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

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.

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.

Heartache

The results of a 2004-2008 study by Dr. Robert G. Hauser, Minneapolis Heart Institute, and Dr. David L. Hayes of the Mayo Clinic indicate that the failure rate of Medtronic’s Sprint Fidelis lead is, over time, increasing.

The study involved of 3,000 heart defibrillator leads, 848 of which were Medtronic’s Sprint Fidelis. In comparison to the others, the Sprint Fidelis had a significantly higher rate of failure and was less stable. See: Study Suggests Higher Failures for Heart Device - NYTimes.com

Recently, after citing the Riegel v Medtronic Supreme Court decision, a federal judge threw out hundreds of lawsuits regarding Medtronic’s Sprint Fidelis lead. Please read the NYT link and come back and tell us what you think. Should devices with such a poor track record be protected under FDA preemption?

SEAGULL V. MEDTRONIC

Medtronic Sues Aquarium Manufacturer for Faulty Wiring

As most of you Liliputs will know, Medtronic is the company that earned fame--or whatever--for its success in the Riegel case involving device preemption. That case involved a balloon catheter Medtronic manufactures. Meanwhile, Medtronic is dealing with a number of other suits charging faulty wiring in the pacemakers they manufacture. Presumably, in those cases, too, the company is likely to be shielded by FDA preemption.

It is with some irony, therefore, that we learn that Medtronic has filed suit against Petco for manufacting aquaria that themselves have alleged faulty wiring. As reported, the problem is not that the resident fish will die as a result. Indeed, it appears there were no fish in the aquarium at the time. It is rather that alleged faulty wiring caused a fire that, in turn, caused the sprinkler system to go off. A squishy mess ensued (so to speak).

Here is the report:

http://www.twincities.com/ci_11752438?nclick_check=1

As far as we know, aquaria are not pre-approved by FDA and thus do not have to go through the exacting and agonizing process in which FDA provides its optimal scientific weighing and measuring of risks and benefits. Nor do we assume that lay juries are capable of swimming their way into the complexity of aquaria. After all, all liquids have dangers. Particularly, if you are not a fish.

Meanwhile, at the corporate headquaters, we hope that nothing else was short-circuited. Especially integrity.

Past Time to Right a Wrong

Remember Riegel v Medtronic and the Supreme Court decision exonerating Medtronic because their heart catheter was FDA approved? Well, Medtronic is back in the news. It should be apparent to anyone who reads the NYT’s article Lawmakers Seek to Return Right to Sue Device Makers - NYTimes.com, that enough is enough.

Because of the Supreme’s misguided Riegel decision, injured Americans throughout the country have had their cases tossed out of court. Bills have been written to end this insanity, but have not yet passed. Congress needs to pass them, now, before anymore women are burned internally, hearts are shocked or torn apart, and defective implants and treatments go horribly wrong.
Please read the Times piece and come back and tell us your thoughts.