Don’t Be Fooled

A bill before the Alabama Legislature threatens to deny our citizens the right to sue drugmakers who trick doctors into believing that medicines the companies market do not cause harmful side‑effects. The bill is HB 617. It takes aim at a recent Alabama Supreme Court decision which affirms that citizens injured by the drugs can sue when fraud of that type is perpetrated on their doctors. The case is Weeks v. Wyeth, and my law firm represents the plaintiff in it. The bill’s supporters have been misinformed about it.

Referring to the decision in our case, the legislator who introduced the bill, stated, “In its ruling, the Court said that a brand name manufacturer can be held liable for injuries suffered by a plaintiff using a generic product made and sold by a different company. This new Alabama precedent is being referred to as ‘innovator liability.’” That is wrong.

There is no “innovator liability” in our case.  The defendants, led by pharmaceutical giants Wyeth and Pfizer, never innovated or invented the drug which injured our client. They bought it from a French company, specifically to market it in the U.S. They promoted it here as a long‑term drug therapy for reflux, something the innovating company (the French company) never did. So, innovator liability is a red herring. The only thing the defendants innovated was a marketing plan to profit from the drug. Part of the plan was suppressing information about the drug’s worst side‑effect. The side‑effect is permanent neurological damage.

The “spin” specialists of the defendants try to make these facts disappear. Their public relations campaign is proof. “Innovator liability” has nothing to do with the Supreme Court’s decision in our case, but the Legislature has been told exactly the opposite.

The misinformation poses a risk to every citizen, because the bill would twist the protection Alabama law affords patients into a weapon against them, changing it into a shield for wrongdoers who injure patients.

Alabama’s drug substitution law allows a prescription for a brand drug (what our client was prescribed) to be filled with a generic replica. That occurred with our client. He received the generic replica.  The substitution law requires that the federal FDA first approve the generic tablet as a bioequivalent replacement for the brand drug, ensuring that the patient receives the same medicine, not a different medicine. Those are facts known by everyone who works with prescription medicines. They know that generic drugs like the tablets our client ingested can be made and sold only because the brand maker has received FDA approval both for the drug and for the warnings which accompany it. Without passing the FDA’s test of a bioequivalent drug, the generic manufacture cannot make a replica. Without following exactly the brandmaker’s information about the drug, it cannot sell the medicine. Which is why the brandmaker’s information, or lack of it to be precise, is the issue. Innovator liability isn’t.

Credible news sources like the Wall Street Journal know all of this. They describe the case correctly. The WSJ, in its edition of February 25, 2013, accurately stated both the basis of our suit and the Supreme Court’s ruling in it. The doctor, as WSJ described it, “relied on the representations made by the name brand manufacturer to assess the risks [of the drug].” The Court’s decision turns on that allegation, the WSJ further reported: “A brand name manufacturer could ‘reasonably foresee’ that a physician would rely on its warning label ‘even if the patient ultimately consumed the generic version of the drug,’ Justice Bolen wrote for the 8 1 majority.”