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Remember “Dr. Strangelove“?
“Ripper: Have you ever heard of a thing called fluoridation. Fluoridation of water?
Mandrake: Uh? Yes, I-I have heard of that, Jack, yes. Yes.
Ripper: Well, do you know what it is?
Mandrake: No, no I don’t know what it is, no.
Ripper: Do you realize that fluoridation is the most monstrously conceived and dangerous Communist plot we have ever had to face?”
We have a rule here at the Drug and Device Law Blog: We don’t write about unpublished Tenth Circuit opinions unless they remind us of “Dr Strangelove.”
You’re in luck!
In Ronwin v. Bayer Corp., No. 08-8089, slip op. (10th Cir. June 17, 2009) (link here), Ronwin, age 77, ingested the statin Baycol for seven months. Two years later, Rowin was diagnosed with a torn rotator cuff, which he had surgically repaired. Naturally, he sued Bayer, claiming the statin caused the torn rotator cuff.
Ronwin proffered his own expert testimony and that of Dr. Raul Reyes in support of his claim. Reyes was a surgeon with over 50 years experience, but “he admitted in his deposition that he had never prescribed statin drugs and that he was unaware of any published medical literature linking statins, or Baycol in particular, to rotator cuff injuries.” Slip op. at 6-7.
Ixnay on the expertsay.
Now Ronwin himself was a different story. He’d been a chemist and biochemist for nearly 20 years before going to law school and then practicing law for 20 years. And here was his theory — and our “Dr. Strangelove” moment!
Ronwin said that Baycol’s chemical structure “can give rise to flouride ion which can, in turn, cause injury to numerous body components . . . . In support of this theory, he cited a book and a number of scientific papers addressing the effects of flouridated drinking water on various parts of the human body.” Id. at 8.
The Tenth Circuit gave Ronwin’s contention more dignity than we have here — what with our snitty comments about Dr. Strangelove and all that — holding only that “Dr. Ronwin’s relevant practical experience in biochemistry was too stale to qualify him to give an expert causation opinion in this case.” Id. at 9.
The appellate court also trotted through a few other familiar issues to wrap things up. A plaintiff is required to offer existing scientific proof of causation and cannot rely on a hope that future studies will link the plaintiff’s injury to the defendant’s drug. Id. at 9-10. A treating physician must rule out all other possible causes of an injury if a differential diagnosis is to be trusted. Id. at 11. And, in addition to ruling out other causes, a physician must also “rule in” the defendant’s drug as a possible cause of injury. Id.
So we’re generally happy with this opinion, although we wouldn’t have minded if the Tenth Circuit had chosen to publish it.
In fact, there’s really only one other issue that’s eating at us:
“We must be . . . increasingly on the alert to prevent them from taking over other mineshaft space, in order to breed more prodigiously than we do, thus, knocking us out in superior numbers when we emerge! Mr. President, we must not allow . . . a mine shaft gap!”