Anybody who watches the evening news has seen them—advertisements for prescription drugs of all sorts to ease chronic pain, lighten depression, make things that won’t get up get up, and make things that won’t stay in stay in. Each comes with a soothing voiceover noting that the drug in question “is not for everyone” and that serious side effects can occur. The litany of admonishments ends with sage advice to “ask your doctor” and a repetition of the slogan that started the whole ad. End scene.
In Centocor, Inc. v. Hamilton, an appeal from the Corpus Christi Court of Appeals, the Texas Supreme Court now wades into the issue of whether a drug manufacturer can still rely on the “learned intermediary” defense that has long been a staple of any drug or medical device manufacturing defendant’s legal arsenal. The defense essentially says that, if you give appropriate warnings about the dos and don’ts of using a particular drug or device to a patient’s doctor—the one who is actually prescribing the use of the drug or device in question—you are insulated from telling the patient, himself. The law assumes that the doctor will pass on any necessary warnings to the patient because the doctor himself has a duty to the patient.
Does this make sense? Well, yes and no. On the one hand, a doctor does have a duty to his patient—both in the form of prescribing medications where the potential risk is outweighed by the reward and of educating himself and informing his patient of the potential side effects. On the other hand, no doctor can be expected to read his patient the entire entry on a drug from the Physicians’ Desk Reference (PDR)—which exhaustively details the results of every study on a particular prescription medication. If you read those full descriptions any time the doctor gave you a prescription, you’d never agree to take anything again, as they read like a catalogue of disaster akin to something from the Old Testament. (No arthritis treatment has ever been connected to a plague of locusts, but just wait.) Moreover, with drug companies now taking it upon themselves to advertise directly to consumers, do they have a duty to give all sides of the story? And not just the one that makes their product look like a miracle cure? (Notably, these drugs that are being advertised still can be prescribed only by a physician, so a physician’s involvement and approval is still very necessary.)
In Centocor, set for oral argument on December 8, the Court will likely consider the effect of all those ads on the nightly news. Does the direct marketing of drugs to consumers create a greater duty for the manufacturers of those drugs, and is it a duty that they cannot fulfill by merely providing warnings to an intermediary?
It’s a good question. Right now, patients get all the spin but very little of the real information. Even so, it seems like manufacturers should be able to tell prospective buyers that their product exists and that it might be helpful. One thing is certain though: if the Court makes inroads on the “learned intermediary” defense, those voiceover warnings in the TV ads are going to be longer and louder. Either that, or expect a free copy of the PDR any time you visit the pharmacy.
Tip o’ the hat to the Supreme Court of Texas Blog.
UPDATE: Surprise!!! They held for the drug manufacturer.