Congressgave the FDA the power to regulate medical devices becausethe failure of A series of high-profile medical devicesintended

Many think it is in the hip pocket ofthe big drug and device companies, even Rosetta Stone the more so underthe Republicans. Yet the screw-the-small-guyfive-plus-two-and-one-half want to take away the protectiongiven by state law against such federal incompetence --against incompetence, if not venal ity, of the type that In her powerful dissent, Ginsburg said Congressgave the FDA the power to regulate medical devices becausethe failure of A series of high-profile medical devicesintended for human use . . . . Conspicuous among thesefailures was the Dalkon Shield of horrendous history. ButCongress never intended, Ginsburg said, to prevent (topreempt, in legalese) state common law claims by injuredparties, a point for which she cited various elements of thelegislative history and even cited a supporting statement bythe former chief counsel of the FDA itself. Scalia, on theother hand, ignored legislative history because he leads amovement to completely abandon its use.&nbs Sowhat we have here is a Supreme Court decision that onceagain screws over the small man, does so without any basisin Congressional history or purpose, but, rather, contraryto that history and purpose, and screws him over on thebasis of unsupported assumptions of what juries might do andwith no regard for the recognized fact that the federalagency that is supposed to protect the small guy isincompetent and, apparently, is in the hip pocket of the bigdrug and device makers. This is not the concern for thegeneral welfare, the concern for a jurisprudence of welfare,or the concern for what investigations or social scienceshow to be the facts, that was articulated so many years agoby Pekelis and Miller I close with a last pointthat I am unable to resist. Thirty-six years ago, in 1972,the Rosetta Stone Chinese DePaul Law Review printed a symposium on the shiftingbalance of powers between the federal government and thestates. The federal/state balance is a subject that is everwith us, and is with us still, of course. I was asked to anddid write the Introduction to that Symposium, and think theantepenultimate and penultimate paragraphs of theIntroduction are pertinent to a case likeMedtronics:The abuses of modern technology and themodern economy are usually perpetrated by interstateorganizations, and curtailing these abuses will consequentlyhave interstate effects of one kind or another. Thus, theeasy answer for courts to give on the preemption problem isoften that the power of cure resides solely in the nationalgovernment. This is particularly easy when the nationalgovernment has already addressed itself to the problem insome way. But, knowing what we do know of the inadequaciesin Washington, the easy answer may not always be the safeone from the standpoint of health and welfare.Thereal challenge is for the courts to work out a set ofcoherent legal doctrines which have the effect of insuringthat the citizen obtains adequate protection againsttechnological and economic abuse. Such doctrines would haveto be flexible enough to permit protection to be given bythe political branches of the federal government when theyare doing a better job than the states, and to be given bythe states when they are doing a better job than thepolitical branches of the federal government. At the sametime, the doctrines would have to be sufficiently principledso that decisions would not be rendered on a totally ad hocbasis. Lastly, the complete set of doctrines would have toprovide for judicial protection in cases where neither thestates nor the political It is obvious, is itnot, that what is suggested in these two paragraphs isemphatically not what the Supreme Court did in Medtronics,where it did not protect the citizen but instead found a wayto screw him over in favor of big business and big,centralized government as represented by an ineffectivefederal agency? Nor does the Medtronics opinion do whatPekelis and Miller urged by maximizing human welfare insteadof screwing people over. And such screw-the-small-guy,Medtronics type jurisprudence from the Supreme Court is oneof the re This posting represents the personal views ofLawrence R. Velvel. 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