Tests may not be as reliable as advertised

PRIEST RIVER — On Aug. 24, the Food and Drug Administration approved the ImPACT test (for 12-59 year olds) and its sister product, the ImPACT Pediatric test, (for 5-11 year olds) for concussion-related marketing purposes.

That means that the company can now all but promise parents of grade school, middle school, and high school students that their athletes will be perfectly safe from unnecessary brain injury, thanks to the watchful eye of ImPACT, or Immediate Post-Concussion Assessment and Cognitive Testing. Since its creation in 2002, the company had implied as much, but without the FDA stamp of approval.

On August 5, all Priest River Lamanna High School athletes wishing to play fall sports had to take an ImPACT baseline test as a prerequisite to playing this season. The school has used the computerized ImPACT test for about four or five years now, said PRLHS athletic director Matt George Aug. 18.

The ImPACT test product page claims that it “provides highly reliable neurocognitive data.” Unfortunately, according to several studies, ImPACT can’t claim to accurately diagnose its athletes.

In an Aug. 10, 2007, article on ImPACT, ESPN senior writer Peter Keating quoted Steven Broglio, professor of kinesiology at the University of Illinois at Urbana-Champaign, who published a Journal of Athletic Training study in 2007 showing that ImPACT and other computerized concussion-assessment tests were unreliable 38.4 percent of the time.

As Keating also reported, another study in 2006 of 122 concussed athletes and 70 uninjured athletes showed that ImPACT tests diagnosed 30 percent of the uninjured athletes as if they had suffered concussions.

In a 2013 study on ImPACT’s reliability done by University of Texas scientists and published in the Journal of Athletic Training, researchers concluded that ImPACT was “reliably unreliable.” The test may be a tool in the doctor’s toolbox, but the scientists said it shouldn’t be the only one, since it did not consistently and accurately diagnose an athlete’s condition. “Our current data support a multifaceted approach to concussion assessment using clinical examinations, symptom reports, cognitive testing, and balance assessment,” wrote the scientists.

George said that following a concussion PRLHS athletes get evaluated by a local physician who follows a strict protocol that gradually gets the athlete back on the playing field. In his own son’s case at Timberlake High School in 2012, George said it took six weeks before a doctor, who used the ImPACT test as an evaluation tool, cleared his son to return to play.

What legal recourse do parents and athletes have if the tests are wrong?

In section 6.3 of the product’s terms of service agreement, which schools must sign in order to purchase the ImPACT tests, any student-athlete who suffers injury and is misdiagnosed by the tests cannot sue the company in court.

Section 6.1 specifically says that “ImPACT’s sole obligation and Customer’s sole remedy with respect to any failure of the Product to substantially conform to the specifications therefore is for ImPACT to use commercially reasonable efforts to remedy any such failure as soon as is reasonably practicable, and if such failure is not remedied in a reasonable time, for Customer to terminate this Agreement upon written notice to ImPACT and receive reimbursement of any Product Fees paid hereunder.” In other words, if the testing software doesn’t work properly, the company will pay for a replacement test, and the school district can get its money back.

However, and most importantly, the company isn’t going to do anything else for your child or your family should your child be misdiagnosed and sent back onto the field, only to suffer debilitating brain injury.

As it states in section 6.3 On limitations of liability: “In no event shall either party be liable for...Any exemplary, punitive, special, indirect, incidental or consequential damages (including, without limitation, claims related to diagnostic accuracy and/or medical malpractice), regardless of whether such damages arise under any theory of tort, contract, strict liability or otherwise and regardless of whether such party is advised of the possibility of any such damages.”

That means that you can’t sue them for personal injury or other claims in the event of an injury related to their tests.

At the end of the day, it might be more of a gamble to walk onto the playing field this fall than parents and students had thought.