Utah Personal Injury Blog - Medical Devices & Implants

New Heart Procedure May Be Alternative to Open Heart Surgery

Bret Hanna — Mon, 01 Jun 2009 22:02:22 GMT

Heart valves are typically replaced through invasive open heart surgery procedures which, along with the benefits, pose significant risks. A new procedure, however, may offer an alternative for those who are not good candidates for open heart surgery because of age or other physical limitations. A new minimally invasive procedure which uses a catheter inserted through a leg to replace valves could be the answer for thousands who are not good candidates for the open heart procedure option.

Massachusetts General Hospital in Boston is conducting a clinical trial on the new procedure which involves the insertion of the catheter into an artery through a small incision in the groin area. The catheter then follows the artery to the heart and when in the proper position, a balloon unfurls and implants the new valve so that it can begin its normal function. One patient in the Mass General clinical trial, Robert Shaw, is now a believer. And now this cutting edge procedure has made its way to the Intermountain West.

The Salt Lake Tribune reported today that Rose Felice, an 87 year old from Helper, Utah, who suffers from heart disease, is the first to undergo the procedure in the region. The procedure was performed by the cardiac team at Intermountain Healthcare's new flagship facility, the Intermountain Medical Center in Murray, Utah. Rose's procedure was part of the clinical trial known as Placement of Aortic Transcatheter Valve Trial or PARTNER sponsored by Edwards Life Sciences. U.S. Food and Drug Administration approval may be two to three years down the road but the prospects look very promising for those who are not candidates for open heart surgery.

Originally posted at InjuryBoard by Bret Hanna

Doctor Falsifies Study In Favor of Medical Product Infuse - Chapter 2

Bret Hanna — Fri, 22 May 2009 10:13:19 GMT

Last week, I reported that ex-army doctor and paid consultant to medical product manufacturer Medtronic, Timothy Kuklo, falsified a study which overstated positive results with his use of the bone graft product Infuse in soldier patients injured while serving in Iraq. After an alleged co-author doctor alerted the Army, the Army investigated and found that Dr. Kuklo forged the names of four doctors he claimed helped author the study, and that he over-stated his findings because the numbers of patients chronicled in the study were larger than they could have been given the census of patients treated by the Army with Infuse for the period covered by the study. The Army called for and the British journal that reported the study retracted it.

My post generated some immediate commentary. One comment was authored by "david," who some suspect may be affiliated with Medtronic:

Posted by david
May 16, 2009 10:59 AM

Let's get the facts straight. Innovation in medical devices is commonly the result of industry and physicians working together.

Medtronic did not participate in the collection or analysis of the data, the preparation of the manuscript for the journal article, or the submission of the journal article for publication. Additionally, the study was not funded by Medtronic, either directly or indirectly.

Neither the JBJS article, nor the data presented in that article, was used by Medtronic to secure any current indication for any product, including INFUSE Bone Graft. And since the article was called into question, we are not using it or the data to seek regulatory approval for any product.

Dr. Kuklo has been involved in a large number of research projects in his own right and he is also an author of numerous scientific papers and published journal articles. Neither the retrospective study conducted between 2003 and 2005 that formed the basis for the JBJS article, nor the submission and publication of this particular journal article was related to Dr. Kuklo's role as a consultant to Medtronic.

Regardless of whether "david" has an official affiliation with Medtronic, he certainly is/was a Medtronic cheerleader. But Medtronic itself is now back-pedaling from Dr. Kuklo as fast as it can. Yesterday, The New York Times reported that Medtronic has suspended its consulting contract with Dr. Kuklo and that Sen. Charles Grassley (R. Iowa) "rebuked" Medtronic for the failure to report Dr. Kuklo's involvement with consultation on Infuse. Chapter 2 of this story seems to highlight further the cozy relationship between big medicine and big business; perhaps Chapters 3 and beyond will reveal the truth for the patients who are on the receiving end of this "medicine" because they are the most deserving of the truth.

Originally posted at InjuryBoard by Bret Hanna

House Committee Considers Medical Device Bill

Bret Hanna — Sun, 17 May 2009 08:00:00 GMT

Last week, the House Energy and Commerce Subcommittee on Health heard testimony on the Medical Device Safety Act of 2009. This legislation was drafted to overturn the 2008 U.S. Supreme Court decision in Riegel v. Medtronic, Inc. This anti-consumer/pro-tort reform decision precludes those injured by some FDA approved medical devices from pursuing state law product liability claims for damages.

Predictably, pro-tort reform organizations like the American Tort Reform Association have launched a full-frontal attack on those dedicated to protecting the rights and interests of those injured by medical devices by calling the proposed bill a stimulus package for personal injury lawyers. Also, a former chief counsel for the Federal Drug Administration testified that oversight of medical devices is best left to the entity that approved them in the first place, the FDA. But even the most casual observer of the FDA's efforts on such matters knows how ineffective such oversight by the FDA has been.

The incoming Federal Trade Commission's chief of consumer protection, David Vladeck, however, provided contrasting testimony. Vladeck testified that since the FDA cannot have a perfect track record when it comes to approving medical devices, Riegel creates a catch-22 for injured consumers; there will be injuries caused by medical devices and there will be no recourse for those injured. Such sentiments were echoed by the American Association for Justice when it pointed out that the proposed legislation would simply restore victims' rights taken away by a pro-business Supreme Court decision.

We will track this bill as it progresses through the legislative process and keep you posted.

Originally posted at InjuryBoard by Bret Hanna

Doctor Falsifies Study In Favor of Medical Product Infuse

Bret Hanna — Sat, 16 May 2009 08:00:00 GMT

A former doctor at Walter Reed Army Medical Center has been accused a falsifying a study which extols the virtues of Infuse, a bone graph product manufactured by Medtronic. At the time the study was published, Dr. Timothy R. Kuklo was a paid consultant for Medtronic.

After conducting an investigation, the Army claims that Dr. Kuklo's study makes false claims and overstates the benefits of Infuse that was used to treat soldiers severely injured in Iraq. Specifically, the Army claims to have no record of a large number patients reported to be part of the census used to support the study findings. The Army also alleges that the success rate for bone healing reported by Dr. Kuklo was inconsistent with that reported by other Army doctors using Infuse under the same or similar circumstances. Finally, the Army claims that Dr. Kuklo forged the signatures of four doctors falsely indicating they are co-authors of the study and that Dr. Kuklo published the study without its permission.

One of the four supposed co-authors, Lt. Col. Romney C. Andersen, brought the bogus study to the attention of the Army. The British medical journal that published the study retracted it this March at the Army's request. The Army has provided the results of its investigation to Medtronics chief executive and to Dr. Kuklo's current employer, Washington University School of Medicine in St. Louis.

Not surprisingly, Medtronics denies any wrongdoing and the university will not confirm that it is investigating Dr. Kuklo. But Dr. Kuklo is still on the faculty and he is keeping a low profile by refusing to participate in the Army's investigation or to respond to any inquiries concerning the study. This is one more example of big business and big medicine blurring the lines between maximizing profits and independent research. Where does it end and who is watching out for the patient?

Originally posted at InjuryBoard by Bret Hanna