[Drug and Device Law] Another Aredia-Zometa Win, Read Against That Institute You Can't Disparage

1 view

Skip to first unread message

Steve McConnell

unread,

May 22, 2013, 7:30:04 AM5/22/13

to drug-and-...@googlegroups.com

Marriage is a civil institution, so it's natural that there are so many laws respecting it. Marriage is also an emotional, fragile relationship, so it's also natural that many of the laws are a bit nutty. For instance, on Sundays in Hartford, Connecticut, it is illegal for a man to kiss his wife. A married couple in a rented room in Massachusetts may not legally sleep in the nude. In Vermont, a wife must have written permission from her husband to wear false dentures. And marriage-law-madness is not confined to New England. You might have heard of proxy weddings, where the marriage ceremony takes place without the presence of either the groom or the bride -- somebody else stands in for one of them. There might be perfectly good reasons for that to happen. But in Montana (and, as far as we can tell, only in Montana) there can be a proxy for both the groom and the bride. We do not know whether the Big Sky state also countenances proxy honeymoons. In Kentucky, a woman is not allowed to marry the same man more than 3 times. Hmmm. Maybe that’s not so strange. Maybe that’s just common sense.

We’ve all likely heard the phrase that the “law is an ass.” It comes from the Charles Dickens novel Oliver Twist, when a character is schooled on the fine points of the doctrine of coverture. Specifically, Mr. Bumble is informed that “the law supposes that your wife acts under your direction”. Mr. Bumble replies “If the law supposes that … the law is a ass – a idiot. If that’s the eye of the law, the law is a bachelor; and the worst I wish the law is that his eye may be opened by experience.”

Joe Hollingsworth recently sent us another defense win in the Aredia-Zometa litigation, and there are a number of aspects to it that will cheer and empower other defense practitioners. But the case also reminded us of the way marriage sometimes sits rather oddly in the legal matrix. In Wheeler v. Novartis Pharmaceuticals Corp., Case No. 1:11-cv-0021 (S.D. Ga. May 15, 2013), a husband brought suit both on behalf of the estate of his deceased wife and in his personal capacity for loss of consortium. The claim was that his wife developed osteonecrosis of the jaw (“ONJ”) as a result of her use of Zometa. The court granted summary judgment for the defendant on the claims of both the estate and the husband, but for different reasons.

The court had no problem holding that the underlying claim on behalf of the wife’s estate was barred by Georgia’s statute of limitations for personal injury actions. Georgia law requires that “[a]ctions for injuries to the person shall be brought within two years after the right of action accrues…”O.C.G.A. §9-3-33. The lawsuit was filed on December 28, 2011. The court gave the plaintiff the benefit of the doubt by treating the prescription of the drug as a continuing tort (there were continual doses of Zometa), thus permitting the plaintiff to invoke the discovery rule. But even the discovery rule could not save the underlying claims.

The wife arguably discovered her injury as early as July 14, 2009, when she underwent the extraction and grafting procedure of her jaw. Less than a week after that extraction, her doctor told her that Zometa was a potential cause of her jaw injuries. On October 8, 2009, another doctor told the wife that “she had evidence of osteonecrosis of the jaw and that continuing the Zometa would worsen the condition.” Consequently, the wife knew the cause of her ONJ on or before October 8, 2009 at the latest. That was more than two years before she filed suit, so the claims based upon her personal injury were untimely and barred by the statute of limitations. On July 10, 2010, the wife passed away due to her metastatic breast cancer.

The husband’s loss of consortium claim was a different matter. We usually think of a loss of consortium claim as being completely derivative of the underlying claim. But the Wheeler court held that “[t]he running of limitation for a personal injury claim does not bar a derivative loss of consortium claim.” The statute of limitations for a claim of loss of consortium is four years, and thus the husband’s loss of consortium claim was filed well within the limitation period.

Thus we are presented with a case where the injured party might be out of court but the spouse could proceed with the loss of consortium claim. Still, the court granted summary judgment on the loss of consortium claim as well, because all of the underlying claims failed on the merits. First, there was “no probative evidence” to establish causation. The plaintiff failed to designate any expert witness to opine on causation. Slip Op. at 14-15. The learned intermediary doctrine barred the failure-to-warn claim because the wife’s prescribing oncologist testified that he was aware of the risks associated with Zometa at the time he prescribed it, that such risks were well known in the medical community, and most significantly, that he continues to prescribe Zometa in the same manner today as he did for the wife. Slip Op. at 16-18. Finally, the warranty claim failed due to a lack of privity, as there was no evidence that the drug was purchased directly from the defendant.

Maybe there are sound reasons why loss of consortium actions should enjoy a longer limitations period than the underlying action. Maybe the theory is that the spouse is less in a position to know when an action accrues. Here, the wife had died, so maybe there is some sense in giving the surviving spouse more time to figure out that there is a lawsuit. But the rule would seem to apply whether of not the primarily injured party was alive or not, and one could envision a very odd case where the injured party would be reduced to being a spectator to the loss of consortium claim. It would be just another case of marriage and the law making strange bedfellows.