DEVICE LOBBY TO HOUSE--SUSTAIN PREEMPTION!

In a statement released by Advamed, the medical device folks appear to be endorsing significant provisions of health-care reform as passed by the U.S. House. But they go out of their way to warn about compromising FDA preemption, framed in the code language of allowing states to create a variety of standards.

See the statement here:

http://presszoom.com/story_150419.html

As others have observed, it appears that the language of "tort reform" and "preemption" will be at the core of arguments used by those who would like to "bend the curve" of reform toward their particular interests.

600 Suits Against Medtronic Dismissed

The (Preemption) Beat Goes On.....


FDA preemption in the arena of devices still rules in many cases. Here is a report about a judge in Minnesota who dismissed 600 cases against Medtronic over the Sprint Fidelis pacemaker.

http://massdevice.com/news/minnesota-judge-dismisses-600-sprint-fidelis-suits-against-medtronic

As most here will know, there is a bill in Congress now that would amend the Medical Device Act in order to allow tort liability for FDA-approved medical devices.

It is also well known that "irregularities" in FDA's device approval process increasingly make the news. As we report below, FDA itself publicized the story of a device the review of which was apparently influenced by the intervention of four Democratic congresspeople

THE NEW PHARMALITTLE

It's Not Good-bye. It's Onward!

Friends--Now that our beloved Ed Silverman and Pharmalot have returned, Pharmalittle will refine its focus.

Of course, we never imagined we could be more than a small stop-over for a few people. We are glad that we have been that and had some fun along the way. That will continue. But, beginning today, we will devote the lion's share of our reporting and commentary to the issues of accountability in the medical device and drug industries--both nationally and, for drugs, especially in Michigan. That means the issues of FDA preemption and civil liability, of course. But it also includes FDA regulation, Department of Justice actions, incentives for integrity, and examples of self-regulation that we view as terrific.

We expect to discuss these issues in detail--not only the law, but the politics, the spin, the tactics, the money, and more. We will connect the dots. And we will do so as advocates. No surprise there.

We are also what we have always been--a group of people representing both major political parties, healthcare professionals, academics, folks from industry (yes, that's true), patient advocates, and--above all--concerned citizens.

Our discussions will be linked directly to the combined organizations, Americans for Drug and Device Accountability / Justice in Michigan.

http://pharmaccountability.org/index.html

Whatever our own positions, we fervently hope that this space will serve as a forum for discussion and debate. In our view, the greatest travesty of all is that most people know nothing about these issues, or what they think they know is simply false.

For those who represent perspectives we oppose: If we think you knowingly lied, we will call you a liar, and we will say why. If we think you are arguing sincerely, you will maintain our respect, and we will tell you so. Count on both.

Let's hash it out. Let's tell the truth. Let's see what just and rational policy dictates.

Onward!

DIABETES CHARITABLE GROUP DUMPS MEDTRONIC

IPump.Org, Inc. Will Refuse Diabetic Supplies Made by Medtronic

In what could become an unprecedented kind of initiative, IPump, Inc. has issued a statement that it will no longer accept donated products manufactured by Medtronic.

IPump is a 501(c)3 organization founded to get needed supplies to diabetic children in families that cannot otherwise afford that care. It is no small thing, therefore, for such an organization to close the door on a corporate donor.

IPump's statement on the matter can be accessed at:

http://www.ipump.org/blog/2009/08/08/why-we-are-no-longer-accepting-medtronic-insulin-pumps-and-pump-supplies/

There is discussion both of recurrently failing Medtronic devices, cover-ups, and Medtronic's role in the the fight for FDA preemption in the arena of medical devices.

The statement begins:

"Legal and Ethical Concerns Over Medtronic’s Business Practices

Medtronic has a court-documented track record of failing to properly notify its customers in a timely fashion of known product defects. Product failure has resulted in deaths, hospitalizations, and both individual and class action lawsuits against the company. Their inexcusable behavior has even prompted new proposed legislation because legal rights for patients who died or were injured by Medtronic products were substantially limited when it came to suing for tort damages."

IPump further describes Medtronic collecting used and returned devices and "donating" them to IPump, so that the organization has become (their phrase) a "medical device dumpster." It is also a tax write-off for individual donors of used devices and, until now, good PR for the company.

Quite extraordinary development, I think.

Adverse Event Reporting - Problem, What Problem?

As reported by the Wall Street Journal on 7/20/2009 - GAO: FDA Can't Determine Its Funding Needs "The Food and Drug Administration isn't able to reliably determine how much money it needs to regulate medical products because, among other things, its staff can't track all the adverse-event reports it handles, according to the Government Accountability Office."

(click on the title to access the full article)

Which is the worse problem? Can't track adverse-event reports or Don't know how much my budget should be to do my job adequately. Either way it sounds like a train wreck in the making.

Adverse Event Reports Go Unreported While Consumers Loose Eye Sight.

In a report by the Associate Press (June 20, 2009) the company – Advanced Medical Optics - chose to not report at least 9 Adverse Events cause by it’s product Complete MoisturePlus that showed a connection between its product and a serious eye infection caused by Acanthamoeba.

“Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP,three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage. By June 2007, the CDC had confirmed nearly 160 cases of the infection in patients across the U.S.

Currently there are 257 Adverse Events listed in the Medical Device database (MAUDE).

When questioned by FDA inspectors, company officials said they were not obligated to report the complaints because the product's labeling does not say it protects against Acanthamoeba, according to the FDA documents.”

Apparently AMO chooses to not understand the requirements or purpose of Adverse Event Reporting. Suggesting that they are not required to report a problem that their label does not specifically address seems to indicate that the company feels that they are not obligated to be at all concerned about the consumer after they have taken payment for their product.

It is a given that AMO will play the FDA Preemption card in their liability defense. It is also likely that the case will be thrown out of court on those grounds.

PREEMPTION TIES THE HANDS OF JUSTICE

In an article solidly behind preemption we see this from the Southeastern Texas Record -

Citing federal preemption, MDL judge dismisses hundreds of Medtronic suits

"Stating the plaintiffs' claims are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, Judge Kyle wrote that the court recognized that at 'least some plaintiffs have suffered injuries' but that the 'plaintiffs assert claims for which the Court simply cannot provide a remedy.'

The article goes on to support the decision but what becomes obvious is the simple fact that no matter how much harm might come to unsuspecting medical device patients and no matter what a judge might want to do to remedy that, preemption does not allow any other course of action, even including discussion, fact finding or investigation into management practices, fraud or outright criminal conduct.

With FDA Preemption we live in a town without a sheriff. Be very careful that you don’t come into the company of a bad crowd.

STUDY ON MEDICAL DEVICE PREEMPTION - Your Thoughts?

Title Revision 2

I will go ahead and copy the report on this study word for word as I think it is important to see.

Your thoughts on this are appreciated.


Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access

BOSTON, May 6 /PRNewswire-USNewswire/ -- In a white paper released today by Ernst Berndt and Mark Trusheim of the Massachusetts Institute of Technology, research shows that eliminating FDA's preemption protection would decrease patients' access to life-enhancing medical devices, increase health care costs and reduce medical device industry employment.
The paper, "The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs," comes as Congress considers legislation that would remove Federal preemption of state rules and litigation that exists for a small percentage of medical devices that undergoes the most rigorous FDA review. The report highlights the damaging economic, health and societal impacts the legislation would have on patients, medical device industry innovation and employees, and the public health.
"As economic and health care researchers, we felt it was important to examine how this regulatory change could harm innovation, and ultimately impact the patients who rely on these treatments and the people who are employed by the device industry" said co-author Ernst Berndt, Ph.D., Louis E. Seley Professor in Applied Economics, MIT Sloan School of Management. "Congress should carefully weigh any policies that could increase health care costs and reduce high-paying jobs, particularly during an economic downturn."
The authors' research highlights the consequences to multiple stakeholders - patients and the public health, medical device inventors and manufacturers, their employees and the government - if medical device preemption were eliminated. For example,
Patients' access to medical devices and the benefits they provide would be reduced; as prices increase, products may be withdrawn, and fewer new products will be developed.
Physicians will increasingly practice defensive medicine to avoid litigation and expose patients to added risks of otherwise unnecessary procedures.
For those employed by the medical device industry, the increased manufacturers' costs would discourage investment in medical device development, reducing the R&D pipeline of innovative new products created and brought to market, and lead to layoffs of high-paying jobs.
Medical innovation would be affected, as decisions about health care products shift from expert, science-based regulators to untrained, non-expert juries, creating a duplicative, fragmented and inconsistent national framework administered by state and federal courts.
The government would experience increased costs, as Medicare and Medicaid spend more than they otherwise would due to fewer new product innovations, and government pays for increasing judicial system, tort and duplicative state regulatory costs.
"The question is not whether eliminating preemption will reduce innovation, but rather by how much and how rapidly," said co-author Mark Trusheim, Visiting Scientist at the MIT Sloan School of Management. "High levels of tort risk discourage investment in new technology. Eliminating preemption substantially alters the benefit/risk ratio of complex medical devices, increases the costs for all stakeholders, and negatively affects patients' future access to treatment options."
"Given these findings, and current economic circumstances, Congress should carefully consider any change to current law as the ramifications could substantially harm patient choice and health," Trusheim concluded.
The report was made possible by a grant from the Advanced Medical Technology Association. The views expressed are those of the authors only, and do not necessarily reflect views of the sponsor or MIT.
SOURCE Berndt Associates

FDA MEETING ON DIVISIVE DEVICES

ALL HANDS ON DECK, NONE BEHIND BACK

After months of reports of relative "horror stories" emerging from FDA's device approval and review departments, the FDA will today hold a meeting to discuss these issues. The NYT report is at:

http://www.nytimes.com/2009/04/22/health/policy/22fda.html?_r=1&hpw

This should be the first test of whether the Obama FDA's leaders will respond differently to dissenting reviewers than more recent versions of the agency. It will certainly be interesting and important to follow.

The New England Journal of Medicine's Opinion on Medical Device Safety

THE SUPREME COURT'S RULING IN RIEGEL - NOT BASED ON WHAT IS BEST FOR THE HEALTH OF THE PUBLIC.

The attached statement by The New England Journal of Medicine says it all and explains their view on what needs to be done.

The Medical Device Safety Act of 2009

Medical Device Patient Lobby Day - March 31 2009

Stop Corporate Immunity. Org is the site that is sponsoring the Medical Device Patient Lobby Day.

On March 31st, Medical Device Patients from around the country will travel
to Washington, DC and ask Congress to pass the Medical Device Safety Act.

These organizers have written a letter to Congress in support of HR 1346/S 540, THE MEDICAL DEVICE SAFETY ACT

Now is the time to contact your Senators and Representatives to enlist their support for this measure.

New England Journal of Medicine Urges Congress - Pass Medical Device Safety Act!

In an editorial published on the 18th of March 2009, the New England Journal of Medicine states that FDA Preemption places consumers in harms way. They further request that bills in the House of Representatives and Senate be passed to repeal Preemption.

"We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts."

The article is titled:

The Medical Device Safety Act of 2009

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.

Medical Device Preemption on Stage With Congressional Bill Introduction

As reported by AP today - 
Waxman and Pallone reintroduce their bill to overturn medical device preemption today.

Supporters of preemption claim that without preemption it will -

produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans.

Those against preemption claim that the decision to impliment preemption -

ignored decades of precedent, in which lawsuits brought by patients in state courts helped bolster safety regulation at the federal level.

See the full report by the AP here