This post is not from the Dechert side of the Blog.
We exchanged e-mails today with one of our first mentors, many years retired. With this long-ago colleague, we tried our first prescription drug cases when we were fresh out of law school, creating some of the fondest memories of our decades-long legal career. Back then, a pharmaceutical case typically involved a single plaintiff suing her doctor for medical malpractice and including, in the alternative, a product liability claim against a prescription drug manufacturer. We remember sitting on the concrete floor of the “NDA room” in the client’s headquarters, spending hours upon hours sorting through manila folders of hard-copy documents in a frantic effort to comply with a discovery order. And any talk of mass torts, MDLs, or electronic documents would have been written off as science fiction.
As usual, today’s case is part of that “brave (not so) new world,” and, as you’ll hear, it includes a portent of a possible unpleasant corruption of a familiar doctrine. Luna v. Atrium Med. Corp., 2021 U.S. Dist. LEXIS 92244 (D.N.H. May 14, 2021), is a decision out of the hernia mesh MDL pending in the District of New Hampshire. In Luna, the plaintiff underwent umbilical hernia repair in California using the defendant’s hernia mesh patch. More than two years later, the plaintiff was hospitalized for fever and abdominal pain. She was diagnosed with an abdominal abscess infected with staphylococcus aureus, and the hernia mesh patch was removed. The plaintiff filed suit, asserting all of the standard product liability claims as well as claims under New Hampshire’s and California’s consumer protection statutes. The defendant filed for summary judgment on all of the plaintiff’s claims. The court denied the motion as to a number of claims based on its prior rulings, and several other claims were dismissed by stipulation. That left only the two consumer protection claims to be decided. The plaintiff alleged that the defendant violated both statutes “by knowingly and falsely representing” that the mesh patch “was fit to be used for the purpose for which it was intended while in fact it was defective and dangerous.” Luna, 2021 U.S. Dist. LEXIS 92244 at *10.
The New Hampshire Consumer Protection Act Claim
Under the NHCPA, it is “unlawful for any person to use any unfair method of competition or any unfair or deceptive act or practice in the conduct of any trade or commerce within” the State of New Hampshire. Id. at *9 (citation omitted). The defendant argued that the plaintiff lacked standing to bring her NHCPA claim because “the alleged misrepresentations or false advertising would have been received” in California, where the plaintiff’s doctors were located and where she underwent her surgery, and not in New Hampshire. Id. at *10. The court agreed, explaining that, although the New Hampshire Supreme Court had “yet to address the territorial limitations” of the NHCPA, several trial court decisions had held that “a NHCPA misrepresentation claim cannot be brought where premised on misrepresentations allegedly made in New Hampshire but received or heard by a consumer outside of New Hampshire.” Id. The court held, “It follows that defendant is entitled to summary judgment in its favor as to plaintiff’s NHCPA claim.” Id. at *11.
The California Consumer Legal Remedies Act Claim
To establish standing to bring her CCLRA claim, the plaintiff was required to show that she “suffered injury in fact . . . as a result of unfair competition.” Id. (citations omitted). As the court explained, “the phrase ‘as a result of” . . . requires a showing of a causal connection or reliance on the alleged misrepresentation.” Id. at *12 (internal punctuation and citations omitted). Under this formulation, the analysis of the claim proceeds in a manner that is nearly identical to a “warnings causation” analysis; to wit, to survive summary judgment, the plaintiff must adduce evidence that reliance on the “misrepresentation,” or inadequate warning, proximately caused her alleged injury.
This is particularly true because the court framed the analysis against the backdrop of the learned intermediary doctrine which, it held, applied with equal force to prescription medical devices like the hernia mesh patch at issue. (“There being no principled basis for distinguishing pharmaceuticals from medical devices in this context, the court assumes for purposes of this motion that the learned intermediary doctrine applies to a medical device manufacturer’s duty to warn regarding risks associated with its products.”) Id. at *14 (citations omitted).
Here is how the learned intermediary doctrine entered the equation: the defendant argued that the plaintiff “lacked standing to pursue her CCLRA claim because she [could not] prove the reliance element.” According to the defendant, the plaintiff could not have relied on false representations about the product because she herself did not make the decision to use the particular patch and because she did not see any advertising or representation about the product before it was used in her surgery. The court “agree[d] with defendant that plaintiff cannot establish that she personally relied on any advertising or representation regarding the” patch, but “disagree[d] that the reliance inquiry begins and ends with the plaintiff herself.” Id. at *12-13.
Instead, according to the court, “to the extent it was plaintiff’s medical providers who made the decision on plaintiff’s behalf to purchase and use” the patch, “it was those medical providers’ reliance (if any) on defendant’s advertising or representations,” under the learned intermediary doctrine, that was “at issue in connection with [the] CCLRA claim.” Id. at *13. At that point, the court paid the familiar, if always frustrating, lip service to the doctor’s testimony implying that adequate knowledge of the infection risk might have affected his decision to use the patch. The court held, “. . . [V]iewing the evidence in the light most favorable to plaintiff, a jury could reasonably find on the basis of [the doctor’s] testimony that . . . defendant had opportunities to convey any reasonably necessary warnings” about the patch, that it “failed to warn [the doctor] about any increased infection risk,” that “[the doctor] relied on that omission when he elected to use the defendant’s surgical mesh product,” and that “warning’s regarding increased rates of infection associated with the” patch would have “gotten [the doctor’s] attention and made him less likely to use” the patch. Id, at *15 (citations omitted). The court also fell down the “manufacturer didn’t warn that its product should not be permanently implanted in the human body” rabbit hole, crediting the doctor’s testimony that such information (though it likely did not exist) also would have affected his prescribing decision. Id. at *16.
Though distasteful, none of this was surprising. But then the opinion really went off the rails. The court stated, “Moreover, the record establishes that [the doctor] did not make the decision to purchase” the patch for use by surgeons at the hospital at which the plaintiff’s surgery was performed. Instead, “that decision was made by” others, and the doctor “relied on a risk-benefit analysis he assumes was performed by someone” at the hospital at the time the product was purchased.” Id. at *16. The court concluded, “The testimony of [the doctor] raises the reasonable inference that he (or whomever at the hospital exercised authority to purchase surgical products for the hospital) would not have chosen defendant’s product had it been accompanied by appropriate warnings . . . .” Id. at *16-17. Summary judgment denied.
We heard alarm bells when we read this. Even assuming that it is appropriate to view the reliance element of a consumer protection claim through the lens of the learned intermediary doctrine, the analysis should stop with evidence, or lack of evidence, of the doctor’s reliance. That is what the doctrine provides: the manufacturer has a duty to warn only the prescribing physician. Broadening the reliance/causation analysis to include unknown hospital personnel renders the argument unwinnable for a defendant, and it inevitably will lead to some sort of “ordinary person” reliance standard instead of the subjective standard – what the doctor actually knew—that is at the heart of the learned intermediary doctrine. We shudder at the possible slippery slopes.
From a defense perspective, Luna includes good and not-so-good results and one ominous footnote. We will keep you posted on similar decisions in all three categories. In the meantime, stay safe out there.