Generic drug makers lose a pre-emption argument at 8th Circuit 

Posted: 1:00 am Mon, December 7, 2009
By Barbara L. Jones

State law failure-to-warn and misrepresentation claims brought against the makers of a generic drug were not pre-empted by federal law governing drug labeling, the 8th U.S. Circuit Court of Appeals recently ruled in a case of first impression.

Mensing v. Wyeth, et al. reverses a District of Minnesota ruling. Similar cases are pending in the 5th and 6th Circuits.

Mensing follows three pre-emption decisions from the U.S. Supreme Court this year, notably Wyeth v. Levine, which said failure to warn claims against name brand manufacturers are not pre-empted by the federal Food, Drug and Cosmetic Act. In Mensing, the 8th Circuit followed suit, but addressed generic rather than name brand drugs.

“Mensing is a natural extension of Wyeth,” said Minneapolis attorney Michael K. Johnson, who represents the plaintiff.

William Mitchell College of Law Professor J. David Prince, who teaches products liability and torts, agreed. Wyeth made it clear that there is a post-sale duty to warn and that the manufacturers have a duty to bring safety concerns to the FDA, he said.

Generic labels at issue

The plaintiff, Gladys Mensing, was prescribed Reglan and her pharmacist gave her the generic equivalent, metoclopramide. After taking the medication for four years, Mensing developed tardive dyskinesia, a neurological disorder that produces involuntary movement.

Mensing sued the makers of the generic drug and also the name brand drug under the theory that her doctor relied on Reglan’s warning label when assessing the risk of metoclopramide.

Under the Hatch-Waxman Amendments to the FDCA, manufacturers of generic equivalents to brand drugs are required to provide a label that is in all relevant aspects identical to that of the brand drug. The District Court, deciding the case prior to Wyeth v. Levine, entered summary judgment for the defendants on the brand name claim, finding no duty of care since the plaintiff did not take the brand name drug, and on pre-emption grounds for the generic manufacturer because the generic warnings would no longer be the same if the generic manufacturer used a different label. Although there was no express pre-emption, the court found pre-emption applied because the laws conflicted.

But the 8th Circuit found that the generic manufacturer could have sought a modification to the label, and reversed as to the generic defendants. (The court agreed that the brand name defendants did not owe a duty of care to the plaintiff.)

The generic manufacturers may not passively accept an inadequate label while profiting from the sale of the drug, the court said.

“The generic defendants were not compelled to market metoclopramide. If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product. Instead, they are alleged to have placed a drug with inadequate labeling on the market and profited from its sales,” wrote Judge Diana Murphy.

The case places a significant burden on the manufacturers of generic drugs, Johnson said.

“Generic manufacturers can no longer be content simply copying a name brand drug’s formula and label and sitting back while profiting from the sale of a drug that may have an inadequate label and that it is not monitoring for safety. Rather, this decision now requires generic manufacturers to have the same responsibility that name brand manufacturers have to monitor adverse event reports and to stay abreast of the current medical literature regarding the safety of the drugs that they are selling. If they then see a potential problem regarding the safety of the drug that they are selling, they have an obligation to at least notify the FDA and request a label change,” Johnson explained.

Prince said the 8th Circuit was correct in expecting the generic manufacturers to at least propose a label change. “They are not precluded from picking up the phone,” he said.

The case is also important for others who claim to be injured by Reglan, Johnson said. Schwartz Pharma, Inc., which owns the rights to the name brand, appears to have essentially stopped selling name brand Reglan, he said. “As a result, if the generic manufacturers are not monitoring the adverse events and staying abreast of the medical literature on the drugs that they are selling, then no one may be tending the store,” Johnson said.

Prince also noted that drug studies by their very nature don’t necessarily reveal a relatively small risk. “It makes sense that there is a process for responding to risk. You have to keep an eye on how products are performing,” he said.

Defense attorneys in Mensing could not be reached for comment.

Other cases

The other U.S. Supreme Court pre-emption decisions in the past year, Warner-Lambert v. Kent and Riegel v. Medtronic, differ from Wyeth and Mensing because they construed different statutes. In Riegel, the court said that Minnesota-based Medtronic Inc. correctly claimed pre-emption in a case involving medical devices because a federal statute addressing devices states that if a state law requirement conflicts with a federal law requirement, the state law requirement is invalid. Riegel differs from Wyeth because in pharmaceuticals, there is no such statute, so any pre-emption would be implied and not express.

Warner-Lambert v. Kent construed a Michigan statute that stated that plaintiffs couldn’t file a claim against a drug manufacturer unless approval of the product has been obtained by fraud, which is what the plaintiffs claimed had happened in the case of Warner-Lambert’s Rezulin.

Warner-Lambert claimed pre-emption, and the District Court judge agreed. The 2nd Circuit reversed that decision, however, and the appeal ended up in the U.S. Supreme Court. After a 4-4 split decision, with Justice John Roberts recusing, the case returned to the trial court.

Johnson views the influx of pre-emption cases as the result of the Bush administration efforts to reform tort law. Pre-emption isn’t a new doctrine but was frequently used in the Bush years and those cases are now coming to the appellate courts, he said.