Avandia Product Liability Litigation Bolstered By Harvard Research Study

It’s no secret among people who know me, that, as a Boston Massachusetts product liability lawyer, I’m one of the sharpest critics in the legal community of the pharmaceutical industry, and particularly, pharmaceutical advertising. Yes, I’m fully aware of the societal value that pharmaceutical companies can and do bring to bear, in addressing a number of diseases and medical conditions. And I believe that they are entitled to make a healthy profit in so doing. But what I’ve – and we’ve – all witnessed in the last 10 or 12 years, is the way that pharmaceutical companies pimp their products to the general public through television, radio, and print advertising. It is often obscene, and in my opinion ought to be legislated as illegal. However, there’s a sticky little thing called “commercial free speech”, which delves into an entirely separate subject of First Amendment issues, which I won’t distract my readers with right now. Not that it isn’t very important, but I’ll save that for another day.

Long gone are the days when pharmaceutical company sales reps solely called on – of all things – doctors’ offices – to sell their products. No, they got around that. Their thinking: “Why rely on doctors to write prescriptions for our products, when we can generate demand at the consumer level? Yeah, we’ll flood print and broadcast media with ominous-sounding ads showcasing all kinds of diseases and medical problems, and in the process, get millions of people to march into their doctors’ offices, and demand to be given prescriptions for our products.” This seemed like an even surer bet than taking doctors out to lunches and dinners, and hosting them with everything from golf outings to “professional seminars” at warm, sunny destinations. (Which they still do, but that practice has been gradually dropping, as regulators see more and more how incestuous and unethical a practice it obviously is.)

Take a little test: The next time you’re watching a TV show (ideally during prime time, (8:00-11:00 PM,) keep a pen and paper next to you. Write down the number of advertisements that you see about any kind of drug or health product. Ninety per cent of the time, it’s a pitch from a pharmaceutical company, talking about the horrors of this or that medical condition, and urging you to “Ask your doctor about_______.” Do the same thing the next time you’re reading a newspaper or a magazine. Or listening to the radio (except when driving.) Chances are you’ll realize that the average viewer, reader or listener is inundated, constantly, by drug companies trying to get you to “Ask your doctor” about whether you “might have” some medical problem or condition, and whether their product “might help you.” Not only are ads in newspapers across the country regular fare, but full page ads. Any idea what a full page ad in an average major city daily newspaper goes for, say, Monday through Friday? About $10,000.00 – and more on weekends. Hawking everything from Aspirin to Zithromax, for every condition from high cholesterol to depression to heart disease to smoking, they never cease their constant drumbeat to “Ask your doctor about ______.”

Not quite the harmless commercial activity it’s claimed to be (at least by the pharmaceutical companies.) You see, in the mad frenzy to get drug companies’ products to market so they could hawk them in this way straight to the general public, science and sound practices took a back seat. “Clinical Studies” were skewed. “Scientific research” became less important than scientific fact, and profits became the driving force in research and development. It doesn’t take a genius to see what flows from all this.

One glaring example of this is what happened with a diabetes drug manufactured, and quite forcefully marketed, by GlaxoSmithKline. The drug, Avandia, has become well-known for causing serious injuries in persons taking the drug. About 13,000 former Avandia users in the United States have suffered heart attacks and other serious injuries while using Avandia, and many of these users have filed suit against GlaxoSmithKline in state and federal courts. Product liability lawyers across the United States have known for years that this drug was dangerously defective and posed an extremely elevated risk of harm to those who used it. Now, a Harvard University study has shown that Avandia creates more than double the risk of heart attack in users, compared with other diabetes drugs. The study is slated for publication soon by the American Diabetes Association.

GlaxoSmithKline’s own study of Avandia, conducted with i3 Drug Safety, an independent drug safety firm, found that Avandia users have a 35 percent to 41 percent increased risk of heart attack over users of Actos, Avandia’s main competitor. The Harvard study analyzed clinical data from the medical records of 26,375 patients at several Boston area hospitals and clinics associated with Harvard Medical School. All the records reviewed involved a diagnosis of diabetes and the use of at least one oral diabetic medication used between 2000 and 2006. The researchers then scoured the records to find all patients who suffered “myocardial infarction” or heart attack. The incidence of heart attack was more than double for Avandia compared with its main competitor, Actos.

A company spokeswoman was unavailable for comment Wednesday. No surprise there. The 13,000 people who have filed suits against GlaxoSmithKline, are distributed across the United States, and the suits are filed in both federal and state courts. In California alone, almost 3,000 suits have been filed in state Superior Court. All of the suits accuse GlaxoSmithKline of falling to warn patients about the increased risk of heart attack, strokes and heart failure, and of aggressively marketing Avandia in the face of clear evidence of this elevated risk. On the federal court level, thousands of cases have been consolidated, initially into three bellwether test cases. Medical negligence is one thing. Negligence by definition involves an unintentional act. But from all indications in the Avandia case, GlaxoSmithKline intentionally hid damaging clinical information from the public, all in the name of higher sales and fatter profits. Nothing new there.

When will corporate America wake up and realize that the viral corporate greed that has previously infected so many companies, whether automobile manufacturers, tobacco companies, or toy manufacturers, doesn’t pay? When will they break out of their frenzied drive for more sales and profit at any cost, and place the interests of their customers first? When does this all end? The best and, in the real world – only answer to these questions is “When they get hit so hard in court, that none of them will ever think of it again.” That’s why the tort system in this country is so critical. The day the average citizen loses his right to hold corporate America accountable for its misdeeds, is the day we will all suffer a loss that can not be replaced. Remember that the next time that some pro-business type tells you that “tort reform” is a good idea.

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