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Wyeth v. Levine's Preemption Analysis Extended to Generic Drug Cases

By Karen L. Stevenson, Litigation News Associate Editor – April 5, 2010

Recent Eighth and Fifth Circuit decisions extend the influence of the U.S. Supreme Court’s landmark preemption opinion, Wyeth v. Levine [PDF], to generic drugs. Wyeth addressed common law claims against brand name manufacturers. Now, courts are increasingly ruling that state law failure to warn claims against generic drug manufacturers are also not preempted by FDA labeling statutes.

“These decisions dealt a real blow to the generic manufacturers,” observes Sam L. Felker, Nashville, cochair of the ABA Section of Litigation’s Pharmaceuticals Subcommittee of the Products Liability Committee.

“There is tension in this area given the public policy favoring generic drugs—the desire to make them less expensive and more readily available—but absent express direction from Congress, the courts are not going to leave consumers without a remedy,” Felker notes.

Eighth Circuit Extends Wyeth’s Influence
In Mensing v. Wyeth, Inc. [PDF], the Eighth Circuit concluded that a patient’s failure to warn claims under Minnesota law against generic manufacturers of metoclopramide (sold under the brand name, Reglan) were not preempted.

The court first examined the federal labeling regulations for generic drugs. In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act, which amended the Food, Drug, and Cosmetic Act (FDCA) 21 C.F.R. § 314.50 to provide an abbreviated new drug application procedure for generic manufacturers. 21 U.S.C. §355(j). Makers of generic drugs must demonstrate that their drug is “essentially the same as the name brand drug and that their proposed label is in relevant part identical to the name brand drug label.”

The manufacturers argued that the regulatory requirements make it impossible to satisfy both the federal regulations and state law duties to warn of adverse effects after the brand name drug’s labeling has been FDA approved. The Eighth Circuit disagreed.

Relying on Wyeth, the Eighth Circuit underscored that manufacturers, not the FDA, bear primary responsibility for the content of their drug labels.

The court found that nothing in federal law forbids the generic manufacturers from taking steps to warn their customers about adverse effects either through the FDA’s “changes being effected” (CBE) procedures or with “Dear Doctor” letters.

Thus, the court ruled that implied preemption principles did not bar the patient’s state law tort claims.

Fifth Circuit Weighs in Against Preemption for Generic Labeling Claims
Most recently, the Fifth Circuit, in Demahy v. Activis, Inc. [PDF], joined the Eighth Circuit in refusing to find common-law failure to warn claims generic drug manufacturers preempted.

Judge Patrick E. Higginbotham wrote that Wyeth “shadows our conclusion that the federal regulatory regime governing generics is also without preemptive effect.”

After Demahy, “we are stirring around in the ashes trying to find some life to the preemption doctrine, but the Fifth Circuit really seems to have shut that door,” says Felker.

Demahy involved personal injury claims brought under Louisiana law. The plaintiff alleged that Activis, the generic manufacturer of metoclopramide, failed to request changes in the drug’s labeling even after learning that the drug’s long-term use posed higher risks of the neurological disorder that she developed.

The Fifth Circuit, observing that generic drugs now account for 7 out of 10 prescriptions filled nationwide and that federal law provides no remedy for an injured consumer, held the state law claims were not preempted.

To do otherwise “would leave us with the bizarre conclusion that Congress intended to implicitly deprive a plaintiff whose doctor prescribes a generic drug of any remedy, while under [Wyeth], that same plaintiff would have a state-law claim had she only demanded a name brand drug instead,” the court said.

“Courts are not drawing a line between generic versus brand name drug manufacturers in terms of keeping the burden for appropriate labeling on the manufacturer,” says Neville H. Boschert, Jackson, MS, cochair of the Section’s Medical Device Subcommittee of the Products Liability Committee.

“The Fifth Circuit makes clear that it is Congress’s choice to make a clear and manifest indication that it intends to preempt consumers’ state law tort claims in this area, and until it does so, courts are unwilling to find otherwise,” notes Boschert.

Division Among District Courts Remains
Prior to Wyeth, a majority of district courts, including the Northern District of California , Western District of Kentucky , and Southern District of Florida , found state law claims against generic manufacturers preempted, largely based on the defense of impossibility preemption [membership required].

After Wyeth, courts have begun going the other way, with decisions in the Middle District of Georgia , Northern District of Illinois , New Hampshire , and Northern District of Florida , finding tort claims against generic manufacturers are not preempted [membership required].

Currently, there are three generic drug cases pending in the Sixth Circuit, notes Felker.

“It remains to be seen if a split might emerge in the circuits to provide a possibility of getting the question before the Supreme Court,” Felker says.

Keywords:Wyeth v. Levine, Eigth Circuit, Fifth Circuit, Mensing v. Wyeth, Inc., products liability, generic drug cases

Related Resources

  • June 10, 2011 – @Tracy - as a fellow health insurance consumer, I know what it is like to have generics substituted for brand name pharmaceuticals. What I also know, though, is that I can request no substitution. This is a higher cost to me, but nobody is forcing me to take the generic. Insurance is priced assuming some economies/savings. If brand name drugs are simply allowed, the cost of health insurance will skyrocket. It's just the way the economics work.

  • June 4, 2010 – Another element that I hope is covered is the insurance companies forcing us patients to take generic drugs instead of the more thoroughly tested and tried brand name drug. That issue will eventually rise to the top like heavy cream and then the insurance companies that are regulating medicine by second guessing my private physician will have to answer for their mandatory requirements.
    Thank you,
    Tracy - Bountiful, Utah

  • December 19, 2010 – Our eperience has shown this drug CAN cause deleterious symptome in LESS than twelve weeks in some patients


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