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

Healthcare lobbyists outnumber Congress 5 to 1. Are the voters revolted yet?

Polluted Political Games

MAY 28, 2015  Nicholas Kristof                                                                                                                                       I’ve admired the Clintons’ foundation for years for its fine work on AIDS and global poverty, and I’ve moderated many panels at the annual Clinton Global Initiative. Yet with each revelation of failed disclosures or the appearance of a conflict of interest from speaking fees of $500,000 for the former president, I have wondered: What were they thinking?

But the problem is not precisely the Clintons. It’s our entire disgraceful money-based political system. Look around:

• Gov. Chris Christie of New Jersey accepted flights and playoff tickets from the Dallas Cowboys owner, Jerry Jones, who has business interests Christie can affect.

• Senator Marco Rubio of Florida has received financial assistance from a billionaire, Norman Braman, and has channeled public money to Braman’s causes.

When problems are this widespread, the problem is not crooked individuals but perverse incentives from a rotten structure.

“There is a systemic corruption here,” says Sheila Krumholz of the Center for Responsive Politics, which tracks campaign money. “It’s kind of baked in.”

Most politicians are good people. Then they discover that money is the only fuel that makes the system work and sometimes step into the bog themselves.

Money isn’t a new problem, of course. John F. Kennedy was accused of using his father’s wealth to buy elections. In response, he joked that he had received the following telegram from his dad: “Don’t buy another vote. I won’t pay for a landslide!”

Yet Robert Reich, Bill Clinton’s labor secretary and now chairman of the national governing board of Common Cause, a nonpartisan watchdog group, notes that inequality has hugely exacerbated the problem. Billionaires adopt presidential candidates as if they were prize racehorses. Yet for them, it’s only a hobby expense.

For example, Sheldon and Miriam Adelson donated $92 million to super PACs in the 2012 election cycle; as a share of their net worth, that was equivalent to $300 from the median American family. So a multibillionaire can influence a national election for the same sacrifice an average family bears in, say, a weekend driving getaway.

Money doesn’t always succeed, of course, and billionaires often end up wasting money on campaigns. According to The San Jose Mercury News, Meg Whitman spent $43 per vote in her failed campaign for governor of California in 2010, mostly from her own pocket. But Michael Bloomberg won his 2009 re-election campaign for mayor of New York City after, according to the New York Daily News, spending $185 of his own money per vote.

The real bargain is lobbying — and that’s why corporations spend 13 times as much lobbying as they do contributing to campaigns, by the calculations of Lee Drutman, author of a recent book on lobbying.

The health care industry hires about five times as many lobbyists as there are members of Congress. That’s a shrewd investment. Drug company lobbyists have prevented Medicare from getting bulk discounts, amounting to perhaps $50 billion a year in extra profits for the sector.

Likewise, lobbying has carved out the egregious carried interest tax loophole, allowing many financiers to pay vastly reduced tax rates. In that respect, money in politics both reflects inequality and amplifies it.

• Lobbyists exert influence because they bring a potent combination of expertise and money to the game. They gain access, offer a well-informed take on obscure issues — and, for a member of Congress, you think twice before biting the hand that feeds you.

The Supreme Court is partly to blame for the present money game, for its misguided rulings that struck down limits in campaign spending by corporations and unions and the overall political donation cap for individuals.

Still, President Obama could take one step that would help: an executive order requiring federal contractors to disclose all political contributions.

COMMENTS

“President Obama could bring the dark money into the sunlight in time for the 2016 election,” notes Michael Waldman of the Brennan Center for Justice at the New York University School of Law. “It’s the single most tangible thing anyone could do to expose the dark money that is now polluting politics.”

I’ve covered corrupt regimes all over the world, and I find it ineffably sad to come home and behold institutionalized sleaze in the United States.

Reich told me that for meaningful change to arrive, “voters need to reach a point of revulsion.” Hey, folks, that time has come.☐

http://www.nytimes.com/2015/05/28/opinion/nicholas-kristof-polluted-political-games.html

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

End Secrecy, Save Lives: Consumers Union patient stories

Steven Baker profiled by Consumers Union Safe Patient Project.
Information on growing patient harm is suppressed by powerful interests that benefit from underfunded research and regulation.  Taxpayers and consumers deserve to know which medical devices are safe and effective.  (Especially now when joint replacements are the #1 expenditure of Medicare!)  Patients deserve to know more about an implant device than they do about a toaster oven they are considering for purchase.  Informed consent must include a discussion about the FDA 510(k) clearance debate and medical device Supreme Court pre-emption (Riegel v Medtronic) and tort reform that weakens patient protections when a device fails.  The epic failures of various ICD's, surgical mesh and metal-on-metal hips were preventable.  The device industry is not entitled to profit without accountability.
Please support Consumers Union Safe Patient Project!  These patients are bravely telling their stories to benefit us all!  

Gratitude for Blog interview by 'Confident Voices' Beth Boynton

Rehab Counselor’s MissionWhen Brother’s Surgery Failed? Campaign for Surgeon & ManufacturerAccountability

November 7, 2012 By Beth Boynton

“Escape Fire” is a documentary film that explains how broken our healthcare system is in some big ways and inspires focus on people who are working to make it safer, kinder, and more cost-effective.  We can do amazing things in USA healthcare, but not always.  And when things go wrong, patients, families, and even healthcare professionals suffer terribly. As tragic as such eye-opening experiences can be, some people respond by trying to understand what went wrong and why and then work to prevent similar problems from happening to others.  In today’s post, I interview Joleen Chambers, who’s brother, Steven had elbow replacement surgery at the Mayo Clinic.  The replacement elbow failed, leaving him with more suffering and a healthcare system that is unresponsive and unaccountable.

Tell us a little bit about your background.

I grew up in small town Minnesota in a family of three children. I am the middle child and my brother is younger than me by 4 years.   After college I married and completed my education with a MS in Rehabilitation Counseling in Chicago.  I have enjoyed living on the east coast and the last two decades in Dallas, TX.  I am active in support of the arts locally and of women’s leadership programs statewide and nationally.

What led your brother to seeking a right elbow replacement at the Mayo Clinic?

My brother is a life-long Minnesotan, Air Force veteran and father of two young adults.  For seven years he attempted to overcome a severe work injury by having 7 surgeries of plates and screws to hold his elbow together.  Maintaining employment as a millwright (a 20 year-long job that he loved) became impossible.  Finally, his surgeon in Minneapolis, MN told him about the Mayo Clinic option to have an elbow replacement. 

What happened after the surgery and how is he doing now?

Steven was quite confident immediately after the 5/19/2008 elbow replacement that he would have significantly less pain and more functionality, but at just 4 months, he felt and heard the elbow “pop” and the pain began.  My advocacy began one morning when I called Steven and he was in so much pain he could not speak/think clearly.  His arm was yellow, green, blue, purple & black.  I phoned his surgeon/Tornier device designer, Shawn O’Driscoll and Steven was told to return to the Mayo Clinic.  On 9/29/2008 the elbow was “revised”.  When Steven read the clinical records he learned that two components were removed.  Steven asked that the surgeon report the elbow to the FDA MedWatch because a revision of a joint replacement is considered an adverse event.  The surgeon refused (and is not legally required to report unless there is a fatality).  Steven reported as #5009052.  I became his ‘scribe’ because of his injury and the amount of correspondence that was required.

How did the Mayo Clinic respond to concerns about the elbow and your brother’s persistent problems?

 There was an astonishing disconnect between the marketing (patient-centered care) and the reality of care for this harmed patient.  A registered/certified letter I wrote to the Mayo Trustees went unanswered.   Steven and I met with Mayo Clinic Patient Affairs to no effect.  Steven was referred to surgeons with less experience than the original surgeon (trained by Tornier and only on cadavers!).  July 10, 2010 Steven received a letter stating that Mayo Clinic would provide only federally mandated emergency care because of ‘communication and trust difficulties’ with no notice and no appeal. This summer I applied and competed for a scholarship to the Mayo Clinic Social Media Summit and I was ‘unselected’. 

What are your concerns about the surgeon, the medical device, (elbow replacement) and the medical device company?

I believe that the surgeon/designer is conflicted by his profitable business association with the medical device company.   His elbow (which is an innovation on the more traditional Morrey elbow) had not been proven to be safe and effective.  It was FDA approved through FDA 510(k) process that does not require clinical testing.  The Institute of Medicine  7/29/2011 report states that 510(k) is flawed legislatively.  In Canada, the elbow had been recalled.

What are your concerns about the judicial system in situations where medical devices fail and or cause problems for patients?

Lawsuits (especially class action, i.e. metal-on-metal hips, surgical mesh, ICD, etc.) highlight that current regulation of implanted medical devices is in disarray and does not protect patients.  Patient harm from implants is catastrophic and cannot be compensated in a court of law.  It is too little, too late! 

Tort reform limits the cases that injury lawyers can afford to take and Supreme Court Riegel v Medtronic gives the medical device industry preemption from state courts.  The system is corrupted because there is no feedback to/accountability by the medical device industry that prompts responsiveness to reduce/eliminate patient harm. 

What are you doing to make healthcare safer?

I use social media to join with other patient advocates, consumer organizations and activist legislators to support

their efforts and to stay current with progress towards:

•             Medical device registry accessible to patients,

•             Unique device identifiers (UDI),

•             Product warranty,

•              FDA Patient Representative stakeholders with full voting rights,

•             Rescind/reduce medical device industry judicial entitlements.

Do you and/or Steven have anything you would like to ask Dr. O’Driscoll?

I would ask him, if he believes that his treatment of my brother fulfills the Hippocratic Oath he took and to please explain.

Steven would ask Dr. O’Driscoll two questions:

1. How do you justify continuing to implant Tornier elbows when the patient harm is so catastrophic and the failure rate is undetermined?

2.  What was it about my communications that prompted you to request of Mayo Clinic that I be medically abandoned by the entire institution without appeal?

Thanks Joleen,  for all of your work to help create safer kinder healthcare.  You can reach Joleen Chambers at  jjrk_ch@swbell.net.

I wonder how tricky boundaries we face in healthcare sometimes and ask how we have create systems that respond to patients when we think we can help them but shut down when we fail.

To understand more about our struggling healthcare system and get involved, watch the movie, “Escape Fire” on Itunes or through  “Escape Fire” Website.  The trailer itself is full of talking points!

Harmed patients blocked by Supreme Court & Citizens United

Alliance for Justice: Overturn Citizens United.

Harmed patients cannot access justice.  The system is rigged.