Perez v. Wyeth Laboratories Inc.

• Decision Date: 09 August 1999
• Citation: 161 N.J. 1,320 NJ Super. 34,734 A.2d 1245
• Parties: Saray PEREZ, Cheryl Bailey, Kimberly Bartlett, Anna Cesareo and Soraya Arias, Plaintiffs-Appellants, v. WYETH LABORATORIES INC., a subsidiary of American Home Products Corporation; American Home Products Corporation; Wyeth-Ayerst Laboratories Division of American Home Products Corporation; Wyeth-Ayerst International Inc.; Wyeth-Ayerst Laboratories Company and Dow Corning France, S.A., Defendants-Respondents.
• Court: New Jersey Supreme Court

734 A.2d 1245

161 N.J. 1

320 NJ Super. 34

Saray PEREZ, Cheryl Bailey, Kimberly Bartlett, Anna Cesareo and Soraya Arias, Plaintiffs-Appellants, v. WYETH LABORATORIES INC., a subsidiary of American Home Products Corporation; American Home Products Corporation; Wyeth-Ayerst Laboratories Division of American Home Products Corporation; Wyeth-Ayerst International Inc.; Wyeth-Ayerst Laboratories Company and Dow Corning France, S.A., Defendants-Respondents.

Supreme Court of New Jersey.

Argued March 2, 1999.

Decided August 9, 1999.

Richard Galex, East Brunswick, for plaintiffs-appellants (Galex, Tortoreti & Tomes, attorneys).

John W. Vardaman, a member of the District of Columbia bar, Washington, DC, for defendants-respondents (Porzio, Bromberg & Newman, attorneys; Anita R. Hotchkiss, Lauren E. Handler, Connie A. Matteo and Linda Pissott Reig, Morristown, on the brief).

John F. Brenner, Newark, submitted a brief on behalf of amicus curiae, Pharmaceutical Research and Manufacturers of America (McCarter & English, attorneys; Mr. Brenner and Jerry P. Sattin, on the brief).

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, 191 Conn. 282, 465 A.2d 294, 299 (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.

I

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.¹ 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 plaintiffs² 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, 713 A.2d 588 (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, 713 A.2d 588. 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, 713 A.2d 588. 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, 713 A.2d 588. Although the trial court listed pain and scarring associated with removal among plaintiffs' complaints, id. at 650-52, 713 A.2d 588, 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, 713 A.2d 588. Consequently, the court concluded that plaintiffs had failed to prove failure to warn and proximate cause, and dismissed plaintiffs' complaints. Id. at 660, 713 A.2d 588.

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, 713 A.2d 520 (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....