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COA clears way for negligence complaint against medical device company

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A lawsuit filed against medical device manufacturer Medtronic following the death of a man who had one of the company’s medical devices implanted can continue, the Indiana Court of Appeals ruled Friday. It held the Medical Device Amendments to the Federal Food, Drug and Cosmetics Act does not preempt a family’s negligence claim.

Dr. Lawrence Klein implanted a Medtronic defibrillator and a Medtronic Transvene Model 6936 right ventricular lead in David Malander in 1997. The lead was a Class III medical device subject to premarket Food and Drug Administration approval. Malander’s lead experienced several short V-V intervals, in which the defibrillator senses electrical activity not related to the heart. A surgery was performed to replace the defibrillator, but the lead was left in place in December 2006. Malander died several weeks later after an incident of ventricular tachycardia on Dec. 31, 2006. Testing revealed 361 short V-V intervals of his defibrillator Dec. 14-31, 2006.

During the surgery, Klein called Medtronic’s technical services department to ask questions.

Malander’s relatives sued the doctor and Medtronic, alleging negligence, when Medtronic did not recommend that the lead be removed or capped off during the December surgery. Medtronic argued the claim was preempted by the MDA of the Food, Drug and Cosmetics Act. The preemption clause from the amendments has only been interpreted once by Indiana courts, but that case was distinguishable from the instant one. Turning to jurisdictions outside of Indiana, the appellate court affirmed the denial of summary judgment for Medtronic.

“The Malanders’ claim concerns the allegedly negligent interaction between the physician and Medtronic’s technicians. Their claim does not concern the design, manufacture, or labeling of the lead,” Judge Michael Barnes wrote. “Rather, the Malanders’ challenge involves negligence of Medtronic’s technicians in giving David’s physician allegedly faulty advice regarding the performance of one specific lead. As such, we conclude that the Malanders’ claim is not preempted by the MDA, and the trial court properly denied Medtronic’s motion for summary judgment on this issue.”

The judges also found there to be genuine issue of fact as to whether the company owed a duty to David Malander, so denial of summary judgment was proper in Medtronic, Inc., v. Lori A. Malander, Individually and as Personal Representative of the Estate of David M. Malander, Sr., Deceased and Kathleen Malander, 49A02-1211-CT-925.
 

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  1. Where may I find an attorney working Pro Bono? Many issues with divorce, my Disability, distribution of IRA's, property, money's and pressured into agreement by my attorney. Leaving me far less than 5% of all after 15 years of marriage. No money to appeal, disabled living on disability income. Attorney's decision brought forward to judge, no evidence ever to finalize divorce. Just 2 weeks ago. Please help.

  2. For the record no one could answer the equal protection / substantive due process challenge I issued in the first post below. The lawless and accountable only to power bureaucrats never did either. All who interface with the Indiana law examiners or JLAP be warned.

  3. Hi there I really need help with getting my old divorce case back into court - I am still paying support on a 24 year old who has not been in school since age 16 - now living independent. My visitation with my 14 year old has never been modified; however, when convenient for her I can have him... I am paying past balance from over due support, yet earn several thousand dollars less. I would contact my original attorney but he basically molest me multiple times in Indy when I would visit.. Todd Woodmansee - I had just came out and had know idea what to do... I have heard he no longer practices. Please help1

  4. Yes diversity is so very important. With justice Rucker off ... the court is too white. Still too male. No Hispanic justice. No LGBT justice. And there are other checkboxes missing as well. This will not do. I say hold the seat until a physically handicapped Black Lesbian of Hispanic heritage and eastern religious creed with bipolar issues can be located. Perhaps an international search, with a preference for third world candidates, is indicated. A non English speaker would surely increase our diversity quotient!!!

  5. First, I want to thank Justice Rucker for his many years of public service, not just at the appellate court level for over 25 years, but also when he served the people of Lake County as a Deputy Prosecutor, City Attorney for Gary, IN, and in private practice in a smaller, highly diverse community with a history of serious economic challenges, ethnic tensions, and recently publicized but apparently long-standing environmental health risks to some of its poorest residents. Congratulations for having the dedication & courage to practice law in areas many in our state might have considered too dangerous or too poor at different points in time. It was also courageous to step into a prominent and highly visible position of public service & respect in the early 1990's, remaining in a position that left you open to state-wide public scrutiny (without any glitches) for over 25 years. Yes, Hoosiers of all backgrounds can take pride in your many years of public service. But people of color who watched your ascent to the highest levels of state government no doubt felt even more as you transcended some real & perhaps some perceived social, economic, academic and professional barriers. You were living proof that, with hard work, dedication & a spirit of public service, a person who shared their same skin tone or came from the same county they grew up in could achieve great success. At the same time, perhaps unknowingly, you helped fellow members of the judiciary, court staff, litigants and the public better understand that differences that are only skin-deep neither define nor limit a person's character, abilities or prospects in life. You also helped others appreciate that people of different races & backgrounds can live and work together peacefully & productively for the greater good of all. Those are truths that didn't have to be written down in court opinions. Anyone paying attention could see that truth lived out every day you devoted to public service. I believe you have been a "trailblazer" in Indiana's legal community and its judiciary. I also embrace your belief that society's needs can be better served when people in positions of governmental power reflect the many complexions of the population that they serve. Whether through greater understanding across the existing racial spectrum or through the removal of some real and some perceived color-based, hope-crushing barriers to life opportunities & success, movement toward a more reflective representation of the population being governed will lead to greater and uninterrupted respect for laws designed to protect all peoples' rights to life, liberty & the pursuit of happiness. Thanks again for a job well-done & for the inevitable positive impact your service has had - and will continue to have - on countless Hoosiers of all backgrounds & colors.

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