The Supreme Court Blocks Civil Rights of Medical Device Harm Citizens

Essure Harm Shielded by the Supreme Court

Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD.

FRIDAY, JANUARY 8, 2016, 10:52 AM

One of the underlying tenets of our free-market is that consumers alleging harm should have legal recourse in our court system. And the 14^th Amendment of our Constitution guarantees citizens equal protection under the law.

So, if a product or service is unreasonably harming people, the court system usually provides feedback to the supplier and problems are removed.

But, if legal barriers prevent consumers from taking their cases to court, harmful products and services will persist in the market.

That’s the scenario playing out in the multi-billion-dollar medical device sector of our economy.

Most Americans do not realize that when the Food and Drug Administration (FDA) approves “high-risk” devices through its “Pre-Market Approval” (PMA) pathway, these devices are automatically shielded from litigation. This shield was created by the Supreme Court in the 2008 decision, Riegel v. Medtronic.

You can read about Riegel v. Medtronic here and here.

The presumption is that if and when a PMA device harms people, recourse will be provided through FDA review. But, unfortunately, FDA and, in particular, its Center for Devices and Radiological Health (CDRH) is a “captured” agency. What that means is that the FDA process is overly influenced by industry advocates, at the expense of patients.

Here is a clear example of why CDRH is considered a “captured” agency by prominent FDA watchdog groups.

When the federal government, on the one hand, blocks consumers’ access to state courts and, on the other, takes on the job of addressing allegations of harm outside of a courtroom, that’s not the free-market working - it’s Big Brother at work. And that’s the process protecting PMA-approved devices.

A specific example of this problem is playing out in the case of a device used to permanently sterilize women. This PMA-approved device is known as Essure, made by a German company, Bayer Health.

You can read about Essure here and here.

More than 25,000 women across the United States claim they have been harmed by Essure, but they do not have access to the state court system.

FDA did conduct a hearing on Essure in September 2015, but last I checked FDA is not an arm of the Department of Justice.

Pennsylvania Congressman Mike Fitzpatrick is fighting to overturn Riegel vs. Medtronic.

On Dec. 6, he introduced an amendment proposing the removal of all barriers to civil litigation in product liability cases against medical devices.

You can watch him introduce this amendment here at 41:50.

But Fitzpatrick’s amendment was rejected, based on technicalities, by the House Rules committee. So it will not come up for a vote in the House.

Incredibly, those voting against the amendment were Fitzpatrick’s Republican colleagues – the supposed guardians of “free-market” economics and vocal critics of federal government protectionism over the market.

Democrats are also rejecting rep. Fitzpatrick’s call to remove Essure from the market, despite many in that party who advocate for women’s health and patient safety. The party machine won’t support Fitzpatrick’s E-Free Act.

Meanwhile, Bayer is defending its product and claiming that the harm done to a relatively small group of otherwise healthy women is to be accepted given the product’s supposed benefits.  

But our country was built on protecting minority groups who are wrongly harmed.

Fitzpatrick’s position on Essure and Riegel offers Republicans an opportunity to live up to their free-market ideology and to claim women’s health as a real Republican platform – but many are failing to see this. 

Read more at http://www.philly.com/philly/blogs/healthcare/Essure-Harm-Shielded-by-the-Supreme-Court.html#ZJTeV8mB59FL1LhF.99

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.

Star Tribune photo galleries

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

Citizen claims right to safer implant devices.

LINK

 Medical devices need impartial oversight

JUNE, 27 2012

MARY BOLAND

POST INDEPENDENT

GLENWOOD SPRINGS, CO COLORADO (FiDA blog bold)

My husband has a full hip joint replacement, the kind where they lop off the bone and replace it with a metal rod and ball. Fortunately an easier procedure is now available where they just recoat the ball in the hip joint. But we thank our lucky stars that his metal hip joint is, so far, not causing any problems that we know of.

Many people who underwent the same procedure as my husband have had major problems, requiring repeated surgeries and causing long periods of, if not permanent, immobility.

And that is why I was particularly interested to read an article In “Public Citizen Health Letter” about the $350 billion medical device industry's “massive lobbying campaign to weaken the already lax oversight of medical devices and to accelerate the already too-quick review of high-risk medical products.”

The law setting the Federal Drug Administration's user fees and regulation requirements for both new medical device applications and ongoing oversight is up for renewal this year. And already the members of Congress who have received the most campaign finance help from the industry have introduced 14 bills aimed at easing regulation and weakening measures intended to ensure patient safety.

That patient safety measures need to be strengthened, not weakened, may be inferred from the substantial increase in recalls in recent years. Recalls of devices posing high risk to patients have doubled between 2007 and 2011, and recalls of devices posing moderate risk have increased sevenfold.

And the growth of recalls cannot be explained by any increase in the number of new medical devices, whose number has been stable or declining in recent years.

Among recently recalled devices are:

• Faulty implanted heart defibrillators that incorrectly deliver dangerous electrical jolts to the heart.

• Surgical clips that pop off, causing patients to bleed to death internally.

• Artificial hips that shed metal fragments into the bone and surrounding tissue, causing extreme pain and restricting mobility.

• Infusion pumps that shut down unexpectedly or dispense incorrect intravenous medicine doses.

In the face of this record, the medical device industry spent $33.3 million on lobbying in 2007. In the third and fourth quarters of 2011 there were at least 225 of these lobbyists hard at work, including 107 who had previously worked for the federal government.

Interestingly, one of the bills introduced in Congress would weaken the financial conflict of interest prohibition against individuals with industry interests serving on the FDA advisory committee overseeing medical device approvals.

Members of a key House health subcommittee with jurisdiction over medical devices have received campaign contributions from the industry double those of the average House member. And actual sponsors of the House bills seeking to weaken regulation and oversight have received about three times more.

Public Citizen asserts that in addition to allowing far too many dangerous devices to reach the market, the FDA has inadequate post-market surveillance for adverse advents. The FDA primarily depends on manufacturers and hospitals to report incidents of serious injuries or deaths related to these devices. It is not in the manufacturers' or hospitals' interest to do so.

Furthermore, Public Citizen points out, the Republican-dominated Supreme Court held in 2008 that manufacturers of FDA approved devices cannot be held liable for harms. Congress should restore patients' rights to sue in such cases.

Public Citizen calls on Congress to replace the current weak medical device regulatory regime with a process that requires the same scrutiny as that given to new drugs, particularly for moderate and high-risk devices that are permanently implanted in the body.

The whole situation is just one more sad example of our desperate need to amend the Constitution to overturn the Supreme Court's disastrous Citizens United ruling that corporations are people and the Constitution's free speech guarantee protects their right to spend all the money they want to influence Congress.

Only then can we revamp our election process to get campaign contributions out of the picture. And only after that is done, could legislation possibly be enacted to end the “revolving door” between industry regulators and lobbyists.

For further details, go online to www.citizen.org/hrg. And write your representatives and senators.

— “What Do We Really Want?” appears on the second and fourth Thursdays of the month. Mary Boland is a retired teacher and journalist, a proud grandmother, and a longtime resident of Carbondale. Follow her on twitter@grannyboland.