Perez v. Wyeth Laboratories, Inc.
| Decision Date | 05 December 1997 |
| Citation | 713 A.2d 588,313 N.J.Super. 646 |
| Parties | Saray PEREZ, Cheryl Bailey, Kimberly Bartlett, Anna Cesareo and Soraya Arias, Plaintiffs, 1 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. |
| Court | New Jersey Superior Court |
Frances Tomes, East Brunswick, for plaintiffs (Richard Galex, on brief) (Galex, Tortoreti & Tomes).
Anita Hotchkiss, Morristown, for defendants (Anita Hotchkiss, Linda Pissott Reig, and Toby A. Holbreich, on brief) (Porzio, Bromberg & Newman).
The Norplant System is a long-term, reversible birth control method which consists of six capsules. Each capsule contains the synthetic hormone levonorgestrel and is implanted below the skin of the patient's arm. The system provides contraception for up to five years but may be removed to permit a women to become fertile.
Norplant was designed and developed by The Population Council. The Population Council is a nonprofit organization committed to the advancement of reproductive health. In 1966, The Population Council began development of Norplant and over the next two decades tested the system on more than 55,000 women in forty-four countries. The Population Council granted Wyeth Laboratories Inc. the exclusive right to market Norplant in this country and, in December 1990, the FDA approved The Population Council's and Wyeth's New Drug Applications. Subsequently, in 1991, Wyeth began distributing Norplant with the labeling approved by the FDA.
Beginning in June 1995, plaintiffs began to file complaints in the various counties of this state alleging personal injuries from their use of the Norplant System. There are currently twenty-six Norplant cases consolidated in Middlesex County, which involve fifty Norplant recipients. Prior to the consolidation of these cases, defendants had filed motions to compel the production of plaintiffs' expert reports. After consolidation, however, several different judges in Middlesex County ordered that thirteen of the plaintiffs produce the reports between twenty and sixty days.
Subsequently, this court assumed responsibility for the management of the Norplant litigation and, on March 7, 1997, held a case management conference to address the service of plaintiff's expert reports, among other things. The court vacated the prior orders and proposed that expert reports be filed within thirty days. In response to Judge Richard Schell's ruling in In re Norplant Contraceptive Prods. Liab. Litig., 955 F.Supp. 700 (E.D.Tex.1997), however, plaintiffs' counsel opposed the production of the reports and suggested that the court determine the applicability of the learned intermediary doctrine to these matters. Five plaintiffs were chosen to be bellwether plaintiffs and to challenge defendants' motions for summary judgment concerning the issue of the learned intermediary doctrine. Although these plaintiffs allege varying problems associated with their use of Norplant, all of them complain that Wyeth did not warn of the pain and scarring that resulted from the capsules' removal. A description of the five bellwether plaintiffs and their healthcare providers follows.
Ms. Arias had Norplant inserted on March 12, 1993 and removed more than two years later. She complains that Norplant has caused her to suffer from weight gain, headaches, nausea, vomiting, fatigue, irregular menstruation, hair loss, leg cramps, anxiety and nervousness, vision problems, anemia, mood swings and depression, high blood pressure and nightmares. Additionally, she alleges that she experienced a difficult and painful removal of Norplant which resulted in scarring.
Ms. Arias' Norplant was prescribed and inserted by Dr. Ashgar Chuback. Dr. Chuback is a Board Certified Obstetrician and Gynecologist. Prior to prescribing Norplant, the doctor was aware of the risks and side effects of Norplant.
Ms. Bartlett had Norplant inserted on January 13, 1994. Norplant, however, was removed from her arm eleven months afterwards so she could become pregnant. Although Ms. Bartlett never reported any complaints to any healthcare providers while using Norplant, she alleges that she suffers from mood swings, nervousness, fatigue, hair loss, blurred vision, rash, weight gain bloating, and irregular menstruation. Ms. Bartlett also contends that the removal was painful and resulted in scarring.
Ms. Bartlett's Norplant was prescribed and inserted by Dr. Chandravdan Shah. Dr. Shah is a Board Certified Obstetrician and Gynecologist. In his deposition, he stated that he believed that Norplant is "safe and effective" and that Wyeth's labeling "fairly and accurately describe[s] the risks and benefits associated with Norplant." The doctor's opinion is based upon his training, experience, and review of medical journal articles. Even though he is aware of the possible side effects of Norplant, Dr. Shah still believes that Norplant is an effective and safe form of contraception.
Ms. Bailey had Norplant inserted on August 6, 1992 and removed nearly five years later for non-medical reasons. In her deposition, Ms. Bailey stated that Norplant has caused her to suffer from irregular menstruation, weight gain, facial hair growth, numbness in leg and arm, fatigue, headaches, and dizziness. She also complains that the removal of Norplant resulted in pain and scarring.
Ms. Bailey's Norplant was prescribed and inserted by Dr. Gregory Carlson. Dr. Carlson is Board Certified in family medicine. The doctor believes that Norplant is as "safe as other forms of birth control." Dr. Carlson's opinion is based upon his experience, training, discussions with colleagues, and reference articles in medical periodicals. Prior to prescribing Norplant to Ms. Bailey, Dr. Carlson was aware of many of Norplant's potential side effects. Despite this knowledge, he finds Norplant to be a safe and effective contraceptive choice and would prescribe Norplant for Ms. Bailey again.
Ms. Cesareo had Norplant inserted on May 20, 1993 and removed on September 20, 1995. She alleges that Norplant has caused headaches, hair loss, irregular menstruation, visual disturbances nausea, vomiting, stomach cramps, depression, mood swings, emotional upset, breast tenderness, chest pain, muscle pains, fatigue and lighheadedness. She also complains of odor, diarrhea excessive urination and pain and scarring from the removal of Norplant.
Ms. Cesareo's Norplant was prescribed and inserted by Dr. Francine Sinofsky. Dr. Sinofsky is certified in Obstetrics and Gynecology by the American Board of Obstetrics and Gynecology. After joining Rutgers Medical School in 1985, she was a co-investigator for a clinical trial of Norplant. The doctor has also written several articles on different contraceptive devices, including Norplant. Before recommending Norplant to Ms. Cesareo, Dr. Sinofsky was aware of the risks and side effects of Norplant. Despite the risks, she believes that Norplant is a safe and effective form of birth control and that the labeling for Norplant is sufficient.
Ms. Perez had Norplant inserted on August 18, 1994 and removed two years later on April 23, 1996. She believes that Norplant has caused irregular menstrual bleeding, weight gain, hair loss, hair growth on chin, headaches, acne, idiopathic intracranial hypertension, depression, and arm pain. She also alleges that she experienced a difficult, painful removal process which included scarring.
Ms. Perez's Norplant was prescribed and inserted by Nurse Diane Brevet. Nurse Brevet is certified in women's health by the National Association of Obstetricians and Gynecologists. She is authorized by law to prescribe and insert Norplant. Nurse Brevet believed that Wyeth "fairly and accurately described the risks and benefits" of Norplant. Understanding these risks, she believed that Norplant was still the appropriate choice of contraception for Ms. Perez.
This court recognizes the unique effect that this opinion will have on future Norplant litigation. Norplant may be properly described as a mass tort. Mass torts may be distinguished from other personal injury claims by several distinguishing features. First, mass torts involve large number of claims that are associated with a single product. Second, despite the number of claimants, there is a commonality of factual and legal issues. Third, there is a value interdependence between the different claims. Unlike other torts, causation and liability in mass torts are often dependent upon the success or failure of prior lawsuits. Fourth, mass torts frequently involve both temporal and geographic dispersion. Although mass torts may require state law to be altered or refined in the future, this court believes that the learned intermediary doctrine may be applied in this matter without modification.
Under Brill v. Guardian Life Ins. Co. of America, 142 N.J. 520, 666 A.2d 146 (1995), an issue of material fact exists if the competent evidence presented by the non-moving party is sufficient to permit a rational fact-finder to resolve the alleged dispute in favor of that party. Id. at 533, 666 A.2d 146. In a summary judgment motion, a court "must grant all the favorable inferences to the non-movant." Id. at 536, 666 A.2d 146. This court must inquire whether the evidence presents a sufficient disagreement to require submission to the fact-finder or whether it is so one-sided that defendant must prevail as a matter of law. Id.
In a strict liability action for a defective product, a plaintiff must show not only that a product was defective when it left the manufacturer's control but also that the defect proximately...
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