We blogged about the highly suspect decision in Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App. 2010), and last month awarded it the dubious honor of our #4 worst drug/device decision of all 2010.
Well, that isn’t all we’ve done. We (well, Bexis) submitted an amicus brief in Hamilton in the Texas Supreme Court earlier this week. Doing that required us to sit down and think about the supposed (except in New Jersey) “DTC (direct to consumer) exception” to the learned intermediary rule – more than we had before (which was relatively little). And it just so happened, that when we exercised our brains, we came up with more thoughts.
As we mentioned in the earlier post, the first problem with Hamilton was that it wasn’t even a DTC advertising case. Instead, it was a situation where the defendant provided patient-friendly material (a videotape) to the doctors and those doctors had the final say in whether the plaintiff ever saw the material.
Our gut reaction then was that this sort of professionally-mediated information wasn’t what anybody really considered DTC advertising. Now, having looked at that question further, we know we’re right. Why? Well, for one thing the FDA says so. The Agency itself doesn’t consider a videotape (or anything else) provided to a physician for the physician use with patients (or otherwise) to be DTC advertising – or “advertising” at all.
The FDA considers material provided to physicians for them to use (or not) with their patients to be “labeling”:
(l)(1) Advertisements subject to section 502(n) of the act include advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems.(2) Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints and similar pieces of printed, audio, or visual matter descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by medical practitioners, pharmacists, or nurses, containing drug information supplied by the manufacturer, packer, or distributor of the drug and which are disseminated by or on behalf of its manufacturer, packer, or distributor are hereby determined to be labeling as defined in section 201(m) of the act.
21 C.F.R. §202.1(l)(2) (emphasis added). Indeed, a lot of package inserts have patient-friendly information (often called “medication guides”) attached directly to them in “tear off” form for distribution for patients if the physician so chooses. The FDA even compiles and makes this material available on its website.
Nor has any other court ever treated professionally-mediated patient information as if it were “DTC advertising. See In re Prempro Products Liability Litigation, 514 F.3d 825, 830 (8th Cir. 2008); Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 852 (10th Cir. 2003); In re Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700, 708-09 (E.D. Tex. 1997), aff’d in pertinent part, 165 F.3d 374, 379 n.4 (5th Cir. 1999); Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1033 (D.N.J. 1988); Frye v. Medicare-Glaser Corp., 605 N.E.2d 557, 560-61 (Ill. 1992); Seley v. G.D. Searle & Co., 423 N.E.2d 831, 840 (Ohio 1981); Terhune v. A.H. Robins Co., 577 P.2d 975, 979 (Wash. 1978); Banner v. Hoffmann-La Roche, Inc., 891 A.2d 1229, 1236 (N.J. Super. App. Div. 2006); Kennedy v. Merck & Co., 2003 WL 21658613, at *5 (Ohio App. July 3, 2003); Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 93 (Tex. App. 2000); Presto v. Sandoz Pharmaceuticals Corp., 487 S.E.2d 70, 74 (Ga. App. 1997); Taurino v. Ellen, 579 A.2d 925, 930 (Pa. Super. 1990); see also 3 American Law of Products Liability 3d §33.33, at p. 61 (1997 & Supp. 2010).
But even putting aside that the court in Hamilton reached for an irrelevant “exception” in its desire to find some sort of way around the prescribers’ full knowledge of the relevant risks, we don’t think that a DTC exception to the learned intermediary rule has any merit in prescription medical product liability litigation – for two reasons. First, such an exception is at odds with the policy reasons why 48 states (and DC and Puerto Rico) follow the learned intermediary rule. Second, such an exception is totally unnecessary, because the scenario that the exception purports to address – patients marching into their doctors’ offices and demanding drugs based upon DTC advertising – is subsumed in the existing causation element of the learned intermediary rule.
We’ve seen a lot of discussion of reason #1, but not much of reason #2.
As for the first, there are about five policy reasons that courts have adopted the learned intermediary rule. They are:
- The warning duty is owed to the physician because the physician is the only person with knowledge of both the particular patient’s medical history and condition (in Texas, the word used is “susceptibilities”) and the risk/benefit profile (called “complex” and “esoteric”) of the drug.
- Directing the warning duty to the physician keeps the common law in accordance with the restricted distribution system for prescription drugs/devices imposed by the federal Food, Drug & Cosmetic Act.
- Requiring prescription drug/device information to be routed through the doctor preserves the physician/patient relationship from outside interference.
- Lay patients would be unable to understand the medical terminology necessary to explain the risk/benefit profile of prescription drugs/devices.
- As a practical matter, it is difficult for drug/device companies to communicate directly with patients.
The DTC exception does damage to all except possibly the last.
Doctors are still uniquely situated in that they know (in Texas-speak) both the “patient and the palliative.” If anything, the divide between physicians and patients has grown. Just take a look at practically any package insert for a prescription drug or device. The amount of technical terminology – particularly in the contraindications/warnings/precautions sections – is enormous. What was “esoteric” three decades ago is even esotericer now. The same is true of the other side of the interface, the patient’s medical condition, with genetics and MRIs and hosts of other new tests and knowledge crowding around. And, of course, the law of informed consent still exists, so doctors remain obliged to have the risk/benefit discussions that the learned intermediary rule envisions with their patients. If they don’t do it, because of “managed care” or whatever, that’s hardly a drug/device company’s fault, and there’s an independent basis for informed consent liability.
Nor can a patient motivated by DTC advertising (legally) get around the need for a doctor’s evaluation. The law hasn’t changed. Prescription drugs are available only by prescription. That it’s somewhat tautological doesn’t mean it’s still true. The FDA requires involvement of a physician precisely because of the inherent risks and benefits of prescription drugs. If the consumer alone can handle the information, with no need for physician input, the drug would be over-the-counter.
Anytime an individualized physician/patient relationship exists, it should be protected from invasion by outsiders acting under compulsion of overly intrusive tort duties. The supposed fear that “managed care” is eroding the physician/patient relationship: (1) doesn’t justify the law ignoring such relationships where they do exist, and (2) is already addressed by the existing “mass immunization” exception, which covers the use of prescription drugs where there is no physician/patient relationship worthy of the name. To the extent there is pressure on the physician/patient relationship, a DTC exception only makes it worse by broadly forcing drug/device companies to provide information that, at best, the patient’s physician considers unnecessary and at worst considers affirmatively harmful.
Nor would a DTC exception provide patients with comprehensible information beyond what is already available. Modern package inserts already contain patient-friendly information, and that information is widely available on the web, including on the FDA’s website. If a doctor wants to give this information to a particular patient s/he can do so. If s/he doesn’t, there’s probably a good reason why not (for example, a lot of psychiatrists don’t bring up suicide risk with depressed but non-suicidal patients), and forcing a manufacturer to provide information a doctor doesn’t want to provide is rarely a good idea.
Given the Internet, the practicalities of communications have indeed changed. But that’s hardly a reason for a broad DTC rule that ignores the facts of individual cases. Sure, the warnings, etc. are out there – or can be put out there – so that they’re only a few mouse clicks away. That’s usually mentioned on DTC ads anyway (and the print ones provide full risk information already). But this change in accessibility assumes that the patient is actively seeking the information, we would hope at the direction of the prescribing physician. As to patients who are not taking positive steps to become informed, all of the practical problems remain, since drug/device companies rarely if ever know the identities of patients so that they could provide timely direct to patient information even if they wanted to. If anything, the increasing emphasis on medical privacy only aggravates the practicality problems identified by the courts.
Since the DTC exception has always flown in the face of the jurisprudential policies that caused courts to adopt the learned intermediary rule in the first place, it’s hardly surprising that practically every court (except the New Jersey Supreme Court, which sprang it on everyone out of the blue) to consider such an exception has declined to adopt it. In re Diet Drugs Products Liability Litigation, 2009 WL 902351, at *2 (E.D. Pa. April 2, 2009) (applying Missouri law); Allgood v. Glaxosmithkline PLC, 2008 WL 483574, at *3-4 (E.D. La. Feb. 20, 2008), aff’d, 314 Fed. Appx. 701 (5th Cir. 2009); Mendez Montes De Oca v. Aventis Pharma, 579 F. Supp.2d 222, 229 (D.P.R. 2008); Beale v. Biomet, Inc., 492 F. Supp.2d 1360, 1376 (S.D. Fla. 2007); Cowley v. Abbott Laboratories, Inc., 476 F. Supp. 2d 1053, 1060 n.4 (W.D. Wis. Feb. 28, 2007) (applying North Carolina law); Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 378 n.6 (D.N.J. 2004) (applying Pennsylvania law); In re Meridia Products Liability Litigation, 328 F. Supp.2d 791, 812 n.19 (N.D. Ohio 2004), aff’d, 447 F.3d 861 (6th Cir. 2006); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 594 (W.D. Tex. 2002); In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp.2d 795, 812 (E.D. Tex. 2002) (applying law of every state except NJ); Norplant, 955 F. Supp. at 707-08; Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1148 (D. Or. 1989) (rejecting concept pre-Perez); Larkin v. Pfizer, Inc., 153 S.W.3d 758, 766 (Ky. 2004); Albertson v. Wyeth, Inc., 63 Pa. D. & C.4th 514, 539 (Pa. C.P. Philadelphia Co. 2003). The ALI also excised such an exception from the Third Restatement of Torts after some academics floated it as a trial balloon in an initial draft. See Restatement (Third) of Torts, Products Liability §103(a)(3)(iii) (Council Draft No. 1, 1993) (including DTC exception); Restatement (Third) of Torts, Products Liability §4(b)(3), at Preface (Council Draft No. 1A, 1994) (reiterating that a restatement of the law is no place for theoretical exceptions with virtually no case support).
But aside from all of the policy reasons why a DTC exception is a bad idea, after having considered the situations in which the New Jersey Supreme Court in Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. 1999), postulated it would be applicable, we simply don’t think there’s any need. While some of that opinion sounds like the court simply decided to give vent to its personal dislikes about advertising (id. at 1247, 1251, see Hamilton, 310 S.W.3d at 506), the substantive reason offered for the rule is that DTC advertising encourages patients to confront their doctors with demands for the drugs they saw advertised:
Physicians no longer make the final decision as to whether a patient will take a drug – patients make those decisions. . . . After years of patients being subjected to direct advertising, physicians state that they are increasingly asked and pressured by their patients to prescribe drugs that the patient has seen advertised. . . . Physicians argue it is not their fault; rather, they claim pushy patients, prodded by [direct-to-consumer] advertisements, pressed, wheedled, begged and berated them for quick treatments. Physicians claim that it is impossible to compete with pharmaceutical companies’ massive advertising budgets, and resign themselves to the fact that if consumers make enough noise, they will eventually relent to patient pressure.
Hamilton, 310 S.W.3d at 507 (various citations omitted).
We personally doubt that doctors are patsies in the face of patient demands, as Hamilton suggests, but even assuming that the supine-physician scenario exists, so what? Under that rationale, there’s no reason whatsoever to adopt a blanket exception to the learned intermediary rule for DTC advertising. The existing requirement of warning causation under the learned intermediary rule is perfectly capable of handling this described situation.
Here’s what we mean.
In any product liability case (involving any product) the plaintiff can only recover is s/he proves that the defect in the product caused the injury. In any warning case (involving any product), ignoring such monstrosities as heeding presumptions, applying the general principle means that there must be facts establishing that a defect in the warning caused the injury. That means that somebody, somewhere had to rely upon the defect in the warning when selecting or using the product.
OK, let’s get more specific. We’ve discussed the role of warning causation in learned intermediary rule cases many, many times, since it’s one of our major defenses. Causation in a learned intermediary case means proving that the doctor in some way relied upon the inadequate information in a drug/device warning while deciding to put the plaintiff on the product. Otherwise the plaintiff loses. In Hamilton, for instance, there was no way for plaintiff to prove causation because the doctors who prescribed the drug both testified that they already knew about the risk in question, discussed it with the plaintiff, and elected to prescribe anyway. 310 S.W.3d at 485 (first prescriber “testified that he also discussed the risks of using Remicade, including the risk of developing a lupus-like syndrome”), 493 (second prescriber’s “notes indicate that she discussed the possibility of lupus-like syndrome with” plaintiff).
Since the Hamilton plaintiff was not exposed to any DTC advertising before a prescription was written, Hamilton is pretty far from the situation the DTC exception purports to address. That’s not accidental.
If the facts were otherwise, a plaintiff wouldn’t need to resort to the DTC exception at all. If there was some inadequacy (whatever it might be) in DTC advertising that helped motivate a patient to go to his/her doctor and hector the doctor until the doctor rolled over and prescribed the drug/device, then under standard warning causation principles as routinely applied with the learned intermediary rule, the case goes to the jury on causation. That’s because in the supine physician situation – the one postulated in Perez and Hamilton – the defect in fact caused (albeit indirectly, through motivating the patient to confront the doctor) the doctor to modify his/her prescribing decision from what it would otherwise have been.
So the DTC exception is totally unnecessary in the supine physician situation for which courts claim that it’s been created: where assertive patients, influenced by DTC advertising, force changes in the prescription decisions made by their doctors. That scenario, like other forms of indirect causation (one doctor telling another; overpromotion; misleading medical articles, etc.), is already encompassed by the warning causation element of the intact learned intermediary rule. If the defect – some inadequacy in the DTC advertising – in fact causes the patient to do something that in turn causes the doctor to prescribe the drug/device when otherwise s/he wouldn’t, then there’s a jury submissible case under the learned intermediary rule.
Carrying this analysis further, when does a DTC exception actually make a difference in a case outcome?
When the patient deserves to lose anyway, that’s when.
A DTC exception makes a difference where – like Hamilton – in fact, the supposed DTC advertising (assuming that there was any) does not have any causal effect under the specific facts and circumstances of a particular case. In Hamilton the patient didn’t even see the film until after the prescription had already been made. 310 S.W.3d at 486 (“the decision to take Remicade has already been made by the time a patient arrives at his infusion clinic” where plaintiff saw the film). DTC advertising causation in Hamilton, was in a word, impossible, since the prescription preceded the film. The most basic cause-effect is absent.
As compared to current law, a blanket DTC exception only helps plaintiffs who have no right to expect assistance from the law – those whose prescriptions weren’t, in fact, affected by any DTC advertising. Maybe: (1) they weren’t exposed to DTC advertising at all, or (2) (as with the first prescriber in Hamilton) weren’t exposed until after the prescription was made. Maybe (3) they were exposed, and (like most advertising) it didn’t motivate them to do anything. Maybe (4) they were exposed, and motivated to see their doctors, but they never said anything to their doctors about the advertised drug, because the doctor brought it up first. Or maybe (5) they were exposed, and motivated, and did mention it, but the doctor (like the second prescriber in Hamilton) knew about the risk that the DTC advertising omitted.
In none of these five situations – and we doubt on any other set of facts where a DTC exception would produce a different result than current law – do the plaintiffs deserve to win. The DTC advertising itself was simply non-causal. It did not affect the decision of the physician to put, or to keep, the plaintiff on the drug/device. Thus, in the only situations where a DTC exception makes a difference, the plaintiffs that it would benefit don’t deserve to win.
In sum, we think that when causation is factored in, a DTC exception is worse than useless. It’s unnecessary in the supine physician situation that its advocates present as the paradigm because there’d be a jury-submissible causation case under current law. It’s worse than useless because it allows plaintiffs to get to juries merely because DTC advertising existed, even when it had no effect whatsoever (as in Hamilton) on the doctor’s decision to prescribe the drug.
But if there’s some legal theory out there that would impose liability because of those ridiculous beer commercials…. We’re all ears.