By Damian D. Capozzola, Esq., and Jamie Terrence, RN
News
The Iowa Supreme Court reversed a $97,402,549 verdict in a medical malpractice case, ordering a new trial because of the improper admission of hearsay evidence. The case involved a child who experienced severe brain injuries allegedly caused by the negligent use of an obstetrical vacuum during delivery. The jury had awarded substantial damages against the hospital and the obstetrics clinic employing the physician, but the Supreme Court found that the trial court erroneously admitted a vacuum manufacturer’s package insert, which warned against using the device after failed forceps attempts. The court determined that the insert was inadmissible hearsay and that its admission was prejudicial, as it likely influenced the jury’s verdict. As a result, the court vacated the judgment and remanded the case for a new trial, underscoring the importance of strict evidentiary compliance in medical malpractice litigation.
Background
The case arose from the August 2018 birth of a child at a hospital in Iowa City. During labor, the obstetrician attempted to deliver the baby using forceps. After two unsuccessful attempts, she proceeded with a vacuum-assisted delivery using a Mityvac obstetrical vacuum system. Following the birth, the child exhibited signs of severe distress. Medical evaluations revealed that the infant had sustained a skull fracture and suffered from hypoxic ischemic encephalopathy (HIE), a condition caused by oxygen deprivation that can lead to long-term cognitive and physical disabilities. The plaintiffs argued that these injuries were a direct result of the doctor’s improper use of the vacuum following failed forceps attempts.
The child’s conservator, acting on behalf of the child, filed a medical malpractice lawsuit against the hospital, obstetrician, and the clinic employing her. The plaintiffs alleged that the obstetrician’s use of the vacuum device was negligent and that both the hospital and clinic bore vicarious liability for her actions. Before trial, the plaintiffs dismissed their claims against the obstetrician, focusing their case solely on the hospital and clinic under a theory of respondeat superior liability.
During the trial, the plaintiffs sought to introduce into evidence the package insert from the Mityvac vacuum system. The insert contained explicit warnings against using the vacuum after a failed forceps delivery. It listed possible adverse effects, including skull fractures and brain hemorrhages. The plaintiffs argued that this document was evidence that the obstetrician’s decision to proceed with the vacuum was below the standard of care. The trial court admitted the insert over the defendants’ objections, and the plaintiffs relied heavily on it in closing arguments.
The jury found in favor of the plaintiffs, awarding damages for past and future medical expenses, loss of earning capacity, pain and suffering, and permanent disability. The total verdict came in at more than $97 million. On appeal, the defendants argued that the trial court erred in admitting the package insert, as it was inadmissible hearsay evidence. They claimed that the document was an out-of-court statement offered to prove the truth of its contents — that vacuum use after failed forceps attempts is contraindicated — and that it did not fall within any recognized hearsay exception. They also argued that admitting the insert was highly prejudicial because it improperly bolstered the plaintiffs’ claims and gave the jury an impression of regulatory endorsement that was unwarranted.
The Iowa Supreme Court agreed with the defendants, ruling that the package insert was hearsay and did not qualify for admission under any recognized exception. The court found that the residual hearsay exception did not apply because the package insert was not the best available evidence. Expert testimony was available to explain the risks of vacuum use, making the insert cumulative and unnecessary. The court also rejected the plaintiffs’ argument that the insert fell under the market reports exception to hearsay, as the document contained recommendations and warnings rather than neutral, objective data.
In analyzing the prejudicial impact, the court noted that the plaintiffs relied extensively on the insert during trial and particularly in closing arguments. The plaintiffs emphasized that the manufacturer itself had issued a blanket prohibition on vacuum use in situations like the one at trial, suggesting to the jury that the obstetrician’s actions were unequivocally negligent. The Supreme Court found that the plaintiffs’ reliance on an improperly admitted document unfairly influenced the jury. The court found that the insert undermined the defendants’ ability to challenge the plaintiffs’ claims through expert testimony and cross-examination.
As a result, the Iowa Supreme Court reversed the trial court’s judgment and remanded the case for a new trial.
What This Means for You
From the medical perspective, using vacuums after failed attempts for a forceps delivery is not a rare occurrence. It can be used successfully once or twice. But continued attempts to deliver the infant using either method is extremely risky. Prenatal care with frequent and accurate assessment of fetal weight is a prudent approach to avoid delivery complications. With a diabetic mother, as was the case here, precautions are critical, and an emergency cesarean delivery becomes a strong possibility.
Anticipating and preparing for complications is essential in every obstetrical setting. Medical equipment should be used only as designed by the manufacturer after training staff on its use. The purpose of the package insert is to provide basic instructions for use, but it cannot replace personalized individual instructions. Another purpose of the package insert is to protect the manufacturer of the device from litigation. The most stringent requirements usually are in bold print regardless of how trivial or exaggerated the circumstances. Or it may be in a font so tiny that it is overlooked. Relying on the assessment of the patient by trained practitioners is the safest way to reduce risk of harm.
In legal proceedings, hearsay refers to an out-of-court statement offered in court to prove the truth of the matter asserted. Generally, hearsay is not admissible as evidence. This principle is designed to ensure that all evidence introduced in court can be tested for credibility. One of the flaws of hearsay is that the party against whom the statement is introduced does not have the opportunity to cross-examine the person who made the original statement.
Without cross-examination, the factfinder is unable to assess the declarant’s demeanor, motives, and reliability, which are essential for determining whether a statement is credible. The rule against hearsay is thus rooted in fairness and procedural integrity.
Courts exclude hearsay to prevent unreliable evidence from influencing a jury. If hearsay were freely admitted, trials could be dominated by second-hand reports or speculation. For example, if a document containing allegations about a defendant’s conduct were admitted without the author being available for cross-examination, the jury would have no way of evaluating the credibility of the statement. This concern is relevant in medical malpractice cases, where scientific accuracy and expert interpretation are crucial in determining liability. If hearsay materials — such as manufacturer instructions or regulatory warnings — were freely admissible, plaintiffs could use them to sidestep the requirement that they prove negligence through expert testimony.
Despite the broad prohibition on hearsay, there are exceptions where courts deem certain out-of-court statements sufficiently reliable. These exceptions exist because, in some circumstances, the nature of the statement carries guarantees of trustworthiness. Some of the most relevant hearsay exceptions in medical malpractice litigation include statements made for medical diagnosis or treatment, business records, public records, and excited utterances.
Even when a hearsay exception applies, courts still must determine whether admitting the statement would unfairly prejudice the opposing party. Courts weigh the probative value of the evidence against the risk of undue prejudice, confusion, or misleading the jury. In Iowa, as in most jurisdictions, judges have discretion to exclude evidence if its potential to mislead jurors outweighs its usefulness in deciding the case. This balancing test is important in medical negligence cases, where improper reliance on hearsay materials — such as manufacturer warnings or package inserts — can skew the jury’s understanding of a physician’s duty of care.
The Iowa Supreme Court’s decision reinforces the principle that liability in medical negligence cases must be proven through admissible, cross-examinable evidence rather than hearsay materials such as manufacturer warnings. The plaintiffs sought to introduce a manufacturer’s package insert as evidence to demonstrate that the physicians deviated from the standard of care and committed negligence. The defendants objected, arguing that the package insert was inadmissible hearsay and should not have been presented to the jury as authoritative proof of negligence.
The Iowa Supreme Court ultimately agreed with the defendants. The package insert was hearsay and did not fall within any applicable exception. Although the manufacturer’s labeling may help establish the industry standards, they could not serve as a substitute for competent medical testimony from an expert witness regarding the standard of care. The ruling highlights a strict approach to hearsay, emphasizing that regulatory or instructional materials from third parties cannot replace the need for expert testimony. Medical negligence must be proven through direct, admissible evidence rather than external materials not subject to cross-examination.
For plaintiffs, this ruling presents challenges but also clarifications. On one hand, it removes a potential shortcut — plaintiffs cannot introduce manufacturer instructions as a stand-alone proof of negligence. This means plaintiffs’ attorneys must have expert witnesses who can articulate how a physician’s actions deviated from the standard of care without relying on external warnings. On the other hand, the ruling provides clear guidance on what is required to succeed in a medical negligence case. It clarifies that plaintiffs should focus on building strong expert-driven arguments rather than rely on evidence that could be struck down on appeal.
For defendants, the ruling serves as a reminder of the importance of making evidentiary objections and preserving issues for appeal. Improper evidence should be challenged as early as possible so that defendants do not waive their arguments on appeal and so that the appellate court has a fully developed record to review.
Ultimately, the case underscores the fundamental legal principle that evidence admitted in court must be reliable, relevant, and subject to scrutiny. Courts should ensure that verdicts are based on strong and rigorously tested evidence. The conduct of medical professionals should be judged based on expert analysis rather than external instructional materials.
Reference
- Decided on Nov. 8, 2024, in the Supreme Court of Iowa, Case No. 22-1317.
The Iowa Supreme Court reversed a $97,402,549 verdict in a medical malpractice case, ordering a new trial because of the improper admission of hearsay evidence.
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