Monday, June 15, 2009

Physician Confusion: Do Physicians "Sell" Prescription Drugs?

Does "situational ethics" mean that your ethics change to fit the situation?

Because "practical lawyering" sure seems to mean that your legal status should change to fit the situation.

We couldn't help but laugh when we read Hadley v. Wyeth Laboratories, Inc., No. 14-07-01055-CV, slip op (Tex. App. [14th Dist.] May 28, 2009) (link here).

There's nothing funny about the opinion on its face. Dr. Hadley and Wyeth had both been named as defendants in a "diet drug" (Pondimin/Redux) product liability case. Both successfully moved for summary judgment based on the statute of limitations. Dr. Hadley filed a cross-claim against Wyeth, claiming that he was an innocent seller entitled to indemnity from the product manufacturer under Texas Civil Practices and Remedies Code Sec. 82.

The parties filed cross-motions for summary judgment on the indemnity claim. The trial court granted Wyeth's motion and denied Hadley's, and the appellate court affirmed. The court of appeals held that physicians are not, under the common law, "considered sellers for products liability purposes," because physicians are primarily providing medical services, not goods, and "the essential nature of the relationship [between physician and patient] is . . . a professional, medical one."

The court also held that the statutory definition of "seller" does not expand the common law definition so as to include physicians. Under the statute, a seller must be "engaged in the business of selling," and physicians are not: Physicians "are not selling the medication for commercial purposes but are engaged in the business of providing professional medical services."

So why, you might ask, did we think that was funny?

We spend our lives watching physicians tell courts that physicians are not "sellers" of prescription drugs and devices. A "seller" of a product may theoretically be liable on a product liability claim, because a "seller" is arguably in the chain of distribution of the product. A physician named as a defendant in a product liability case will thus scream that he's not a "seller."

And "sellers" may also be theoretically liable under contract theories because of the nature of the relationship between "buyer" and "seller."

So, nine times out of ten, physicians insist that they are not sellers of prescription products.

That's what we're used to.

And along comes Hadley. The situation changes, and a physician decides that it would be convenient to be deemed a seller.

But that's not enough to make us laugh. (We're easy, but we're not that easy.)

No, no, no.

We wouldn't have laughed unless we had represented the medical device defendants in Balderston v. Medtronic Sofamor Danek, 285 F.3d 238 (3d Cir. 2002). There, a prescribing physician, Dr. Balderston, sued the companies that manufactured the medical devices he prescribed. Balderston alleged that the companies had deceived him about the FDA regulatory status of the medical devices, which exposed Balderston to lawsuits by patients claiming that he had not given them appropriate informed consent.

Balderston had blown the statute of limitations on any conventional claims, so he sued under the Pennsylvania Unfair Trade Practices and Consumer Protection Law, which had a six-year limitations period. But to have standing under the UTPCPL, a plaintiff must be a "purchaser" of a product.

You guessed it: In Balderston, the plaintiff pleaded that a physician is not a seller of a prescription medical product, but rather a buyer -- a "purchaser" -- of them.

So there you have it: Physicians do not sell prescription medical products. Unless it's convenient to do so, and then they do.

And, in the right situation, physicians are not sellers but buyers -- "purchasers" of the products they prescribe to their patients.

It's enough to make your head spin.

Or at least to make you ponder the meaning of the phrase "situational ethics."

1 comment:

Tom Hurney said...

The WV Supreme Court held, in Blankenship v. Ethicon, Inc.,
656 S.E.2d 451 (WV 2007, that claims arising from infections caused by unsterile sutures (manufactured by Ethicon) were governed by the Medical Professional Liability Act. Plaintiffs sued the manufacturer and distributors and also two hospitals (coincidentally diversity destroying defendants) but did not comply with the presuit Notice of Claim and Certificate of Merit requirements, WVCode 55-7B-6.

The Court held the hospitals were engated in "health care" as defined in W. Va.Code § 55-7-2(e) (2006)as "any act or treatment performed or furnished, or which should have been performed or furnished, by any health care provider for, to or on behalf of a patient during the patient's medical care, treatment or confinement." The Court stated "[t]he implantation of sutures is a classic example of health care. Sutures, by their very nature, are implanted during the course of and in furtherance of medical treatment, i.e., surgery or wound repair."

So, in WV, hospitals can't be sued as "distributors" of devices; instead, the plaintiffs must comply with the MPLA, and plead and prove a malpractice case.