USC football team doctor James Tibone said in a deposition that he was at odds with the FDA's cardiovascular warnings regarding the painkilling drug Toradol.
The deposition is part of a lawsuit filed by former USC DE Armond Armstead, who says in the suit that he suffered a heart attack in 2011 because of repeated Toradol injections. He filed the suit in 2012 against USC, Tibone and University Park Medical Center.
Documents from the case were obtained by Vice Sports. Armstead received the injections of the non-steroidal anti-inflammatory throughout the 2010 season and said he received 10 injections from September to December. And he said neither he nor teammates were told what they were being injected with.
Toradol is a popular painkiller for football and in 2001, 28 of the 30 current NFL teams had said they administered the drug. It can be utilized in both preventative and reactive fashions. The drug's warning says it is for short-term acute pain.
From Vice:
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.
In February of 2011, Armstead went to University Park Medical Center three times and initially diagnosed with costochondritis, which (guess what?) resulted in more Toradol injections. The school didn't comment to Vice for the story. The scheduled trial was delayed last April and, according to Boston.com, is set for March of this year.
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 also said in his deposition that he didn't follow the NCAA's sports medicine handbook and rather used his own judgment. Per Vice, USC now has student athletes sign a waiver about Toradol injections.
Armstead didn't play in 2011 because of the heart attack and wasn't selected in the 2012 NFL draft. He played in the CFL in 2013 and was signed by the New England Patriots before he retired in July.
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Nick Bromberg is the assistant editor of Dr. Saturday on Yahoo Sports. Have a tip? Email him at nickbromberg@yahoo.com or follow him on Twitter!
From Dr. Saturday - NCAAF - Yahoo Sports - Court documents: USC doctor didn't 'agree with' FDA's Toradol warnings
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