Changing times for the learned intermediary defense.

For the past nine years I have devoted the bulk of my time to litigating wrongful death cases against pharmaceutical companies. My typical case involves a suicide induced by Prozac, Zoloft, Paxil, or one of their cousin selective serotonin reuptake inhibitor(SSRI) drugs. One of the most common defenses that manufacturers invoke is the "learned intermediary" doctrine.

The courts have produced voluminous case law on the doctrine, including a few plaintiff-friendly decisions that have either recognized exceptions to the rule or limited when and how it is applied. But several questions remain unanswered, and lawyers who represent people injured by defective drugs must seek opportunities to confine this defense to its proper role.

Although the learned intermediary rule appears in neither the text nor the comments of the Restatement (Second) of Torts, almost every state has adopted a version of it--usually as a matter of common law--while interpreting and applying [section] 402A. (1)

When the American Law Institute promulgated the Restatement (Third) of Torts: Products Liability in 1997, the doctrine was elevated to "black letter" status in [section] 6, which provides that "a prescription drug or medical device is not reasonably safe ... if risks of harm are not provided to ... prescribing and other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings." In June, the Kentucky Supreme Court, in Larkin v. Pfizer Inc., became the country's first court of last resort to adopt this version of the learned intermediary doctrine. (2)

As the Larkin court acknowledged, the principal rationale supporting this defense is that because these products are available to the consumer only by prescription from a "learned intermediary," the manufacturer's common law duty to warn should extend only to the intermediary, who is responsible for weighing the risks and benefits of the drug as declared in the manufacturer's package insert.

Although this understanding of the doctrine has some surface appeal, it is out of touch with the reality of medical practice in the early 21st century. For example, as a result of an FDA ruling, drug companies can and do advertise directly to consumers. Television viewers are besieged with drug ads, and marketing research shows that they are highly effective. In Tobin v. SmithKline Beecham, one of my cases, the company's vice president of marketing, Bonnie Rosello, admitted in a deposition on October 19, 2000, that when patients heed an ad and "ask [their] doctor" about a particular brand of drug, 84 out of 100 patients will leave the doctor's office with a prescription for it. (3)

The Restatement (Third)acknowledged this development in marketing practices and provided for an exception to the learned intermediary rule "when the manufacturer knows or has reason to know that health care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings." (4) In such circumstances, the restatement requires that manufacturers warn patients directly.

Open questions

The New Jersey Supreme Court was the first state high court to address the direct-to-consumer advertising exception. In Perez v. Wyeth Laboratories, Inc., it held that a drug manufacturer's duty to warn the consumer is coextensive in proportion to the extent of its direct-to-consumer advertising. (5) If other states' high courts follow suit, they will almost certainly have to decide whether to require a causal link between the company's advertising and the prescription given to the plaintiff. In other words, to invoke the exception, must I prove that my client, or his or her family, saw an ad for a specific drug and asked a physician to prescribe it?

Such evidence will certainly make a stronger case. For example, during the first of many days of deposition testimony in Blowers v. Eli Lilly, my client told the defense lawyer that his son had pinned a Prozac "poster" to his bedroom wall a few clays before he hanged himself in the close t of that same room. (6) "Do you still have it?" defense counsel asked.

"It's still there," my client answered.

The "poster," which my client brought to the second day of deposition, was actually a two-page magazine ad that had run at Christmas.

On the left page there was a dimly lit, limp Christmas tree superimposed on a red background. A large caption read, "DEPRESSION HURTS." The tree on the facing page was brightly lit, with a background of vivid yuletide green. "PROZAC HELPS" was written above the tree. In small print below, the manufacturer warned about the drug's relatively harmless side effects, such as dry mouth or nausea.

There it was, in plain print. By addressing the consumer directly in the ad, the company had significantly diminished the protective role of the learned intermediary. If the case had been tried, I doubt that Lilly would have been granted a jury instruction about the learned intermediary doctrine.

Although clear-cut evidence of a consumer's response to a manufacturer's advertising can be invaluable, is it really necessary? Several courts have acknowledged that a drug company's overpromotion can create an exception to the learned intermediary doctrine. (7) In Smith v. Pfizer Inc., the U.S. magistrate judge granted my client discovery regarding Pfizer's marketing efforts for Zoloft, based on these rulings and the commonsense notion that overpromotion can nullify even valid warnings--consciously or subconsciously?

It may be possible to circumvent the learned intermediary doctrine by introducing into evidence handouts and other "patient education" tools. All SSRI manufacturers have prepared expensive, four-color brochures--avail able in doctors' waiting rooms and online--designed to attract patients to their drugs and keep them popping pills, even when they experience early side effects.

I have argued that the learned intermediary doctrine is a species of "no duty" argument. Based on the theory--accepted in most states--that no one owes a duty to rescue a drowning person, there is no legal duty for a drug manufacturer to warn the consumer; however, once a person undertakes a rescue effort, he or she has a duty to use reasonable care. According to this logic, a manufacturer that seeks to "educate" patients with brochures has a duty to instruct them in the product's safe use. So far, the argument has been neither accepted nor rejected.

Would the courts require me to prove that my injured client or my client's family received and read a patient brochure? Again, this evidence surely helps.

One of my clients sat with her husband and read the patient brochure for Paxil, which his doctor had just prescribed. The husband had first taken Prozac and had suffered side effects that usually indicate the patient may become suicidal, including akathisia. These effects were so severe that his wife, a registered nurse, bad flushed the remaining Prozac down the toilet.

The doctor switched the husband to Paxil, but without allowing thee for the long-acting Prozac to clear his system. As the couple read the Paxil brochure, they were comforted by the manufacturer's assurances about the drug's efficacy and the relative mildness of listed side effects. The next day, with a double dose of psychoactive drugs at work on his brain, this decorated police officer and SWAT team cocommander shot himself. Evidence that the couple had read the brochure proved crucial in settlement negotiations, an d the case settled before trial.

Clearly, this is powerful evidence for any plaintiff, but whether it is needed to circumvent the learned intermediary defense is still an open question.

Points to consider

Here are three significant points to remember when considering the applicability of the learned intermediary defense:

* First, the prescribing doctor's opinion of a plaintiff's proposed language for an adequate warning is not the key question. To posit it that way is to load the scales of justice from the get-go by vesting the doctor, who may have his or her own agenda, with case dispositive power.

Rather, the relevant legal question is, What would the doctor--either the client's actual doctor or a hypothetical, objectively "reasonable physician"--have done with an adequate warning from the drug company? There is a big difference between the prescribing doctor's opinion and the reasonable physician's action.

* Second, focus on the nature and quality of the prescribing physician's testimony about what he or she learned from the manufacturer's warning and might have done differently if other information had been provided. Find out if the doctor has an axe to grind or is equivocal. The plaintiff lawyer must prevent summary judgment based on the doctor's deposition testimony or--worse--on sworn affidavits or declarations that were not subject to cross-examination.

For example, in Tobin, SmithKline Beecham (SKB) sought summary judgment based on favorable snippets from the prescribing doctor's deposition testimony. We pointed out that these excerpts were equivocal at best and contrary to other parts of his testimony. The court agreed and denied the motion.

At trial, we confronted the prescribing physician with evidence that the jury had already seen and heard: It showed that SKB had made its own internal assessments of suicide problems relating to Paxil--the company had concluded that there was a risk--and that packages of the drug sold in Germany included a suicide warning. We also pointed out to the doctor that a drug salesman, who was an SKB employee, had testified that Paxil should be titrated, which means that the patient should be started on a low close and ramped up over time.

The physician responded that he would have liked to have had this information before prescribing Paxil for our client and that it would have affected his treatment decisions. The jury clearly believed that the prescribing doctor would have heeded an adequate warning from SKB and found the company 80 percent responsible.

* Finally, consider whether there is a "heeding presumption" in the state whose law governs the case. Comment j to Restatement (Second) [section] 402A creates a presumption in favor of a product manufacturer that gives a legally adequate warning. The presumption is that the consumer will heed this warning--or; in a pharmaceutical case, that the learned intermediary will do so.

Most courts that have addressed the issue have held that this presumption can also benefit plaintiffs: Where a court has determined that a warning is legally inadequate, it is presumed that the consumer or the intermediary would have heeded a legally adequate one. (9) In some states, this presumption even rises to one of causation--that is, that the lack of an adequate warning about the dangers of the drug caused the bad outcome. (10)

I have argued sadly, with little success to date--that this presumption may be rebutted by the defense only by evidence that shows that an independent, reasonable, objective prescribing physician would have and should have heeded the manufacturer's warning. A contrary rule would mean the prescribing physician's testimony alone could determine the case: If the doctor testifies that he or site would not have heeded the warning, the manufacturer is shielded from liability, and the court must dismiss the claim. A physician with no interest in the case might give very different testimony.

A significant benefit of the presumption of causation is that it shifts the burden of proof to the manufacturer, which means that it is not up to the plaintiff to prove what a doctor may or may not have done had he or she been adequately warned.

Regardless of the courts' differing interpretations of the rule and its exceptions, the learned intermediary doctrine is here to stay. To effectively counter this common defense, plaintiff lawyers must be well versed in its nuances and well prepared to circumvent it by both pleading and proof.

Notes

(1.) See, e.g., Vitanza v. Upjohn Co., 778 A.2d 829, 838 n.11 (Conn. 2001).

(2.) No. 2002-SC-0746-CL, 2004 WL 1361954 (Ky. June 17, 2004).

(3.) 164 F. Supp. 2d 1278 (D. Wy. 2001).

(4.) RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY [section] 6(d) (2) (1998).

(5.) 734 A.2d 1245, 1263 (NJ. 1999).

(6.) 100 F. Supp. 2d 1265 (D. Haw. 2000).

(7.) E.g., Stephens v. Parke Davis & Co., 507 P.2d 653, 661 (Cal. 1973); Proctor v. Davis, 682 N.E.2d 1203, 1214 (Ill. App. Ct. 1997).

(8.) No. CIV. A. 984156-CM, 2001 WL 968369 (D. Ran. 2001).

(9.) Wooderson v. Ortho Pharm. Corp., 681 P.2d 1038 (Kan. 1984), cert. denied, 469 U.S. 965 (1984) ; See also Cunningham v. Charles Pfizer & Co., 532 P.2d 1377 (Okla. 1975).

(10.) Wooderson, 681 P.2d 1038, 1049, 1057; See also Cunningham, 532 P.2d 1377, 1382. Sadly, this point seems to have eluded both the district judge and the Tenth Circuit in Miller v. Pfizer, 196 F. Supp. 2d 1095, 1126-27 (D. Kan. 2002), aff'd, 356 F.3d 1326 (10th Cir. 2004), petition for cert. filed (Apr. 30, 2004) (No. 03-1505).

ANDY VICKERY is a partner in Vickery & Waldner in Houston.