Constitutional concept, device law and Supreme Court rulings
stymie suits.
WASHINGTON – Hundreds of people who
say they’ve been harmed by a Medtronic spinal device are pursuing a new
legal pathway around rulings that have kept them from getting a day in court.
They argue that the Food and Drug
Administration, which approved limited use of the Infuse bone growth product in
2002, offered a 2008 warning to doctors about “life-threatening complications”
from unapproved applications. Then, the Spine Journal in 2011 and the U.S.
Senate Finance Committee in 2012 each harshly criticized Medtronic for
allegedly paying physicians hundreds of millions of dollars to write scholarly
articles about Infuse while editing those articles to downplay Infuse’s
dangers.
Yet for all the claims of poor
performance, dangerous outcomes and shoddy scholarship, Infuse has never been
the subject of a personal-injury trial because of a legal concept called
“pre-emption.” That means federal law takes precedence over state law. The
Supreme Court has extended this premise to say that almost no one can sue for
damages caused by medical devices that received premarket approval from the
FDA.
Now, hundreds of new lawsuits —
including dozens in Minnesota — aim to find a way around that obstacle by
accusing Medtronic of illegally promoting uses of Infuse that differ from what
the FDA specifically approved.
If the allegation is upheld, legal
experts say the world’s biggest medical device maker could find itself awash in
settlements or judgments that could push the entire medical device industry
into a new era of corporate liability.
“The cases are important,” said Prof.
David Prince of the William Mitchell College of Law. “The whole area of law
certainly doesn’t make sense, especially to consumers.”
Medtronic declined a Star Tribune
request for an interview, but issued a statement that denied any wrongdoing and
disputed “any suggestion that the company improperly influenced or authored any
of the peer-reviewed published manuscripts discussed in the [Senate] report, or
that Medtronic intended to under-report adverse events.”
Landmark case
Judges have ruled that pre-emption
requires them to throw out Infuse cases before a jury hears evidence. Their
decisions are based on a landmark
2008 case, Riegel vs. Medtronic,
in which the Supreme Court ruled that patients generally are forbidden from
suing device manufacturers because that would let state courts trump federal
regulators who review clinical test results and let devices onto the market.
In the case of Infuse, however,
patients’ lawyers think they have found a way to get to trial by linking
Medtronic to so-called “off-label” uses that the FDA did not approve.
Doctors can legally use devices in
off-label applications, and federal
health statistics show that Infuse is used off-label 85 percent of the time.
Jennifer Fuson, a spokesman for the American Association for Justice, said a
critical question is who is responsible “if you are injured by a product that
was used in a way not approved by the FDA?”
The Department of Justice dropped a
criminal investigation of Medtronic’s off-label promotion of Infuse without
explanation in May 2012 and did not respond to a request for comment.
In a statement, the FDA declined to
say if it has investigated the promotion of Infuse.
“Promotional materials are unlawful
if they promote an unapproved use for the product; contain claims relating to
the dosing, safety or effectiveness of the product that are inconsistent with
the approved labeling; or if they lack a fair and balanced presentation of
information, i.e., of benefits and risks,” the agency said.
In
a December 2012 report, the Senate Finance Committee claimed that Medtronic
employees, including some in the marketing department, wrote, edited and
otherwise influenced the content of scholarly articles about Infuse written by
doctors who were collectively paid $210 million by Medtronic from November 1996
through December 2010.
A spokesman for the Finance Committee
declined to say whether Chairman Max Baucus, D-Mont., thought Medtronic
violated any regulations or laws. “The editing of the journal articles and
large payments to the authors of those articles raises troubling questions
about whether Medtronic crossed the line regarding off-label promotion of
Infuse,” the spokesman said.
Lou Bograd of the Center for
Constitutional Litigation said the overwhelming off-label use of Infuse
suggests that promotion is going on. Doctors are free to use medical devices any way they see fit, he
acknowledged, but in this case more than eight in 10 uses are not FDA-approved.
“[It] defies credibility to say it’s
just doctors deciding to do this on their own,” Bograd said. “Medtronic engaged
in a false, misleading promotional campaign.”
Bograd argued this point to Hennepin
County District Judge Laurie Miller in May in what could become an influential
case nationally.
Minneapolis lawyer Stuart Goldenberg, Bograd’s
co-counsel, represents clients in 35 Infuse cases in Minnesota who will be
affected by Miller’s decision. Goldenberg said he has “hundreds more” suits
that might be filed.
In the Hennepin County case,
Medtronic’s lawyers denied off-label promotion of Infuse and argued that none
of the 35 Minnesota plaintiffs has the right to sue.
“Many [cases] have already been
dismissed based on the pre-emption doctrine established in Riegel,” Medtronic
said in its statement to the Star Tribune. “We have a number of defenses for
these cases, including pre-emption, and will stand behind our product and
vigorously defend it in court.”
Conflicting opinions
Miller’s
decision is expected this summer. It will add to a handful of conflicting
lower-court opinions that almost everyone believes will eventually end in a
Supreme Court decision.
Prince also believes the issue “cries out for federal
legislation.”
“Off-label promotion is prohibited by
federal law, but state law could also prohibit it,” he said. In that case, a
personal injury law suit might be allowed to go forward. But the courts have
thus far “confused this by going off in all directions.”
On
June 18, a two-year, $2.5 million Medtronic-funded comprehensive re-analysis of
all past Infuse research showed that the bone growth product did not perform as
well and had more adverse effects than Medtronic-sponsored researchers had
said.
The only use of Infuse that has
received FDA approval is to implant it through the front of an adult’s body to
help recovery from lower-back spinal fusion surgery and then only if the bone
growth factor is constrained in a specific brand of cage.
Otherwise, studies show that unwanted
and potentially dangerous bone growth can occur and cancer risks may arise,
said Dr. Eugene Carragee, editor of the Spine Journal. Carragee devoted the
June 2011 issue to a scathing critique of the Infuse research that Medtronic
sponsored.
Carragee said he took on Medtronic
because its sponsored research results differed so markedly from research the
company did not pay for and because of Medtronic’s influence on the content of
scholarly articles.
Still, that may not rise to the level
of off-label promotion.
“Manufacturers can send
representatives to medical conferences and say, ‘Doctors A, B and C used the
device in this way,’ ” said Prince. Doctors can also write about off-label
device use in scholarly journals. “That’s not considered promotion.”
Ron Goldman could be the first lawyer
in the country to actually get an Infuse off-label-promotion case before a
jury. The Los Angeles attorney persuaded a judge there to let his client go to
trial. The case is set for November, although Goldman expects a delay.
“Underlying
all the legal mumbo jumbo,” he said, “we have people who are severely injured.”
Jim Spencer • 202-383-6123
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