INNsight article by Alan Klein & John Lyons

The United States Supreme Court recently accepted an appeal to consider an issue that is very important to every generic pharmaceutical manufacturer doing business in the U.S.  In Pliva, Inc., et al. v. Mensing, the Supreme Court will consider whether generic manufacturers can be held liable for failing to warn doctors about side effects associated with their drugs, even though the warnings on their products are identical to those appearing on the corresponding drug manufactured by the innovator (known as the “Reference Listed Drug” or “RLD”).  To answer this question, the Supreme Court will have to determine whether generics are permitted under federal law to strengthen warnings based on developments in the medical literature or Adverse Event Reports (“AERs”) when no changes to the warning have been proposed or requested by the innovator.  As discussed below, Mensing is one of the most significant generic pharmaceutical cases in years to reach the U.S. Supreme Court, and the decision in this case is likely to have a major impact on all generic pharmaceutical companies selling drugs in the United States.

The Mensing Case

The Mensing case was appealed to the Supreme Court by several generics which were sued for failing to adequately warn a woman about the risks of tardive dyskinesia, a frequently irreversible neurological condition resulting in involuntary muscle spasms, allegedly associated with metoclopramide (Reglan).  The generic manufacturers argued that generic drugs must have warnings identical to the RLD at all times and that generic manufacturers are not permitted to strengthen warnings unless the warnings are first changed on the corresponding RLD.  Ms. Mensing, the plaintiff in this case, claimed that generics are under an obligation to request FDA approval to strengthen warnings, regardless of whether any similar request is made by the innovator manufacturer, whenever the developing science or medical literature, or the generics’ own AERs, suggest that a stronger warning is necessary.  This is an issue being litigated by drug companies throughout the United States, and the Supreme Court’s decision is likely to provide much needed guidance to both generics and the courts.  Both have struggled with whether generics are permitted to strengthen warnings under the Hatch-Waxman Act, the law that creates the framework under which generic drugs are approved and regulated in the United States.

Potential Impact of the Supreme Court’s Decision

The Supreme Court’s decision in Mensing may have a substantial impact on the ability of patients to successfully file lawsuits against generic pharmaceutical manufacturers for injuries allegedly caused by their drugs.  If the Supreme Court determines that generic manufacturers are not permitted to change warnings independent of the RLD, then it would become very difficult for patients to sue generics based on an alleged failure to adequately warn about a drug’s risks.  If the Supreme Court does not bar all failure to warn suits against generics, then the Court will certainly provide needed guidance on the circumstances under which a generic drug manufacturer can strengthen label warnings.

Currently, FDA regulations do not differentiate between innovators and generics for pharmacovigilance purposes, but generic drug companies have long been required to have labeling that is the “same as” the RLD at the time the generic equivalent is approved by the FDA.  Ms. Mensing has disputed that warnings on generic drugs always must remain the same as those accompanying the RLD for as long as the drug is on the market, claiming instead that after an ANDA’s approval, generic manufacturers have the same ability to change warnings as the innovator.  The Supreme Court’s decision, hopefully, will clarify these issues for the industry, federal regulators and patients.

Conclusion

The Supreme Court has not yet scheduled oral argument in this case, which must occur before the Court issues its decision expected by July of this year.  Attorneys at Duane Morris are following the case closely and plan on updating this article in a future INNSight newsletter discussing the Court’s decision in Mensing and its impact on generic drug companies.