Does Congress Afford too many Protections to Makers of Medical Devices?

Nick Avgerinos — Mon, 07 Jul 2008 11:33:00 GMT

Technological advancements add lifesaving and revolutionary products that enhance the practice of medicine. Doctors can save lives with devices such as artificial pacemakers and dialysis machines, or improve one’s quality of life with a joint replacement procedure. However, there can be problems with these medical devices that may cause harmful injury or death to the patient when they are either defective or malfunctioning.

The major problems with medical devices come through a defective product, incorrect use of the device, or medical incompatibility. According to the Institute of Medicine , about 1.3 million Americans are seriously injured each year by adverse events involving medical products.

In order to regulate these potential dangers, the FDA has regulations with which these medical devices must comply. To use the device should be logical and not confusing, with a minimal dependence on the memory or mental calculations of the patient. There should be appropriate warnings, labels, and alerts, and the devices should be well tested and re-checked regularly. If these regulations are not followed, a patient typically has the right to sue the manufacturer to recover for their injuries.

In February, the Supreme Court decided 8-1 that makers of medical devices that have passed the most rigorous review standards and approved by the FDA are protected from lawsuit. Justice Scalia wrote the opinion of the majority based on the principle that federal law preempts imposition of liability for such manufacturers under state law. Those who support this decision see the protection of the companies as crucial in furthering more medical advancements. Also, in a lawsuit, a jury is not confronted with the benefits a device may have for millions of people, not just how a malfunction harmed one person.

While the decision is narrowly tailored for devices that have passed the highest level of scrutiny, it can be potentially dangerous for those who have been wrongly injured. Such protections could encourage a greater sense of carelessness on the part of the manufacturers. Traditionally, lawsuits have acted as a check to ensure that quality standards are kept high when human lives are at stake. Furthermore, even the FDA admits that in many areas they are understaffed and under-funded . If this is the case, defective devices might gain FDA approval, harm someone, and the manufacturer would be immune from liability, leaving victims with no means to seek justice in the courts.

In the past few months, highly publicized petitions to Congress have been made to reform laws to make sure negligent companies are held liable for medical devices that are either defective or not properly labeled to ensure that patients can easily use them. Many members of Congress , such as the chairman of the House Committee on Oversight and Governmental Reform , want to pass legislation to protect the rights of the wrongly injured.

In the meantime, doctors and patients should continue to do everything they can to avoid tragic accidents. Patients should research medical devices on which they rely, and be sure to report any malfunctions, so they can hopefully be improved. They should also be sure to read and understand any warning labels and instructions, and treat even a simple device with the utmost care.

Originally posted at InjuryBoard by Nick Avgerinos

Faceless Foibles: Who’s To Blame For Medical Device Mishaps?

Nick Avgerinos — Wed, 25 Jun 2008 16:47:00 GMT

A lot of people see the legal arena as a battlefield. The goal? The attach blame to the enemy faction and extract compensation. But behind those battle lines, there are people. Mistakes have been made and everyone just wants to move on. What makes matters trickier is when there is no one to blame. No, I’m not talking about those rare “Act of God” cases; rather, I’m referring to medical devices gone wrong. Here are some common problems:

Prescription drugs
Heart valves and pacemakers
Implantable contraceptives and intrauterine devices
Prostheses
Latex gloves
Silicone implants
Surgical and physical therapy equipment
Respiratory devices
Contact lenses and dental care products
Laser and orthopedic tools

You assume that just because you’re treated at a well-respected hospital by a well-trained doctor, you’ll be safe. Unfortunately, that’s not the case. Sometimes it’s not about human error. Instead, machines are to blame. And that makes your situation more difficult all around. There’s “no one” to blame, no face to attach to your pain. So what now? Do you have a personal injury claim? Are you the victim of medical malpractice? Well, it depends.

Of particular interest to patients is the recent Supreme Court decision of Riegel v. Medtronic, Inc. As Injury Board member Dan Firth discussed in May, this case involved the bursting of a balloon catheter, manufactured by Medtronic, during angioplasty surgery. The result: Medtronic was not held liable. The suit was dismissed on grounds that the malfunctioning device had pre-market FDA approval and, thus, was barred by the Food, Drug, and Cosmetic Act.

The Court reasoned that the FDA has the responsibility for evaluating the risks and benefits of a new device and assuring that it is safe and effective for its intended use. Thus, they should take the blame for the mistake. And while that may make legal sense to some, it doesn’t make much common sense to most. Why? The FDA approves devices for sale, but it does not guarantee that a particular product is safe. Seems like a game of hot potato, passing the buck as to who’s to blame.

So, where does that leave you? We don’t know yet. The legal landscape is still growing up around this fresh decision. But there’s little question that patients deserve more protection. Keep up-to-date on the latest recalls and always question your care. Until someone is forced to take responsibility for these faceless foibles, you’ll have to be extra aware of choices affecting your health.

Originally posted at InjuryBoard by Nick Avgerinos

Rockford & Moline Personal Injury Lawyers - FDA

Does Congress Afford too many Protections to Makers of Medical Devices?

Faceless Foibles: Who’s To Blame For Medical Device Mishaps?