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The FDA law blog has a very interesting post today about Massachusetts’ enactment of a law governing prescription drug and medical device marketing. Not only is the Commonwealth regulating promotional activities, but its also decided to do its part to combat the obesity epidemic – by prohibiting the “free lunch.” Can’t have fat doctors, we guess.
We’re not going to duplicate our fellow blogger’s efforts. But reading the bill itself (most of the interesting stuff in in chapter 111N) raises a number of litigation related questions – we don’t purport to have the answers – in our minds.
First, section five of the first part of the statute essentially sets up a state-run “counter-promotion” program to disseminate information about prescription medical products. Oh, goody, another independent source of risk information. Defense attorneys in the Commonwealth should be alert to this, since such additional information can support a motion either that our client’s warnings were adequate (if the state’s people were not doing anything more) or that there’s no causation because the learned intermediary already knew about whatever’s being litigated from these independent actors.
Second, we don’t see any immunity provisions in section five, so how long will it be until this program itself (either the Commonwealth, the University of Massachusetts Medical school, or the outreach personnel) gets sued for negligent failure to warn – especially in a case involving a PMA device otherwise subject to Riegel preemption and the plaintiff is looking for a viable defendant?
Third, we note that the act: (1) is “notwithstanding” any “general law,” (2) provides no private right of action, and (3) explicitly restricts enforcement to the state attorney general. That being the case, we think that gives rise to an argument that the act ousts, as improper attempts at private enforcement, Massachusetts tort claims that purport to base liability, in whole or in part, upon our client’s promotional activities. Either the act allows something, in which case the “notwithstanding” provision preempts common law, or the act prohibits something, in which case the issue is in the hands of the attorney general, not the tort system.
Third, while the act does not explicitly limit its scope to activities involving Massachusetts physicians or occurring on Massachusetts soil, neither is there any explicit grab for extraterritorial power. Thus, our take is to avoid potential constitutional infirmity (we don’t think Massachusetts has the power, in our federal system, to regulate CME events occurring, say, in New Hampshire) and interpret the statute as limited to promotional activities in Massachusetts or involving Massachusetts citizens.
Fourth, does the act restrict activities by Massachusetts manufacturers of prescription medical products that take place solely in other states? We don’t know, but potentially affected manufacturers will need to consider their options.
It will interesting to see what the answers to these questions turn out to be.