Disappearing Act by Sierra Pre-Filled Owner Perhaps Starting to Make Sense; Missing News Coverage Still a Mystery

"Here’s a crisis that could get much bigger before it goes away. All signs so far point to a lack of ownership and management of a problem whose proportions are still uncertain." (From my blog, December 19, 2007)

There is no story I have blogged about more than the Sierra Pre-Filled tainted syringes. Follow the trail from the 2007 archive through January and February of this year. In a nutshell: Dozens of patients were severely sickened by heparin-filled syringes contaminated by bacteria. The syringes were produced by Sierra Pre-Filled in Angier, North Carolina. Shortly after the product was recalled in December, the FDA stated that the company was "not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes." Several victims have filed law suits.

What does Sierra Pre-Filled President Dushyant Patel have to say? Absolutely nothing. No comment. No apology. No 'we'll try harder" pledge. The plug was even pulled on the company's web site. Nothing but silence. Perhaps now I know why. There may be more to this company and this case of contamination than appeared on the surface.

Last week, U.S. Special Agent R. Michael Hiser of the Office of Criminal Investigations of the FDA confirmed that "a federal search warrant has been issued for AM2PAT (aka Sierra Pre-Filled)." About 15 FDA and FBI agents swarmed the Angier facility on April 2 and spent most of the day there. They left with 17 cardboard file boxes and two paper bags. No one with either agency nor the U.S. Attorney General's Office has revealed the nature of the search. (See the article at http://www.dunndailyrecord.com:80/main.asp?SectionID=1&SubSectionID=1&ArticleID=95671.) When they do tell us what they were looking for, we might know why Patel hid from the public and failed in every way possible to manage his company's crisis.

I've written this before about this story, but: I still find it disheartening that reporters haven't dug deeper. Patel clearly was in hiding. The company seemed to abandon its operations without notifying employees, the community and other stakeholders. Yet not even local reporters in Angier covered the story in any depth or explained what happened to this company, which reportedly employed 90 people as of last summer. I see no indication that any reporters investigated the Chicago parent, AM2PAT, also owned by Patel. Where are you, news media? I'm glad the FDA is doing its job.