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Perez v. Wyeth Laboratories

August 09, 1999


On certification to the Superior Court, Appellate Division, whose opinion is reported at 313 N.J. Super. 511 (1998).

The opinion of the court was delivered by: O'hern, J.

Our medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received in the doctor's office from a physician who most likely made house calls if needed. The patient usually paid a small sum of money to the doctor. Neighborhood pharmacists compounded prescribed medicines. Without being pejorative, it is safe to say that the prevailing attitude of law and medicine was that the "doctor knows best." Logan v. Greenwich Hosp. Ass'n, 465 A.2d 294, 299 (Conn. 1983).

Pharmaceutical manufacturers never advertised their products to patients, but rather directed all sales efforts at physicians. In this comforting setting, the law created an exception to the traditional duty of manufacturers to warn consumers directly of risks associated with the product as long as they warned health-care providers of those risks.

For good or ill, that has all changed. Medical services are in large measure provided by managed care organizations. Medicines are purchased in the pharmacy department of supermarkets and often paid for by third-party providers. Drug manufacturers now directly advertise products to consumers on the radio, television, the Internet, billboards on public transportation, and in magazines. For example, a recent magazine advertisement for a seasonal allergy medicine in which a person is standing in a pastoral field filled with grass and goldenrod, attests that to "TAKE [THE PRODUCT]" is to "TAKE CLEAR CONTROL." Another recent ad features a former presidential candidate, encouraging the consumer to "take a little courage" to speak with "your physician." The first ad features major side effects, encourages the reader to "talk to your doctor," and lists a brief summary of risks and contraindications on the opposite page. The second ad provides a phone number and the name of the pharmaceutical company, but does not provide the name of the drug.

The question in this case, broadly stated, is whether our law should follow these changes in the marketplace or reflect the images of the past. We believe that when mass marketing of prescription drugs seeks to influence a patient's choice of a drug, a pharmaceutical manufacturer that makes direct claims to consumers for the efficacy of its product should not be unqualifiedly relieved of a duty to provide proper warnings of the dangers or side effects of the product.


The Norplant System (Norplant)

This appeal concerns Norplant, a Food and Drug Administration (FDA)-approved, reversible contraceptive that prevents pregnancy for up to five years. The Norplant contraceptive employs six thin, flexible, closed capsules that contain a synthetic hormone, levonorgestrel. *fn1 The capsules are implanted under the skin of a woman's upper arm during an in-office surgical procedure characterized by the manufacturer as minor. A low, continuous dosage of the hormone diffuses through the capsule walls and into the bloodstream. Although the capsules are not usually visible under the skin, the outline of the fan-like pattern can be felt under the skin. Removal occurs during an in-office procedure, similar to the insertion process.

We have no doubt of the profound public interest in developing new products for reproductive services. We intend no disparagement of the product when we recite plaintiffs' claims concerning the efficacy of Norplant. The procedural posture that brings this case before us requires that we accept as true plaintiffs' version of the facts. The motion to dismiss was in the nature of a motion for judgment on the pleadings.

According to plaintiffs, Wyeth began a massive advertising campaign for Norplant in 1991, which it directed at women rather than at their doctors. Wyeth advertised on television and in women's magazines such as Glamour, Mademoiselle and Cosmopolitan. According to plaintiffs, none of the advertisements warned of any inherent danger posed by Norplant; rather, all praised its simplicity and convenience. None warned of side effects including pain and permanent scarring attendant to removal of the implants. Wyeth also sent a letter to physicians advising them that it was about to launch a national advertising program in magazines that the physicians' patients may read.

Plaintiffs cite several studies published in medical journals that have found Norplant removal to be difficult and painful. One study found that thirty-three percent of women had removal difficulty and forty percent experienced pain. Another study found that fifty-two percent of physicians reported complications during removal. Medical journals have catalogued the need for advanced medical technicians in addition to general surgeons for Norplant removal. Plaintiffs assert that none of this information was provided to consumers.

In 1995, plaintiffs began to file lawsuits in several New Jersey counties claiming injuries that resulted from their use of Norplant. Plaintiffs' principal claim alleged that Wyeth, distributors of Norplant in the United States, failed to warn adequately about side effects associated with the contraceptive. Side effects complained of by plaintiffs included weight gain, headaches, dizziness, nausea, diarrhea, acne, vomiting, fatigue, facial hair growth, numbness in the arms and legs, irregular menstruation, hair loss, leg cramps, anxiety and nervousness, vision problems, anemia, mood swings and depression, high blood pressure, and removal complications that resulted in scarring. Class action certification was denied. All New Jersey Norplant cases were consolidated in Middlesex County. Eventually, twenty-five New Jersey Norplant cases involving approximately fifty Norplant users were pending in the Superior Court in Middlesex County.

After a case management conference, plaintiffs' counsel sought a determination of whether the learned intermediary doctrine applied. Pursuant to that conference, five bellwether plaintiffs *fn2 were selected to challenge defendant's motion for summary judgment concerning the learned intermediary doctrine. See Perez v. Wyeth Labs., Inc., 313 N.J. Super. 646, 650 (Law Div. 1997). The trial court dismissed plaintiffs' complaints, concluding that even when a manufacturer advertises directly to the public, and a woman is influenced by the advertising campaign, "a physician is not simply relegated to the role of prescribing the drug according to the woman's wishes." Id. at 658.

Consequently, the court held that the learned intermediary doctrine applied. Ibid. According to the court, the physician retains the duty to weigh the benefits and risks associated with a drug before deciding whether the drug is appropriate for the patient. Ibid. Because N.J.S.A. 2A:58C-4 of the Products Liability Act, N.J.S.A. 2A:58C-1 to - 11, measures warning adequacy based on the knowledge and characteristics of the health-care provider, the court was not "concerned with the effect that a warning had on the . . . consumer-plaintiff." Id. at 659. The court found, however, that plaintiffs failed to provide expert testimony to rebut the statutory presumption under N.J.S.A. 2A:58C-4, that the manufacturer's warning is adequate when it has been approved by the FDA, as is the case here. The court found that plaintiffs failed to rebut the presumption by demonstrating that the manufacturer's warnings to the physicians were inadequate or that a warning as to the difficulty of removal would have altered the health-care providers' decisions to implant Norplant. Id. at 659-60. Although the trial court listed pain and scarring associated with removal among plaintiffs' complaints, id. at 650-52, when addressing proximate cause the court subsequently stated that "none of the bellwether plaintiffs complained of difficult removals or that they have significant scarring." Id. at 660 n.5.

Consequently, the court concluded that plaintiffs had failed to prove failure to warn and proximate cause, and dismissed plaintiffs' complaints. Id. at 660.

Plaintiffs appealed. Plaintiffs challenged the court's failure to hear expert testimony on the adequacy of the warnings and the decision concerning proximate cause because "it was specifically agreed that the production of expert testimony would await the outcome of the decision on the issue of the learned intermediary doctrine." The Appellate Division affirmed the trial court's grant of summary judgment in favor of defendants and its determination that the learned intermediary doctrine applied. 313 N.J. Super. 511 (1998). The court supplemented the trial court's opinion, comparing Section 6d of the Restatement (Third) of Torts: Products Liability (1997) (Restatement) to N.J.S.A. 2A:58C-4, the similar provision of New Jersey's Products Liability Act. Section 6(d) of the Restatement provides:

"(d) A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:

(1) prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or

(2) the patient 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.

As noted by the Appellate Division, the new Restatement is similar to N.J.S.A. 2A:58C-4, which defines an adequate warning as one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, . . . in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician."

The court noted that Section 6(d)(2) of the Restatement may require a warning when the physician or health-care provider has a "diminished role as an evaluator or decision maker," in which case the manufacturer would have a duty to warn patients directly. 313 N.J. Super. at 515 (citing Restatement (Third), § 6d comment b). *fn3 Consequently, the court agreed with the trial court that if the warning was "legislatively deemed adequate and has been given to the proper party," no warning defect under N.J.S.A. 2A:58C-4 had been established. Ibid.

We granted plaintiffs' petition for certification. 156 N.J. 410 (1998).


In Feldman v. Lederle Laboratories, Inc., 97 N.J. 429, (1984) (Feldman I), we considered the relationship between principles of products liability law and pharmaceutical products. In Feldman I, we declined to "hold as a matter of law and policy that all prescription drugs that are unsafe are unavoidably so." Id. at 447. We explained:

"Drugs, like any other products, may contain defects that could have been avoided by better manufacturing or design. Whether a drug is unavoidably unsafe should be decided on a case-by-case basis; we perceive no justification for giving all prescription drug manufacturers a blanket immunity from strict liability manufacturing and design defect claims under [Restatement (Second) Torts § 402A] comment k [(1965)].

Moreover, even if a prescription drug were unavoidably unsafe, the comment k immunity would not eliminate strict liability for failure to provide a proper warning. As Justice Pollock stated in O'Brien [v. Muskin Corp., 94 N.J. 169, 183 (1983)], "[w]ith those products, the determination of liability may be achieved more appropriately through an evaluation of the adequacy of the warnings." [] Thus, a manufacturer who knows or should know of the danger or side effects of a product is not relieved of its duty to warn. Rather, as the comment expressly states, it is only the unavoidably unsafe product "accompanied by proper * * * warning" that is not defective. (Emphasis added.)" [Ibid. (citations omitted).]

As explained in Niemiera by Niemiera v. Schneider, 114 N.J. 550, 559 (1989):

"In New Jersey, as elsewhere, we accept the proposition that a pharmaceutical manufacturer generally discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug's dangerous propensities. See, e.g., Bacardi v. Holzman, 182 N.J. Super. 422, 442 A.2d 617 (App. Div. 1981). This concept is known as the "learned intermediary" rule because the physician acts as the intermediary between the manufacturer and the consumer. The phrase appears to have been coined in the case of Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966)."

We observed that there were circumstances, such as in Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968), in which the manufacturer should not be relieved of a duty to warn. Niemiera, supra, 114 N.J. at 559. In Davis, the manufacturer of a polio vaccine was held to have an independent duty to warn the consumer because in mass immunization clinics such as where the plaintiff received a polio vaccine, there was "no physician present to weigh the risks and benefits of the drug therapy for each patient." Ibid. (quoting Reyes v. Wyeth Labs., Inc., 498 F.2d 1264 (5th Cir.), cert. denied, 419 U.S. 1096, 95 S. Ct. 687, 42 L. Ed. 2d 688 (1974); see also Stephens v. G.D. Searle & Co., 602 F. Supp. 379 (E.D. Mich. 1985) (manufacturer of oral contraceptive has duty to warn consumers directly of risks and side effects); Samuels v. American Cyanamid Co., 495 N.Y.S.2d 1006 (N.Y. Sup. Ct. 1985) (pharmaceutical company had duty to warn recipient of "travel" vaccines when company knew vaccines were ordinarily given without meaningful balancing of risks and benefits by informed intermediary).

We were satisfied in Niemiera, supra, that sufficient reasons existed with respect to the DPT vaccine (for diphtheria, pertussis and tetanus) to conclude that the "`learned intermediary' doctrine should apply." Id. at 560. The question in this appeal is whether sufficient reasons exist to warrant its application under these facts. Norplant appears to be a hybrid prescription medical device exhibiting characteristics both of a medical device implanted in the body and of a drug. For convenience, most of our Discussion will use the terminology relevant to prescription drugs, the context in which most such claims may arise.


Direct-to-Consumer Advertising

It is paradoxical that so pedestrian a concern as male- pattern baldness should have signaled the beginning of direct-to-consumer marketing of prescription drugs. Upjohn Company became the first drug manufacturer to advertise directly to consumers when it advertised for Rogaine, a hair-loss treatment. Jon D. Hanson & Douglas A. Kysar, Taking Behavioralism Seriously: Some Evidence of Market Manipulation, 112 Harv. L. Rev. 1420, 1456 (1999). The ad targeted male consumers by posing the question, "Can an emerging bald spot . . . damage your ability to get along with others, influence your chance of obtaining a job or date or even interfere with your job performance?" Ibid. (footnotes omitted). A related ad featured an attractive woman asserting suggestively, "I know that a man who can afford Rogaine is a man who can afford me." Ibid. (footnote omitted).

Advertising for Rogaine was the tip of the iceberg. Since drug manufacturers began marketing directly to consumers for products such as prescription drugs in the 1980s, "almost all pharmaceutical companies have engaged in this direct marketing practice." Ibid. (footnote omitted). Consider the following example:

"A hot-air balloon floats lazily across the backdrop of a beautiful, cloudless, sunny sky. Cole Porter sings in the background, "Blue skies smiling at me[.] Nothing but blue skies do I see." A kind voice instructs the viewer to "see your doctor about Claritin (R)" because a "clear answer is out there." This advertisement for Claritin (R), a nondrowsy prescription antihistamine, aired prior to the . . . (FDA's) release of new direct-to-consumer (DTC) broadcast advertising guidelines in August 1997. The viewer often was bewildered because the "clear answer" about what Claritin (R) treated was not in the otherwise well-produced thirty-second television advertisement." [Kelly N. Reeves, Direct-to-Consumer Broadcast Advertising: Empowering the Consumer or Manipulating a Vulnerable Population?, 53 Food & Drug L.J. 661, 661 (1998) (footnotes omitted).]

These campaigns "bring to `bear all the slick pressure of which Madison Avenue is capable'." Hanson & Kysar, supra, 112 Harv. L. Rev. at 1456 (footnote omitted).

Pressure on consumers is an integral part of drug manufacturers' marketing strategy. From 1995 to 1996, drug companies increased advertising directed to consumers by ninety percent. Bob Van Voris, Drug Ads Could Spell Legal Trouble[.] Consumer Campaigns May Result in Greater Liability, Nat'l L.J., July 21, 1997, at B1. In 1997, advertising costs of pharmaceutical products surpassed the half-billion dollar mark for the first time, "easily outpacing promotional efforts directed to physicians." Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 Ga. L. Rev. 141, 141 (1997) (footnote omitted). "John F. Kamp, senior vice president of the American Association of Advertising Agencies, said that prescription drug companies spent $1.3 billion on print and broadcast advertising aimed at consumers last year, up from $843 million in 1997 . . . ." Robert Pear, Drug Companies Getting F.D.A. Reprimands for False or Misleading Advertising, N.Y. Times, Mar. 28, 1999, at 28. These efforts are not just an essential part of manufacturers' marketing plans; they are an extremely successful one. As of December 1998, "because of its testimonials" in print and broadcast media by renowned personalities, sales of a product that treats male impotence had increased to $788 million, with approximately 7.5 million prescriptions having been written. Jay P. Speivack, Direct Ads May Create Liability Dangers. Consumer Advertising by Drug Manufacturers Has Reopened the Issue of Expanded Liability., Nat'l L.J., Mar. 15, 1999, at B7 n.1.

Without vouching for every decimal point in the Discussion, the following is a summary of changes in pharmaceutical marketing.

"[Significant technological] advances in [medical] treatment have been accompanied by significant increases in the cost of health care. It is estimated that in 1996, Americans spent more than $1 trillion on health care products and services. Health care is the single largest business in the United States, representing 14% of the gross domestic product. Health care expenses comprise the largest single area of non-government spending.

Corresponding with the financial burdens attendant to our modern health care system, a fundamental change has taken place in the way Americans pay for their health care [from individually-funded to third-party-funded health care] . . . . These fundamental changes have drastically altered the delivery of health care services.

As [pharmaceutical] manufacturers attempt to appropriately position their products in the chain of delivery, new techniques are often employed to supplement traditional marketing efforts which have historically consisted of direct physician education, information provided in medical references, educational seminars, and research grants. . . .

Among the most controversial of the new marketing techniques employed by pharmaceutical manufacturers is direct-to-consumer prescription advertising in a variety of formats and media. Pharmaceutical remedies for varied problems such as allergies, nail fungus, hypertension, hair loss, and depression are placed directly before the consumer in magazines, television, and via the Internet. The utilization of direct consumer marketing raises questions and issues addressing manufacturer liability for failure to adequately warn of risks possibly associated with pharmaceutical use. . . . .

The American Medical Association (AMA) has long maintained a policy in opposition to product- specific prescription ads aimed at consumers. A 1992 study by the Annals of Internal Medicine reports that a peer review of 109 prescription ads found 92 per cent of the advertisements lacking in some manner. [Michael C. Allen, Medicine Goes Madison Avenue: An Evaluation of the Effect of Direct-to-Consumer Pharmaceutical ...

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