Battling the FDA in Court

For attorney Michael Pasano, going up against the U.S. Food and Drug Administration is especially gratifying. Government agencies typically initiate criminal prosecutions based on a clear violation of the law with real victims. In the case of the FDA, they often create their own legal definitions in order to bring imaginary charges against those who disseminate alternative health information.

In court, Michael is an
aggressive litigator who
isn't afraid to attack the
government's testimony,
pointing out the inevitable
inconsistencies and
inaccuracies. He has tried
cases across the country,
from Hawaii to Texas and
Puerto Rico.

Judges often preside over cases involving monstrous violent acts. The FDA’s first burden is to convince a Judge why those involved in alternative medicine somehow fit into this same criminal category. It is Michael Pasano’s job to respond to the FDA’s allegations and persuade the Judge that the FDA’s legal definitions are seriously flawed. In doing so, Michael spends enormous amounts of time documenting the legislative intent, case histories and the labyrinth of regulatory procedures that govern the FDA’s own conduct. In many cases, Michael shows that the FDA failed to follow its own rules in determining whether a particular act was permissible.

In defending people brought up on FDA criminal charges, Michael’s first task is to meticulously create legal motions to document to the Judge that a crime has not been committed. If the Judge fails to dismiss the case, Michael’s job actually gets easier. That’s because the FDA then has to convince a jury that a real “crime” has occurred. In South Florida, where prospective jurors read daily reports of heinous violent offenses, the FDA can have a difficult time convincing jurors that being involved in alternative health constitutes a serious felony. A “waste of time and taxpayer resources” is a frequent comment from jurors who have spent months sitting through FDA criminal prosecutions, only to acquit the defendant because they as jurors weren’t convinced that a “crime” had even been committed.

“The FDA is never to be treated lightly,” Michael explains. Most victims of FDA-initiated terrorism lack the resources to mount an effective defense. The FDA often strikes first by raiding the premises and seizing the company’s assets without warning. Even dedicated alternative health practitioners can lack the economic ability to mount a sustained counter-offensive. While the FDA has unlimited tax dollars at their disposal, natural health companies often cannot afford the costs of a multi-year battle against the FDA.

 

“What happened over the last twelve years, however, is that the FDA picked on the wrong people,” says Michael. These companies had the organizational ability to raise legal defense monies, often from the very customers who the FDA alleges had been “defrauded” by their activities. The FDA created a further problem for itself by assuming these customers would testify against the alternative health companies. To the FDA’s surprise, many of these people defiantly stated that they thought it was the FDA who was committing the health fraud by trying to deprive them of products they knew to be effective.

To Michael Pasano, the challenge of going up against the Federal government’s vast resources makes a victory in court even sweeter. To see the FDA spend millions of dollars prosecuting a case and having the jury not convinced that a crime was committed is the ultimate triumph. “It’s a fight you can feel proud engaging in. There’s a bit of David versus Goliath,” says this 50-year-old graduate of Yale Law School.

Michael Pasano emphasizes that he is not against everything the FDA does. In reviewing the weekly FDA Enforcement Reports, Michael says that “there are obvious situations where companies are engaged in behavior that could hurt people.” The problem, according to Michael, is that “the FDA pretends that anyone involved in alternative medicine is automatically harming the public, and that’s just not true.”

In many cases, Michael is able to work with FDA officials to convince them that their view of his clients’ activities do not constitute criminal acts. Sometimes a change in the labeling is all that’s required. In other cases, he prepares lawsuits against the FDA in an attempt to force the agency to recognize the scientific and legal validity of his client’s product.

Michael has also done extensive work for the Life Extension Foundation (See “Victory Over the FDA,” Life Extension magazine, September 1996.) He and attorney Ralph Burns handled the Foundation’s successful defense against 56 criminal charges brought by the FDA in 1991 against Foundation officers Saul Kent and William Faloon. Every single charge was ultimately dismissed.

In court, Michael is an aggressive litigator who isn’t afraid to attack the government’s testimony, pointing out the inevitable inconsistencies and inaccuracies. He has tried cases across the country, from Hawaii to Texas and Puerto Rico.

Though today he’s a highly accomplished adversary in an ongoing fight against government over-reaching, Michael wasn’t always on this side of the fence. He started his career with the Justice Department, working for seven years as a Federal Prosecutor, first in Washington, D.C., then in South Florida, where he ran the Economic Crimes unit of the U.S. Attorney’s Office in Miami and served as chief of its Fort Lauderdale and West Palm Beach divisions. During that time, Michael was calling the shots for agencies, like the FDA.

But in 1985, he left the U.S. Attorney’s Office to become a partner in the firm Zuckerman, Spaeder, Taylor & Evans, eventually finding himself facing off in court against many of the government agencies that he had once been supporting. His focus on defending people against the FDA began slowly, through word-of-mouth references. His early cases typically involved a counter-culture clientele of people who had been selling products that they believed to be in the common good (but weren’t FDA approved). In the midst of that, Michael was recommended as a cracker-jack addition to the Life Extension team in its nine-year battle against the FDA. “It happens so often in life that good things happen as much by accident as by planning,” he says of his introduction to the battle to make all products that have a positive impact on health available to U.S. citizens.

"What happened over the last
twelve years, however, is that the
FDA picked on the wrong people"

All those hours spent reviewing health claims in his professional life have had an impact on his personal life as well. “I am very interested in health,” he says, adding that his wife, Eva, has long been ahead of the curve when it comes to alternative medicine and that they often frequent the health food stores near his home. “I take a ton of vitamins.” Indeed, included in his daily arsenal is a general multivitamin and a multivitamin specifically for males, as well as glucosamine to keep his joints and cartilage functioning, so as not to undermine his ongoing passion for exercise. Michael takes zinc, Echinacea and “lots and lots” of vitamin C for general good health and to boost his immune system if he feels a cold coming on. Then there’s lutein for eye care and beta carotene, an antioxidant that helps prevent the degenerative diseases associated with free-radical damage—not to mention the occasional other supplements that he says “catch my eye.”

As for exercise, Michael is a self-proclaimed sports nut. In his younger days he played on different sports teams—including softball, volleyball, basketball and bowling—every night of the week after work. And on weekends, he’d find time to fit in a game of tennis, a round of golf or the occasional 10k race. Now that he’s married, he’s toned down his team-sport commitments a bit, though he still indulges his passion for basketball by playing pick-up games on his lunch break at a gym across the street from his downtown Miami office. And, he’ll work in a round of golf whenever possible. “I believe strongly in the stress relief that playing sports can provide,” he says. “But don’t get me started on the near fights that old guys can engage in when they’re acting like kids on the basketball court.”

Michael is less enthusiastic in talking about his diet. “I eat all the wrong things,” he says.

Though free time is a rare commodity, Michael has been known to take in a movie or two—his favorites are Godfather I and II. He also loves to read—particularly classics, like The Great Gatsby—and manages to escape with Eva every now and then to the Florida Keys, the mountains or to the California wine country. He also serves on several court committees, including the Eleventh Circuit Lawyer Disciplinary Committee and the South Florida Criminal Justice Act Committee. He is a frequent speaker at American Bar Association and Florida Bar Association functions and he often writes articles on current legal affairs.

He’d like to be able to fit in more of these activities—not to mention find more time in which to take on even more casework. But he always encounters the same problem: “My biggest challenge,” he says, “is accepting that there are only 24 hours in a day.”

—Twig Mowatt