Hope for Victims of Defective Medical Devices

Washington, DCPatients who have been injured by defective medical devices are hoping that a hearing into medical device safety will result in the reinstatement of their lawsuits against medical device makers. Although the same issue has been dealt with regarding medical drugs, there is a difference between drugs and medical devices, so, while US Food and Drug Administration (FDA) approval does not preempt a lawsuit regarding drugs, it currently does regarding medical devices.

The concern is a Supreme Court decision in Riegel v. Medtronic. In that ruling, the justices found that consumers cannot sue medical device companies over medical devices that have been granted approval by the US Food and Drug Administration. Essentially, this means that patients do not have any means of holding device makers accountable, even if those devices are faulty, because the device received FDA approval. This ruling resulted in hundreds of lawsuits being thrown out of court, including lawsuits involving patients who claimed they were severely harmed by defective pacemakers.

The Supreme Court ruled in Wyeth V. Levine, however, that pharmaceutical companies are responsible for their drug's labels. This means that even if a medication has FDA approval, if it is found to cause harm to patients, or be defective, FDA approval does not shield pharmaceutical companies from a lawsuit.

However, there is still hope for those plaintiffs who say they were harmed by medical devices. On May 12, the House Commerce Committee's health subcommittee held a hearing regarding the issue. The chairman of the subcommittee has co-authored the Medical Device Safety Act, which would allow patients injured by medical devices to sue the device makers. If the bill is passed, lawsuits against the device makers could go ahead.

Testimony at the subcommittee hearing included Bridget Robb, a single mother with a heart condition. Robb had a defibrillator implanted to prevent fatal arrhythmia. However, one evening, her defibrillator malfunctioned resulting in 31 dangerous—and unnecessary—shocks to her heart. Following that, Robb has had multiple stints in the hospital.

Some medical device makers, including Medtronic, manufacturer of pacemakers with wires that reportedly resulted in unnecessary shocks to patients' hearts, have said the bill does not improve patient safety but does stifle innovation and will restrict access to medical technologies.

That might sound scary, but it may not be entirely true. According to a study published in Heart Rhythm, the Official Journal of the Heart Rhythm Society, in February, 2009, by the time Medtronic recalled its Sprint Fidelis leads, there were already a reported 665 lead failures and 5 reported deaths. Furthermore, a study of 3,037 cardioverter-defibrillator leads found that of 94 total lead failures, as many as 72 lead failures were attributed to the Sprint Fidelis leads. Furthermore, there were only 848 Sprint Fidelis leads included in the study.

"The hazard of Sprint Fidelis lead failure is increasing, whereas the failure rates of other defibrillator leads are low and stable," researchers wrote, in the conclusion to their study.

Basically, there were other, safer options on the market for patients who received the Sprint Fidelis lead. So, why would patients not hold Medtronic accountable for allegedly allowing a defective, not to mention dangerous, product on the market? Surely some of those patients, if they had been told there was a risk of unnecessary shocks, would have chosen a different product. At the very least, they would have had that option.

Lawsuits designed to hold medical device makers accountable for their defective products do not stifle innovative technologies. Instead, they force medical device makers to work harder to ensure their products are safe before they are implanted in patients. These companies should be held accountable for defective products that cause harm to patients. Why should they be allowed to keep the profits of a device that does not work the way it was intended? Furthermore, why should the patient have to bear the cost of any medical bills related to the implantation of a defective device?

Even considering that the FDA has approved a product, a lot may not be discovered about that product until it goes on the market, meaning the FDA may not have current information about that medical device and the product's maker should take action of its own accord.

So patients who were harmed by medical devices wait to hear whether or not the Medical Device Safety Act goes through. They may have some help from President Barack Obama, who recently reversed the Bush administration's stance that encouraged federal agencies to allow rules pre-empting state laws. President Obama said that state law should only be pre-empted by federal law where there is a "well-defined legal basis." Although no industries were specifically named, that memo could easily apply to medical device makers.