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Kromphardt v. Mercy Hospital arises from an obstetrical negligence claim involving forceps delivery, vacuum extraction, and profound neonatal brain injury. In March 2022, a Johnson County jury returned a $97.4 million verdict, one of the largest medical malpractice verdicts ever issued in Iowa.
The case gained broader significance when the Iowa Supreme Court reversed the judgment in November 2024. The ruling reshaped how courts evaluate documentation from medical device manufacturers, particularly in assessing the admissibility of design specifications and instructional materials.
This article examines the procedural history, the evidentiary dispute underlying the reversal, and the ruling’s implications for trial strategy and expert development in obstetric and medical-device litigation.
Kromphardt v Mercy Hospital: Case Background
The underlying incident of Kromphardt v Mercy Hospital occurred in August 2018 during delivery at Mercy Hospital, Iowa city. Plaintiffs S.K. (minor), Kathleen Kromphardt (mother), and Andrew Kromphardt (father) sued Mercy Hospital Iowa City, Dr. Jill C. Goodman (obstetrician), and Obstetric and Gynecologic Associates in the Iowa District Court for Johnson County.
Plaintiffs alleged the attending obstetrician employed improper forceps traction followed by vacuum extraction using a Mityvac device, resulting in skull fractures, ischemic brain injury, and seizures in the newborn. Fetal monitoring strips reportedly displayed non-reassuring tracings prior to instrument use.
The infant sustained severe neurological impairments requiring lifelong medical care:
- Permanent cerebral palsy.
- Learning disabilities.
- Facial nerve palsy.
- Subdural hemorrhage.
- Documented skull fractures and oxygen-deprivation injuries.
Prior to the verdict, Mercy Hospital settled for $7 million, leaving the remaining defendants to proceed through trial on standard-of-care allegations.
Kromphardt v Mercy Hospital: Medical Context & Instrumentation Standards
Obstetric guidelines generally caution against sequential use of forceps followed by vacuum extraction due to increased risks of hemorrhage, skull injury, and ischemic complications. The practice presents elevated injury potential compared to single-instrument approaches or timely conversion to cesarean section.
The obstetrician's sequential use of forceps followed by Mityvac vacuum extraction resulted in documented neonatal injuries. Mityvac vacuum systems and manufacturer guidance became central to plaintiffs' breach-of-care arguments during trial.
The Iowa Supreme Court ultimately held that this package insert constituted inadmissible hearsay under the state’s hearsay rule, which restricts the use of out-of-court statements offered for their truth.
Kromphardt v Mercy Hospital: Trial Proceedings & Evidentiary Dispute
The central evidentiary dispute involved a Mityvac package insert that plaintiffs offered to demonstrate warnings about vacuum use following failed forceps attempts. The manufacturer's documentation contained specific instructions and contraindications that plaintiffs argued established the relevant standard of care.
Defense counsel objected that the package insert constituted inadmissible hearsay because plaintiffs failed to present manufacturer witnesses or qualified experts to authenticate the document. The defense argued that offering manufacturer statements for their truth value required proper foundation through testimony from individuals with personal knowledge of the document's creation and accuracy.
The trial court admitted the Mityvac package insert over defense objections, creating the primary grounds for appellate review. The jury returned a verdict of $97.4 million, reflecting the severity of the injuries and projected lifetime care requirements.
Iowa Supreme Court Appellate Decision
In November 2024, the Iowa Supreme Court reversed the jury verdict and ordered a new trial, holding that the trial court committed reversible error by admitting the manufacturer's package insert.
The Court's decision established several critical precedents for medical device documentation in malpractice litigation.
1. Hearsay Analysis
The Court applied a two-part analysis under the residual hearsay exception, examining both trustworthiness and necessity:
Trustworthiness: The Court emphasized the inherent unreliability of manufacturer-created materials due to self-interest in avoiding liability exposure. Manufacturers craft warnings and instructions partly to protect against legal claims, making such materials less trustworthy than neutral medical authorities.
Necessity: The Court found that expert testimony could establish the same standard-of-care facts without relying on manufacturer documentation. When qualified experts can testify based on professional knowledge and medical literature, manufacturer materials are not "more probative" than available alternatives.
Market Reports Exception Rejected
The Court rejected the application of the market reports exception under Iowa Rule 5.803(17), distinguishing between factual compilations (quotations, directories) and opinions or recommendations contained in manufacturer guidance. Package inserts constitute the manufacturer's opinions about proper practice rather than neutral factual data.
Presumption of Prejudice
The Court established a presumption of prejudice for hearsay admission, shifting the burden to the party defending the verdict to demonstrate harmless error. Because the package insert related directly to core liability issues and likely influenced the jury's assessment of standard-of-care violations, the Court found the evidentiary error prejudicial and warranting reversal.
Strategic Implications From Kromphardt v Mercy Hospital
The Kromphardt reversal reshapes exposure assessment and evidentiary planning in device-related malpractice cases. Because the ruling centers on authentication failures and improper reliance on manufacturer materials, litigation teams must tighten expert preparation, objection preservation, and documentation workflows.
Risk Assessment and Appellate Strategy
The Kromphardt decision shifts exposure modeling by demonstrating that even large verdicts remain vulnerable when technical documentation is not properly authenticated. Appellate teams must now expect heightened scrutiny of device-related exhibits, particularly where documentation substitutes for expert explanation.
Key adjustments for risk evaluation include:
- Reweighting verdict durability when plaintiffs rely heavily on device manuals, package inserts, or manufacturer guides without expert linkage.
- Integrating appellate vulnerability into early valuation models, especially in obstetric or surgical-device cases, where technical materials are central to causation or standard-of-care theories.
Coverage counsel should reassess reserves and settlement thresholds in cases where documentation may face similar evidentiary challenges.
Evidentiary Preparation Protocols
The ruling establishes that manufacturer inserts constitute inadmissible hearsay when used to define standard of care, requiring substantive revision of how litigation teams prepare device-related evidence. Iowa Rule 5.901 authentication standards now take on a more central role, and expert testimony becomes the necessary conduit for introducing technical materials.
Practical workflow implications include:
- Routing all device documentation through expert authentication, eliminating reliance on the documents themselves as independent proof of standard of care.
- Building redundant evidentiary pathways—professional guidelines, peer-reviewed literature, expert analysis, and institutional policies—to replace manufacturer materials that can no longer stand alone.
Paralegals should implement structured objection templates targeting unauthenticated documentation and maintain parallel evidence tracks to safeguard admissibility at trial.
Future Litigation Outlook
The Iowa Supreme Court's November 8, 2024, remand order directs the trial court to conduct a new trial. No publicly confirmed retrial date has been scheduled as of late 2024.
Retrial will likely proceed with significantly different evidentiary parameters, requiring plaintiffs to establish standard-of-care violations through expert testimony without reliance on the excluded manufacturer documentation.
The bankruptcy filings by both defendant healthcare entities following the initial verdict add procedural complexity to any retrial or settlement negotiations, though no verified reporting provides updates on bankruptcy proceedings or their impact on the litigation timeline.
Establishing New Precedent for Device Documentation
Kromphardt v. Mercy Hospital demonstrates how evidentiary rulings can fundamentally reshape liability assessment in birth-injury litigation involving complex instrument-assisted deliveries. The Iowa Supreme Court's November 2024 decision provides critical guidance on the inadmissibility of medical device manufacturer package inserts when offered to establish standard of care.
The Court's emphasis on strict authentication requirements and hearsay rule adherence establishes demanding standards for introducing technical materials as evidence in medical malpractice cases. Future plaintiffs must develop more sophisticated expert testimony strategies that establish standard of care through qualified expert witnesses based on professional knowledge, rather than relying on standalone manufacturer document admission.
As medical-malpractice litigation increasingly involves complex technical documentation, the Kromphardt precedent underscores the necessity of rigorous evidentiary compliance regardless of case strength or potential damages. Streamlined record retrieval also becomes critical, ensuring litigation teams have complete and timely documentation before developing expert strategies.
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