J U LY 2 0 1 5 O U T P A T I E N TS U R G E R Y. N E T 1 3
Dr. Schroer, who performs 700 total knees per year, says he was curious about
Exparel and had no pre-formed opinions about it. But he had observed that
there were "no prospective, randomized, controlled studies by someone who
has no financial relationship with Pacira that show that liposomal bupivacaine
is any better than plain bupivacaine injections." So he conducted his own. His
soon-to-be published study in The Journal of Arthroplasty compares periarticu-
lar injections with liposomal bupivacaine versus plain bupivacaine in 111 total
knee arthroplasty patients. Exparel went 0-for-3 in the study. There was no sig-
nificant difference in pain scores recorded twice daily during hospitalization,
opioid use during hospitalization and hospital length of stay. Opioid use actually
increased in Exparel patients after discharge, which Dr. Schroer says may repre-
sent a rebound phenomenon.
"This study," says Dr. Schroer, "does not justify the routine use and cost of
liposomal bupivacaine as part of a multimodal pain management program."
In 2014, the FDA also denied Pacira's application to get liposomal bupivacaine
approved as a single-shot nerve block. In a company-sponsored study of 180
patients, the drug also failed to show a consistent benefit. A 14-patient Pacira-
funded study by anesthesiologist Brian Ilfeld, MD, MS, of the department of anes-
thesiology at the University of California San Diego, showed that the drug works
unpredictably for regional blocks. Dr. Ilfeld's study showed that the drug lasted
for more than 24 hours, but the magnitude of the blocks varied widely. Strangely,
the higher the dosage, the lesser the effect.
More trouble was ahead. Last September, after examining the company's adver-
tising, the FDA issued a warning letter to Pacira, calling Exparel a "misbranded"
product and forcing the company to redact claims in print advertisements that
the drug offered 72-hour pain relief when in fact it was only deemed effective for
a 24-hour period. The FDA took the very unusual step of forcing Pacira to run
full-page correction ads in all the journals in which the company had advertised
Exparel, including Outpatient Surgery. In an awkward confession, Pacira was
