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Exparel has been demonstrated to be safe and effective in various other surgical
procedures." The FDA listed as examples: knee arthroplasty, gastric sleeve, open
hysterectomy, lumbar interbody fusion and abdominoplasty.
This spring, Pacira got more bad news when the U.S. Department of Justice
subpoenaed a broad range of documents related to the marketing and promotion
of Exparel. It is not known what the DOJ has in mind or what it will find.
Potentially the investigation may turn up nothing, or it could be existential. Pacira
says it is cooperating. Erol Onel, MD, Pacira's vice president of clinical research
and medical information, declined to discuss the investigation further. Earlier DOJ
investigations of big pharma companies resulted in fines of $2.3 billion for Pfizer,
$950 million for Merck, $3 billion for Glaxo and $2.2 billion for J&J.
What 's next?
The controversy hasn't stopped many surgeons from using Exparel — and
insisting that it controls surgical pain.
Some orthopedic surgeons "swear by this product. Are they blinded by the
new, fashionable, sparkly product, or are they right and we are wrong and it
truly does make a difference and the studies were not designed well enough to
show the difference?" asks anesthesiologist Sergio Bergese, MD, chief of neu-
roanesthesia and director of clinical research at Ohio State University in
Columbus, Ohio. "Does the published data reflect clinical outcomes? No. It just
reflects data."
Pacira's Dr. Onel says that's because the drug does work. "If you just look at
pain scores, you're missing the boat," he says. With a long-acting analgesic like
Exparel, he says, pain studies can be deceptive because they don't account for
the impact that opioids and other pain medications have on subjective pain
scores over time among study participants. Dr. Onel says the pain scores of
patients who've received Exparel "normalize" with those who receive bupiva-
caine, saline or nothing at all at around 24 hours — the point at which non-
