Richard Epstein’s Food and Drug Law class is not for the timid. The famously opinionated libertarian, who is the Laurence A. Tisch Professor of Law, moves even faster than the area of law he’s teaching; Epstein was once clocked speaking 218 words per minute.

Yawn in the 9:00 a.m. class, and you could miss a wryly exasperated aside such as “I might blow up the FDA.” But the students are there for more than the intellectual entertainment value. Epstein characterizes them as a bright group of learners who want to be challenged as they steep themselves in a complex area of the law.

Daniel Nudelman ’12 has a longstanding interest in administrative law. That focus, plus the lure of Epstein’s reputation for delving colorfully but thoughtfully into any topic he teaches, made the class a must-take for Nudelman.

Richard Epstein“The FDA is an area of regulation where even a libertarian agrees there’s a role for government there,” Nudelman said, “so his perspective on it is even more interesting in this context. It’s such a focal point for so many really big issues: not just public choice matters but ideological tensions, what we want from our government, and they all play out in this sphere. I think he’s been really balanced.”

Some of the balance comes from Epstein’s co-teacher, Bruce Kuhlik, executive vice president and general counsel of Merck & Co. Sharon Goswami ’12 has a chemical engineering background and an interest in the intellectual property aspect of pharmaceuticals. She appreciates hearing two sides in the class: Kuhlik, not a libertarian, often provides an opposing view. But there are also differences in their respective angles of expertise.

“I think it’s really beneficial to have someone who works in the field in addition to someone who’s an academic teaching a class like this,” said Goswami. “Professor Epstein will go through the theoretical and legal aspects, and Professor Kuhlik will say how it actually affects the drug company and its strategy.”

Nudelman appreciates the contrast as well: “They’re kind of like a double act, with a Martin and Lewis or Abbott and Costello feel sometimes. That’s actually appropriate, because some of the statutory interpretation is a ‘Who’s on first?’ kind of thing.”

While Epstein, a senior fellow at the University of Chicago’s MacLean Center for Medical Ethics, has worked as a consultant to the pharmaceutical industry, co-hosted a conference on the FDA and oncology drugs, and written about off-label drug use, clinical trials, and tort liability, Food and Drug Law is a new course for him.

“After a while you do enough of this stuff and you say, ‘You know, I can talk about all the peripherals, but I don’t know how the system is put together,’” said Epstein. “To me it’s perfectly sensible to say, ‘I don’t know how it’s put together. Why don’t I just teach it?’ Now, I could have taught this thing alone and normally would, but Bruce has been such a good friend, and he’s got the perfect personality to be a co-teacher. He has this incredible knowledge base, having worked in this area for about 30 years, and is at the very top of that particular profession.... It was an area in which I knew enough to realize that I didn’t know everything that I needed to know if I wanted to be a responsible practitioner in it.”

The constant pursuit of new knowledge has defined Epstein’s teaching career; his classes have run the gamut from real estate development and finance to Roman law. “My view as a teacher is very simple,” he said. “Either you teach new things or you’re making a mistake.” Epstein strives to stay up-to-the-minute on the ever-evolving state of health care.

In class, Epstein tackles thorny legal questions: the difference between a drug claim and a health claim in policing pharmaceutical advertising, or the distinction between a drug and a medical device. For drug companies, those are literally million-dollar questions.

No one knows that better than Kuhlik. He was primarily responsible for Merck’s litigation defense in lawsuits over Vioxx, an anti-inflammatory drug withdrawn from the market after studies indicated an increased risk of heart attack and stroke associated with long-term use. Billions of dollars are involved.

Kuhlik freely discusses Vioxx, or at least as much of it as he can with litigation still pending. “I think it’s great that he’s willing to talk about something like the Vioxx controversy,” said Goswami, “even though that’s something it’s obviously difficult for him to deal with and might not put him and his company in the most favorable light.”

“The big reason that I’m doing this is that I’ve known Richard for a long time,” said Kuhlik. “Although we disagree on a number of the policy issues—and that comes out during the class—I’ve learned a lot from him and have enormous respect for his approach to this stuff. It’s a real treat for me.”

As a new associate at Covington & Burling in 1982, Kuhlik wasn’t familiar with food and drug law, but he took to it immediately when his first assigned case was a pharmaceutical one. “One of the things I want to convey is what a great career you can have in food and drug law. Hopefully that comes through—my excitement with this area of the law.” Apart from his firsthand knowledge of Vioxx, Kuhlik also gives students the inside scoop on the sweeping Prescription Drug User Fee Act, which Kuhlik played an instrumental part in negotiating leading up to its passage by Congress in 1992.

“I tend to be more flamboyant, he tends to be more steady,” Epstein said of Kuhlik. “I tend to be more provocative, he tends to be clearer. He’s so cooperative, and it’s also clear whose class it is. The hardest thing to organize is a pure joint partnership between equals. And this is not bad.”

As well as they seem to complement each other, Epstein and Kuhlik don’t even agree on which of them gets more words in.

“I probably talk a little bit more than half the time, but not excessively so,” said Epstein.  “Maybe 55 to 45 or something like that.”

But Kuhlik has a different view: “I’ve probably interrupted him quite a bit more than he’s interrupted me.”

Posted on February 14, 2011