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9th Cir - No Negligence Per Se Claim for Off-Label Promotion

By James M. Beck and Mark Herrmann

In an (unfortunately) not-for-publication opinion, the 9th Circuit affirmed a defense summary judgment in Carson v. Depuy Spine, Inc., No. 08-56698, slip op. (9th Cir. Feb. 16, 2010).  There's nothing particularly interesting about the affirmance as to the manufacturing defect claim.  But what the court had to say about plaintiff's allegations concerning off-label promotion is music to our ears.  First, there's nothing improper about off-label use:

The FDCA expressly protects off-label use: ?Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.? 21 U.S.C. § 396. In addition, the Supreme Court has emphasized that off-label use by medical professionals is not merely legitimate but important in the practice of medicine.

Slip op. at 5 (citing, you guessed it, Buckman).

Beyond that, plaintiff couldn't prove either a violation or causation with respect to her claim of supposedly illegal off-label promotion:

Because the FDCA prohibits private enforcement, 21 U.S.C. § 337, [plaintiff] asserts a state law negligence per se theory predicated on violation of federal law. . . .  In California, there are four elements required to establish a viable negligence per se theory: (1) the defendant violated a statute or regulation; (2) the violation caused the plaintiff's injury; (3) the injury resulted from the kind of occurrence the statute or regulation was designed to prevent; and (4) the plaintiff was a member of the class of persons the statute or regulation was intended to protect. . . .

The district court correctly concluded that [plaintiff] had failed to present sufficient evidence to create a genuine issue as to two of the elements: violation of federal law and causation. . . .  There is no evidence in the record to support [plaintiff's] claim that [defendant] illegally promoted an off-label use of the [device], that [the prescriber] was influenced by such promotion, or that the off-label use of the disk caused [plaintiff's] injury.

Slip op. at 6-7.

OK, we would have preferred a holding that because the federal statute prohibits private enforcement, you negligence per se is unavailable to make an end run around congressional intent, but you can't have everything.  Two other important principles were upheld:

(1) an illegal off-label promotion claim fails absent evidence that the prescriber was influenced by the off-label promotion.  That means no fraud on the market-type theories.

(2) there must be something about the off-label use - not just the use - of the product that actually caused injury.  The mere fact of an off-label use is not tortious.

Full post as published by Drug and Device Law on February 19, 2010 (boomark / email).