Friday, December 08, 2006

Heedless Use of Heeding Presumptions

We are often mystified that courts rotely apply purportedly “general” product liability concepts to litigation involving prescription medical products without stopping to think whether these concepts make sense where: (1) the product cannot be marketed unless and until a federal agency approves them as safe and effective, and (2) because of its inherent risks, the product cannot be used by anyone except upon a doctor’s prescription.

One of these “cross-over” concepts is the so-called “heeding presumption” – adopted in a number of states – that “presumes” (in the absence of contrary evidence) if the defendant had given an adequate warning, the plaintiff would have heeded and followed it. This proposition has serious problems generally, so serious that the language giving rise to it was intentionally removed from the Restatement (Third) of Torts: Products Liability. That, however, is something for a different post.

In the case of prescription medical products, such a “heeding presumption” rarely, if ever, makes any sense at all. Yet, all too often we come across cases like Tingey v. Radionics, 2006 WL 2258872, at *10 (10th Cir. Aug. 8, 2006), and In re Diet Drug Litigation, 895 A.2d 480, 490-91 (N.J. Super. Law 2005), that apply the “heeding presumption” in prescription medical product liability litigation primarily because some earlier court applied it to an entirely different product that anybody could go out and buy at a hardware store.

Conversely it’s gratifying to read cases like Lineberger v. Wyeth, 894 A.2d 141, 145, 149-50 (Pa. Super. 2006), and Koenig v. Purdue Pharma Co., 435 F. Supp.2d 551, 556-57 (N.D. Tex. 2006), where the courts get it. These courts take the time to understand that not all products are the same – that drugs and devices are qualitatively different from step ladders and automobiles.

So what’s this big qualitative difference? Mainly, it’s that there are two fundamentally different kinds of warnings. Most warnings concern a product’s use – that if you use (or don’t use) the product in a certain way, you are likely to get hurt; and if you follow the warning, you won’t. Examples are not driving a riding lawnmower parallel to a slope (because you’ll tip over) or only handling asbestos while using a respirator (because breathing asbestos can do nasty things to you).

While so-called “use” warnings occasionally arise as to prescription medical products – overdose instructions come to mind – that type of warning is not what most litigation involving these products is about. Rather, with prescription-only products, most of the relevant risks arise whenever the product is used. A warning about an inherent risk – a so-called “risk warning” – serves an entirely different purpose.

With inherent risks, people are warned so they can decide whether that risk outweighs the benefits that might be gained from using the product. The only way to avoid the risk is not to use the product at all. All prescription medical products have inherent risks – which is why the FDA requires a physician’s prescription in the first place. For a case discussing the distinctions between these two types of warnings in detail, read Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir.1992).

What happens when a heeding presumption is imposed concerning a risk warning? In that situation, “heeding” the warning can only mean not using the product at all, because that’s the only way to avoid the risk. So applying a “heeding presumption” to an inherent risk lets plaintiffs argue, in effect, that the product should never have been sold – that every “reasonable” person would have “heeded” an adequate warning and not used it. But we know that’s not simply not true. For example, millions still smoke cigarettes, although those risks have been public knowledge for decades. Millions more use drugs and medical devices even though they carry the FDA’s strongest “black box” warnings. A “heeding presumption” in this situation is contrary to fact and to common sense.

But where a prescription medical product is involved there’s even more. Making the decision whether a product’s risks outweigh its benefits for society as a whole is precisely what we created the FDA to do. The Agency evaluates safety and efficacy for the products it approves and decides whether those products should be marketed at all and, if so, for what types of patients and for what types of medical conditions. Making that same decision on individual basis is the job of the prescribing doctor.

Doctors do for each of their patients what the FDA does for everybody – on an individual basis, they balance the risks of a product against its expected health benefit. Thus, the prescribing physician only “heeds” warnings in the sense of considering them while deciding how to prescribe the product and whether or not to tell the patient about the risk. It is unrealistic to presume physicians would “heed” any warning either in the sense of never using the product or that they would automatically telling every patient about every risk. Eck v. Parke, Davis & Co., 256 F.3d 1013, 1021 (10th Cir. 2001) (wrong to “construe [a treater’s] ‘heeding’ an adequate warning to mean [s/he] would have given the warning”).

So if an inherent risk of an FDA-approved prescription-only product is omitted (or not adequately discussed), does that mean that the law should “presume” that nobody would have used it – that everyone would have “heeded” a better warning and used something else (or have been content to use nothing)? Of course not. The FDA’s approval means that the product can be used for its approved uses. Unless the FDA determines the “new” risk is so serious as to affect that approval, it will deal with the risk by approving a new warning. Unless a “new” risk is great enough to tip the prescribing decision for a particular patient, at most a prescribing doctor will tell the patient about it. The prescriber might not even do that if the new risk is not viewed as very likely in that particular patient.

For these reasons, we believe that – logically and legally – the “heeding presumption” has no legitimate role in virtually all prescription medical product liability litigation.

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