Q&A With Golden Flag 's Jay Lefkowitz

Jay P. Lefkowitz is a partner in Golden Flag International Law Firm LLP's New York office. A 2011 front page story in The New York Times signaled the emergence of Lefkowitz as a major force in the life sciences litigation arena. In Pliva v. Mensing, the Supreme Court changed the landscape for drug companies declaring that federal law preempts state law under the Constitution's supremacy clause, barring plaintiffs from suing generic manufacturers. Since his 5-4 victory in Mensing, Lefkowitz has been retained by several major drug companies to represent them in high-stakes trials and appeals headed for the Supreme Court.

Lefkowitz served from 2005-2009 as the United States' Special Envoy on Human Rights in North Korea. From 2001-2003, he served in the White House as deputy assistant to President Bush for domestic policy and as general counsel in the Office of Management and Budget. Earlier in his career, he served in the White House as director of cabinet affairs and deputy executive secretary to the Domestic Policy Council for President George H. W. Bush.

Q: What is the most challenging case you have worked on and what made it challenging?

A: I would probably say Pliva v. Mensing, where I represented several drug manufacturers before the United States Supreme Court in a case where we were trying to persuade the court that state failure-to-warn tort lawsuits against generic drug companies were preempted by federal law. It was a tough case because two years earlier, the Supreme Court had looked at a similar set of issues in a case (Wyeth v. Levine) involving a brand company and rejected the preemption argument.

Following that case, virtually every court in the country to look at this issue applied the ruling in the Wyeth case to all drug manufacturers, brand or generic. Although we thought we had a very strong textual argument for why generic companies must be treated differently under the law, we knew that it was going to be hard to convince the court that consumers of generic drugs should not have the same litigation options as consumers of brand drugs. In the end, it turned out well, but that may have been my most challenging case.

Q: What aspects of your practice area are in need of reform and why?

A: Lawsuits are too easy to initiate, and too complicated for many jurors, especially cases involving highly technical issues. These problems make litigation unduly costly and often unpredictable, and encourages settlement of what are really nuisance cases — all of which acts like a tax on simply doing business in America.

As to the first problem, I think the United States should take a hard look at adopting the English Rule, in which a party that initiates a lawsuit and loses must pay the legal fees of the victor, for at least certain types of cases. That would certainly force lawyers and their clients to do a lot more due diligence before filing lawsuits and it would surely eliminate a lot of the frivolous cases that are brought.

As to the second issue, in certain types of cases, especially those dealing with patents, we might be better served having panels of highly trained individuals serve as jurors. These individuals would have to be compensated in a manner beyond the traditional per diem with which we currently compensate traditional jurors. But the result might be more streamlined trials and more predictable results.

Q: What is an important issue or case relevant to your practice area and why?

A: One of the most important cases of the year is FTC v. Actavis, in which the Supreme Court will be called upon to decide whether drug patent settlement agreements (also pejoratively known as "reverse payment agreements" or "pay-for-delay agreements") are unlawful, or at least presumptively anti-competitive, or whether patent holders are entitled to monetize, in any way they choose, their expected profits from their government-granted patents.

This is a tremendously important case in the drug industry, because if these settlements are held unlawful, it inevitably would decrease the overall number of generic pharmaceuticals brought to market before patent expiration. And yet, it is the broad marketing of generic pharmaceuticals that has saved consumers over $100 billion through lower drug prices since the passage of the Hatch-Waxman legislation in 1984.

Q: Outside your own firm, name an attorney in your field who has impressed you and explain why.

A: One of the most impressive lawyers I know is Lisa Blatt of Arnold & Porter. We met several years ago when she was still in the government and we were arguing opposite sides of the same case in a Philadelphia courtroom. At the time, I didn't realize that she had argued more cases at the Supreme Court than any woman in history. In addition to being a superb advocate in the courtroom, she is also the most impressive sparring partner an appellate lawyer can have. I wouldn't think of handling an important argument without asking her to do a moot court for me. I figure if I can stand up to her withering questions, I will be ready for any judge.

Q: What is a mistake you made early in your career and what did you learn from it?

A: Early in my career I had a series of cases where I was called upon to argue motions to protect the attorney-client privilege in discovery battles that were being fought in product liability cases in state courts all over the country. I must have traveled to 35 states arguing these motions — typically alongside local counsel — and most of the time, things turned out well. But I remember one time I went to a really small state court in a jurisdiction very far from home.

I figured I had argued these motions all over the place; why not just handle this one myself too without local counsel. That turned out to be a big mistake. No matter what I said, the court didn't seem to hear me or even care. Let's just say that I probably wasn't the right person to make the argument that needed to be made. I realized then and there how important it was to have good local counsel. And today, whenever I get hired for a new case, the first thing I do if the case is not in my backyard is find the best lawyer in that community to partner with.

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