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Practice Tip: Will the Real Drug Manufacturer Please Stand Up?
You are defending a manufacturer in a pharmaceutical product liability action. The plaintiff has testified that she obtained a prescription from her doctor for your client's medication and filled it at a reputable, national chain pharmacy. The doctor's records confirm that the prescription was written and the pharmacy records confirm that it was filled with your client's product. Normally, that scenario would dispel any doubts concerning the adequacy of product identification and you would identify other fronts on which to defend.
Never judge a book by its cover, or the contents of a bottle of prescription drug medication by its label.
Most Americans believe that our drug supply is secure and that the problem posed by counterfeit drugs only pertains to 'recreational' drugs sold on the street or through fly-by-night Internet sites. But is our supply secure? The problem may be more widespread than most Americans think. The Food and Drug Administration ('FDA') has noted an increase in its investigations of counterfeiting activities. After averaging only five counterfeit investigations per year through the late 1990s, investigations have more than quadrupled to more than 20 per year since 2000, with 30 in 2003 and 58 in 2004. The FDA has reported an 'increased sophistication in the methods used to introduce finished dosage form counterfeits into the otherwise legitimate U.S. drug distribution system.' Combating Counterfeit Drugs, A Report of the Food and Drug Adminis-tration, February 2004, www.fda.gov/oc/
initiatives/counterfeit/report02_04.html. (See 'Looks Can Be Deceiving,' Minsk, Gardner, LJN's Product Liability Law & Strategy, October 2005.)
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