Mind the Gap

There’s an accountability gap in federal drug law, and W. Lewis Garrison Jr. is trying to close it—at least in Alabama.

The gap exists, in essence, because of the often-competing desires to make drugs both safe and affordable. In 1962 under the Kefauver-Harris Drug Amendments, drug companies, including generics, were required to prove the efficacy and safety of their products to the FDA. (That’s the safety aspect.) Twenty-two years later, the Hatch-Waxman Amendments allowed generic companies—after a period of brand-name exclusivity—to bypass costly human trials and only prove that their product has the same active ingredients, and uses the same warning label, as the brand-name drug. (That’s the affordable aspect.)

But what if a generic drug causes harm that’s not listed on the warning label? Who’s accountable then?

According to a 2011 U.S. Supreme Court decision, it’s not the generic drug manufacturer. In PLIVA v. Mensing, the court ruled 5-4 that generic companies couldn’t be held accountable for inaccurate warning labels since they have no control over what warning labels say.

But even before the Mensing decision, Garrison, a class action/mass torts attorney with Heninger Garrison Davis in Birmingham, spotted another route.

For several years, his client Danny Weeks took a generic version of Reglan, a drug used to treat acid reflux and other stomach disorders. Then he developed a side effect not listed on the warning label: tardive dyskinesia, or involuntary and often painful movements of the face and body. The disorder is generally irreversible.

But did Weeks’ case fall into the accountability gap? Not according to Garrison.

“We believed that under Alabama law we would have a claim against the brand maker, even though Danny Weeks ingested the generic,” Garrison says. “The way the pharmaceutical industry works, the brand makers are the ones who do all of the developing, testing, marketing. … The generics are just ‘me toos.’ … It all goes back to: What incentive does the brand maker have to keep things up to date?”

He notes that when generics hit the market, the market shares of brand-name drug companies, like Reglan’s manufacturer Wyeth, “drop to virtually nil.” He adds, “They made all their money on the drug, so they’re going to say, ‘We’re not going to keep up with the label. We’re not going to do anything.’”

Nothing is what Wyeth wanted the courts to do with Weeks v. Wyeth Inc.; they quickly filed a motion for summary judgment. Around the country, the company was getting similar cases involving Reglan and its generics dismissed. But in those cases, Garrison says, federal judges were interpreting how state courts might rule on the matter. “Our judge had the intelligence to think, ‘I need to send this to the Alabama Supreme Court rather than me guessing what the law is.’”

Alabama, he adds, has common law fraud. “Let’s say you are somebody who wants to dupe somebody else. Party A is the defrauding party. They conceal or misrepresent something to Party B, knowing that Party C is going to rely on whatever they tell or fail to tell B. … Well, you can still be held responsible. That’s been the law in Alabama for over a hundred years.”

But the fraud law had never been applied to pharmaceuticals. “It was new from that standpoint,” Garrison says. “We had that going for us in Alabama.”

The state Supreme Court agreed with Garrison twice: without oral arguments in 2013, and with oral arguments in 2014. And as each ruling allowed his case to proceed, howls of protest emerged from the business press.

“It was like a firestorm, really: the most hyperbolic, gross, inaccurate reaction you can imagine,” Garrison says. “It ranged from ‘OK, Alabama is going back to tort hell days,’ to, ‘Now the camel’s nose is under the tent. You’re going to get sued. It doesn’t matter if you made it or not, you’re going to get sued for it.’”

Garrison, 59, who grew up in Eufaula, a small town near the Georgia state line, has practiced law since 1983. “We have represented thousands and thousands of people in pharmaceutical litigation, successfully getting them settlements and things,” he says. “We take every person’s case very seriously.”

Is a settlement likely in Weeks’ case? “I wouldn’t rule that out, but as of right now, no,” Garrison says. The case is still in discovery; its trial date in federal court in Montgomery is set for early 2016.

As for the accountability gap in federal drug law, Garrison says there’s a movement for new FDA regulations to hold generic companies responsible for updating warning labels. “Which is interesting,” he says, because “the FDA weighed in on all these briefs with Mensing and everything else, saying flatly, ‘Oh, [generics] can’t do it. Under the law, they can’t do it. They can’t change anything.’ Now they’re like, ‘Well, maybe we should, I guess, revisit that.’”

He adds, “It seems like somebody is putting pressure on somebody.”