Medtronic Lead Recall: More Problems on the Horizon

Medtronic Sprint Fidelis Defibrillator Lead wires may cause greater risk to Medtronic defibrillator patients than was originally thought when Medtronic first announced that it was, essentially, recalling the Sprint Fidelis leads. Sadly, and this really underscores where we are in this country with medical device safety, this news comes not from Medtronic, but from a report by a Deutsche Bank analyst named Tao Levy. The report indicates that the Medtronic Sprint Fidelis lead wires had poor sensing capability that may compromise communication between the leads and the defibrillator The Deutsche Bank report stated that potential concerns over the Medtronic Sprint defibrillator lead wires’ sensing and transmitting abilities “is something we have learned from our clinicians contacts, and we could see published in medical journals.”

So, apparently, Medtronic defibrillator lead wires not only have an unacceptable fracture rate, they also appear to have poor sensing capabilities, even if they do not fracture. The first news Medtronic defibrillator lead patients are hearing of this is not from the FDA or Medtronic, but from an investment bank analyzing the stock. Unbelievable. This should be Exhibit A in attacking the preemption defense.   Exhibit B should be the Baxter heparin recall where contaminated heparin entered the market because the FDA confused which the names of the factories in China and believe it had already inspected the plant that make the active ingredient in heparin that supplied half of this life saving medication that we use in this country.

For lawyers not familiar with the litigation, a lead is a wire that is threaded through the blood vessels and connects to a defibrillator in the patient’s chest. The lead sends messages to the defibrillator that a patient’s heart rhythm is significantly abnormal. The defibrillator then returns a shock to the heart, through the leads, to shock the heart back into rhythm. If a defibrillator lead breaks, it can send a painful, and, of course, terrifying shock to the patient who may think he/she is dying. The fractured lead can also fail to give a needed shock to get the patient’s heart back in rhythm.

Unlike a pacemaker or defibrillator recall, these Medtronic leads cannot generally be recalled, because it can be risky and invasive surgery, particularly in those who have had the leads for some time. The FDA has suggested that it is generally not a good idea to replace a defective defibrillator lead. Common sense tells you that patients with the Medtronic defective defibrillator leads should be talking to their doctors about their options.

The Public Relations War Personal Injury Lawyers Must Fight

The Stella Awards are making the rounds on the Internet once again. It seems that the Stella Awards, honors given out to the most unbelievable lawsuits of the year, may highlight cases that are just that: unbelievable. The year's top prize continues to go to the same case, a woman who won almost two million dollars in a lawsuit against the maker of her RV which crashed while it was on cruise control. The catch in this case is that the owner decided to go to the back and fix herself a sandwich while the Winnebago on cruise control fended for itself. The story of this unbelievable case spread quickly over the internet years ago and was picked up not only by mass chain e-mailers but by respectable news outfits such as CNN and New York Daily News as well. Many people were understandably outraged at the state of the current legal system.

The only problem  is that this case of the cruise control to get the sandwich never actually happened, entertaining through it may be.  A little fact finding by one reporter revealed that Winnebago, the manufacturer who reportedly paid the almost two million dollar settlement and changed its owner's manual as a result, was never involved in any such case. It seems that reporters and readers were so mesmerized by such a crazy story that they didn't take the time to do a little digging and find out if the story was actually true.

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Gerry Spence's Trial Lawyers College

I read an interesting wire service article in the Maryland Daily Record today on Gerry Spence's Trial Lawyers College. Given Gerry Spence's trial record and the verdicts he has obtained, it is hard not to be interested in copying the tactics and strategies he employs. The question is whether his approach can be successfully adopted by other lawyers.

The goal of Gerry Spence's Trial Lawyers College is to teach trial lawyers how to be more successful in the courtroom and to win big verdicts for their clients. One of the fundamental principles of Gerry Spence that has filtered down to the Trial Lawyers College is the idea that personal injury lawyers need to learn how to become good storytellers. Obviously, trying a case well requires lawyers to convincingly convey their client's story to the jury. The methods the Trial College uses range from the unusual to the bizarre. The first step in "How to Be a Storyteller" is having the lawyers reconnect with their emotional selves, and the summer camp atmosphere is supposed to enable this process. The Trial Lawyers College has the attorneys share meals, chores, and talks around the campfire in hopes that they will "rediscover their own humanness."

This may be the most normal aspect of the Trial Lawyers College. During their sessions, lawyers role-play scenes from their own lives while complete strangers play the role of loved ones. They are supposed to use this opportunity to embrace personal pain and hardship and to learn to love themselves. Part career workshop, part therapy session, the College's classes use this psychodrama role-play to enable the attorneys to reconnect with their humanity. Once the participants connect with themselves (or have themselves voluntarily committed), the Trial Lawyers College teaches them to translate this into a connection with their client. The role-play switches from scenes from the lawyers' pasts to scenes from their clients' own lives. The ultimate goal is to enable the attorneys to create opening or closing statements that truly capture the personal impact on the client.

Last night, the 23 point underdog Philadelphia Eagles played a surprisingly close game against the obscenely dominant New England Patriots. The talk after the game was how the rest of the league will now copy Philadelphia's defense schemes against the Patriots. With obvious limitations, this can work in football. But when it comes to connecting with a jury authentically, the copycat game plan can lead you astray.

I wrote a post a while back for the Trial Lawyers Resource Center, commenting on one writer's view that trial lawyers should not wear bowties at trial. My response was essentially that you should wear bowties if you are a bowtie guy because to connect with people, you have to be yourself. Usually I steer clear of such trite advice. But in this case, it really is true. You have to be yourself or at least an authentic ambassador of yourself to connect with skeptical juries whose initial suspicions are mistrust.

There are a lot of successful personal injury lawyers who do not have the same connection to their inner selves and try a very effective personal injury case and can connect with a jury. I believe wholeheartedly in the idea that you need to tell a quality story to the jury. There are about 1000 things everyone can learn about trying a case from Gerry Spence which is why I have read all of his books and why if I had the opportunity and did not have three small kids, I would love to go to the Trial Lawyers College. But if you try to copy his touchy-feely emoting style at trial, you better have the personality to back it up or you are going to fall on your face in front of the jury.

Attorney Richard Shapiro's Site: Retinopathy of Prematurity

Richard Shapiro is a nationally renowned lawyer who has devoted his life’s work to helping the victims of medical mistakes.  His compassion for those who have been injured, especially children, is nationally known. He obtained justice for a child in excess of $10 million dollars for a blind, quadriplegic girl named Jessica R.

Now, Richard has launched a site that addresses Retinopathy of Prematurity (ROP) and it implications. ROP is a potentially blinding eye disorder that primarily affects premature infants weighing  approximately three pounds or less, born before 31 weeks of gestation (A full-term pregnancy has a gestation of 38–42 weeks). The smaller a baby is at birth, the more likely that baby will develop ROP. This condition is one of the most common causes of visual loss in childhood and can lead to lifelong vision impairment and blindness.

Go here to check out the site. www.babyblindness.com

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