Pennsylvanians have much to be proud of, including our history, sports, food, culture, and laws. We've got Valley Forge and Gettysburg. We've got the best (okay, after last night, maybe second-best) football team, and the best baseball and hockey teams. We might end up with the best college basketball team. We've got cheesesteaks and Primanti sandwiches. We've got the birthplaces of America's greatest actor, greatest composer, and greatest painter. And we've got pretty good case law. It's a pity when plaintiffs and judges get around that good case law by creating some really bad case law.
That's what happened in James v. Stryker Corp., 2011 U.S. Dist. LEXIS 7927 (E.D. Pa. Jan. 27, 2011). It's yet another pain pump case. The Complaint contained three causes of action: (1) negligence, (2) negligent misrepresentation, and (3) fraud. At issue here was the defendants' motion to dismiss the fraud claim. It turns out that the fraud claim is itself a fraud, because it didn't really allege any sort of fraud. The plaintiff alleged that the defendants "made material misrepresentations to Plaintiff, Plaintiff's physicians, and to the public that pain pumps and the anesthetics used in the pumps were safe for use following shoulder surgeries." Id. at *3. That's general, boilerplate stuff. It doesn't come close to satisfying Rule 9.
What exactly were the lies? Here's what the Complaint said by way of 'explanation': "The Defendants downplayed, understated, and/or disregarded their knowledge of the serious and permanent side effects associated with the use of their products, despite the existence of information available to Defendants that should have demonstrated that Stryker products were likely to cause serious injuries to product users." Id. More twaddle.
So at this point, the defendants figured out that there is less to this 'fraud' claim than meets the eye, and that it's merely a failure to warn claim. The court acknowledges that under Pennsylvania law, the plaintiff "would be required to demonstrate negligence to state a claim on the failure to warn theory." Id. at *6. (That's one of those bits of Pennsylvania law that's so much better than what we see in many other jurisdictions.) No such negligence is alleged in Count 3. So bye-bye bogus fraud claim, right? Nope. The judge bought the plaintiff's argument that the defendant might've "committed fraud by, inter alia, promoting their products for use that had been expressly rejected by the FDA." Id. at * 8. We still don't hear any fraud.
Does the Complaint lay out the deception? The court thinks so. We don't. Here is what the court relied on to find some hint of an off-label fraud:
-- "Defendants and their agents misrepresented to Plaintiff and her physicians that pain pumps and the anesthetics used in the pumps were safe for use following shoulder surgeries."
-- "Defendants knew that the FDA had not yet approved the pain pump for off-label uses, yet they continued to market the product for such uses."
-- "Plaintiff and her physicians relied on these misrepresentations, used Defendants' pain pump, and Plaintiff's injury resulted."
Now maybe we downed too many cans of Iron City last night, but we still don't know what the fraud is supposed to be. We can think of only two possibilities, both of which are utterly dopey: (1) Saying an off-label use is safe is inherently fraudulent; or (2) the defendants falsely said that the off-label use was on-label. The first theory is belied by the fact that there are many off-label uses that are not only safe but are standard medical practice. The second theory makes no sense, because it is inconceivable that a doctor could ever be misled into thinking an off-label use is on-label. Doctors have PDR's, labels, and the internet. Most of all, they have their education and training.
The court's opinion is bereft of logic. In a footnote, the court observes that "[w]here a manufacturer fraudulently markets a drug for 'off-label' uses, the marketing of that product is no longer justified in the way a drug marketed for its approved purposes is." Id. at *9 n. 3. There's nothing clear about that holding save for hostility to off-label use. The court seems to have made up some sort of new claim out of whole cloth, and that is particularly sketchy when it's a federal court presiding over a diversity case. We don't think a Pennsylvania state court would sign off on this silliness.
In short, there's no fraud in sight, except for the claim itself. By letting that claim go forward, the court gave us the equivalent of a dropped pass, a fumble, or a crazy penalty.