Tuesday, February 5, 2013

Drug Compounder Bankrupt, Cleaner Blamed, Industry Scrutinized, Meningitis Victims Outa Luck

If we're smart, we learn from the mistakes of others. Drug compounding firms, especially in Massachusetts, were warned about unannounced inspections following New England Compounding Center's sale of steroid injections tainted with fungal meningitis.

Massachusetts Department of Public Health Tuesday ordered 11 compounding pharmacies to completely or partially close after surprise inspections. The state inspected 40 sterile compounding pharmacies. Eight of the 11 cited have submitted corrective plans, officials said. They must implement the corrective measures, including renovations if necessary, and pass re-inspection. (http://www.cnn.com/2013/02/05/health/massachusetts-compounding-pharmacies/index.html) They had to have seen that coming.

Twenty-one other pharmacies were cited for minor deficiencies that have since been corrected or are being addressed.
 
As for the company that drew regulators' attention to the industry, the public health department in October permanently revoked NECC's license to operate as well as the licenses of its three principal pharmacists. According to its report, state and federal investigators "identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public's health at risk."
 
I'll bet you're feeling sorry for the owners, eh? Don't. "The owners ... received more than $16 million in wages and payments as the company grew increasingly prosperous in its final months. The four family members, who served as the New England Compounding Center's directors, received the money between late December 2011 and late November 2012, according to a bankruptcy court filing. The largest payout went to firm's majority shareholder, Carla Conigliaro, who received $8.7 million.
 
"The vast majority of the money paid to the owners was distributed before the outbreak was discovered in Tennessee in September.... A company spokesman did not respond to a request for comment on the recent filing."  (http://www.cbsnews.com/8301-204_162-57565265/owners-of-embattled-new-england-compounding-center-paid-$16-million-in-wages/)
 
The victims aren't so fortunate. More than 50 federal lawsuits have been filed in nine states, and more are being filed in state courts every day. The lawsuits allege that NECC "negligently produced a defective and dangerous product and seek millions to repay families for the death of spouses, physically painful recoveries, lost wages and mental and emotional suffering....
 
"'The truth is the chance of recovering damages from NECC is extremely low,' said John Day, a Nashville attorney who represents several patients who have been sickened by fungal meningitis." (http://www.cbsnews.com/8301-204_162-57559092/more-than-50-lawsuits-filed-in-meningitis-outbreak/)

NECC claims the steroid contamination wasn't its fault. It is looking to UniFirst Corp., which provides uniforms and cleaning services, to take legal responsibility for claims against the pharmacy. UniFirst acknowledged that its UniClean subsidiary helped clean portions of the pharmacy’s cleanroom facility.

"But UniFirst insisted the cleaning services were limited and it was not responsible for the contaminated drugs. The firm said two of its technicians cleaned portions of New England Compounding’s cleanroom for about 90 minutes once a month ­using the pharmacy’s own cleansing solutions.

“'UniClean was not in any way responsible for NECC’s day-to-day operations, its overall facility cleanliness, or the integrity of the products they produced,' said UniFirst spokesman ­Adam Soreff. 'We believe any NECC claims against UniFirst or UniClean are unfounded and without merit.'”  (http://www.boston.com/business/healthcare/2013/01/04/new-england-compounding-center-asks-unifirst-shoulder-responsibility-for-tainted-drugs/9Dcbq00NAprLd8oHDHYmHP/story.html)
 
 Neither UniClean (http://www.uniclean.com/index.html) nor UniFirst (http://www.unifirst.com/about/about_pressReleases.html) websites have any releases or statements about NECC's allegations against it. NECC's website remains unchanged since it posted information about its recall in October. (http://www.neccrx.com/)

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