Courts have had opportunities to rule on the position taken by the FDA in more than 20 cases to date, with a fairly even split in the decisions.
Dr. Fink is professor ofpharmacy law and policy atthe University of KentuckyCollege of Pharmacy,Lexington.
When a manufacturer has submittedthe draft labeling (package insert) toaccompany a new product that it proposesto market to the FDA forapproval and it has secured thatapproval, does the fact that the FDAapproved the wording about warningsmean that an injured patient who usedthe medication is foreclosed from pursuing,in state court, a legal claim thatthe warnings were inadequate, therebycontributing to the injuries suffered?Does the action by the federal agencypreempt a state-level lawsuit?
Two lawsuits were under considerationby the US District Court serving asouthern state, in which it was allegedthat a prescription medication hadcaused the plaintiffs to suffer heartattacks. As the case proceeded, theattorneys representing the defendantmanufacturer moved for summaryjudgment, and the presiding judgeheard oral arguments on the motion.These arguments indicated that thedefendant did not feel that the plaintiffs'cases would succeed and that theproceedings should end right there.The FDA had approved the wording ofthe warnings, and, in the view of themanufacturer, this agency decisioneliminated the opportunity for thepatients to sue because they had takenthe medication after the labeling hadbeen modified to reflect an increasedchance of cardiac problems associatedwith the use of the pharmaceutical.
The defendant manufacturer's motionfor a summary judgment wasdenied, and so the cases will continueto proceed through the federal courtsystem.
The judge in the case looked closelyat the manufacturer's reliance on policystatements from the FDA reflectingthe agency's view that its standards forprescription-drug product labeling setthe limits for what is required. Underthis perspective provided by theagency, and so long as the product islabeled in accordance with the FDAmandatedlanguage, there can be nolawsuits in state courts using failureto-warn products-liability legal theoryand arguing that the drug producerfailed-to-warn users of the danger. TheFDA stated its perspective in a 2006announcement in the Federal Register:
"Under the Federal Food, Drug, andCosmetic Act, FDA is the expert federalpublic health agency charged byCongress with ensuring that drugs aresafe and effective, and that their labelingadequately informs users of therisks and benefits of the product and istruthful and not misleading."
The judge considering these issuesin the 2 cases reached an oppositeconclusion. The FDA approval of thewording used in product labeling towarn prescribers, pharmacists, andpatients about potential risks with theuse of the medication does not eliminatethe possibility of an injuredpatient suing because the warningswere inadequate. In fact, the judgeincluded in his decision the ratherstraightforward conclusion that "theFDA's current view on the question ofimmunity for prescription drug manufacturersis entirely unpersuasive."
A failure-to-warn claim is based onstate law and is usually pursued instate courts. There is no parallel to afailure-to-warn products-liability legalclaim in the federal court system. Thus,when such cases end up in federalcourt because the parties are citizensof different states—the so-called diversityjurisdiction—the federal courts arebound to apply the law of the statewhere the claim originated.
This fact appeared to weigh heavily inthe judge's decision. He indicated that:
"Because there are no federal remediesfor individuals harmed by prescriptiondrugs, a finding of implied preemptionin these cases would abolish statelaw remedies and would, in effect, renderlegally impotent those who sustaininjuries from defective prescriptiondrugs."
One commentator has pointed outthat the FDA has not been alone in takingthe position that its decisions on atopic or issue are the final word. Boththe Consumer Product Safety Commission,the agency that enforces thechild-resistant closure provisions ofthe Poison Prevention Packaging Actthat pharmacists work with every day,and the National Highway Traffic SafetyAdministration have taken similar policypositions.
The manufacturer is consideringwhether to pursue an appeal of thisdecision. In its view, this is an issue ultimatelyrequiring the attention of theUS Supreme Court to clarify the law inthis area. Courts have had opportunitiesto rule on the position taken by theFDA in more than 20 cases to date, andthat has resulted in a fairly even split inthe decisions.