Monday, December 6, 2010

Pharmaceutical Counterfeiting: The Effect of Technology, Regulation, and Legislation on Manufacturer Liability

“As more technologies become available and affordable, plaintiffs will contend that companies not employing technological protections—especially for drugs highly likely to be counterfeited—breach some duty to consumers.”

Caitlin Blanche an Associate with Snell & Wilmer out of Orange County, writes an outstanding essay in the American Bar Associations Mass Torts, Winter 2010 edition regarding the legal and liability perspective of the pharmaceutical supply chain stakeholder and the overall issue of pharmaceutical supply as it relates to fraudulent, adulterated, sub-standard and counterfeit drug.

While clearly written for a pharmaceutical industry General Counsel, Ms. Blanche’s article should be a must read for all industry insider’s as they look at dealing with one of the most insidious threats to the pharmaceutical industry and health care consumers at large.

Ms. Blanche outlines the issue, discusses relevant technologies/solutions and reports on regulatory initiatives while concluding with:

"Now, more than ever, attorneys should counsel clients about supply chain management, internal audits, the careful analysis and adoption of track-and-trace and anti-counterfeit technology, remedial measures, and monitoring of all relevant legislation introduced. Although courts have not yet imposed common-law liability for drug counterfeiting, there are a number of evolving variables in play, and plaintiffs could use any one of them to allege a new standard of care for manufacturers."

Secure Pharma Chain endorses Ms. Blanche's conclusions and encourages all within the supply chain to take proactive steps to secure their inventories from adulterated, fraudulent, sub-standard and counterfeit medications.

To read Ms. Blanche’s essay visit:

To learn more about anti-counterfeiting solutions for the pharmaceutical supply chain, visit:

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