Mark David Turnidge went into the hospital on January 5, 2009, because his defibrillator was beeping and when a home monitor test was done, it showed the lead was likely fractured. He was advised to come into the hospital that night for observation and to have the lead potentially removed the next day. The cardiologist he saw on January 5th actually said she didn’t think it needed to be removed. When he was wheeled down to the pre-op area on January 6th, however, the surgeon came in and said they remove these all the time and it was a hour to two hour surgery. The surgeon mentioned that the lead could potentially be “fibrous.” I asked if that meant scar tissue and she said, “yes, but it just means it’s a little harder to remove and maybe adds an extra hour onto the surgery but we do these all the time and just did an 80 year old man yesterday”.

Mark was wheeled away and his mother and I went to the cafeteria and I had the beeper. Hours passed and we were curious as to why things were taking so long. I got back up to the cardiac catheterization floor and we sat talking and reading the paper. A nurse later came out to say we needed to come back immediately, as Mark was being rushed to the OR. My heart sunk but in shock I said, “is this serious, like could he die?” and she said, “this is catastrophic.” After several minutes, we heard people running with a cart with Mark on it and as it came around the corner we saw at least 8 people in blue scrubs, yelling how his blood pressure was in the 50’s. As he was wheeled past me, I saw he had on a vent and I could barely see his whiskers and he was out of it. I saw iodine all over his chest and that was the last I saw of him for several more hours.

I called everyone I could think of and posted on caringbridge (you can go back to 1-6-09 and see the entire thing as it played out for the next days). Before we knew it, the waiting room was flooded with 40-50 people or more and they came to retrieve me and bring me to somewhere private. The surgeon told us that they got the hole fixed -- a 3 ½ finger sized hole in his Vena Cava because the lead had implanted itself into the tissue and the laser to remove it ripped through the SVC). Shortly after telling us this, the surgeon ran out of the room and down the hall. I found out later that Mark went into cardiac arrest and had a bunch of other awful things happen to him.

When we were allowed to see Mark, they warned us he may be a little swollen and blue. I fortunately took a before picture and several after pictures and he was more than swollen and blue. They said they fixed the hole but he was without oxygen to his brain for a long time and “may” have suffered brain damage. By Wednesday morning, the small amount of brain stem function he had was gone and by Thursday, I was faced with the decision to pull life support on the love of my life, my high school sweetheart, best friend and father of my son.

The most amazing thing is how he died, with his arms raised during a song that he died to (from start to finish) and at the end, it says “fly to Jesus” and his arms lifted straight off the bed and by the very last word of the song, his heart stopped beating.

This has been the worst tragedy of my whole life. I have suffered with my own health problems but my husband was vibrant, healthy, active, funny and known all around as a goofball. He was a poet and wrote me many beautiful and touching poems, some of which I share openly on my caringbridge site. I love him and miss him and he leaves behind myself, our son Lance who is now 4 and his first son from a prior relationship who is 12. Senseless and tragic is how I describe this whole situation.

Wendy Turnidge
Mark’s Wife

occasional shocks. He also had to return to the hospital 14 days in a row, and then 16 days in a row to fight a staph infection caught from the implant surgery. Ray’s doctor has now recommended that he undergo a third surgery to remove the lead

FDA’s involvement: The Medtronic defibrillator received FDA approval through the most stringent pre-market approval (PMA) process. However, it is still unclear whether the Sprint Fidelis lead inside the defibrillator received FDA approval under the 510(k) approval process, which is an expedited approval process for devices that are “substantially equivalent” to those already on the market. The FDA reportedly took less than 30 days to approve Medtronic’s submission for the ultimately defective Sprint Fidelis lead.

Status: Due to Mr. Thompson’s health problems from the defibrillator, he has had to sell some of his land, and continues to work (at 70 years old) just to pay for additional medical bills that are not covered by his Medicare supplement. As a result of the Riegel v. Medtronic decision, Mr. Thompson understands that he will likely not be able to pursue an individual claim further.

period of 13 minutes in front of her young daughter. Ms. Robb did not realize that the lead had been recalled until her “life-saving” medical device seriously hurt her. Ms. Robb’s health has declined significantly after this incident. In addition to suffering from severe anxiety, she underwent two more surgeries to replace and revise the lead.

FDA’s involvement: See Ray Thompson’s story above (first story).

Status: Though Bridget’s insurance company has been covering her medical care, she will likely experience much higher insurance premiums as a result of her injuries. Ms. Robb’s attorneys have also told her that because of the Riegel v. Medtronic decision, a jury will likely never hear her case.

artificial Charite disc, manufactured by DePuy Spine. Instead of helping his pain, Judd, like hundreds of others, experienced extreme pain and even bouts of paralysis after being implanted with the Charite disc.

FDA’s involvement: The Charite artificial disc received FDA approval through the most stringent pre-market approval (PMA) process, based on a single 2-year noninferiority trial that was only intended to demonstrate that the Charite disc worked just as well as the Bagby and Kuslich (BAK) cage -- another device abandoned due to high failure rates. Experts agree that such a short clinical trial was inadequate for approving a device intended for a lifetime. Furthermore, DePuy Spine’s literature on the device notes that “The Charite Artificial Disc has a clinical history spanning 17 years.”

Status: Claims against DePuy Spine for misleading consumers about the safety and efficacy of the Charite disc have routinely been preempted. Judd is unable to afford the surgery he needs and continues to suffer extreme pain and bouts of paralysis.

underwent surgery to re-implant a new device. He now takes anti-anxiety drugs to quell his fear about the device malfunctioning again.

FDA’s involvement: See Ray Thompson’s story above (first story).

Status: Following the Riegel v. Medtronic decision, Medtronic immediately attempted to have Donald’s claim dismissed. This action caused Donald’s original attorney to drop his claim, as it became too expensive for him to continue handling Don’s case.

times while waiting for surgery to remove the faulty defibrillator lead. Though her doctor installed a new defibrillator, he was unable to safely remove the bad lead and simply unhooked the lead from Madeline’s device. To this day, Madeline still walks around with two bad leads in her heart from 2004.

FDA’s involvement: See Ray Thompson’s story, above (first story).

Status: Though Madeline is a Navy vet with some health insurance, her medical bills to correct the faulty lead have exceeded $70,000. Her attorney has not yet filed her claim, due to concerns that it will be preempted by Riegel v. Medtronic.

required additional surgery. Barry brought suit against the component's manufacturer to compensate him for his injuries.

FDA's involvement: This component had received FDA approval under the 510(k) approval process, which is an expedited approval process for devices that are "substantially equivalent" to those already on the market.

Status: At the federal trial court level, the judge denied the manufacturer's claim that it was immune by virtue of its FDA approval and allowed Barry to move forward with his case.

when he was a teenager. At the time of Adam’s death, he had three times the lethal dose of fentanyl in his system. Although the manufacturers (subsidiaries of Johnson & Johnson) knew that there were problems with the manufacture of Duragesic patches, and that those problems could lead to an overdose, the company did not take steps to solve the problem. After Adam’s death, the company issued a recall of Duragesic patches that were prone to leak, causing overdoses, injuries, and death. However, it was not until 18 months after Adam’s death that the company issued new warnings regarding the use of Duragesic.

FDA’s involvement: In July 2005, the FDA launched a probe into 120 deaths linked to the patches. After a two and a half year investigation, the FDA finally issued a public health advisory regarding the patches in December 2007 but did not mandate a change to the label.

Status: A jury awarded Adam’s family damages for his injuries.