[Drug and Device Law] Court Interprets North Carolina Law to Apply the Learned Intermediary Doctrine to Medical Device Cases
This post comes from the Cozen O'Connor side of the blog.
To those of us who were unable to find a slide in anything that Chase Utley did Saturday night, it made a whole lot of sense to suspend him for two games. The wisdom of the suspension does not only lie in the fact that, at least as we’ve seen it done and done it ourselves, sliding involves an actual slide across the ground in front of the base, not airborne hurtling above the base toward a fielder’s exposed leg. It lies at least as much in the practical decision not to allow Utley to trot to the foul line, walk to the plate, jog to his position, or do anything at Citi Field tonight. Because that might be dangerous. It shouldn’t be. But it might be. Whether you think his play was bush league or clean [the correct answer: “bush league”], there’s no denying that New York now has a palpable dislike for him, one based as much on his getting away with it as his doing it. And, by telling Utley, “no Citi Field for you,” MLB can defuse the situation. It was a sensible and practical decision, whether the suspension is supported by the language of the rulebook or not [the correct answer: “it is”].
So too was the Court’s decision in Carlton v. Boston Scientific Corp., 2015 U.S. Dist. LEXIS 132675 (W.D.N.C. Sep. 30, 2015). [That’s what we call a segue.] North Carolina has codified the learned intermediary doctrine, but its codification mentions only prescription drugs, not medical devices:
[N]o manufacturer or seller of a prescription drug shall be liable in a products liability action for failing to provide a warning or instruction directly to a consumer if an adequate warning or instruction has been provided to the physician or other legally authorized person who prescribes or dispenses that prescription drug for the claimant unless the United States Food and Drug Administration requires such direct consumer warning or instruction to ac-company the product.
N.C. Gen. Stat. § 99B-5(c). The learned intermediary doctrine is based on a real-world construct, however, in which patients gain access to certain medical products only through doctors, educated professionals who can understand and interpret the risks and benefits of medical products and describe them to patients. And that construct applies equally to medical devices and prescription drugs.
The Carlton court understood this. And so, while it recognized that the explicit terms of N.C. Gen. Stat. § 99B-5(c) apply only to prescription drugs, it also recognized that § 99B-5(c) was a codification of the longstanding learned intermediary doctrine. Implicitly reaching back to that doctrine, the court held that it applied equally to the medical device case before it as it would a prescription drug case, citing several decisions under North Carolina law recognizing this and one decision in particular that offered a clear description of why the learned intermediary doctrine should apply:
Although the North Carolina Supreme Court has never expressly ruled on this issue, courts have presumed that the North Carolina Supreme Court would apply the learned intermediary doctrine in a case involving a medical device such as this. See e.g., Baraukas v. Danek Medical, Inc., 2000 U.S. Dist. LEXIS 5122, 2000 WL 223508, at * 4 (M.D.N.C. January 13, 2000) (learned intermediary doctrine applied in context of action challenging surgical bone screw and observing, “There are indications that North Carolina courts would adhere to the learned intermediary doctrine.”) (citing Foyle By and Through McMillian v. Lederle Laboratories, 674 F. Supp. 530, 535-36 (E.D.N.C.1987), citing, Holley v. Burroughs Wellcome Co., 74 N.C. App. 736, 330 S.E.2d 228 (N.C. App. 1985), aff’d, 318 N.C. 352, 348 S.E.2d 772 (N.C. 1986). “According to the learned intermediary doctrine, where a defendant manufactures a product which is dispensed to patients by doctors, rather than directly, the defendant has a duty to warn only the doctor, rather than the patients of any risks associated with the product’s use. It is assumed that the doctors will pass along appropriate information to their patients.” Baraukas, 2000 U.S. Dist. LEXIS 5122, 2000 WL 223508, at * 4 (internal citations omitted).
Carlton, 2015 U.S. Dist. LEXIS 132675, at *6. Good. That’s the right outcome.
The court went on to uphold its earlier decision to grant Boston Scientific summary judgment because the doctor who implanted the device in plaintiff had read the directions for use, understood the risks and benefits, and nonetheless believed that the device [the Uphold device] was appropriate for plaintiff. In other words, plaintiff could not meet her burden to show proximate causation:
After agreeing that he had adequate information to properly evaluate the risks and the benefits of the Uphold for Ms. Carlson [the plaintiff], and aware of all of the risks (e.g., erosion, recurrence, urgency symptoms, urinary incontinence, pain), Dr. Kennelly opined that Ms. Carlson was an appropriate candidate for the Uphold implant. (Kennelly Dep., 155-56). Dr. Kennelly specifically testified, “I believe that for what [Carlson] had that the Uphold device was the optimum therapy for her, given her clinical condition, her concerns, her desire for sparing the uterus.” (Kennelly Dep., 189). Dr. Kennelly’s professional opinion remains that the Uphold is “a safe and effective option for the treatment of pelvic organ prolapse” in certain cases. (Kennelly Dep., 55). In conclusion, while Dr. Kennelly’s deposition testimony shows that Dr. Ken-nelly read the Uphold DFU, his testimony does not indicate that he relied on the DFU or that a different DFU content would have altered his treatment recommendation.
Id. at *9. Even better.
Unfortunately, as we are readying this post to “go to press,” there is news that Utley’s appeal of his suspension may not be heard today. And the suspension will not take effect until the appeal is heard. Oh boy.
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Posted By John J. Sullivan to Drug and Device Law at 10/12/2015 12:29:00 PM --
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