We consistently defend the ability of physicians to engage in off-label use. Bexis helped lay the scholarly foundation for courts to utilize the term “off label use,” and two of his law review articles remain go-to reads on the subject.  Not surprisingly, we follow medical malpractice decisions that address off label use.  Back in 2009, Mark Herrmann (the Blog’s co-founder with Bexis), published a law review article articulating the reasons why package inserts should not be admitted as standard of care evidence in medical malpractice actions. More recently, we wrote a comprehensive post collecting case law rejecting the admission of package insert evidence to establish a violation of the standard of care by physicians who used drugs or devices off label. Today’s case is a detailed opinion from the Iowa Supreme Court joining what is now the majority view—that package inserts should not be admitted as substantive evidence of the standard of care.

S.K. v. Obstetrics and Gynecologic Associates of Iowa City and Coralville, P.C., 2024 WL 4714425 (Iowa Nov. 8, 2024), reversed a nuclear verdict of almost $100 million.  The plaintiff alleged that a baby suffered severe brain damage following an obstetrician’s use of both forceps and a vacuum delivery system during the baby’s birth. During trial, plaintiff’s counsel relied on the package insert for the vacuum to support the argument that the obstetrician delivering the baby should not have used the vacuum device.  The Iowa Supreme Court held that the package insert was hearsay and should not have been admitted, and it remanded the case for a new trial.

The trial was primarily a battle of experts. Plaintiff’s experts opined that (1) the obstetrician misused forceps during delivery and caused skull fractures and brain damage, and (2) the subsequent use of the vacuum device after use of the forceps caused additional brain injuries. They contended that the baby was permanently disabled and would require twenty-four-hour custodial care for the rest of his life. Defendant’s experts countered that the doctor’s use of the forceps and vacuum was entirely appropriate, and that the baby’s skull fractures were the result of natural forces of labor. They also opined that the baby was not permanently disabled and would be able to lead a normal and productive life without any need for continuing medical care. The jury obviously sided with the plaintiff’s experts, as they delivered a plaintiff verdict for $97,402,549.

The defendants (the obstetrics clinic and hospital) appealed on numerous grounds, but the court focused on the admission of the package insert for the vacuum device. As in most places, in Iowa hearsay is a statement made outside of court that is offered in court to prove the truth of the matter asserted.  The package insert contained language under the contraindications section such as “Do not initiate vacuum if any of the following conditions exist: . . .  failed vacuum or forceps attempt.” Id. at *5 (plaintiff claimed the obstetrician utilized the vacuum after two attempts to utilize forceps for delivery were unsuccessful). The adverse events section to the package insert provided:

Fatal Injuries:  Head trauma, bruises, contusions, lacerations, scalp edema, skull fracture, cephalhematoma, subgaleal hematoma, subdural hemorrhage, parenchymal hemorrhage, intracranial hemorrhage, retinal hemorrhage.

Id.  Plaintiff used the package insert to argue that the vacuum should not have been used after a failed forceps attempt, and plaintiff relied on the adverse events section since several of the potential injuries listed there matched what the baby experienced. The court had no trouble determining that the language in the package insert, as utilized by plaintiff, was hearsay.

Plaintiff claimed the hearsay was admissible under two exceptions to Iowa’s hearsay rule – the residual exception and the market reports exception.  The court first addressed Iowa’s residual exception (which tracks Federal Rule 804). The residual exception permits hearsay if (1) the statement is supported by sufficient guarantees of trustworthiness, and (2) it is more probative of the point for which it is offered than other evidence the proponent can obtain through reasonable measures. Iowa precedent holds that the residual exception is “to be used very rarely” and only in “exceptional circumstances.”  Id. at *6.  To be utilized, the exception requires that each of five requirements be satisfied: trustworthiness, materiality, necessity, notice and service of the interest of justice.

Defendants focused on the “necessity” requirement, which requires the hearsay evidence to be superior to other available evidence. The court found that the necessity requirement was not satisfied, because the package insert’s instructions were “general guidelines” for the use of the vacuum. Id. at *7. Importantly, the court recognized that physicians utilize their judgment, experience and training based on the specific facts and situations they encounter, but the package insert said nothing about the specific facts of this case. As a result the package insert was not superior to testimony offered by plaintiff’s experts—who addressed the same topics as the package insert as well as the specific facts of the case.  

The court also addressed the plaintiff’s arguments that the package insert was trustworthy because it required submission to the FDA. The record did not demonstrate whether the FDA specifically approved the insert or explain the clearance process for the vacuum. This cast doubt on whether the “trustworthy” prong of the residual exception analysis was satisfied. But even if it were, the court emphasized that the elements of the five-part test are individual requirements that must each be satisfied rather than weighed. With its finding that the necessity requirement was not met, the insert should not have been admitted at trial.

The court then turned to Iowa’s market exception, which permits the admission of “[m]arket quotations, lists, directories, or other compilations that are generally relied on by the public or persons in particular occupations.” Id. at *8. This exception typically applies to things like telephone directories and price lists. It does not apply to statements “that can be classified as directions, opinions, suggestions and recommendations.”  Id.  The court included a thorough discussion of this exception and cases interpreting it in similar contexts (such as MSDSs), but it had little trouble concluding that the exception did not permit admission of the package insert.

Finally, the court turned to whether the admission of the package insert was prejudicial.  Iowa courts presume that the admission of hearsay evidence is prejudicial, and that presumption can only be overcome if it is shown that the hearsay evidence did not affect the jury’s findings.  Plaintiff argued the evidence was merely cumulative, that the insert was effectively irrelevant, and that plaintiff’s evidence was overwhelming.

Plaintiff’s experts offered testimony relying on certain journal articles that conveyed some of the same warnings in the package insert. But the court emphasized that the journal articles were only discussed by plaintiff’s experts; they were not admitted into evidence like the package insert. The package insert actually went back to the jury room. Further, the journal articles told the jury that the use of the vacuum after forceps created certain increased risks, but they did not suggest that there was an absolute prohibition against using the vacuum after forceps. The package insert did convey that sense of absolute prohibition, and the plaintiff relied on it heavily during closing argument:

The vacuum [insert] says don’t use it if there’s a failed forceps delivery. Why? Because you may have injured the baby’s skull and you will pull the blood into the brain and you will kill brain cells and you will cause a subgaleal hemorrhage, you’ll cause a subdural hemorrhage . . . . Read it. Go back in the jury room. He has every hemorrhage they warn about. Do not initiate the vacuum. These words are pretty clear. You don’t have to be a doctor to know what they say, you can be a nurse. Failed vacuum or forceps attempt, don’t do it. Don’t do it. Don’t do it.  If you do it, here’s what will happen and that’s what happened.

Id. at *13.

The court also expressed concerns about the origin of the package insert. Since it was written by the manufacturer, it allowed the plaintiff to suggest that the manufacturer would not have approved of the doctor’s use of the vacuum. The court cited Mark Herrmann’s law review article to support this point, noting that “public misconception and distrust about off-label use is common and deep-seated.” Id.  These concerns and plaintiff’s use of the package insert would have led the jury to place substantial weigh on the insert—supporting the court’s conclusion that the admission of the package insert was prejudicial.

Finally, the court rejected plaintiff’s claims of irrelevance and overwhelming evidence. Plaintiff suggested there was no failed forceps attempt based on the testimony of the treating physician, but that was at odds with the arguments plaintiff’s counsel made at trial about the package insert and the use of the vacuum. With respect to overwhelming evidence, plaintiff claimed the evidence established the baby suffered severe brain injuries even before use of the forceps, so evidence related to the package insert and injuries from the vacuum were inconsequential. The court disagreed. Plaintiff’s case relied on injuries allegedly caused by the vacuum, and plaintiff used the package insert to support that argument. Further, there was not overwhelming evidence that any injuries suffered occurred before use of the vacuum.

This is a detailed and thoughtful opinion, and we recommend it to anyone contesting the use of package inserts to establish standard of care. We very much like reading and reporting on opinions that rely and build on the earlier scholarship of the blogging team.