If FDA says a drug is safe, is a state court allowed to declare that it isn't? If FDA has approved a drug's labeling, can
the states decide that more would have been better and that pharma companies, by not including information that goes beyond
the FDA-approved label, can be held liable for failure-to-warn?
These are some of the issues that have been working their way through the courts in recent months. At stake, in the long run,
is pharma's ability to rely on FDA rulings as a defense against liability suits. That larger issue is a year or more away
from hitting the Supreme Court, but the Court took an important step forward in September, when it agreed to hear the case
now known as Warner-Lambert v. Kent. The case, which involves a Michigan statute and the diabetes drug Rezulin (troglitazone), promises to provide early signals
of the Court's thinking, as well as potentially changing the playing field for pharma. To find out more, we turned to Mark
Herrmann, a partner in the Chicago office of law firm Jones Day.
What are the details of the Warner-Lambert case?
It's part of a multidistrict litigation where a collection of people have sued the same company. There is a Michigan law that
governs at least the claims of Michigan residents. Part one of the Michigan law says essentially that drug companies are immune
from liability for FDA-approved products. But part two says the plaintiffs are allowed to sue if they can show that the drug
company defrauded FDA. The question in Warner-Lambert v. Kent is whether that exception can exist, or whether it is displaced by federal law so there is no exception. If there is no exception,
then the Michigan law would just be: Plaintiffs can't sue the drug company, period.
What does fraud against FDA mean?
Well, there's a battle over that too. If you leave the meaning of fraud on FDA open, it becomes a loophole that trucks can
drive through, because there is always some scrap of information that companies didn't send to FDA. If the plaintiffs can
say that's fraud, then in essentially every case you have a claim of fraud on FDA.
Some say fraud on FDA should mean FDA itself discovered the fraud—perhaps even prosecuted the company for having defrauded.
If that happened, then private plaintiffs can sue. Otherwise, the private plaintiffs haven't shown a fraud on FDA, so they
shouldn't be allowed to sue.
Relatively few states have laws like Michigan's. What are the implications for the industry in this case?
Eight states have laws that you would say could make a big difference to pharma. Michigan's is the strongest because you simply
cannot sue the drug company unless the drug company defrauded FDA. The next strongest statute that's still a huge help to
the drug industry is the one in Texas that says you cannot sue a drug company for a failure-to-warn claim unless the company
defrauded FDA. Then six other states have laws that say you cannot recover punitive damages from a drug company unless the
drug company defrauded FDA; the six include New Jersey, where an awful lot of companies are headquartered. So the stakes are
reasonably high—but not as high as they will be when the next case comes up.
What is that case and what are the high-stakes issues for pharma in that case?
People are watching a couple of cases. One is Colacicco v. Apotex, which is set for argument in the Third Circuit Court of Appeals on December 10. Another is the cert petition in Levine v. Wyeth. They want to see which will be first to grapple with the big, broad preemption issue that has the potential to give some
real protection to drug companies.