Attorneyatlaw.com

A federal judge in Minneapolis has dealt a major blow to the rights of thousands of people across the United States who are killed or injured by defective medical devices. Citing a recent U.S. Supreme Court decision, the judge dismissed more than two dozen personal injury lawsuits which had been filed seeking damages caused by a faulty heart device.

The ruling comes on the heels of the controversial February 2008 decision by the Supreme Court, which said victims of defective medical devices are barred from seeking damages in state courts once the device has been approved by the U.S. Food and Drug Administration.

Without legal rights to seek financial damages for personal injuries in their state courts, injured parties are left out in the cold and without rights to sue makers of defective heart defibrillators, hip replacements, and other common types of medical devices.

The 27 plaintiffs in the recently dismissed cases were seeking damages for injuries caused by the Medtronic Sprint Fidelis wire leads, which were included in thousands of the company’s heart defibrillator systems. Medtronic recalled the Sprint Fidelis leads in October 2007, after it was found the wires had a tendency to break and may have contributed to five patient deaths and scores of injuries.

Before the recall, the Medtronic defibrillator leads had been implanted in an estimated 257,000 heart patients.

Federal Preemption at Center of Dispute

The legal controversy over patients rights centers on a Constitutional principle called preemption. The doctrine states that a federal law supersedes, or preempts, any conflicting state law or regulation covering the same topic. Legal historians note that the rule is in place because the Federal government, not the individual states, should decide matters that affect the entire nation. In many cases where federal law preempts state law, the party seeking to file a state lawsuit is left without a legal right to sue for damages. This is the case for people seeking to sue medical device manufacturers for state liability claims.

The federal law that was found to preempt state personal injury claims in the Medtronic case is the Medical Device Amendments of 1976, which created federal oversight of medical devices while at the same time limiting the states’ rights to oversee the products. The statute expressly says that states shall not establish rules regarding medical devices that are different from, or in addition to, any federal requirement on the same topic.

Congress Introduces Legislation

Congress reacted swiftly to the Supreme Court ruling by drafting legislation designed to reinstate the rights of people injured by defective medical devices, but until that legislation becomes law, the rulings against filing such suits hold.

If passed into law, the Medical Device Safety Act of 2008 would reinstate patients’ rights to file state liability claims seeking damages from manufacturers for injuries caused by FDA-approved but defectively designed, manufactured, or labeled medical devices. The new law would expressly state that existing federal laws governing medical device approvals do not “modify or otherwise affect” lawsuits brought in state courts. As proposed, the bill would apply to any civil action pending or filed on or after the date of enactment.

The federal judge who dismissed the suits against Medtronic indicated in his ruling that he felt his hands were tied by the Supreme Court, but that he sympathized with the injured parties he was tossing out of court on a legal technicality.

In his opinion, U.S. District Judge Richard Kyle wrote, “… the court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the court is not unsympathetic to their plight. But plaintiffs assert claims for which the court simply cannot provide a remedy…”

Patient Rights Must Be Restored

Whether it is by passage of the proposed federal legislation or on appeals to higher courts, the dismissal of the Medtronic cases must not be allowed to stand. Heart patients who relied on the FDA to ensure the safety of their heart defibrillators were let down and left without legal rights to seek financial damages.

Now, millions more Americans who trust that their hip replacements and countless other medical devices are safe and not defective know that if they are injured, they will have no right to seek compensation for their medical bills, pain and suffering, wrongful death, and other damages.

The Supreme Court’s ruling in the Medtronic case sends a hurtful and disturbing message to American medical consumers, who must face the reality that their health and safety comes second to increasing the profit margin of multi-billion dollar corporations, who allow defective products to injure consumers.