Why a Lightning Rod Lawyer Smells a Rat at FDA

Former FDA commissioner Margaret Hamburg faces serious accusations in a lawsuit filed by the conservative, activist, government watchdog lawyer Larry Klayman. Klayman explains to Qmed why the lawsuit is important when it comes to changing the culture at FDA and Washington in general.

Chris Newmarker

It is hard to find someone important in Washington, DC whom Larry Klayman has not sued. Add former FDA commissioner Margaret Hamburg, MD, to the list.

In a case Hamburg's lawyers have reportedly described as "patently false, reckless and offensive," Klayman is suing in U.S. District Court for the District of Columbia on behalf of six people who say they were injured from using Johnson & Johnson's antibiotic Levaquin. The lawsuit accuses Hamburg of helping to suppress information about Levaquin's harmful effects so that her husband Peter Brown, co-CEO of hedge fund Renaissance Technologies, could profit enormously from hundreds of millions of dollars in J&J stock.

Defendants in the case include Hamburg, Brown, Renaissance Technologies, Renaissance founder James Simons, former Renaissance co-CEO Robert Mercer, Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development LLC, and Ortho-McNeil-Janssen Pharmaceuticals Inc.

Klayman is a highly controversial figure known for hardball tactics. Sometimes his lawsuits merely make a point or uncover damning documents. Other times, Klayman has accomplished more: a lawsuit against the National Security Agency caused a federal judge to question the constitutionality of the agency's phone records program.

Klayman spoke with Qmed about what he hopes to accomplish with his lawsuit against Hamburg:

Qmed: In your lawsuit, you appear to make two major arguments when it comes to Hamburg--that there was a conflict of interest with regards to J&J, and that Hamburg acted in ways that benefited J&J and hurt regular people when it came to Levaquin. But what about a smoking gun linking the two? Do you need one?

Klayman: You hold $500 million of shares in a company, and your husband is profiting from that in terms of Renaissance, and you don't do anything about a very dangerous drug, and you walk off. And then when you're contacted by the lawyers for the victims, you tell them to go take a hike. ... [Her lawyers] were ready to step on them. "Apart from the legal matters, don't you think there's a moral obligation here? Don't you think there's an ethical obligation?" It's typical of the attitude you find here in Washington, DC, which helps explain the rise of Bernie Sanders and Donald Trump. People are just sick of this. ...There is this connection. ... Everybody scratches everybody's back. This is not acceptable.

This is a conflict of interest, however which way you call it. You should not be an FDA commissioner if you have that type of conflict, or you should take yourself off of any aspects of regulating Johnson & Johnson. Instead of doing that, she put Johnson & Johnson people on advisory committees. That's another thing to look into.

When I go into court, I don't need the direct evidence. I believe we have it, and I believe we will get it in discovery. Circumstantial is good enough in court.

Qmed: How much do you think this was business as usual, unfortunately, at FDA? How much is coziness with industry a problem?

Klayman: Always. I was a Justice Department lawyer in the first part of my career and represented FDA. ... They have tremendous power. They have more power, believe it or not, than the CIA or National Security Agency on paper. They can go into any facility without a warrant and essentially go right to the files. They have tremendous power.

Couple that with how pharma is the most powerful lobby in Washington, even more than the insurance industry. They twist Democrats and Republicans alike. Even George W. Bush rolled over to them on drug prices when they didn't want to allow competition in the market for Medicare and Medicaid. ... Pharma is so powerful that they control Congress. They control the executive, in effect. There's been this revolving door, and FDA is the worst example. They go into private industry after they've been in official positions. In this case, she doesn't have to. ... Her husband is there [at Renaissance], and continuing to hold the stock.

Qmed: How much of a problem is this with the medical device industry? Could there be cases like this related to medical devices?

Klayman: It's across the board. I had a call recently from a whistleblower over a medical device dealing with insulin and diabetes. And apparently Hamburg was involved with that, too.  An innovative drug that didn't require insulin injections was kept off the market for a long time because it competed against this major pharmaceutical interest.

Qmed: In an ideal world, how should FDA function?

Klayman: You don't let people run the FDA who are politically or economically conflicted. And if they want to be FDA commissioner, you put in a rule that they can't go into private industry for five years or something to that effect, kind of like the lobbying regulations out of the White House. ... If you want to be FDA commissioner, you have to be clean in terms of conflict of interest, and you can't take a job in the pharmaceutical industry or as a consultant or contractor for at least five years.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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