UNITED STATES SUPREME COURT TO HEAR IMPORTANT PREEMPTION CASE ON NOVEMBER 3, 2008; COURT’S DECISION WILL DETERMINE WHETHER PATIENTS CAN SUE A DRUGMAKER THROUGH STATE LAW WHEN A PRODUCT HAS ALREADY BEEN APPROVED BY THE FOOD AND DRUG ADMINISTRATION (FDA)
A PHILADELPHIA PRODUCTS LIABILITY LAWYER SAYS THAT THE PUBLIC WILL PAY A PRICE
On November 3, 2008, the pharmaceutical giant Wyeth will take its case to the United States Supreme Court to argue that FDA approval of a drug supercedes state law challenging safety, efficacy and labeling. The drugmaker and the FDA will argue that preemption by maintaining the FDA’s actions are the final word on safety and effectiveness. This Court decision is extremely important and being closely watched by drug manufacturers and plaintiffs’ attorneys on behalf of their affected clients because the ruling will determine whether patients can sue drugmakers through state law when a product has already been approved by the FDA. In a press release, the drugmaker Wyeth argued that preemption protects everyone; “The Constitutional preemption is not new; the patients and physicians need to be able to rely on a single Federal standard and guidelines with the risks, benefits and uses of medicines - the FDA-approved labeling, and upholding preemption will leave America’s courthouse doors open to injured patients.”
This case stems from an instance where Vermont musician Diana Levine was given a Wyeth nausea medication called Phenergan during a visit to a hospital emergency room. However, the drug was administered improperly, causing her to lose her right arm below the elbow. She successfully argued that even though the labeling complied with the FDA requirements, the adequacy of the warning still wasn’t established for a particular method of administering the drug. She further contended that Wyeth wasn’t prevented from adding or strengthening the warning on the label even though the FDA rejected a proposed change. In the lower courts, Levine was awarded more than $6 million dollars. In spite of appeals, the Vermont Supreme Court sided with her. But Wyeth appealed again. No surprise the White House backs Wyeth on their preemption position. (New York Times article)
This case has been referred to as the mother of all preemption cases. If the Court accepts the position set forth by Wyeth and the FDA, the result will be an unprecedented elimination of remedies available to consumers injured by drugs. Many large corporations supported by the Bush administration have vigorously pursued the preemption argument to block the roadways to courts and prevent many injured plaintiffs from full ability to exercise their Constitutional rights. Preemption is a legal doctrine based on the Supremacy Clause of the United States Constitution which states that when Federal and State law are at odds, Federal law will take precedent. Its application to state tort litigation represents a radical extension of its original meaning.
As a practicing products liability lawyer for approximately 30 years, it is my belief that trial lawyers are the unsung heroes of society and that tort litigation serves a regulatory purpose complementing FDA regulatory actions, therefore enhancing patient safety. It has been recognized by previous administrations and even Margaret Jane Porter, the former Chief Counsel of the FDA, who wrote “FDA product approval and state tort liability usually operate independently providing a significant, yet distinct, layer of consumer protection.” Persons who are harmed have the right to seek legal redress and preemption would erase that right.
I have written numerous articles and blogs stating that Federal preemption will remove the teeth from many state laws which provide stronger safety protections, replacing them with such Federal laws that favor corporate special interests. Federal preemption will serve to undermine state and local laws that advance public health and safety and other important public policy goals and allow manufacturers and corporations to put profits over safety with little or no oversight. In addition to preventing states from acquiring higher standards for consumer safety and other laws, the Federal preemption of state law removes the compensatory damage element from the civil justice system. One only need look at the financial reports and newspaper reports over the past months revealing the greed of Wall Street and big business. Ultimately, the public will pay the price if preemption arguments prevail at the Supreme Court.
Over the past month, we have been bombarded with news headlines revealing corporate greed due to the unregulation of big business matters. The revelations of the significant corporate greed has been staggering and has crippled America. Under the protection of product liability law in Pennsylvania and many other states, consumers are now able to recover compensatory damages stemming from or relating to injuries from defective products. Under Pennsylvania as well as other state laws, products must meet a certain consumer safety requirements when being used in a lawful and normal manner. Preemption focuses on the idea of changing the rules applicable to the law or tort. It is a given right to have a trial by jury. With tort reforms and preemption, restrictions would be imposed on your rights; the right to a fair trial by jury and the right to get compensation for unjust damages. A vote in favor of Wyeth would prevent claims to be brought against guilty parties, therefore stunting our rights. Judgments and settlements are meant to deter big, greedy corporations from sweeping victims cries for help under the rug. By imposing restrictions via tort reform and preemption, the cries of these victims will never be heard.
The Pennsylvania catastrophic injury lawyers at the Philadelphia product liability firm of Reiff and Bily are committed to representing the rights of individuals injured by defective products and believe that the roadways to the courts should be kept open without Federal interference. If you or a loved one has been injured by a defective product, please contact us for a free consultation at 1-800-421-9595 or online at www.reiffandbily.com
