With both sides lobbing us cases (yes the PR war over Aredia/Zometa has heated up to the point that even plaintiffs send us stuff) in the ongoing Aredia/Zometa (hereafter “A/Z” – for obvious reasons) product liability struggle, we know of four new decisions.  Here’s what’s happening (in chronological order).

On February 8, the Fourth Circuit, in a (thankfully) unpublished and thus non-precedential opinion, affirmed the plaintiff’s verdict in Fussman.  See Fussman v. Novartis Pharmaceuticals Corp., ___ Fed. Appx. ___, 2013 WL 474330 (4th Cir. Feb. 8, 2013).  This is the case where an obviously runaway jury awarded over $12 million in punitive damages.  Well, after that punitive damages award was reduced by over 93% (to $861,000), the Fourth Circuit affirmed it, stating that there was “sufficient foundation” to find “willful” conduct.  Id. at *8.  It’s hard to comment, because the opinion doesn’t state what this conduct evidence was, but any time a punitive award is affirmed (a fortunately rare occurrence), we’re not happy.

What struck us about this aspect of Fussman is the lack of any discussion about the magnitude of the alleged increased risk posed by A/Z.  Our biggest problem with punitive damages in prescription medical product cases is that the absolute risks of harm are generally small – on the order of 1% or less (often much less).  In such cases, even if the product doubled or trebled a pre-existing risk, we’re still talking about a small percentage likelihood that any particular person gets hurt.  The Restatement, on the other hand, uses a “substantial certainty” of harm standard for an inference of intent in the punitive damages context.  See Restatement (Second) of Torts §§8A, 500 (1965).  Lots of cases address this point – here’s a representative example:

This approach is consistent with the view expressed by American Law Institute in distinguishing recklessness − where a defendant knows there is a high risk of physical harm to another, but “deliberately proceeds to act, or fails to act, in conscious disregard of … that risk” − from simple negligence, characterized as “mere inadvertence, incompetence, unskillfulness, or a failure to take precautions.”  Restatement (Second) of Torts § 500 cmts. a & g (1965).  The latter, lacking malice, cannot support punitive damages, while the conscious disregard of a known and sufficiently serious risk of harm is the equal of malice.  [Courts] regularly emphasize[e] the awareness of risk necessary to justify an award of punitive damages: only in those instances where an “actor has intentionally done an act of an unreasonable character in disregard of a known or obvious risk that was so great as to make it highly probable that harm would follow, and which thus is usually accompanied by a conscious indifference to the consequences”. . . .

Accordingly, we hold that the culpability necessary for an award of punitive damages based on reckless or wanton misconduct requires evidence that the defendant acted, or failed to act, in conscious and deliberate disregard of a known, substantial and intolerable risk of harm to the plaintiff, with the knowledge that the acts or omissions were substantially certain to result in the threatened harm.

Fly Fish Vermont, Inc. v. Chapin Hill Estates, Inc., 996 A.2d 1167, 1176 (Vt. 2010) (numerous citations omitted) (emphasis added).  Accord, e.g., Strenke v. Hogner, 694 N.W.2d 296, 304-05 (Wis. 2005).  There are lots more examples – perhaps enough for a separate post.Continue Reading The Latest On Aredia/Zometa