Photo of Michelle Yeary

Today’s topic is something a little different.  We don’t usually think of after market modifications to prescription drugs and medical devices.  If this were a blog about cars, computers, or almost anything with a motor or engine that can be enhanced for speed – user modifications would be a central theme. In the drug and device world when we talk about things that happen “after market,” we’re usually talking about off-label uses.  It’s not so much that the product is changed as the use is changed.  But the decision to us the drug/device in a way other than according to its label is one made by the physician after the product has left the manufacturer’s control.  That after sale choice by the doctor is not a defect for which a manufacturer is liable.

The product at issue in Lowe v. Cerner Health Services, 2020 U.S. Dist. LEXIS 218240 (E.D. Va. Nov. 20, 2020) was an electronic health record system (“EHR”) — a computer system designed to allow healthcare providers to submit orders and prescriptions and record medical information electronically.  The EHR at issue was a “framework” with a variety of options and dropdown menus designed to be configured by the purchaser to meet its needs.  In this case, the EHR was purchased by a hospital, was configured by the hospital, and had been in use at the hospital for six years prior to the plaintiff’s injury.  Id. at *2.  The incident occurred when a doctor put an order into the EHR for continuous monitoring of the patient’s pulse oximetry but based on her selections, the system defaulted to a “start” time of 10:00 am the next morning.  The patient was not monitored and was found in respiratory distress.  Id. at *10-12.     Plaintiff settled with the hospital and sued the manufacturer of the EHR system.  The EHR manufacturer moved for summary judgment on both the design and failure to warn claims.

Plaintiff proffered testimony from two experts that the EHR could have contained design features that would have made it safer.  But what those experts failed to do is explain what standard of care the manufacturer was at odds with.  That’s because the product complied with all industry and governmental standards.  Id. at *16-17.  So, plaintiff’s experts tried to argue that a different standard should apply.  That standard, however, had been rejected by the governing body and therefore was inapplicable.  Id. at *17-18.

Without evidence of violation of an accepted standard of care, plaintiff’s only other recourse was the reasonable consumer safety expectations test.  Under Virginia law, a plaintiff can prove consumer expectations through evidence of industry practices, knowledge of other injuries, knowledge of the danger, published literature, and direct evidence of what of a reasonable purchaser considers defective.  Id. at *19.  It was already established that the EHR complied with industry standards.  The evidence also showed that the manufacturer had received no customer complaints or incident reports similar to what was alleged in this case.  Not even the hospital where this event took place reported it to the manufacturer.  Finally, plaintiff’s expert’s subjective beliefs as to how the system could be better were insufficient to meet an objective standard.  Id.  at *19-20.

Plaintiff’s case also failed because he could not prove the defect existed at the time of sale.     The opinion goes into significant detail about the hospital’s control over the modifications made to the EHR, the fact that the system was designed to allow for those modifications, that the manufacturer was not consulted about the modifications, and the healthcare provider’s ability to review and confirm the orders before they were entered.  Therefore, the only defect alleged is based on the choice made by the hospital after market.  The EHR had been substantially changed after purchase and changed multiple times between purchase and plaintiff’s surgery.  For all these reasons, plaintiff could not sustain a design defect claim.

On failure to warn, the first key element is that the manufacturer “knew or had a reason to know that the product was likely to be dangerous for its intended use.”  Id. at *22-23.  As already noted, defendant had no knowledge of any other patient incidents and had no reason to know that the hospital, a sophisticated purchaser, would not understand any purported dangerous conditions in the settings it chose itself.  Id. at *23-24.  Plaintiff pointed to three adverse event reports from the FDA database, but had no information on how those EHRs were set up so could not show if the events were substantially similar to the event in this case.  Plaintiff’s expert tried to rely on an event that involved no allegation of physical injury, making any inference he drew from that data merely speculative.  Id. at 24-25.

Finally, on causation the record evidence showed multiple possible causes of plaintiff’s injury – the hospital, the doctor, the nursing staff.  Plaintiff’s experts failed to rule out these other causes which was fatal to plaintiff’s claims.  Id. at *27-28.