We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.”  21 C.F.R. §801.109(c).  That requirement comes with an exception:

Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information. . . .

Id. (emphasis added).

Now, we’ve blogged before that a similar exception exists under many states’ common law that a warning need not tell physicians how to practice medicine in order to be “adequate.”  But in the device area – we looked, but did not find an analogous FDA regulatory exception for drugs – the FDA has itself recognized this common-sense, and common-law, exception to the duty to warn.

Somewhat surprisingly, at least until recently, there hasn’t been much case law addressing the FDA’s “commonly known” hazard exception.  The most notable application of this exception was in Ellis v. C.R. Bard, Inc., 311 F.3d 1272 (11th Cir. 2002), which rejected a Georgia plaintiff’s contention that a medical device manufacturer had a duty to place a warning on the product itself “that third parties should not activate the PCA pump on behalf of the patient to whom it is prescribed.”  Id. at 1277.  The evidence showed, however, that “[e]ach doctor and nurse involved with [plaintiff’s] medical care in 1997 was aware that only the patient should activate the [device] unless a doctor instructed otherwise.”  Id.

Thus, all the evidence in Ellis indicated that the plaintiff’s claim was contrary to §801.109(c):

Thus, contrary to [plaintiff’s] contentions, §801.109 did not require defendants to include a written, on-[product] label warning family members against the danger of third parties activating [it]. . . .  Indeed, § 801.109(c) goes further and provides that the labeling information may even be omitted from the dispensing package when the hazard is “commonly known to practitioners licensed by law to use the device.”  Id.  This is also precisely the case here.

311 F.3d at 1286.  The plaintiff’s negligence per se contention that the defendant had somehow violated the FDCA in Ellis therefore failed.

Walker v. Johnson & Johnson Vision Products, Inc., 552 N.W.2d 679 (Mich. App. 1996), is the only other appellate decision we’ve found applying the “commonly known” proviso of §801.109(c).  Walker dealt with preemption in a pre-Lohr (sort of) and pre-Buckman landscape.  It construed the plaintiff’s warning claim as “not based on state law,” but rather as a violation of §801.109(c), for failure to warn of a risk that was not “commonly known.”  Id. at 686.  Other than recognizing §801.109(c), Walker doesn’t add much to current law – since the common-law claim that Walker assumed was preempted would now be allowed under Lohr, and the claim Walker did allow would now be preempted as private FDCA enforcement under Buckman.

In the FDA regulatory context, United States v. Articles of Device (Acuflex; Pro-Med), 426 F. Supp. 366 (W.D. Pa. 1977), recognized that the FDA’s “regulations provide that only when this [device-related] information is commonly known to practitioners licensed to use the device may it be omitted from the packaging.”  Id. at 370 (citing §801.109(c)).  The court upheld FDA enforcement, since the Agency supplied affidavits establishing that physicians “d[id] not commonly know” the relevant information and the defendant “d[id] not assert  that all physicians commonly kn[e]w” it.  Id.

The two recent cases that spurred our interest in the §801.109(c) “commonly known” exception, both brought it to bear in mesh litigation.  See Tedder v. Ethicon, Inc., 2022 WL 970681 (N.D. Fla. March 31, 2022); Robinson v. Ethicon, Inc., ___ F. Supp.3d ___, 2022 WL 614919 (S.D. Tex. March 2, 2022).  In Robinson, which includes the more detailed discussion, one of the plaintiff’s experts – who purported to be an FDA expert – offered the fallacious opinion “that the knowledge of physicians was irrelevant to what should be included in the IFU [defendant’s instructions for use] because there are standards and regulations governing what should be in the label.”  Id. at *4.  That testimony was contrary, not only to the common-law cases discussed in our prior posts, but also flatly contradicted §801.109(c).  Thus:

[The defendant] also cites the FDA’s guidelines that indicate there is no need to warn about commonly known hazards.  It asserts that expert opinions based on incorrect legal standards are inadmissible and that allowing [the expert] to testify about a standard that is different than the standard the jury will apply will confuse the jury.

Robinson, 2022 WL 614919, at *4 (citations omitted).  The court recognized that the defendant was right that the plaintiff’s purported FDA expert had misstated the law:

[The regulation] does, as [defendant] asserts, provide a limited exception to inclusion in the IFU if information is “commonly known to practitioners”. . . .  Thus, theoretically, a warning could be adequate even if it does not warn of certain side effects if the side effects are common knowledge to physicians licensed to use the device.

Id. at *5.  Ultimately, however, Robinson concluded that the expert’s regulatory misstatement was only “an issue for cross examination, not exclusion.”  Id.  The defendant “may ask its witnesses − and [the plaintiff’s expert] − if the items [she] opines should have been included in the label are common knowledge of physicians.”  Id.

A different, but equally off-base, mesh plaintiffs’ expert was excluded in Tedder where he testified that the defendant “failed to warn” of risks that he admitted in his deposition were “commonly known within the relevant medical community” and involved “a potential complication was commonly known by [the relevant community of] surgeons.”  2022 WL 970681, at *4.  Similarly to Robinson:

Defendants argue that [the expert’s] personal opinions conflict with controlling federal regulations, citing 21 C.F.R. §801.109(c), which provides that prescription device manufacturers may omit from the label information on directions, hazards, warnings, and other information commonly known to practitioners licensed by law to use the device.

Id.  The court in Tedder was less forgiving of this expert’s foibles and, on this basis, granted the motion to exclude this warning-related testimony – since this testimony demonstrated his lack of “qualification to testify to IFUs.”  Id. at *5.

So defense counsel should be aware of the “commonly known” exception to the warning requirements of §801.109(c).  It might trip up an opposing expert enough to exclude questionable opinions (Tedder), and if nothing else can provide an authoritative basis for cross-examining a not-very-expert “FDA expert.”