Wednesday, April 30, 2008

Federal Preemption of State Product Liability Law Cuts Both Ways

One current hot topic in product liability law is the scope of federal preemption of state laws. The doctrine of preemption holds that a valid federal law may expressly or impliedly preempt state or local law. Congress may regulate all aspects of interstate commerce, including products produced by the pharmaceutical industry. In short, if Congress has not legislated on the matter, a state or local government may regulate aspects of interstate commerce. If Congress has legislated on the matter, then federal law is said to “preempt” or take precedence over, the state law. Recent cases involving federal preemption focused on whether FDA approval schemes can preempt state products liability actions.

Riegel v. Medtronic, Inc.
Recently, the Supreme Court held in Riegel v. Medtronic, Inc. that the express preemption provision in the Medical Device Amendments of 1976 allows U.S Food and Drug Administration (FDA) premarket approval to preempt state tort law in product liability claims involving Class III medical devices. The Medical Device Amendments prohibit a state from imposing requirements relating to the “safety or effectiveness” of a device that differ from requirements established by the FDA.

While undergoing an angioplasty procedure in 1996, Charles Riegel died because a catheter manufactured by Medtronic, Inc. ruptured during the procedure. The FDA approved label indicated that the device was contraindicated for patients, like Mr. Riegel, who suffered from calcified stenoses. The plaintiff claimed that Medtronic failed to warn about the risks of using the catheter on patients with calcified stenoses. However, because the device was used in a manner that was not in compliance with the FDA approved design, the Supreme Court, by an 8-1 vote, found that federal law preempted state law in this case. This narrow decision addresses Class III medical devices only.

Warner Lambert v. Kent
Another recent case went against the manufacturer. The Supreme Court let a lower court decision stand with a 4 to 4 vote (Chief Justice Roberts recused himself). The lower court decision held that federal law preempted a Michigan state law that generally grants immunity to drug manufacturers in product liability and negligence actions for FDA approved drugs. Because of the deadlock, the Supreme Court offered no guidance as to their positions and simply reported the result. Thus the state action was allowed to proceed.

Wyeth v. Levine
With no real guidance from Warner Lambert, and only narrow guidance from Medtronic, product liability attorneys are closely watching a case on the fall Supreme Court docket—Wyeth v. Levine. This case should address the scope of federal preemption of products approved by the FDA (except those covered in Medtronic).

The issue in Wyeth v. Levine centers on a state failure-to-warn action. In this case, the plaintiff argues that the FDA-approved label does not set a standard but is merely a minimum requirement and that the label, nevertheless, should have been stronger and more specific.

Unlike Medtronic, the Food, Drug, and Cosmetic Act does not contain an express preemption provision. Thus the Supreme Court cannot base its decision on such a provision and must decide whether the FDA regulatory scheme itself preempts state law.

Thank you for reading our blog. Personal injury suffered due to product liability can be devastating. If you or a loved one has been seriously injured due to a defective product, contact us for immediate assistance. Please note that our postings do not constitute legal advice and your comments will not be treated as confidential. If you wish to discuss your legal matter with us, please contact our office for a consultation.

Monday, April 21, 2008

Colorado’s Physician Apology Law

Several states have passed laws that allow doctors and other health care providers to apologize to a patient or a patient’s family for medical errors. These laws make doctor apologies inadmissible in court to prove liability against the doctor or health care provider.

Advocates of physician apologies contend that many malpractice lawsuits can be avoided if the doctor or health care provider apologizes and lets the patient or loved one know the details of what went wrong. Some health care providers have implemented similar policies with some encouraging results. For example, the University of Michigan Health System in Ann Arbor has a policy of full disclosure and offers apologies without the benefit of a state Physician Apology Statute. Since the program has been in effect, claims against them went down from 262 in 2001 to under 100 in 2005 despite an increase in clinical activity. Administrators claim the program works because, along with an apology and disclosure, they offer the aggrieved patient a reasonable settlement to compensate them for any losses.

Like many other states, Colorado has passed a physician apology statute. Colorado’s law is by far the broadest in the nation. Whereas most states limit the apologies to expressions of sympathy, SECTION 1, Article 25 of Title 13 of Colorado Revised Statutes also protects admissions of liability and guilt. It protects “any and all statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence…” In effect, a negligent doctor can apologize, describe in detail the mistakes he made, and the victim would not be able to use that admission in court.

Texas also has a physician apology statute, but it is much narrower than Colorado’s. Like Colorado's statute, Texas Civil Practice & Remedies Code Sec 18.061(a)(1) bars doctor's statements that “expresses sympathy or a general sense of benevolence relating to the pain, suffering, or death of an individual involved in an accident.” However, unlike Colorado's law, it does not bar a doctor's admission of liability or fault.

By way of example, let's imagine that a doctor makes the following statement after something goes wrong during an operation: “I am sorry for your pain. I mistakenly failed to close-up properly and that failure caused your pain and suffering.” In Texas, only the first part of the statement (“I am sorry...”) would not be admissible in court. The second part of the statement (“that failure caused...”) would be admissible to prove the doctor's liability. On the other hand, in Colorado, the entire statement would not be admissible to prove liability in any malpractice suit against the doctor or hospital.

Some critics of the Colorado statute feel that the policy is unfair and that patients should not have to give up their right to sue just so a doctor can say, “I’m sorry.” Proponents, on the other hand, believe that the statute protects more than a mere apology. Many patients and families file suit as a last resort to find out information about what happened. Because doctors have been advised to say nothing to mitigate the risk of a lawsuit, the patient never got a satisfactory explanation of what went wrong. Thus proponents believe that the statute offers a sense of closure for the patients and families without resorting to litigation.

Thank you for reading our blog. Injuries suffered due to medical malpractice can be devastating. If you or a loved one has been seriously injured due to medical malpractice, contact us for immediate assistance. If you have a question or comment, please reply to this blog or send us an e-mail.

Thursday, April 10, 2008

Senate Bill Proposes Increased Cap in Medical Malpractice Damages

Senate Bill (SB) 164 was sponsored by Senate President Peter Groff (D-Denver) and Assistant Majority Leader Terrance Carroll (D-Denver). It would increase the current cap on non-economic damages caused by medical negligence from $300,000 to $366,250, mirroring the cap on negligence claims that do not arise from medical negligence. Originally enacted under the Health Care Availability Act in 1988, caps on medical negligence have not been adjusted for inflation and have remained unchanged since 2003.

Currently there is a total cap of $1,000,000 on medical negligence/malpractice cases. Under SB 164, this cap would remain in place. Also under the current law, a judge can allow a larger damage award in extraordinary cases. Current law categorizes physical impairment and disfigurement as noneconomic damages, which are limited by the current cap. However, the bill will re-categorize them as economic damages. Noneconomic damages are traditionally non-quantifiable injuries such as pain and suffering, loss of companionship, and loss of consortium (love of a spouse).

SB 164 does not make any drastic changes, and the modest changes it does make will ensure that medical negligence victims are compensated fairly. Even so, special interests, lead by the insurance companies, have mounted a concerted effort to prevent this bill from becoming law. They claim that these small changes will somehow cause medical malpractice insurance rates to “skyrocket” and cause doctors to practice what they refer to as “defensive medicine” by performing more tests.

If more tests will prevent an innocent patient from loosing an arm, a leg, or the ability to see, then more doctors should be practicing defensive medicine. The underlying premise of our tort system is that a person injured due to another’s intentional act or negligence should be made whole. It only makes sense that the negligent party should be the one to foot the bill.

The special interest groups have portrayed victims of medical negligence as greedy opportunists seeking to capitalize off of their injury. Victims of medical negligence are people who have suffered injury through no fault of their own. They are people with injuries who deserve compensation. Although mere dollars cannot adequately compensate one for the loss of a limb or the death of a loved one, that is the only remedy the law allows.

The bill is currently on hold in the Colorado House of Representatives. After a contentious hearing on Wednesday March 18, the House Judiciary Committee decided to delay the vote to get more input from the public. Rep. Cheri Jahn (D-Wheat Ridge) may try to amend the bill to make it more acceptable to opponents.

Thank you for reading our blog. Personal injury suffered due to medical malpractice can be devastating. If you or a loved one have suffered a serious injury or death due to medical malpractice, contact us for a confidential consultation. If you have a question or comment, please reply to this blog or send us an e-mail.