Reliability of Concussion Baseline Testing Company’s Product Challenged in Court

Nov 2, 2012

By Paul Anderson, Esq.
 
ImPACT[12] is used by the big four professional sporting leagues, colleges and thousands of schools across the country. ImPACT dominates the market when it comes to sideline assessment and concussion evaluation. In fact, it has become so popular its use is encouraged in Rhode Island’s return-to-play law.[13]
 
According to ImPACT’s website, it is “the most-widely used, and most scientifically validated computerized concussion evaluation system.” The software has become the go-to tool to determine whether an athlete should be allowed to return-to-play after suffering a concussion.
 
Recently, though, ImPACT has drawn fire from the scientific community for failing to identify concussions and prematurely allowing athletes to return-to-play. According to ESPN’s Peter Keating, a series of studies concluded, “the false positive rate appears to be 30 percent to 40 percent of subjects of ImPACT…[it] may even increase th[e] risk” of returning to play too soon.[14]
 
The family of one former high school student alleges[15] that ImPACT failed to diagnose their son’s traumatic brain injury. During a junior varsity game in South Texas, left tackle Oscar Cordova, III suffered a “hard hit to the head.” Although he felt a little woozy, he remained in the game. Oscar continued to have headaches the following day, but he didn’t report his symptoms to the school’s athletic trainer (AT) until 13 days after the injury.
 
Oscar complained that he felt nauseous and that he had constant headaches. The school’s AT performed the ImPACT test, which resulted in Oscar scoring below average on all portions of the exam. The AT called Oscar’s mother and informed her that he probably suffered a concussion during the game, and that he should refrain from football-related activities until he was symptom free.
 
The following day, Oscar told the AT that his symptoms had subsided, so the AT re-administered the ImPACT test. The test results showed that Oscar had performed average on the verbal memory portion but below average on visual memory. Since Oscar’s results had improved, the AT allowed him to engage in exercises, but he advised, if symptoms persisted he should immediately cease activities.
 
A week later, Oscar returned for another ImPACT test. This time he scored above average on verbal memory and average on visual memory. Oscar told the AT that he felt better but when he jogged he experienced headaches. The AT advised Oscar to engage in exercising and report back to him if he experienced headaches. Shortly thereafter, Oscar complained that his headaches became more severe while engaging in physical activity. The AT advised Oscar to refrain from all activities for 24 hours and to report back to him the following day. As instructed, Oscar met with the AT and explained that he still had a persistent headache. Accordingly, the AT ordered Oscar to seek medical attention to “rule out more serious complications.”
 
Later that evening, Oscar was examined by a neurosurgeon and it was discovered that he had a hairline-skull fracture and brain bleed. Oscar underwent emergency surgery and subsequently made a full recovery, though he was, and allegedly still is, unable to engage in physical activity.
 
With mounting medical bills and believing some party was at fault, the Cordova family decided to lodge an attack against the “cash-flow juggernaut,” that is ImPACT.
 
On September 8, 2011, a product liability and personal injury lawsuit was filed against Mission Consolidated Independent School District and ImPACT Applications Inc.[16] The complaint asserts theories of strict liability against ImPACT for allegedly supplying a defective product.[17]
 
ImPACT successfully removed the case to federal court arguing that the court had subject-matter jurisdiction pursuant to Section 1332(a).[18] The school district was later dismissed as a party due to its broad shield of immunity.
 
The plaintiffs alleged that the school district was negligent in providing, supervising and administering a defective product to Oscar. Under Texas Law, a school’s immunity is waived only when the alleged personal injuries arise from the use of a motor vehicle. See Tex. Civ. Prac. & Rem. Code §§ 101.021, 101.051 Likewise, a school does not waive its sovereign immunity for allegations of negligent supervision. See City of Waco v. Williams, 209 S.W.3d 216, 232. Even without the shield of immunity, the school district likely would have avoided liability since its AT acted reasonably under the circumstance, and the school had a finely tuned concussion protocol in place.
 
ImPACT has not been as lucky. Following the exchange of written discovery and depositions of the injured party, the AT and ImPACT’s corporate representatives, ImPACT filed a motion for summary judgment on August 27, 2012.
 
ImPACT argues, inter alia[19], that the plaintiffs’ claims are fatally flawed because they are unable to prove ImPACT’s alleged wrongful conduct caused Oscar’s brain injury.
 
In order to establish liability, an essential element in all product liability and personal injury cases requires the plaintiff to prove causation. See Sims v. Washex Machinery Corp., 932 S.W.2d 559, 562 (“the failure to warn and/or instruct must constitute a causative nexus in the product user’s injury”) According to ImPACT, “the Plaintiffs have completely failed to show that ImPACT’s software caused any brain injury to Plaintiff.”
 
Based on ImPACT’s motion for summary judgment and the attached exhibits, it appears that the plaintiffs’ have a mighty burden to show that there are genuine issues of material fact in dispute.
 
ImPACT relies on the copious injury report created by the AT and computer records from the ImPACT system – which details the specific dates Oscar visited the AT and the results of each ImPACT test – to show that the tests, and administration thereof, worked as advertised. Oscar repeatedly failed the tests; he was never allowed to return to contact sports; and he was advised to see a doctor for further evaluation. More importantly, the brain injury occurred on October 2, 2008, and the three tests were administered after this date. According to ImPACT, it is temporally impossible to prove ImPACT caused Oscar’s skull fracture.
 
Moreover, in order to counter a theory of false representation, ImPACT points to the service agreement entered into between Veteran Memorial High School and ImPACT which states, “Customers and all end-users should use the data received as a result of using the product to consult with qualified medical personnel. The product is only one component of a concussion management treatment and must be used in combination with the advice of qualified medical personnel.”
 
The plaintiffs have until December to respond to ImPACT’s motion for summary judgment. Unless the plaintiffs are able to produce expert testimony to show that it’s plausible Oscar’s skull fracture occurred sometime after the administration of the exam, it’s doubtful the plaintiffs will be able to survive ImPACT’s motion.
 
Fortunately for ImPACT, it looks like it is going to be able to successfully defend this lawsuit primarily because the AT did an outstanding job of documenting each exam, which was also corroborated by the ImPACT clinical report. Acting with due care, the AT didn’t rely solely on the results of the exam. Rather, he used his clinical judgment and took into account Oscar’s symptoms and complaints about headaches.
 
Nonetheless, it is easy to see how this lawsuit could have cost ImPACT millions. After Oscar scored average on his third ImPACT exam, a busy, and arguably negligent, AT could have ignored the patient’s symptoms and allowed Oscar to return to contact sports. An athlete in the future might not be as lucky.
 
The school was also able to avoid an expensive legal fight and the threat of a million dollar judgment due to its broad shield of immunity. Surprisingly, ImPACT’s service agreement does provide for a pretty customer-friendly indemnification agreement,[20] though triggering the clause may be a difficult task. ImPACT will indemnify and hold harmless a customer – including paying for all damages and attorney’s fees – if a third party is able to prove his/her claims are a result of ImPACT’s negligence or willful misconduct. This may, however, allow ImPACT to shift the blame to the person administering the test, or in the very least, open the door to the empty-chair defense.
 
As ImPACT notes, its system is not to be used as the sole indicator of whether an athlete can return-to-play. No machine should replace the clinical judgment of a skilled athletic trainer or medical professional. Although Oscar suffered short-term serious injuries, the safety valves in place — via the school district and ImPACT — prevented this case from turning into a complete tragedy.
 
Update: At presstime, the parties filed a notice with the court stating that the parties had reached a settlement. The terms of the settlement are currently unknown.
 
[12] Immediate Post-Concussion Assessment and Cognitive Testing
 
[13] See Rhode Island’s School and Youth Programs Concussion Act (“School districts are encouraged to have all student athletes baseline or “impact” tested.)
 
[14] Quoting from Current Sports Medicine Reports, a review of research on ImPACT.
 
[15] The following factual allegations are a summary of the AT’s injury report, the plaintiff’s second amended complaint and the factual allegations in Defendant’s motion for summary judgment.
 
[16] Oscar Cordova, Jr. et al v. Mission United School Dist. et al. Cause No. C-2436-11-G, 370th Judicial Dist. of Hidalgo County, Texas.
 
[17] The complaint does not list specific counts, but it appears that the claims are based on failure to warn.
 
[18] The plaintiffs are citizens of Texas and ImPACT is a citizen of Pennsylvania.
 
[19] ImPACT also asserts that Oscar’s parent’s claim for medical expenses are barred by the two-year statute of limitations – this will likely be a successful argument.
 
[20] 7.1 Indemnification by ImPACT: ImPACT hereby agrees to indemnify and hold harmless Customer from and against all damages, settlement amounts, costs and expenses (including reasonable attorney’s fees) that Customer may be required to pay to third parties to the extent such damages, settlement amounts, costs and expenses are attributable to claims: (a) resulting from the negligence or willful misconduct of ImPACT…


 

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