Is Impossibility Preemption Impossible? Federal Drug Law and Preemption of State Tort Claims

Legal Sidebari

Is Impossibility Preemption Impossible?
Federal Drug Law and Preemption of State
Tort Claims
January 19, 2018
Federal preemption, which is grounded in the Constitution’s Supremacy Clause, has long been one of the
most important and heavily debated defenses for the manufacturers of drugs and medical devices against
state tort lawsuits. In this vein, the question of when “impossibility preemption”— a form of implied
preemption that exists where it is impossible for a private party to comply with both state and federal
law— should shield drug manufacturers from liability in state-law failure-to-warn claims has long been
the subject of dispute, resulting in conflicting opinions from the Supreme and lower courts. The crux of
the tension surrounding preemption in this context is a policy debate— while consumer advocates argue
that state tort liability is key to ensuring patient safety, drug manufacturers urge that such laws may limit
patient access to drugs by leaving innovators vulnerable to costly litigation and undermining FDA’s
authority. Against this backdrop, the Supreme Court is considering whether to grant a petition for
certiorari in what would be its fourth FDA preemption case in the last decade. In Merck v. Albrecht, the
petition asks the court to clarify when a brand-name drug manufacturer has met the burden for showing
that the impossibility preemption defense should apply. This Sidebar begins by providing a brief
background on federal drug labeling law and the Supreme Court’s preemption case law, including the
seminal decision of Wyeth v. Levine. The Sidebar concludes with an overview of the Merck petition,
analyzing the key issues of interest for Congress that the petition raises.
Background. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), before a new drug (i.e.,
brand-name drug) may be legally marketed in the United States, manufacturers are required to obtain
FDA approval through submission of a new drug application (NDA). As part of the NDA, the
manufacturer must propose labeling that is neither false nor misleading. While FDA approval of a new
drug encompasses approval of the product’s labeling, manufacturers are required to ensure that warnings
on the label remain adequate as long as the product is on the market. To this end, manufacturers may
revise warnings on drug labels in two ways. First, under FDA’s “Changes Being Effected” (CBE)
regulation, a manufacturer may unilaterally, through the submission of a supplement to the NDA, change
a drug label to reflect “newly required information,” subject to later FDA review and approval. Such
changes may “add or strengthen a contraindication, warning, precaution, or adverse reaction.” To add a
warning to the label via a CBE submission, “there need only be ‘reasonable’ evidence of a casual
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association with the drug, a standard that could be met by a wide range of evidence.” Alternatively,
another FDA regulation provides that a manufacturer may seek to make “major changes” to the warning
on a product’s label by filing a “Prior Approval Supplement” (PAS). Unlike a CBE change, a change
made via a PAS requires prior FDA approval before it can be implemented. FDA will reject changes
proposed through either method if there is insufficient evidence of a causal link between use of the drug
and the adverse event.
The ability of a brand-name drug manufacturer to make unilateral changes via the CBE regulation was
central to the Supreme Court’s landmark 2009 decision in Wyeth v. Levine. The dispute in Wyeth centered
on whether a brand-name drug manufacturer could be sued for liability under state tort law as a result of
failing to warn adequately consumers regarding concerns associated with a method of administering a
drug when FDA had approved the drug label without such a warning. The Wyeth Court held that federal
law displaces failure-to-warn claims only when a brand-name manufacturer can show “clear evidence”
that FDA would not have approved a manufacturer’s labeling changes. Because the CBE regulation
provides an opportunity for brand-name drug manufacturers to unilaterally strengthen a warning on a
product label and Wyeth had made no such attempt, the Court reasoned, it was not impossible for the drug
manufacturer to change its product label and still comply with federal law. In the years following Wyeth,
the Court, while not backtracking on its holding concerning the impossibility preemption defense for
brand-name drug manufacturers, has twice held that impossibility preemption is a more viable defense in
the context of generic drugs, where there is no comparable CBE regulation.
In Re Fosamax. A more recent preemption case concerning federal drug law—In Re Fosamax— arose
from a dispute centered on Fosamax, a brand-named drug manufactured by Merck and approved by FDA
for the treatment and prevention of bone-loss associated with osteoporosis. Upon reports that a class of
drugs called bisphosphonates, which includes Fosamax, may possibly be associated with femoral (i.e.
thigh) fractures, Merck submitted a request to FDA to amend its label, adding language warning of those
risks. FDA rejected Merck’s proposed label changes on the basis that certain terms included were
imprecise and possibly misleading. A year later, after reviewing new data, FDA announced that it would
require all manufacturers of bisphosphonates to make labeling changes warning of the risk of atypical
femoral fractures. After Merck changed the Fosamax warning label in accordance with the new FDA
requirement, hundreds of patients that suffered atypical femoral fractures after taking Fosamax alleged
that Merck violated state tort laws by failing to adequately warn of that risk. Applying the Supreme
Court’s decision in Wyeth, the district court, noting Wyeth’s “clear evidence” rule, concluded that FDA’s
denial of Merck’s request to add language to Fosamax’s label addressing atypical femoral fractures served
as such evidence, resulting in the preemption of the state law tort claims.
Focusing on FDA’s stated basis for denying Merck’s proposed warning label changes— that certain
terminology used was imprecise and potentially misleading— the U.S. Court of Appeals for the Third
Circuit (Third Circuit) reversed the district court, holding that FDA’s rejection of Merck’s proposed
changes to the warning label alone did not satisfy the Wyeth test. Instead, the Third Circuit held that an
assessment of FDA’s reasoning as to why the agency rejected Merck’s proposed warning label change
was required. Explaining that the “clear evidence” test articulated in Wyeth should be treated as a
“demanding” standard for preempting state law claims, the Third Circuit panel concluded that Merck
failed to show that it was “highly probable” that a reasonable jury would find that FDA would have
rejected a warning that used more precise terminology to address the risks of atypical femoral fractures.
In so doing, the panel determined that the basic Wyeth inquiry— “what do you think FDA would have
done?”— is most appropriately resolved as a matter of fact by a jury, rather than as a matter of law by the
courts, noting that, although an assessment of agency decision making is complex, it does not require
special legal competence or training.
Ultimately, In Re Fosamax appears to have—at least in the Third Circuit—heightened the difficulty in
showing impossibility preemption in two ways. First, according to the Third Circuit, FDA’s actual

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rejection of a warning proposed by a brand-name drug manufacturer is insufficient to show “clear and
convincing evidence” under the Wyeth test. Instead, In Re Fosamax requires the manufacturer to also
account for what the agency would have done if the warning were differently worded, a seemingly
difficult burden. Second, the Third Circuit concluded that whether “clear and convincing” evidence exists
to warrant preemption is a fact-finding issue for a jury to resolve rather than a matter of law for the courts
to decide, meaning drug manufacturers must allow for the expenses of a jury trial in order to prevail with
a preemption defense.
Significance of the Questions Raised by the Merck v. Albrecht Petition. Following the appellate court’s
decision, Merck filed a petition for certiorari, now captioned Merck v. Albrecht, on August 22, 2017. In
the petition, Merck asks the Supreme Court to consider whether “a state-law failure-to-warn claim [is]
preempted when the FDA rejected the drug manufacturer’s proposal to warn about the risk after being
provided with the relevant scientific data; or [whether] such a case [must] go to a jury for conjecture as to
why the FDA rejected the proposed warning.”
While the Court’s reasoning in Wyeth provides insight as to when a manufacturer does not show “clear
evidence” that FDA would have rejected a proposed label change, it is less informative with respect to
when that burden is met, a question that has been left to the lower courts. Some legal experts have
cautioned that the lower courts have interpreted the Wyeth test such that impossibility preemption is all
but impossible, ignoring the Supreme Court’s warning in a later case, PLIVA v. Mensing, that preemption
cannot be rendered “all but meaningless.” In its petition, Merck argues that the Third Circuit’s In Re
Fosamax decision places brand-name drug manufacturers in a precarious position—“if they cooperate
with the FDA, share their safety data, and follow the agency’s direction to ‘hold off’ on adding label
warnings, they still cannot escape costly, burdensome tort litigation complaining about those labels.” As a
consequence, the petition goes on to argue, brand-name drug manufacturers will feel it necessary to
account for the growing potential for costly litigation by increasing drug prices and attempting to ward off
such litigation by inundating FDA with “alternative proposals [and] requests for clarification.” In contrast,
patients alleging injury caused by Fosamax (Respondents) responded to the petition, contending that the
Third Circuit “faithfully applied Wyeth v. Levine.” Respondents maintain that Merck’s petition asks the
Court for a “bright line rule that any FDA rejection of proposed warning language relating to a medical
risk ‘should suffice—as matter of law— to preempt state tort liability’ for all failure-to-warn claims
relating to such a risk,” even where FDA’s rejection provides that the warning was rejected because the
manufacturer’s description of the risk was inaccurate or misleading. Such an argument, respondents
explain, “ignores [Wyeth’s] fundamental teaching that, under federal law, ‘the manufacturer bears
responsibility for the content of its label at all times.’”
Although the Supreme Court has not yet decided whether it will grant the Petition, it has signaled interest
by inviting the Solicitor General to file a brief expressing the views of the United States. Should the Court
move forward with hearing the case, it could serve as a vehicle for addressing a perennial issue of
congressional interest— how to balance patient safety with patient access to innovative drugs. More
broadly, regardless of the Court’s interest in this particular case, Congress has the power to amend federal
drug law and clarify its preemptive scope with respect to state tort claims, something the legislature has
done in the medical device context.

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Author Information

Kathryn B. Armstrong

Legislative Attorney




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