Tuesday, December 04, 2007

Sue the FDA!

Well, now, surprise: Dennis and Kimberly Quaid have sued Baxter Healthcare, the producers of heparin, after their newborn twins were given large overdoses of the drug at Cedars Sinai Hospital in Los Angeles. The suit claims that Baxter was negligent in packaging because both the small and large dosage vials had labels with blue backgrounds, when the vials "should have been completely distinguishable [by] size and shape."

Of course, that might have engendered confusion with some other medicine(s), but, anyway, all pharmaceutical packaging, warnings, etc. must be approved by the FDA. So why aren't the happy parents suing the FDA? And, by the way, why have the Quaids decided not to sue Cedars Sinai, the staff of which made the error? Baxter had sent a letter warning health-care workers to to read the heparin labels carefully, but the suit argues that an "urgent" warning should have been sent. Anyone want to guess the likely outcome if everyone starts using "urgent" warnings so as to keep the lawyers at bay? Hint: Remember the boy crying "Wolf!"

The twins "appear to be doing well." But the lawsuit proceeds so as "to save other children from this fate. [The Quaids are] not looking for money." Right.

What is clear is that "similar" vials are not identical, and that if "blue backgrounds" are the only similarity, then the culpability of Baxter is far from obvious under any definition. But the litigation lottery proceeds apace, and shouldn't the rich and famous get to play too? That all of us ultimately will be the losers is not something that we can sue over.

[cross-posted from www.medicalprogresstoday.com/blog/]

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