Medical Injury Lawyer Blog : Houston Medical Injury Lawyer & Attorney : Arnold & Itkin Law Firm : Pharmaceutical Injuries, Medical Devices : Texas, Dallas, Fort Worth, San Antonio

Boston Scientific Corp. recently announced, a malfunctioning wire in Cognis and Teligen defibrillators may result in an abnormal or unnecessary shock, causing serious medical injuries to patients.

Boston Scientific introduced the defibrillators last year in an attempt to grab market share from other device makers. The company expected sales from the two defibrillators to fast track growth this year. The safety warning, sent to cardiologists, seems to have put a halt on the company's plans, in addition to causing concern to thousands of patients who are implanted with the Cognis and Teligen defibrillators. The company says about 34,000 units have been sold since their introduction. The problem, however, is restricted to about 8,000 of these devices that come with respiratory sensors. The wires that connect the defibrillator to the heart are prone to malfunction which can result in one of two situations:

• The device may fail to operate properly, resulting in failure to emit a lifesaving electrical jolt to the heart when an abnormal cardiac rhythm is detected.
• The device may deliver an unnecessary electrical shock to the heart, resulting in severe pain and cardiac injuries.  

Wire problems with defibrillators tend to increase as the device gets older. The Cognis and Teligen defibrillators however are a relatively new entrant into the $11 billion defibrillator market. This is why the announcement, which warns of the device's susceptibility to early malfunction, surprised so many defibrillator experts. If these warnings seem all too familiar, it is because medical injury lawyers and patients who suffer from cardiac arrhythmia remember the thousands of injuries and 13 deaths caused by Medtronic’s malfunctioning defibrillators in 2007.

Defective Defibrillators

Considering the number of problems linked to these devices, it is fair to assume that there could potentially be malfunctions in defibrillators manufactured by other companies also. Cardiac defibrillator devices have been a blessing for thousands of patients who suffer from heart problems. However, manufacturing companies have been reluctant to inform the public about problems with the devices. To make matters worse, the U.S. Food and Drug Administration, which is supposed to screen devices thoroughly before approving them for marketing, has been slow to warn patients.

If you've been injured by the use of a defective defibrillator or other medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your case.

• Print
• Comments
• Trackbacks
• Share Link

In recent weeks, patients injured by Medtronic defibrillators have watched in pain as judges around the country dismissed their medical injury lawsuits. Law makers' recent plans to reintroduce patients' rights, give them reason to cheer.

Democratic lawmakers are working on plans to reintroduce legislation that would return patients' rights to sue medical device companies for their injuries. In February 2008, the Supreme Court ruled that patients injured by the use of defective medical devices, like Medtronic defibrillators, could not file a lawsuit against the company if the device had received approval from the Food and Drug Administration (FDA). Since then, judges around the country have cited the Supreme Court decision numerous times, using it as an excuse for throwing out hundreds of lawsuits including several against Medtronic. On February 17th, a judge in Wisconsin dismissed a lawsuit filed by a 63-year-old man who needed surgery to remove a Medtronic device after the company warned that the batteries may suffer from a sudden depletion of power causing it to malfunction. Earlier this year, a judge in Minnesota dismissed hundreds of Medtronic injury lawsuits brought by injured patients.

With the new administration, however, it seems like patients may have their right to sue companies like Medtronic returned to them. House democrats, Henry A. Waxman of California, who also serves as the chairman of the House Energy & Commerce Committee, and Frank Pallone Jr. of New Jersey, plan to introduce legislation that would nullify the Supreme Court ruling. Senator Edward Kennedy of Massachusetts and Patrick Leahy of Vermont sponsored a similar bill last year which could be reintroduced later this year.

At the crux of the Supreme Court decision last year was the belief that the FDA, as the country's chief drug and medical device safety agency, could be trusted to approve a product only after ensuring it was entirely safe to use. Since then, we have seen evidence of the agency's ineptitude, not only in the number of defective drugs that seem to enter the market like contaminated Heparin and Vioxx, but also through the whistle blowing efforts of its own staff who allege that the agency's approval processes are questionable. In this situation, where companies attempt to push their products through approval processes as quickly as possible and the FDA continues to lurch from one food and drug safety scandal to another, the only losers are patients who end up with no recourse to civil justice after they suffer injuries. Several lawmakers, medical injury lawyers, and patient advocates have strongly voiced their opposition to the 2008 Supreme Court ruling. With a new administration in power, however, it seems like change is finally coming to American civil justice.

Medical Injury Lawsuits

Going up against big medical device manufacturers like Medtronic can be intimidating. In conjunction with laws prohibiting your right to justice, however, it can seem impossible. Our team of medical injury attorneys can help you find the resources you need in such a situation.

If you have been injured by the use of a defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP to learn how you can begin to recover compensation for your suffering.

• Print
• Comments
• Trackbacks
• Share Link

A judge in St. Paul, Minnesota has dismissed dozens of lawsuits related to heart injuries caused by Medtronic's Sprint Fidelis defibrillator leads, citing federal preemption of state laws on the matter. 

In October of 2007, Medtronic Inc., stopped sales of its Sprint Fidelis defibrillator lead wires after reports that they failed to function properly in the event of heart attacks. The leads are wires that connect the defibrillator to the heart. When the lead is fractured the defibrillator cannot send a life saving shock to the heart in the event of an impending heart failure. The broken wire can also cause a massive and painful shock to the heart. After reports of patient injuries and deaths resulting from defective leads, Medtronic was forced to withdraw them from the market. At the time of the recall, approximately 257,000 patients had been implanted with the Sprint Fidelis defibrillator lead. Since then the company has faced multiple medical injury lawsuits filed by patients across the nation who sustained injuries caused by the defective leads.

In a separate case in February 2008, the US Supreme Court ruled under a controversial doctrine known as "preemption" that FDA approval of a medical device would supersede any lawsuit filed against a medical device maker under state laws. The Bush administration has pushed for preemption of federal regulations over state laws which has been criticized by consumer rights advocates and medical attorneys for the unwarranted protection it offers makers of medical devices. Under preemption, an injured patient would not be able to file a personal injury lawsuit against a medical device maker if the FDA had already approved the device. This doctrine works on the assumption that the FDA can never be wrong in all its approvals and that patients should have blind faith in the agency's ability to ensure that only the safest products enter the market. Unfortunately, the FDA's record on maintaining safety in drugs and devices introduced into the American market give little cause for comfort. The agency has battled allegations from its own scientists that approval for medical devices is obtained through coercive techniques.

Medtronic Sprint Fidelis Lead Lawsuits

Thousands of people around the country who have been injured as a result of the malfunctioning leads have filed lawsuits against Medtronic Inc.  For the remaining who have yet to suffer injuries from the malfunctioning lead, the prospects for replacing the lead are bleak, as it involves an invasive and potentially dangerous surgery.

As is evident from this lawsuit dismissal in St. Paul, taking on major pharmaceutical companies who enjoy the protection of the government is not an easy task. The medical injury lawyers at Arnold & Itkin LLP have the solid expertise and experience, as well as the considerable resources that pursuing Medtronic defibrillator lawsuits requires. We can answer your questions and help you evaluate your options for possible compensation.

If you have been inured by the Medtronic defibrillator leads, contact a medical injury attorney at Arnold & Itkin LLP. 

• Print
• Comments
• Trackbacks
• Share Link

Implantable Cardiac Defibrillators (ICD) marketed by Guidant Corp. have been recalled because of a device malfunction that can lead to potentially fatal consequences.  On June 17, 2005, in the first of multiple recalls, the FDA issued a nationwide notification of recall of certain Guident implantable defibrillators because of short circuiting issues that could lead to a failure of the device to deliver a life-saving shock when it was supposed to.

A later recall issued on April 5, 2007 recalled defective defibrillators and pacemakers marketed by Boston Scientific/Guidant claiming the devices were subject to rapid battery depletion and premature device failure.

Because defibrillators and pacemakers are used to preserve the lives of persons who depend on them, the failure of these devices can lead to very serious injuries and death.

More information on the defective Guidant Defibrilltor recalls can be found on our Medical Injury Lawyer website.

• Print
• Comments
• Trackbacks
• Share Link