Posted by Steve Berman on Jan. 11, 2011

Recently, one of the dozens of movie websites dedicated to silver-screen minutia asked its readers to list the best movie lines of all time. You can guess many of the top contenders, including the classic line from The Godfather – “Leave the gun, take the cannoli.” As you would expect, aficionados of the classic age of the Silver Screen opined that Clark Gable delivered the best line in Gone with the Wind with the oft-quoted “Frankly, my dear, I don’t give a damn.” I’ve long been a fan of Humphrey Bogart, and I was happy to see that this timeless line in Casablanca – “I think this is the beginning of a beautiful friendship” made the list, and bemused that “Play it again, Sam” made the cut, even though he never said those words in that order.

I must admit that the line that took the top honor was a bit of a surprise. The more I thought about it though, the more it made sense. The line was timed perfectly and filled with irony and humor, but underscored a critical aspect of the movie’s theme. The line came from “Jaws” and was quoting Brody, the town’s police chief (played by Roy Scheider) working aboard a boat tasked with landing a yet-to-be seen shark causing havoc with beach-goers. He’s paired with the irascible and overly confident Robert Shaw, a legendary shark hunter. Amid the bluster of Shaw’s running commentary about his prowess, Brody is working alone in the back of the boat when the 40 foot shark breaches, looking at him right in the eye. Brody slowly walks backwards into the galley, slowly, almost in a trance, cigarette nearly falling from his trembling lips as he backs up to Shaw and, with a perfect deadpan delivery says:

“You’re going to need a bigger boat.”

I have to imagine that if I were working at the FDA, or one of the many watchdog groups in and out of government that monitor big pharma, I might say something similar. The FDA often finds itself out gunned and out manned by the big drug companies, whose deep pockets enable them to buy armies of attorneys, researchers and lobbyists.

The FDA could really use a bigger boat.

Consider this: GlaxoSmithKline (GSK), one of the world’s largest drug companies has reported over $45 billion in sales and $6.1 billion in profits over the last year. GSK has the finances to aggressively search for loopholes in regulations and, if challenged in court, fight long and protracted litigation lasting years.

And that’s just one company.

On the other hand, regulators and investigators in the FDA lack the necessary funding to keep drug companies honest. In 2010, the agency’s total funding was just over $3 billion. Given that only a portion of those funds are spent on drug safety, and that the FDA is responsible for monitoring all drug activity, there simply aren’t enough investigators and researchers to deter malfeasance. Often, the drug companies are left to police their own production facilities, knowing that inspections will be a rare event.

This situation will likely only worsen in the immediate future. President Obama signed a bill last Tuesday that expanded the FDA’s authority to promote food safety. However, republicans in Congress have promised to undercut the bill by denying funding to the FDA. In fact, the republicans successfully blocked an increase in the FDA’s budget as part of the Omnibus bill earlier this month. It is unlikely that the FDA will receive greater resources to do its job in this kind of budget-cutting environment.

At Hagens Berman, we have a track record of success challenging the largest drug companies. We have tools that enable us to win time and time again, bringing justice to our clients.

The first is the False Claims Act, a law passed during the Civil War in 1863. The law encourages insiders to blow the whistle on illegal business practices by offering the whistleblower a portion of the money recovered. When consumers and the government are harmed by such practices, we often rely on whistleblowers to help us prove guilt in court.

For instance, Cheryl Eckard, a former Quality Assurance Manager at GlaxoSmithKline (GSK), blew the whistle on a safety nightmare at one of the company’s plants. She exposed a production system in disarray, where it appears that prescription drugs were mixed into the same bottle as over-the-counter drugs. In one case, she claimed that an 8-year-old boy was given more than double the prescribed dose of a powerful antidepressant drug.

Ms. Eckard took on GSK and ultimately, the company pleaded guilty to a felony and paid $750 million to settle the cases.

Whistleblowers like Ms. Eckard prove that in this regulatory environment, policy-makers cannot rely solely on on-site inspections to deter criminal behavior by drug companies. Vigorous legal action along with a strong incentive system for whistleblowers may have saved many lives by forcing GSK to improve its safety enforcement.

Hagens Berman did not represent Ms. Eckard in her case, but it is currently investigating what might be one of the biggest drug safety scandals in history. Several credible medical studies and thousands of individuals claim that Avandia, the company’s diabetes medication, increases the risk of heart conditions, including heart attack and stroke. In fact, one study published in the Journal of the American Medical Association estimated that as many as 47,000 people suffered a heart attack, stroke, heart failure, or died because of the drug.

This case also demonstrates the need for whistleblowers, as some investigators allege that GSK knew about the risks associated with Avandia, but hid them from regulators for as long as possible in order to increase profits.

More importantly, this case demonstrates another crucial tool that Hagens Berman uses to hold the pharmaceutical industry accountable; science. Expert testimony based on clinical research often exposes the worst practices of the industry. The data does not lie, and by passionately arguing for our clients, we hope to find justice for those who suffered severe side effects after taking Avandia.

When we look at the FDA’s authority and resources compared to the big drug companies, it is easy to feel like Sheider’s character in Jaws. But sometimes even if we don’t have the biggest boat, we can be confident in our capacity for success. When the truth is on our side, we find new allies, whistleblowers, scientists, and others, whose passion for spreading the truth enable us to bring justice to our clients.