PHILADELPHIA (AP) — By 2003, surgeons trained by a Pennsylvania
medical-device company had seen serious complications from an unauthorized test
of a bone-cement product.
The cement had been approved to treat broken bones, but not
weight-bearing hips and spines. Yet Synthes Inc. officials forged ahead with
their own tests, teaching doctors how to use it for fractures in places not
approved by federal regulators.
Then, a patient died in the operating room in Plano, Texas.
Within months, two more died in surgery in northern California. Even then, no one called the
FDA.
In a rare move, U.S. prosecutors are seeking prison
time for four top Synthes executives who pleaded guilty last year to
misdemeanors as “responsible corporate officers.” The closely-watched
criminal case is playing out this week in Philadelphia,
where attorneys for the government and the executives are making their cases
before U.S. District Judge Legrome D. Davis. The judge has not yet scheduled
individual sentencing dates.
Prosecutors call their crimes intentional and say a Synthes
consultant warned early on that the tests amounted to “human
experimentation.”
The defendants deny any intent to violate U.S. Food and Drug
Administration protocols.
A lawyer for former Synthes Vice President Richard Bohner
argued Tuesday that his client “made repeated good-faith efforts to
prevent off-label promotion.”
Davis
agreed, to a point. But he asked why Bohner didn’t do more.
“I think that’s a question that he asks himself every
day, why he didn’t go farther. And that’s why he’s here,” lawyer Brent J.
Gurney said.
Prosecutors’ push for prison time caught the executives off
guard after they entered their pleas in mid-2009. Since then, their sentencings
have stalled amid protracted legal filings and a change in judges. But each man
has already lost his job and been fined $100,000.
“It’s a conflict between the (corporate) culture and
the law that brings us here,” Davis
said during this week’s pre-sentencing hearing, where lawyers have been
debating just what each man knew and did. “The intersection here is
whether the company’s culture, the behavior, exceeded the boundaries of what
the FDA would allow.”
The defendants are former Synthes North America President
Michael D. Huggins, 53, of West Chester; former senior vice president Thomas B.
Higgins, 54, of Berwyn; ex-director of regulatory and clinical affairs John J.
Walsh, 48, of Coatesville; and Bohner, 57, of Malvern.
The Justice Department in recent years has collected
billions of dollars from off-label marketing cases, many of them brought by
whistleblowers and filed in Philadelphia, a hub for both pharmaceutical
companies and the department’s health care fraud efforts.
Both Synthes, a global company that specializes in surgical
hardware, and Norian Corp., a subsidiary based in West
Chester, pleaded guilty to corporate health care fraud charges
last year and agreed to pay the maximum $23 million in fines.
The fines pale compared to the $2.3 billion Pfizer paid over
its promotion of several drugs, or the $1.4 billion paid by Eli Lilly for
off-label marketing of the anti-psychotic Zyprexa. But the push for prison time
has caught the industry’s attention.
Some pharmaceutical-industry lawyers say the line between
legal and illegal marketing is not always clear. And Higgins’ lawyer, Adam S.
Hoffinger, noted Tuesday what he called the “disconnect” between the
fact that doctors are free to use products however they wish, while companies
cannot promote the alternative uses.
Synthes was eager to expand its sales to the hundreds of
thousands of Americans, many elderly, who suffer spine fractures each year. But
the process of getting FDA approval for clinical trials is famously slow and
expensive.
Instead, Synthes from 2002 to 2004 paid for doctors to
travel to seminars in San Diego, Dallas and Charlotte,
N.C., to teach them how to inject
the bone cement into the spine, prosecutors said. The product, Norian X, was
used in about 200 spine surgeries.
Earlier pilot studies had shown the cement could cause blood
clots in humans, while pig research suggested such clots could move to the
lungs, according to the June 2009 indictment. But with competitors ahead in the
race to market, Synthes was eager to move forward, authorities charged.
The patients who died in surgery suffered severe
hypotension, or low blood pressure, following the injections. None of the
surgeons could rule out the bone cement as a factor in the deaths, but it also
wasn’t definitively blamed for them. At least one of the patients was already
frail and elderly.
According to prosecutors, the defendants not only tested the
bone cement on humans, but failed to report the deaths and lied to FDA
investigators during a routine 2004 audit.
As part of the corporate pleas, Synthes agreed to sell the
Norian subsidiary.
