FDA Findings | Heparin Deaths

Heparin Contamination – More than Just OSCS

Posted on 25th March 2009 by gjohnson in Uncategorized

Baxter recall of heparin, Chanzghou SPL, Dermatan Sulfate, FDA findings, FDA recall heparin, heparin, heparin attorney, heparin lawyer

One of the surprising things to me when I consider the scope and controversy about the Baxter Heparin debacle, is that all of the focus is on OSCS (the identified anaphylactoid agent) not the total lack of sterility in a IV drug. Defense tactics in major cases are all about misdirection and even though it seems somewhat self-defeating to do so, Baxter has succeeded in limiting the inquiry into the Heparin deaths to the issue of whether there was OSCS in a given dose.

That is wrong. This is a drug intended for intravenous administration to extremely sick people. To assume that the only problem with Baxter’s manufacture of an IV drug outside the U.S. is this one identified contaminant, is naive. What we know from the Congressional testimony of those who inspected the Chanzghou SPL plant is that no proper procedures were being followed, no one on site had any meaningful expertise in the manufacture of heparin and that they were using unsanitary equipment that was being used to product that had to be sterile and pure.

On April 29, 2008, the House Subcommittee on Oversight and Investigations held hearings entitled, The Heparin Disaster: Chinese Counterfeits and American Failures
For more on those hearings, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

The link provides written transcripts of the prepared remarks of the witnesses at such hearing, which included four panels, detailed below. However, the transcript of such hearings has never been added to that page, and I have been unable to find a copy of it online. Further, I requested such transcript the day of the hearing but have never received it.

All of that testimony is significant and I have quoted some of that before. But on the issue of the non-sterility of this IV drug, I believe the Testimony of Regina T. Brown, Consumer Safety Officer might be the most important. I will begin my discussion of her testimony in today’s blog and continue it in later blogs this week.

In such testimony, Brown identified a series of problems with the way in which SPL (Baxter’s supplier of heparin API) was producing heparin at the Changzhou SPL in China. She identified specifically these things about the way Heparin was being manufactured at Changzhou SPL:

That inadequate procedures were being followed to determine what was in the Heparin API,
That the tanks in which Heparin was being made were unsanitary,
Three that the centrifuges which were being used to separate out the Heparin from other raw materials were not calibrated; and
That no one on site had any real expertise in the manufacture of Heparin.

All of these issues point to the inference that this bad Heparin could have contained contaminants far more diverse than OSCS. Almost anything that goes through the small intestines of a pig could have been in that Heparin API. The NEJM of study in June of 2008,
“Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System” identified that the contaminated lots not only contained OSCS, but also another troubling compound: Dermatan Sulfate. But what of germs, other impurities or organic compounds that could cause a completely different but deadly disease process than OSCS?

In our next blogs, we will work thru the different issues identified by Regina Brown in her inspection of the Chanzghou SPL plant.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney

FDA warned syringe producer of serious problems

0 comments

Posted on 26th February 2009 by gjohnson in Uncategorized

AM2PAT, FDA, FDA findings, FDA recalls, heparin syringes, saline syringes, syringe recall, syringes, syringes and bacteria

Date: 2/26/2009 3:32 PM

By MIKE BAKER
Associated Press Writer

RALEIGH, N.C. (AP) — Federal regulators warned a syringe manufacturer of “several significant violations” in its quality control system two years before its needles triggered an outbreak of bacterial infections that prosecutors say led to at least five deaths and hundreds of illnesses.

A U.S. Food and Drug Administration warning letter, made public Thursday by the agency, cited AM2PAT Inc. in August 2005 for nine serious violations at its factory in Raleigh, where it made syringes of heparin and saline to flush IV lines.

The company, which was incorporated in Chicago, later moved its manufacturing to Angier, about 20 miles south of Raleigh.

Among the problems at the Raleigh factory, the letter noted poor documentation of sterility tests, insufficient efforts to maintain a sterile environment and unqualified workers. Each of those issues were cited again this month as prosecutors won guilty pleas from two former AM2PAT employees and charged former CEO Dushyant Patel.

Authorities are searching for Patel, who may have fled to his native India. Prosecutors do not know if he has an attorney. He faces up to 95 years in prison if convicted on 10 charges including fraud, false statements and selling adulterated medical devices.

The 2005 warning letter said the failure to establish and maintain procedures to control the environment “could reasonably be expected to have an adverse effect on product quality.” It said the company’s written quality control procedures were “obsolete” and there was no sign workers had been properly trained.

“Evidence of improperly trained personnel included an employee chewing gum while filling syringes and an employee improperly gowning during sterility testing,” the warning letter stated.

Those issues apparently lingered. Prosecutors have said that the company’s “microbiologist” was a teenager who had dropped out of high school. Photographs introduced as evidence show a “clean room” with a window fan patched with duct tape. Others show paint chipping off the facility’s floor and syringes piled high on a table.

But the criminal case particularly focuses on how the company documented its shipments. Prosecutors contend the company was so consumed with maximizing profit that it shipped syringes without testing to ensure it they were sterile, and then later backdated paperwork to make it look as if the company had followed procedure.

AM2PAT vowed in 2005 to correct its deficiencies, according to the warning letter, and the FDA said a follow-up inspection in January 2006 was satisfactory.

On Wednesday, the FDA said the next inspection didn’t take place until December 2007, and court documents show it didn’t happen until after the Centers for Disease Control reported an outbreak of illness connected to AM2PAT syringes. Prosecutors say the product killed five and sickened up to 300 others, with some of the illnesses resulting in spinal meningitis and permanent brain damage.

On Thursday, the FDA said it discovered it also conducted an inspection in August 2007, after the company moved to Angier, and found only a labeling problem.

But that month, the FDA started receiving reports of dirty syringes. Some reported “orange specks” floating inside the unopened syringes, while others reported “yellow sediment” or “muddy brown” syringes filled with floating white specks.

The FDA has declined to release its inspection reports, saying they are only available through a Freedom of Information Act request, which is pending.

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.

Copyright 2009 The Associated Press.

Timeline: Reports, inspections of syringe factory

0 comments

Posted on 25th February 2009 by gjohnson in Uncategorized

AM2PAT, FDA findings, heparin syringes, saline syringes, syringe recall, syringes, syringes and bacteria

Date: 2/25/2009

By The Associated Press

Court documents and federal officials say a North Carolina syringe factory linked to hundreds of sicknesses and five deaths went for almost two years without an inspection despite a series of complaints about dirty needles. Here’s a timeline of when the complaints and inspections took place:
2005

— June: U.S. Food and Drug Administration inspects Chicago-based AM2PAT Inc.’s facility in Angier, N.C.

— Nov. 15: FDA receives complaint that someone found particles inside a heparin solution manufactured by AM2PAT.
2006

— January: FDA inspects AM2PAT.
2007

— March 20: FDA receives a complaint that a patient’s husband saw “both brown and black particulate matter found throughout unopened flush syringe.” The patient was hospitalized with a blood infection. The company later said the sample was not available for evaluation but that it tested samples from the same lot. FDA records do not show those results.

— May 1: FDA receives a complaint that “white particulate matter of various sizes” was found in multiple syringes produced by Sierra Pre-Filled, another name for AM2PAT.

— June 6: FDA receives a complaint that “white precipitate or powder” was found in syringe produced by Sierra Pre-Filled.

— Aug. 24: FDA begins receiving a series of almost a dozen complaints of “muddy brown,” yellow, orange and “dingy” syringes, some with debris.

— Dec. 11: The Centers for Disease Control and Prevention advises the FDA of two clusters of infections linked to flushes produced at AM2PAT. Prosecutors say the tainted lot sickened hundreds and killed five.

— Dec. 13: FDA initiates inspection of AM2PAT.

— Dec. 20: AM2PAT issues nationwide recall of product found to be contaminated with bacteria.
2008

— Jan. 18: AM2PAT expands nationwide recall of syringes.

— April: Prosecutors file criminal complaints against two AM2PAT workers.
2009

— Feb. 19: Prosecutors indict AM2PAT CEO Patel Dushyant on a range of charges and begin international search for him. Authorities believe he fled to his native India.

— Feb. 23: Former AM2PAT plant manager Aniruddha Patel, 43, of Carpentersville, Ill., and quality control director Ravindra Kumar Sharma, 54, of Richmond, Va., are sentenced to 4 1/2 years in prison each for fraud and allowing tainted drugs into the marketplace.

___

Sources: U.S. Food and Drug Administration; court documents.

Copyright 2009 The Associated Press.

Feds searching for CEO in case of tainted syringes

0 comments

Posted on 24th February 2009 by gjohnson in Uncategorized

AM2PAT, FDA findings, FDA recalls, heparin syringes, saline syringes, syringe recall, syringes, syringes and bacteria

Date: 2/24/2009

By MIKE BAKER
Associated Press Writer

RALEIGH, N.C. (AP) — 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.

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 4½ years in prison for fraud and allowing tainted drugs into the marketplace.

___

Associated Press Writer Estes Thompson contributed to this report.

Copyright 2009 The Associated Press.

Prosecutors: NC company shipped tainted syringes

0 comments

Posted on 24th February 2009 by gjohnson in Uncategorized

AM2PAT, FDA findings, FDA recalls, heparin syringes, saline syringes, syringe recall, syringes, syringes and bacteria

Date: 2/24/2009

By MIKE BAKER
Associated Press Writer

RALEIGH, N.C. (AP) — A North Carolina company is accused of bypassing sterilization tests for medical syringes in a cost-cutting move prosecutors say sickened hundreds of patients and led to five deaths.

U.S. Attorney George Holding said Tuesday that federal authorities have launched an international search for the executive charged with rushing shipments of bacteria contaminated syringes from an AM2PAT Inc. plant. Two former plant workers who provided prosecutors details about the plant’s operations have pleaded guilty for their roles in shipping tainted syringes.

The syringes contained Heparin, a blood thinner, and saline, and were recalled in December 2007 after an outbreak of illnesses. Health inspectors identified bacterial infections in Colorado, Texas, Illinois and Florida.

Heparin and saline are used to flush intravenous lines during cancer treatments, kidney dialysis and other procedures.

The U.S. attorney said investigators believe AM2PAT CEO Dushyant Patel has fled to his native India. Patel was indicted last week on 10 charges including fraud, false statements and selling adulterated medical devices.

“Our office is committed to pursuing him and bringing him here to account for his actions,” Holding said. “We’re putting all resources available to bringing him back here.”

Holder did not know who Patel’s attorney was.

AM2PAT is based in Chicago and had a subsidiary in North Carolina.

Patel’s company sold nearly $7 million worth of heparin and saline syringes in 2006-07. Prosecutors said the facility in Angier, about 20 miles south of Raleigh, cut corners and failed to follow rules for checking sterility. They also said manufacturing dates were falsified to make it appear that safeguards were followed.

The scheme led to bacterial infections in 200 to 300 patients around the country, some of them resulting in spinal meningitis and permanent brain damages, prosecutors said. Even more people may have become infected.

“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 its 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.”

Patel said about a year ago when federal officials were investigating the outbreak that company voluntarily recalled the implicated syringes and there was “nothing out there anymore.”

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 4½ years in prison for fraud and allowing tainted drugs into the marketplace.

Copyright 2009 The Associated Press.

Heparin Deaths

Websites

Blogs

Contact Us

About

SUBSCRIBE

Heparin Contamination – More than Just OSCS

FDA warned syringe producer of serious problems

Timeline: Reports, inspections of syringe factory

Feds searching for CEO in case of tainted syringes

Prosecutors: NC company shipped tainted syringes

For More Information, visit:

Archives

Categories

Disclaimer

Connect