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The Facts—Wyeth vs. Levine

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The Facts—Wyeth vs. Levine 

Complete immunity preemption is truly a stealth issue. It began quietly and without much fanfare only after President Bush was inaugurated in 2005 for a second term. Federal agencies—without any authority from Congress—started putting language in the preamble of regulations. Previously the preamble was used as the agency’s interpretation of the regulation. Suddenly, the agencies shifted to use the preambles to change to law. That same year, Business Week’s cover story on “How to Fix the Tort System” described preemption as Corporate America’s preferred solution to litigation that might also fall under regulatory realms.i

Preemption in 2008

To date, seven federal agencies – many times without any opportunity for public comment which is required by law (the Administrative Procedure Act) – have issued over 56 rules with preemption language in the preamble to the rule. The Constitution of the United States holds that the decision to preempt state law rests entirely with the United States Congress. Where the intent of the Congress is not clear, it is the responsibility of the Judiciary to interpret. As a result of these preambles, states have had their authority curtailed by federal agencies.

While the American Association for Justice believes these regulatory preambles to be unconstitutional, some trial courts have given federal agencies the force of law. Moreover, some agencies have adopted these regulations in the absence of federal regulation or even in direct contradiction to Congress’ direction. In addition, these new rules have not been voted on by any member of Congress, and in some cases not even revealed during the public comment period.1

Government regulations only set a minimum safety standard and can’t guarantee safety. Through the preamble language, the agencies argue that federal standards override state safety standards and that all state tort claims should be discarded. State remedies were designed to complement, not conflict with, federal health and safety regulations. The agency action is a direct affront to the authority of state courts, state legislatures, and Congress.

Background on FDA Labeling

The FDA’s labeling rules require a prescription drug or medical device manufacturer to make any changes to its labels to add or strengthen a warning about a possible adverse reaction as soon it has reasonable evidence that the drug or device caused an adverse reaction.2 The importance of this rule was underscored in Congressional debate regarding the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gave the agency additional authority to better regulate prescription drug approvals. When Congress passed this law, it understood the FDA’s rules to impose a duty on drug manufacturers to update their labels when they became aware of potential hazards. Congress had every intention to maintain that duty. For example, Senator Ted Kennedy (D-MA) stated:

This new post market authority for FDA is not intended to alter the drug companies’ independent obligation to promptly warn consumers of a drug’s risks. Under current FDA regulations, a drug company is required to add new warnings to its labels as soon as it learns about new risks potentially posed by its drugs. The company must add the new warning even if FDA has not required a labeling change.3

Therefore, the FDA regulations and Congressional intent illustrates that drug and device manufacturers must update their labels with information about possible adverse reactions without waiting for FDA approval of such changes.

WYETH V. LEVINE

On April 7, 2000, Diana Levine, a professional musician, went to the hospital to treat a migraine headache and, after being injected with a drug manufactured by Wyeth, left with injuries that led quickly and irreversibly to the loss of her right arm. Specifically, Levine’s arm was amputated because Wyeth’s drug Phenergan, prescribed to alleviate nausea associated with a migraine headache, reached her arteries. Phenergan was given to Levine using a method of administration that was permissible under Wyeth’s label instructions, even though Wyeth knew this method increased risk of contact with arteries and serious injuries.

The drug was administered intravenously through a technique known as direct IV, or “IV push.” In this method, a syringe pushes medication directly into the patient’s vein. Wyeth had known for decades that when Phenergan is administered by the IV push method, even by experienced clinicians, inadvertent arterial contact can result. This is in contrast to administration through a free flowing IV bag, which reduces the risk of inadvertent arterial injection because the nurse or physician can be more certain that the needle has been placed in a vein. A solution dripping from an IV bag will not flow freely into an artery due to back pressure from the patient.

Wyeth had also known that when Phenergan comes in contact with an artery, the artery dies, and necrosis, gangrene, and amputation result. Four experts testified at the state level that if Phenergan is used intravenously, it should be done only through a hanging IV bag and that the label should have warned against the use of IV push. However Phenergan’s label did not contain any warnings regarding use of the IV push method. And, as the Vermont Supreme Court held, the FDA never made any determination as to whether the label should have warned against the IV push method.

Because the IV push method was used to administer Phenergan to Levine, the drug penetrated her artery. For seven weeks after the injection, she suffered unimaginable physical and emotional pain as she watched her right hand turn black and die. In short, as a result of being subjected to an unsafe and unnecessary method of administration of a drug to curb nausea, Levine endured two amputations. She first lost her right hand and then her right arm up to the elbow, harming her profession and lifelong passion to be a musician and play the guitar.

i How to Fix the Tort System, Business Week, March 14, 2005.
1 FDA: Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels, 65 Fed. Reg. 81082, 81103 (proposed Dec 22, 2000).
2 21 C.F.R. §§ 201.57(c)(6)(i), 314 .70(c)(6).
3 153 Cong. Rec. S11831, 11832 (daily ed. Apr. 20, 2007) (statement of Sen. Kennedy, Floor Manager of bill).


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