The University of Southern California's football team doctor, James Tibone, injected a player with the controversial painkiller Toradol in a manner contrary to Food and Drug Administration warnings about the safe and proper use of the drug and also failed to warn the player about the drug's possible adverse effects, according to court documents obtained by VICE Sports.
Tibone administered Toradol, a non-steroidal anti-inflammatory prescription painkiller widely used in professional and college football, to the player far more frequently than recommended by the FDA's black box warning for the drug-a special warning that appears on the package insert of certain prescription drugs, indicates a risk of serious or life-threatening side effects, and is the strongest warning the agency will issue short of removing a drug from the market altogether.
In August of 2012, former USC defensive lineman Armond Armstead sued his alma mater, the University Park Medical Center, and Tibone-a prominent, respected Southern California orthopedic surgeon who has been USC football's head physician since 1991-for the improper administration of Toradol.
According to the suit, Tibone's off-label usage resulted in Armstead suffering a heart attack in early 2011, when he was 21 years old.
A VICE Sports review of depositions and other documents from the ongoing suit reveals a seemingly cavalier attitude by Tibone toward the use of Toradol, a potent painkiller that became increasingly popular among both major National Collegiate Athletic Association Division I football programs and National Football League teams during the 2000s and was once described by former NFL safety Darren Sharper as a "wonder drug" that allowed him to get "shot in the butt, and within 10 minutes nothing hurts."
In his deposition, Tibone admitted to ignoring black box warnings for the drug because he didn't "agree with them."
Armond Armstead following a 2009 USC win over Notre Dame. Photo by Brian Spurlock-USA TODAY Sports
Available in pill and injectable forms, Toradol generally is given to relieve short-term pain following surgery and can cause serious side effects including gastrointestinal and kidney damage. Many European countries limit the drug to postoperative hospital use or ban its administration outright.
Toradol's black box warning-which, like all black box warnings, is based on medical studies-states that the drug is intended for "short-term (up to five days in adults), management of moderately severe acute pain..." and that it carries an increased risk to patients for "serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal."
However, USC athletic department records, trainer's notes, and testimony by Tibone and Armstead show that Toradol was used repeatedly to treat Armstead's chronic pain from football injuries, and that the former lineman was never informed of the drug's risks. His heart attack was consistent with the dangers of repeated Toradol use: a myocardial infarction due to a blood clot.
In his deposition, Tibone said he didn't "agree with" FDA warnings about Toradol's cardiovascular risks. He did not provide supporting evidence for his position, admitting that before and during the period he gave the drug to Armstead and other USC players he: (a) conducted no research or surveys on Toradol's adverse effects; (b) read no peer-reviewed journal articles on the matter prior to Armstead's heart attack; (c) did not investigate the drug beyond talking to NFL trainers he knew and having a brief, informal conversation with a friend who is a cardiovascular surgeon.
Tibone also said that he doesn't prescribe Toradol to patients in his private practice, and that he personally had taken the drug once, to treat pain from a kidney stone.
According to a 2012 paper co-authored by St. Louis Rams team doctor and NFL Physicians Society president Matthew Matava, Toradol has been used widely in the NFL since at least the early 2000s, with players from 28 of 30 league teams reportedly receiving game day injections during the 2001 season.
The drug also has been used in college football. Gene Sapakoff of South Carolina's Post & Courier reported in 2009 that Toradol was the "drug of choice" for the University of South Carolina and Clemson, with the former school administering 169 Toradol injections on 13 game days in 2008, up from 133 injections over 11 games the previous season.
Four years later, ABC News asked the Associated Press Top 25 teams if they used Toradol on game day: five said yes, four said no, and 16 didn't respond or refused to comment.
USC was not one of the teams polled.
The bulk of Armstead's case focuses on the 2010 season, his junior year at Southern Cal. During an 84-day period from September 11 through December 4, Armstead received 10 injections of Toradol, either pregame or at halftime. Neither Armstead nor any of his USC teammates were ever informed of the drug's potential risks-nor were they ever told what, exactly, they were being injected with.
Ketorolac, AKA Toradol, in its 60 mg single dose form. Photo via WikiMedia Commons
In some cases, the use of Toradol was prophylactic-that is, given before games in anticipation of future pain, and not to treat current injuries-and accompanied by little or no physical examination of players. Tibone stated in his deposition that both practices are inappropriate: "If [a player] came to me in the hallway and said, 'Listen, I'm aching,' I would say, 'no, get away from me, you don't need anything.'"
In a class-action painkiller abuse lawsuit filed against the NFL by former players that last month was dismissed by a federal judge, retirees alleged that Toradol was used prophylactically across the league for much of the 2000s.
After injuring his left shoulder during practice in the week prior to a September 11 game against the University of Virginia, Armstead sought treatment. According to USC athletic department training notes, Tibone performed a physical examination of Armstead's shoulder and designated him for "practice/no contact" while rehabbing the injury.
Armstead retained this status throughout the week, but claims that he received a Toradol shot before playing against Virginia. The university has no record of that injection.
According to both Armstead and university records, he received a 60 milligram injection of Toradol in his buttocks-a standard dose-prior to USC's game against Minnesota the following week and played despite still being labeled as fit for "practice/no contact." Responding to a question during his deposition about this discrepancy, Tibone said, "so obviously you can't play without contact. So that's a mistake."
Although the Minnesota pregame shot provided temporary relief, Armstead was still in pain during halftime, at which point he said Tibone "poked and prodded my shoulder, and he stuck a needle in my shoulder." Again, Armstead said, his pain became manageable for a brief period, but by the fourth quarter he was taken out of the game because his left arm hurt so much that he couldn't use it at all.
In the days after the game, USC's training staff continued to classify Armstead as unfit for contact. He sat out of the team's next game against Washington State, but returned to action on October 2 against the University of Washington.
A university record dated the day of the game, October 2, claims Armstead received only a pregame shot. However, a separate record, dated October 3, claims Armstead received a shot at halftime. Armstead recalls getting both a pregame and halftime shot. Tibone has no specific recollection of injecting Armstead with Toradol any time that season.
In the October 3 note-which Tibone argues in his deposition should have been dated the 2nd-Armstead's pain is described as stemming from a "history of left AC joint sprain," a reference to his shoulder injury prior to the September 11 game against Virginia. The phrase "history of" is one of many indicators that the USC training staff perceived Armstead's shoulder pain as chronic, making any administration of Toradol to treat it effectively off-label.
Over the next six weeks, the USC training staff recorded no injury or treatment reports for Armstead, shoulder injury or otherwise. Yet from mid-November through early December, Armstead received a Toradol injection prior to each game without any accompanying trainer's note to document an injury-a practice Tibone described as inappropriate.
After the season ended, Armstead reported to the University Park Health Center three times between February 4 and February 23 of 2011, complaining of constant chest pain. He was initially diagnosed with costochondritis, a temporary inflammation of the chest cartilage that can cause acute chest pain but resolves itself in time.
USC's University Park Health Center. Photo via USC
As a result of this diagnosis, two of Armstead's visits to the Health Center resulted in additional Toradol injections. The attending doctor, Jorge Bernardez, did not seek out or view USC's athletic training notes documenting Armstead's repeated previous injections of the drug, which according to the FDA black box warning should not be given over a period greater than five days.
By the beginning of March, Armstead's condition worsened. A MRI exam revealed that he had suffered an acute anterior apical myocardial infarction, more commonly known as a heart attack. Myocardial infarctions are specifically mentioned by the FDA as a possible risk of Toradol use, made likelier by repeated off-label use and combining the painkiller with other non-steroidal anti-inflammatories such as Ibuprofen and Naproxen, drugs that Tibone and USC training staff also had administered to Armstead during the season.
Tibone and USC argue they used Toradol properly because they were treating Armstead's acute pain resulting from a single injury. Whether or not the definition of "acute" pain includes an orthopedic injury lasting for months-a highly contested point in the lawsuit-the extended duration of Armstead's treatments seemingly disregarded FDA warnings, which impose a five-day limit on using the drug.
Moreover, the multiple Toradol shots approximately two hours apart alleged by Armstead and indicated by USC athletic records would exceed the FDA's recommended daily dose limit of no more than 60 milligrams, or one such injection.
Tibone-and USC's-apparent failure to inform Armstead and his teammates of Toradol's risks and recommended uses violated the American Medical Association's informed consent requirement which states, "The physician's obligation is to present the medical facts accurately to the patient or to the individual responsible for the patient's care and to make recommendations for management in accordance with good medical practice." Likewise, Tibone and USC also violated the NCAA's sports medicine handbook, which states that "individuals receiving medication should be properly informed about what they are taking and how they should take it."
Asked during his deposition if he uses the NCAA's sports medicine handbook "as a resource of information for you in doing your job as a team physician," Tibone replied, "Not really. I use my own. This is a guideline. I use my own medical judgment to make decisions."
After Armstead filed his lawsuit, USC began issuing a form to athletes titled, "Toradol [ketorolac] Injection: Information for USC Student Athletes," which requires their signature and provides basic information about the drug, including a summary of its black box warnings. In the half-page document, USC informs its athletes that "Ketorolac is used widely in the NFL for game-day pain management. Per team surveys, most NFL athletic trainers consider 1x / week use during season [sic] appropriate and safe."
The waiver also indicates that Toradol's risks don't actually apply to the vast majority of college athletes. "Serious risks should NOT be of major concern for healthy young athletes without chronic diseases," the form states. "Use in the NFL has produced minor side effects with no reports of serious bleeding or kidney failure."
At best, this is an overly optimistic assessment of the drug; at worst, it's patently false. In the NFL painkiller lawsuit-which includes allegations about Toradol-several players allege that drug misuse caused their kidneys to fail. For example, named plaintiff and former Dallas Cowboys defensive lineman Marcellus Wiley told ESPN's Mike & Mike he was diagnosed with acute renal failure at age 39. (USC declined to comment citing pending litigation. Dr. Tibone did not reply to a request for comment.)
In his deposition, Armstead said that he "trusted Dr. Tibone to do what was best for me and put my interests first." Was his trust misplaced? Following Armstead's myocardial infarction, all of his tests for preconditions came up negative. Nobody could tell him why-despite being a starter on one of the best football teams in the country-he had suffered a heart attack. This mystery likely contributed to him having to sit out his senior year at USC, which in turn contributed to him not being selected in the 2012 NFL Draft.
With no answers and his professional football career uncertain, Armstead and his father, Albert, went to see Dr. Michael Rosove, a cardiologist at UCLA. Although USC released some of Armond's medical records, they didn't provide Dr. Rosove with any documentation about the Toradol injections.
After extensive research, Albert discovered Toradol's connection with football and found out about all the injections his son had received. It was only then, in October of 2011, eight months after Armond's heart attack, that the Armsteads first learned the name of the drug that likely caused it.