When the "Fen-Phen" class-action lawsuits began rolling through the courts in 1997, no one could have predicted what a debacle it would turn out to be. In the April 10th, 2006 issue of Forbes Magazine, authors Robert Lenzer and Michael Maiello examine the circuitous legal fallout of that ongoing drama in their engrossing investigative report " The $22 Billion Gold Rush." You can read the article in its entirety here. (Free registration required).

This case makes for a strong argument in favor of tort reform. I couldn't help but wonder how a settlement process could spin so far out of control, or that the media has generally disregarded the magnitude and consequences of this never-ending nightmare.

Now suppose we change the circumstances a bit. Instead of the diet drug Fen-Phen, suppose it was a drug of wide-scale use that raised the risk of serious illness or death as the result of inadequate or insufficient stability studies related to temperature cycling? What if that drug became dangerously adulterated due to improper storage or exposure to temperatures in distribution which adversely affected its efficacy or potency? The repercussions are unfathomable.

Couldn't happen you say? As Lenzer and Maiello point out, there are any number of opportunistic trial lawyers who chum the waters of unsuspecting drug makers whose compendial oversights, unintentional or otherwise, have landed them in court.

I have, for a long time, advocated that storage and distribution are neither separate nor exempt from the manufacturing process, but an extension of it. Everyone involved in the process has an obligation to the end-user, not just the drug maker. I'll bet I wouldn't have to look very hard to find an aggressive trial attorney to agree with me.

All the more reason to "get it right."