March 3, 2008

U.S. Supreme Court Ruling in Pre-emption Case Victory  for Rezulin Patients

Statement of Allison Zieve, Attorney, Public Citizen

The United States Supreme Court today affirmed a decision rejecting the drug industry’s claim to immunity from lawsuits in Michigan. The 4-to-4 decision in Warner-Lambert v. Kent, affirming a ruling of the U.S. Court of Appeals for the Second Circuit, although it has no precedential value, is a great victory for the 18 patients involved in this case, all of whom suffered very serious liver damage because of Warner-Lambert’s diabetes drug Rezulin, which has since been withdrawn from the market. Those patients and their families now have some hope of obtaining compensation from the company.

At issue in the case was a Michigan statute that provides that a drug company cannot be held liable to a patient injured by a drug approved by the Food and Drug Administration (FDA) unless: 1) the company failed to submit required information to the FDA or misrepresented the information that it did submit; and 2) the FDA would not have approved or would have withdrawn approval of the drug if the company had been honest with it.   In Warner-Lambert v. Kent, the company had argued that this exception to the statute was pre-empted because it interfered with FDA’s authority to police fraud by drug companies in the regulatory process.

The patients-plaintiffs disagreed, pointing out that the Michigan law does not police enforcement with FDA regulations or punish companies for non-compliance with regulations. Rather, the law assumes that FDA approval demonstrates that drug companies have satisfied state-law duties of care owed to patients and recognizes that the basis for that assumption disappears when the basis for the approval is unreliable because the company was not honest with the FDA. 

The Supreme Court divided 4 to 4 and therefore issued a decision affirming the Second Circuit decision, which had held that the exception to the Michigan statute was not pre-empted. Public Citizen handled the Supreme Court briefing and argument for the plaintiffs.

The case highlights the very harsh nature of the Michigan drug law, which allows Michigan patients to hold companies liable in only the most egregious cases, the most narrow circumstances. A bill to repeal the Michigan law passed the state House last year and has been pending in the state Senate since last February. Michigan voters should urge their state senators to end the delay and pass this important repeal promptly.

Most serious adverse effects are not fully discovered until a drug has been on the market for several years.  The reality is that patients will be injured in the interim.  At a time when the FDA is—by its own admission—underfunded, lacking in the resources of the industry, and lacking the expertise to adequately protect the public health, the ability of injured patients to hold drug companies liable for injuries caused by their products is particularly important.