Posted on HealthCare Medical Institute website
17 October 2010
Chief Justice Roberts Agrees with Justice Sotomayor
The Supreme Court Justices seemed concerned that design defects were disallowed as a reason to sue in the court system as a result of prior rulings in this case. Justice Sotomayor asked pointedly of Ms. Sullivan, attorney for the pharmaceutical company Pfizer, Inc. (now owner of Wyeth), “Point me to the FDA regulations or law where the FDA, in giving a license to or permitting a new vaccine, actually looks at whether that vaccine is the most efficacious way with the least serious harm to the population. Is there a regulation that requires that judgment by them before they issue permission to market?” Ms. Sullivan replied, “There is not, Justice Sotomayor.” Justice Sotomayor responds, “All right. What is the motivation? If there is no — there’s no approval mechanism for the FDA to look at that issue, what is the motivation for manufacturers to voluntarily remove a drug that is causing harm to the public before the FDA acts? If they are completely immune under your reading of this preemption statute, what motivates them to act more quickly?” The drug company lawyer did not respond with an answer. Justice Sotomayor continued, “Could you please just answer that question? What is the motivation for the manufacturer to either continue the testing of their product and voluntarily stopping it if a better design has been found by someone else or even an inducement for them to find a better design if a competitor comes around? Because I don’t see why they should stop until they have caused as many injuries as they need to before the FDA says stop.” Once again, Ms. Sullivan did not answer the question only to be probed by Chief Justice Roberts, “Before you get to that, I think your answer to Justice Sotomayor’s question is: Nothing; the manufacturers have no reason to take the vaccine off the market until the FDA tells them to.”
The Court is Stunned
In the following argument, Justice Kennedy is concerned that the pharmaceutical company attorney asserts that the drug company need never inform the government of safer vaccines and that the consumer may not sue on the basis of the drug company intentionally withholding drug safety information. Justice Kennedy asked, “But if the manufacturer is slow or remiss or negligent or willful in not giving the information to the Government, there is nothing the injured person can do. There is still complete preemption, under your view?” The drug company attorney replied, “Of design defect claims, Justice Kennedy, but not of warning claims.” Justice Kennedy replied, “The warning doesn’t have to say, ‘Warning: We could make something better if we wanted to’.”
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