Medtronic ignores patient harm for profit. Justice?

Injured Infuse users struggle to get their day in court against Medtronic

•                Article by: JIM SPENCER , Star Tribune Updated: July 6, 2013 - 8:24 PM

Constitutional concept, device law and Supreme Court rulings stymie suits.

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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

Patients Deserve to Know: Medical Device Ownership

Feds issue special fraud alert onphysician-owned distributorships

By Joe Carlson

Posted: March 26, 2013 - 12:30 pm ET      FiDA highlight

Doctors who hold part ownership in medical device companies, beware: people in HHS' inspector general's office are watching you. And they don't like what they see.

The inspector general's office published a special fraud alert Tuesday (PDF) on the rapidly growing phenomenon of physician-owned distributorships, or PODs, saying, “OIG views PODs as inherently suspect under the anti-kickback statute.”

The office is already investigating physicians who hold ownership stakes in spinal-implant businesses, and whether those doctors practice at hospitals whose Medicare patients receive a higher-than-average proportion of spinal-fusion procedures. That case may also widen to include doctors with stakes in cardiac-device makers, the office's 2013 work plan says.

The alert follows a letter from five bipartisan members of the Senate Finance Committee in June 2011 (PDF) that said a Senate investigation had turned up evidence physicians were being pressured into taking on lucrative ownerships in device companies because of a dearth of federal rules on the topic left it open to abuse.

Under federal law, it may be legal for a surgeon to hold shares in a company that manufactures devices that the doctor prescribes for his patients, even if it's a small company that manufactures a product not widely used outside of the hospital where the doctor practices. But such arrangements are risky and easy to abuse, the alert says.

Medicare's Anti Kickback law makes such arrangements illegal if even one of the doctors' motives in prescribing devices he has ownership in is personal profit. Those risks are particularly acute, the alert says, for physicians who own stock in companies that make surgically implanted medical devices, because hospitals typically listen to doctors' preferences when making purchasing decisions about those devices.

In figuring whether a particular arrangement may be illegal, the inspector general considers, among other factors, whether the profits gained from device-maker ownership are out of proportion to a small investment by the doctor; whether the price of the stock varies depending on how much prescribing the doctor is expected to do; and whether doctors have to sell their ownership if they change specialties.

Failing to report an ownership interest is also a red flag, the alert says.

“This is important guidance for providers who legitimately want to avoid getting into difficulty with the federal Anti Kickback law,” said Don White, a spokesman for the inspector general's office.

The senators' 2011 letter said that such specific guidance was needed by physicians who were being encouraged to enter physician-owned distributorships of uncertain legality. The letter cited specific feedback from doctors: “One surgeon who was pushing back against his colleagues pressuring him to join a POD wrote that those colleagues were citing the absence of any prevailing guidance specifically on point on this topic as a reason for joining a POD venture, and that 'this sort of thought is what prevails unless OIG takes a stand.'”

The HHS inspector general's office is slated to release its sweeping investigation of PODs later in 2013, according to the office's work plan.

“Anytime a few bad actors determine the treatment and care of patients, as this warning makes clear, patient safety is put at risk and millions of dollars are lost to fraud. This is simply unacceptable,” said Sen. Orrin Hatch (R-Utah), the ranking Republican on the Senate Finance Committee.

Hatch, who released a critical report on PODs in June 2011, was joined by committee chairman Max Baucus (D-Mont.), who said the alert raised serious questions about the practice.

“Patients have a right to know they're getting treatment that's tailored to them – not someone else's bottom line – but physician-owned distributorships may put that guarantee in doubt,” Baucus said in the emailed statement.

Senator Max S. Baucus

202.224.2651

max@baucus.senate.gov

511 Hart Senate Office Bldg

Washington, DC 20510

Bad Medicine By Congressional Design?

http://bit.ly/XeL4Lm

A little extra in the fiscal deal

Backroom deals are bad medicine and no way to set payment policy

By Merrill Goozner  Modern Healthcare  FiDA highlight

Posted: February 2, 2013 - 12:01 am ET

Legislators in Washington all claim they want to hold down healthcare spending, recognizing it is the main driver of the nation's long-term deficit. Yet that doesn't stop them from tinkering with the Medicare payment system to reward favored friends at the expense of taxpayers, insurers or providers.

The latest cases of special-interest dealing came in the fiscal-cliff deal passed during the waning hours of the last Congress. The legislation contained at least two provisions that needlessly rewarded companies with well-heeled lobbying operations.

The first involved Amgen and its drug Sensipar, which is used in dialysis patients. Five years ago, Congress created a bundled payment system for dialysis, which is Medicare's most expensive program. The bundle included all drugs except oral medications such as Sensipar, which were delayed until 2014. The fiscal-cliff bill delayed their inclusion again—until 2016 at a cost estimated at $500 million.

A story in the New York Times highlighted Amgen's 74 lobbyists and their ties to Sen. Max Baucus (D-Mont.), Sen. Orrin Hatch (R-Utah) and Sen. Mitch McConnell (R-Ky.), who played key roles in getting the rider inserted in the bill. So it goes in Washington. But there is a different reason for finding their actions contemptible.

Sensipar is an oral medication that reduces the overabundance of a hormone produced by the parathyroid gland, a secondary effect of kidney failure. Without treatment, it can lead to high calcium levels, brittle bones and easy fractures. Treatment usually relies on high doses of active vitamin D, which is cheaply available because the CMS included it in the bundle. Generic and brand manufacturers now compete on price in order to sell their products to dialysis clinic operators.

However, each year, treatment failure causes about 1% of dialysis patients to have their parathyroid surgically removed, a relatively minor operation. Sensipar has been sold as a way of reducing that number. About 20% of dialysis patients now take it.

A large post-approval trial sponsored by Amgen showed Sensipar did cut the surgery rate in half—from 1 in 100 to 1 in 200—but did not reduce mortality, cardiac problems or bone fractures compared with vitamin D. And, it has a severe side-effect problem—lots of nausea and vomiting.

Keeping Sensipar, which is the only drug in its class, out of the bundle means it doesn't have to compete with vitamin D. And because it is paid for by Medicare Part D, clinic operators and nephrologists have no incentive to balance its costs against its actual medical value. Putting the drug in the bundle would require Amgen to lower its price to compete.

Senate Majority Leader Harry Reid (D-Nev.) did a similar favor for Varian Medical Systems, whose Linac X-ray radiation machine competes with Swedish firm Elekta's high-precision gamma knife. While both machines cost more than $5 million, the gamma knife is used almost exclusively for brain tumors because it requires fixing its target—possible with the skull but impossible with, say, the pancreas or prostate.

Reid, whose home state has deep ties with Varian, inserted a provision in the fiscal-cliff deal that reduced Medicare's payment for a gamma knife session from $7,000 to $3,000—the same as a Linac radiation session. That ignored the fact that brain tumors treated with standard X-ray radiation devices—even the latest generation of high-precision machines—often require multiple sessions and, medical literature suggests, cause more collateral damage. There is no evidence that either machine produces a superior outcome in terms of reducing cancer recurrence.

And that, really, is the bottom line. Medicare payment policy is being set on Capitol Hill without regard to medical evidence or cost-effectiveness. The nation will never get its healthcare costs under control as long as that continues to be the case.

Merrill Goozner, Editor