Siobhan DeLancey declined to immediately discuss the
syringe case. She acknowledged that it's impossible for inspectors to be in
every plant at once but said the FDA performs regular checks.

Several people have sued since the fallout of the tainted syringe case, and
prosecutors still aren't sure exactly how many were affected by it. Heparin
and saline are used to flush intravenous lines during cancer treatments,
kidney dialysis and other procedures.

"One of the worst things about this case is that the people who were taking
saline and heparin, they're usually sick already or have some debilitative
illness and need these medicines to try to get well," Holding said.
"Sometimes it's hard to determine whether they were killed from the tainted
heparin or whether it was the original illness. We're not able to say any
more than five."

AM2PAT was incorporated in Chicago, where Patel lived, but had its only
plant in North Carolina.

Patel said about a year ago when federal officials were investigating the
sicknesses that his company voluntarily recalled the syringes in question
and there was "nothing out there anymore." Prosecutors do not know if Patel
still has an attorney. He faces up to 95 years in prison, if convicted.
Plant manager Aniruddha Patel, 43, of Carpentersville, Ill., and quality
control director Ravindra Kumar Sharma, 54, of Richmond, Va., each were
sentenced Monday in U.S. District Court in Raleigh to 4 1/2 years in prison
for fraud and allowing tainted drugs into the marketplace.
___
Associated Press Writer Estes Thompson contributed to this report.
+++++++++++++++++++++++++++++++++++++++++++++++++++

http://theoriginalgreenwichdiva.com/2009/02/24/us-attorney-is-looking-for-th
e-ceo-dushyant-patel-of-am2pat-inc-who-continuously-shipped-contaminated-syr
inges/

U.S. Attorney is looking for the CEO Dushyant Patel of AM2PAT Inc. who
continuously shipped contaminated syringesPosted in February 24th, 2009 by
Claudette Rothman in crazy, crime
Federal authorities in Raleigh, North Carolina, are looking for the CEO of
a company that is being accused of bypassing sterilization tests for
medical syringes, which led to five deaths.

Authorities have launched an international search for the CEO of AM2PAT
Inc., Dushyant Patel, who rushed shipments of bacteria contaminated
syringes from his company in a cost-cutting move.

Two employees, who pleaded guilty to their roles in the shipping of the
tainted syringes, have provided authorities with details about the
companys operations.

U.S. attorney said that Patel, who has fled to his native country of India,
and was indicted last week, was charged with false statement and selling
adulterated medical devices and fraud.

Authorities alleged that Patels company sold almost $7 million worth of
heparin and saline syringes in 2006-2007. These syringes were later
recalled in December 2007, after an outbreak of illnesses.

Prosecutors said Bacterial infections were later indentified in about 300
patients in Colorado, Texas, Illinois and Florida, and some patients who
were infected with the bacteria now suffers from spinal meningitis, and
permanent brain damages, from syringes that were shipped from his facility
in Angier, which continued to cut corners and failed to follow rules for
checking sterility.

About a year ago, Patel told federal officials that his company voluntarily
recalled the implicated syringes and there was "nothing out there anymore."
Plant managers Aniruddha Patel and quality control director Ravindra Kumar
Sharma were sentenced yesterday to 4 = years in prison for fraud and
allowing tainted drugs into the marketplace.
+++++++++++++++++++++++++++++++++++++++++++++++++++

http://www.newsobserver.com/news/health_science/story/1418047-p2.html
FDA ignored debris in syringes
Complaints of filth came in 2005; plant's microbiologist was a teenage
dropout

Sarah Avery and Sabine Vollmer, Staff Writers
Comment on this story

RALEIGH - Months before an Angier company shipped deadly bacteria-tainted
drugs, the federal Food and Drug Administration received numerous
complaints about sediment and debris in the medicine.
The FDA received reports about AM2PAT as early as 2005, but not until
December 2007 did the agency issue recall notices to pull the drugs off the
market.

AM2PAT, which is now the subject of a criminal investigation, sold tainted
syringes of heparin and saline that have been linked to five deaths. At
least 100 more people were sickened, often after receiving the medicines
during chemotherapy, kidney dialysis and other intravenous procedures.
Two men pleaded guilty in U.S. District Court this week for their roles in
the scheme, which involved falsifying documents to make it appear that
proper sterility tests had been conducted. The companys president,
Dushyant Patel, faces 10 charges, but he has not been arrested. Authorities
believe he fled to his native India.

Conditions at the plant, detailed in court documents and photographs,
depict a facility in flagrant violation of proper manufacturing processes.
Prosecutor Jason Cowley said the companys "chief microbiologist" was a
teenager who dropped out of high school (country of origin of the teenager
isn't being revealed). A key piece of laboratory equipment designed to
catch evidence of contamination was broken, and another gauge was out of
commission for a year. The so-called clean room, where air is carefully
controlled to reduce the spread of germs, was ventilated with an ordinary
room fan.

The U.S. Food and Drug Administration -- charged with overseeing more than
10,000 drug-device makers in addition to thousands more pharmaceutical
manufacturers, food processing companies and animal-feed plants -- received
complaints about the companys saline products the summer before the
bacterial infections erupted in December 2007 and January 2008.
Starting in June 2007, doctors and clinics began reporting to the FDA
orange specks floating in the syringes. Other complaints noted "wispy
debris" or "yellow-orange sediment" that caused the normally clear product
to be tan, orange, "muddy" and "dingy brown" in color.

A complaint in 2005 noted food particles inside a heparin syringe.
An FDA spokeswoman. Siobhan DeLancey, said a "non-exhaustive" search of
inspection reports indicates the Angier plant was visited six times by FDA
inspectors, including May 1999, February 2000, March 2004, June 2005,
January 2006 and December 2007. But the company wasn't licensed to do
business in North Caroline until 2001, and it's original home was in
Raleigh. It didn't get FDA approval to load syringes with heparin until
2003.

Patient advocates said the issues that criminal prosecutors detailed in
court documents about the plant were red flags that would have prompted an
investigator to shut down the plant.

"If they had done inspections, those people would be alive," said Dr. Ned
Feder, a former scientist with the National Institutes of Health who now
researches FDA issues at the advocacy group Project On Government
Oversight. The plant operators, he said, "were counting on the fact that
they were unlikely to be inspected. They were counting on it."
Federal law does not require the FDA to inspect a device plant such as
AM2PAT before production starts, said Jeffrey Gibbs, an FDA expert with the
Washington law firm of Hyman, Phelps & McNamara, who advises health-care
companies.

Although they are supposed to be inspected every two years, plants such as
AM2PAT have instead gotten site visits about once every five years,
according to a report from the Government Accountability Office. Between
2002 and 2007, FDA inspectors visited only about one-quarter of the 5,616
registered plants per year, the GAO report states.

"The system depends on companies complying with the law," Gibbs said. "If
they dont comply, the FDA is not there double-checking all the time.
They cant. They dont have the resources."

Patient advocates said the regulatory agency is woefully underfunded and
overburdened. Recent scandals involving medicines that cause heart attacks,
imported toys full of lead, and contaminated peanut butter have caused a
string of embarrassments for the federal agency.

"The FDA is clearly asleep at the switch," said Forest Horne, a medical
malpractice lawyer with Martin & Jones in Raleigh.

A few years ago, Horne sued a manufacturer that shipped steroid-filled
syringes contaminated with a fungus. Hornes client died in 2002 after
she received an injection from one of the tainted syringes and developed
meningitis.

Lacking the funds to prevent harm, the FDA often doesnt step in until
patients start to get sick or doctors complain, Horne said.

In the AM2PAT case, the agency issued recall notices of the heparin and
saline in December 2007. Both drugs are used to flush intravenous lines,
and people who used the tainted syringes became immediately and dangerously
sick. At least five deaths are associated with the drugs, while others
suffered irreparable brain damage. Most incurred massive hospital bills.
Many survivors and their families have sued the company, but their
prospects for recovering damages may be dim. The companys insurance
carrier has filed court papers indicating it covered liability of only $2
million, and wants AM2PAT to be excluded from paying damages above that
amount.

A criminal case was launched last spring after the falsified reports were
discovered. The plant manager, Aniruddha Patel, and the quality control
director, Ravindra Sharma, were sentenced to 4.5 years in federal prison
Monday for their participation. The Indian men, in the United States
legally with work visas, said they feared they would lose their jobs and
their U.S. residencies if they didnt go along with Dushyant Patels
scheme.

The company sold $6.9 million worth of heparin and saline syringes in
2006-07 that did not undergo proper sterility testing.
"This strikes at the fear everyone has when it comes to the medical
supplies or medicine," said George Holding, U.S. attorney for the Eastern
District of North Carolina, whose office prosecuted the case. "Were
talking about things you need to have confidence in. This raises serious
alarms."

News researcher Brooke Cain and reporter Sam Spies contributed to this
report.
savery@newsobserver.com or 919-829-4882
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http://sev.prnewswire.com/health-care-hospitals/20071127/AQTU03227112007-1.h
tml#

Sagent Pharmaceuticals Inc. and Astral Pharmaceutical Industries Announce
Collaboration for Developing and Manufacturing Injectable Antibiotics
SCHAUMBURG, Ill., Nov. 27 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a
privately-held specialty pharmaceutical company, and Astral Pharmaceutical
Industries, a global pharmaceutical manufacturing company located in India,
today announced an agreement in which Astral will develop, manufacture and
supply injectable products for which Sagent will obtain U.S. regulatory
approval and market in the United States.

"Sagent is committed to establishing strategic partnerships that provide
the most diverse and extensive pipeline for our hospital-focused
customers," said Jeffrey M. Yordon, CEO, founder and chairman of the board
of Sagent Pharmaceuticals, Inc. "We are thrilled to have the opportunity to
partner with Dr. Patel and Astral, a leading, worldwide manufacturer of
much needed antibiotic injectable products. This partnership in a key
therapeutic category strongly positions Sagent in our target markets."
"Astral is rapidly establishing a global footprint," said Dushyant R.
Patel, CEO, Astral Pharmaceutical Industries. "Collaborating with a partner
of Sagent's caliber in the United States is a fantastic opportunity for
Astral to quickly expand our science, quality and manufacturing expertise
in injectable anti-infectives to the U.S. market."

About Sagent Pharmaceuticals, Inc.

Sagent Pharmaceuticals, founded in 2006, is a privately held specialty
pharmaceutical company focused on developing, manufacturing, sourcing and
marketing pharmaceutical products, with a specific focus on injectable
products. Sagent has created a unique, global network of resources,
comprised of rapid development capabilities, sophisticated manufacturing
and innovative drug-delivery technologies, quickly yielding an extensive
portfolio of pharmaceutical products that fulfills the evolving needs of
patients. Sagent currently has more than 200 products in development.
For more information about Sagent, please visit

http://www.sagentpharma.com

About Astral Pharmaceutical Industries

Astral Pharmaceutical Industries, located in Vadodara, India, is an
exclusive state-of-the-art manufacturing company specializing in sterile
antibiotic powder injectables. Founded in 1991, Astral was the first Indian
company to develop indigenous technology to manufacture sterile amoxicillin
sodium and has subsequently integrated into production of sterile
antibiotic powder formulations. Astral has independent and dedicated
facilities to manufacture injectable formulations for cephalosporin and
penicillin products.

For more information about Astral, please visit
http://www.astralpharma.com.
Website: http://www.sagentpharma.com/
Website: http://www.astralpharma.com/
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