Maryland Injury Lawyer Blog

Medical device maker St. Jude Medical reported that regulators both here and in Europe have approved its new Durata lead wires, which attach implantable defibrillators to the heart and regulate heart beat. Ostensibly, the Durata leads have a softer tip and slightly curved coil that will make these defibrillator leads more flexible and durable.

There were reports late last year that the Riata leads, which are similar to the Medtronic Sprint leads that were recalled in October, broke and perforated patients’ hearts in at least four reported cases. St. Jude chose a different path and did not recall the Riata defibrillator leads. It will be interesting to compare the St. Jude defibrillator leads with the recalled Medtronic leads (with the benefit of hindsight) to see whether the St. Jude’s leads are just as defective as the Medtronic leads. As I have written before, there is plenty of reason to be concerned that the St. Jude leads have the very same defects as the Medtronic defibrillator leads.

An editorial in the Wall Street Journal last week discusses the Medtronic recall of its Sprint Fidelis defibrillator leads. On October 15, 2007, due to reports of at least five patient deaths associated with defects in its Sprint Fidelis defibrillator leads, Medtronic withdrew from the market all defibrillators with those leads. Leads are connected to a defibrillator that both transport information of an irregular heartbeat to the defibrillator and carry what are often lifesaving electric impulses to the heart. The Sprint Fidelis leads were withdrawn because many of the leads were either not performing at all or were administering unnecessary shocks to the heart.

This editorial, as you would expect in the Wall Street Journal, has a pro-medical device manufacturer slant. The article claims that cardiologists have been calling for smaller leads because they are easier to thread through the veins when implanting the defibrillator and because they are less likely to lead to blood clots or distort heart valves. The actual evidence as to this groundswell among cardiologists for thinner leads is less clear.

This editorial argues that in the post-Vioxx era, drug and medical device companies “are under pressure to get out in front of even modest risks in spite of the fact that all therapies carry some risk.” The editorial opines that these withdrawals “strip choices from patients and their doctors.”

But this editorial does not point to a single medical doctor in the country who has stated that he/she would still rather use the Sprint Fidelis leads instead of the Sprint Quattro leads that were working just fine before the Fidelis leads came along. In fact, the editorial does not refer to any recent time when doctors protested the withdrawal of any drug or medical device because risk/benefit analysis favored continued use of the drug.

The editorial also expresses concern that Republican Senator Chuck Grassley is pushing legislation to require full disclosure of the terms of drug and medical device companies’ financial relationships with doctors to resolve the problem of pharmaceutical companies buying the allegiance of the leading doctors and researchers.

Trust me, as someone who has gone around the country developing experts for both drug and medical device companies, this is a huge problem. With certain drugs and medical devices, it is impossible to find a doctor who is an opinion leader with no financial ties – directly or indirectly – to a pharmaceutical company. Most of these doctors are good, honest doctors trying to do the right thing by patients, but it is hard even for the straight shooters not to be influenced by financial ties with these companies. And if you do cross these companies, look out. They very well may come after the doctor’s career. (This post discusses just one example.)

On this issue, this Wall Street Journal editorial goes to the tried and true: blame the trial lawyers. It claims that publishing the names of doctors will “create a registry of the deepest pockets for trial lawyer browsing,” which will have a chilling impact on the participation of the best doctors needed to conduct the studies to get these drugs on the market.

Continue reading "Medtronic Recall: Comment on Wall Street Journal Editorial" »

The Medtronic recall and the concern being expressed about the St. Jude Riata leads has left patients in fear that they have defective defibrillator lead wires in their chest that cannot be removed. Both Medtronic and the FDA have suggested that for most patients, removing the leads is not the best option because of the risks associated with the removal.

The good news, according to a recent article in Medical Device Week, is that medical technology is moving towards a safe and effective way to remove leads if they become damaged or dangerous to the patient.

Leads can become hazardous for any number of reasons, whether it is a question of faulty manufacturing like the defective Medtronic leads, or because they become infected or blocked over time. In the 1980s, most implantable leads were removed by mechanical sheaths. However, they were eventually replaced by power sheaths which were in turn abandoned for the newer laser sheaths. Cook Medical in Bloomington, Indiana has taken a more traditional approach in creating Evolution, their new tool for defibrillator lead removal and throwback to the mechanical sheaths of the ‘80s.

According to Cook Medical, the new Evolution mechanical dilator sheath boasts improvements over the traditional mechanical sheaths and has none of the drawbacks which plague the power and laser sheaths of today. The design of the original mechanical sheaths caused them to be somewhat awkward and require a large degree of physicality to operate. The new Evolution design has eliminated this concern. They are not as bulky or as costly as the current electronic sheaths, and they are able to avoid the unintentional damage to surrounding tissue sometimes caused by their electronic counterparts. The mechanical Evolution does not require the additional capital equipment, annual maintenance and calibration, biomedical inspection, electricity source, or on-site laser officer necessitated by a laser sheath. Reportedly, the mechanical sheath also maximizes physician control.

Continue reading "Medtronic Lead Recall: Possible Good News for Medtronic Defibrillator Patients with Defective Leads" »

Our lawyers receive calls every day asking about what a Medtronic class action lawsuit means to them. The Medtronic class action will be in the form of a multidistrict litigation (“MDL”). Pursuant to 1968 law, an MDL is a procedural mechanism that will pull all of the Medtronic lead recall cases in federal court together in a single action for consolidated pretrial handling. Under this law, a seven judge-panel appointed by the Chief Justice of the Supreme Court has the authority to consolidate the Medtronic cases and select a MDL judge to oversee the Medtronic class action.

In an MDL, there is not a single trial that resolves all of the cases. An MDL only pertains to pretrial discovery matters. After discovery has been conducted of the key witnesses and all of the relevant documents have been obtained, the Medtronic cases will be returned to the original court in which they were filed.

This actually makes sense both for Medtronic and for Medtronic defibrillator lead recall plaintiffs because it does not makes sense for anyone to have to depose the same witnesses over and over again if the same witnesses are people of interest in all of the Medtronic leadcases. For example, the person who made the decision to put the Medtronic leads on the market is going to be a relevant witness in every single case. In the Medtronic MDL, they will conduct what is called a trial deposition (or de bene esse deposition), in which the witness gives testimony by videotape which has the same effect as if the witness were to testify live a trial.

If you are a Medtronic plaintiff who would prefer to settle your case as opposed to going to trial, the MDL is a good vehicle to settlement. While an MDL is technically just for pretrial proceedings, functionally, if history is any guide, it will be the end point for the overwhelming majority of Medtronic cases. Big companies like Medtronic are driven by stock prices and financial reporting requirements. Investors typically want to limit a risk, which means resolving large cases through settlement. So an MDL class action creates an incentive to Medtronic to access the risk and what the value of the Medtronic lead recall cases really is which usually helps induce a reasonable settlement.

Continue reading "Medtronic Class Action: What Does a Class Action Mean to Medtronic Defibrillator Lead Recall Victims?" »

Merck is being lauded for its strategy of aggressively fighting virtually every injury claim. In spite of a $4.85 billion settlement that may only settle only 85% of open claims, Merck is getting pats on the back from Wall Street and kudos for its Churchillian cry to wage war. The question is will Medtronic follow suit in the defibrillator lead class action lawsuit?

If this is the course Medtronic takes, I suspect they will find themselves in the same category as many asbestos manufacturers who took the same path: financial ruin.

Why, then, was Merck arguably successful? Setting aside the insanity of calling a $4.85 billion settlement a success, Merck has been successful at trial because these cases are tough. Heart attacks and strokes with patients on Vioxx are what epidemiologists call confounding by indication, which means that people taking Vioxx, because of their typically more advanced age, are people also at risk for heart attacks independent of the Vioxx. Moreover, the injury itself is the leading cause of death in this country.

While there no question that Merck dropped the ball on patient safety with Vioxx, the question was always whether Vioxx caused the heart attack or stroke with the particular patient. This is the problem for Vioxx plaintiffs. Trust me, if a lawyer has a 25 year-old otherwise healthy client who took Vioxx, that lawyer is not going to be recommending that client join the class action settlement and that case is going to be worth a great deal of money. The problem was that most of the Vioxx plaintiffs were much older people at high risk for heart disease with or without Vioxx.

Causation is going to be much easier in the Medtronic cases for a host of reasons. First, everyone with these leads is injured, at least in the sense of fear that their Medtronic defibrillator will fail because the leads fail to detect an abnormal rhythm or because the leads shock the heart when they shouldn’t. If you have one of these Medtronic defective leads in your chest, you obviously know what I’m talking about. If you do not, think about it for a second. You made the choice to get a defibrillator which shows how concerned you were about abnormal heart rhythms. That is a serious choice to make. Now, for many patients, these wires are imbedded into their tissues with no meaningful way to recall them. How would you feel knowing you have a defibrillator that has wires that may fail to shock your heart when your heart falls out of rhythm or might shock your heart when you do not need a shock? Every juror hearing a Medtronic case is going to appreciate this harm.

Secondly, the liability is virtually established by Medtronic’s own statements about the failure of the leads. When all is said and done, the issue in these cases is going to be one of damages, not liability. In cases like these, Medtronic lawyers are going to have to have a lot more resolve to continue fighting than in the Vioxx cases where it appears that every individual case is an uphill battle.

Continue reading "Medtronic Class Action Lawsuit: Will Medtronic Follow the “Merck Model”" »

We received today a letter from one of our clients that she received from Medtronics.

Our attorneys are representing patients with these Medtronic defibrillators with defective leads not only in Maryland but around the country. You can find more information about the Medtronics Lead Recall below:

Questions and Answers About Medtronics Lead Recall (frequently asked client questions)

More News and Information on the Medtronics Lead Recall (class action information)

Medtronics Defibrillator Lead Recall Lawyer Analysis (discussion of what happened)

Congress Responds to the Medtronics Recall (details of congressional inquiry of Medtronics leads)

Medtronic's Response to the Defibrillator Lead Problem (what did Medtronic know and when did it know it?)

Medtronics Letter to Patients with Recalled Lead (received from one of our lead recall clients)

Commentary on How FDA Failed Medtronics Defibrillator Patients (discussion of flawed system)

Information for Lawyers Seeking to Refer Medtronics Cases to Our Law Firm (information about our firm for attorneys referring Medtronics lead recall cases)

Will Medtronic Follow the "Vioxx Plan" in the Medtronic Defibrillator Lead Lawsuits?

Contact Us (call 800-553-8082 or contact us by email for class action information).

In a blog post a few weeks ago on the Medtronic recall, I noted that I thought Medtronics was doing the right thing, acting conclusively without equivocation once the decision to recall the leads was made. Apparently, the FDA agrees. Medtronic has been praised by the FDA for ordering the recall in the “absence of conclusive data.”

I agree with part of the premise, but I disagree that there is an “absence of conclusive data.” Medtronic has confirmed 665 chronic fractures in returned leads already. Exactly how many people have to die or have their lives put at risk before the FDA believes that there is conclusive data? Does anyone wonder why Congress feels compelled to investigate what the FDA has done in its oversight role in the Medtronic recall?

While Medtronic may have acted decisively, which is commendable, there is increasing evidence that it should have acted sooner to get in front of the problem. According to Dr. Sidney Wolfe, director of the health research group at Public Citizen, Medtronics waited too long to act. "Why did the FDA, aware of the rapidly mounting number of injury reports, not force the company to recall defibrillators not yet implanted in the early part of this year?" wrote Dr. Wolfe in a letter to the FDA, pointing to data that shows that 1,194 associated injuries had been reported - up from 296 injuries reported in the first 10 months of 2006, a 400% increase. Congress is also concerned. Iowa Senator Charles Grassley wrote in a letter to the FDA that it appears "Medtronic was aware of the potential lead fractures several months before suspending sales of the Sprint Fidelis defibrillation leads. I am concerned that action may not have been taken in a timely fashion in this case as well.” Dr. William Maisel, who specializes in medical devices for the heart in Boston, told the New York Times that Medtronic's warning to doctors in March, which told doctors of some early fracture reports, is another example of medical device companies’ failure to get out in front of the problem. "What is frustrating here is that this was another situation that was predictable,” Dr. Maisel told the paper. The Minneapolis Heart Institute apparently also knew where this was headed even before Medtronic's initial warning and discontinued using defibrillators with these leads back in February.

While the speed at which Medtronic acted is certainly an issue that will be addressed by Medtronics lead recall lawyers, the core problem is not the speed at which these companies act to recall. Instead, the root problem is that medical device manufacturers, like Medtronic, rush these products to market because of the huge profit margins defibrillators provide to those who can gain market share. In the last fifteen years, companies selling cardic medical devices have been on the rise. The stock price of one of Medtronic competitors, Canadian-based St. Jude Medical Inc., rose 232 percent between November 2002 and January 2006. Like we saw the housing boom, these kind of great rewards lead people to take risks they should not take.

The same thing happened just a few years ago. In June 2005, Guidant, which has since been bought by Boston Scientific, also recalled its defibrillators. It certainly appears the Guidant defibrillators were rushed onto the market, as well. Reportedly, the clinical trial data on these leads was not reviewed by the FDA. I really have a hard time believing this is true. If it turns out to be true, and there is a lot of investigation to be done both by Congress and by Medtronic defibrillator lead recall lawyers, it underscores once again that the fox is guarding the medical device hen house.

The competitive advantage these defibrillators had is that the Medtronic Sprint Fidelis lead was the smallest and thinnest wire Medtronic offered, which was alluring to doctors implanting defibrillators, because a thin lead is easier to thread through blood vessels. So Medtronics had a powerful hook to sell this new advance. But while the technology was superior, there was no longitudinal history of safety or efficacy. It is not surprising that Medtronics has now turned to an older lead, the Quattro lead, which has a more complete safety profile.

Our Medtronic defibrillator lead recall lawyers are reviewing defective lead cases throughout the country. If you want to discuss your case with a Medtronics defibrillator lead recall lawyer, call for a free consultation at 800-553-8082 or click here for a free Internet consultation. You can also click here for a question and answer of the issues in the defibrillator lead recall class action.

Plaintiffs in the Medtronic defibrillator litigation are seeking class action certification against Medtronic for their defective implantable defibrillators. Five deaths have already been attributed to broken wires in the leads of these Medtronic defibrillators. Regrettably, more are expected given that 235,000 Americans have the four Sprint Fidelis lead wires that even Medtronic concedes are failing. Medtronic estimates that four to five thousand patients with the Sprint Fidelis lead will experience a lead fracture within 30 months of implantation. (You cannot help but assume this is low.) Medtronic is asking the 235,000 people with these defective electrical leads to have their physician evaluate whether their lead has developed a fracture. Certainly, you should contact your doctor if you do not know whether you have a Medtronic defibrillator - many people do not know the brand of their defibrillator, much less details as to the component parts (although most patients have a wallet card that will specify the manufacturer of their defibrillator leads). The Sprint Fidelis leads that have been recalled have the model numbers 6949, 6948, 6931 and 6930.

Obviously, lead recalls are particularly serious given the difficulty to replace them. Should a defective Medtronic defibrillator be replaced if there is no evidence of a fracture? This is an issue that can and should be addressed with your doctor.

While Medtronic has not disclosed the precise mechanism of how these Sprint Fidelis lead fracture failures have failed, it appears that the defect is caused by the small diameter of the coil and conductors in the lead. Because of this, the lead is subject to stress damage both during and after the defibrillator is implanted. A lead fracture occurs when the conductor is critically overstressed. While only five deaths have been reported, many people are reporting repeated electrical shocks due to their lead having fractured.

Medtronic appears to be trying to do the right thing after the damage has been done. Medtronic deserves credit for this. But the problem with Medtronic and these other medical device companies selling defibrillators is that because defibrillators are so lucrative, in an effort to sell more product than the competition, companies rush out new defibrillators, supposedly technologically superior to older defibrillators, but with no proven history of safety and reliability.

Our lawyers are representing patients with these Medtronic defibrillators with defective leads not only in Maryland but around the country. Fill out this brief form if you need additional information or would like us to review you case, or call us at 800-553-8082.

You can also click here for a question and answer of the issues in the defibrillator lead recall class action.