On appeal from Superior Court of New Jersey, Law Division, Essex County, No. L-547-03.
The opinion of the court was delivered by: Wefing, P.J.A.D.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Before Judges Wefing, Wecker and Graves.
Plaintiffs Debbie and Kevin Banner appeal from trial court orders granting the motion of defendants Hoffmann-La Roche Inc. and Roche Laboratories Inc. ("Roche") to dismiss plaintiffs' complaint for failure to state a claim, R. 4:6-2(e), and subsequently denying their motion for reconsideration. After reviewing the record in light of the contentions advanced on appeal, we affirm.
The Banners reside in the State of Virginia and were residents of that state at all times relevant to this litigation, which they filed in New Jersey in January 2003. The Banners have never resided in New Jersey. In this action, they seek damages, both individually and as the natural guardians of their child Devin, who was born with severe physical and cognitive deficits on October 4, 1996. The Banners attribute these deficits to the drug Accutane, which is manufactured and distributed by Roche, whose principal place of business is in New Jersey.
Accutane is a prescription medication developed by Roche and approved by the Food and Drug Administration; it is intended for the treatment of severe disfiguring nodular acne that has been recalcitrant to standard therapies. Accutane is known to be a teratogen, that is, there is an extremely high risk that if the drug is taken by a woman while she is pregnant, her child will be born with severe abnormalities.
In November 1995 Debbie Banner met with her physician and discussed whether Accutane would be an appropriate medication for her. The record does not disclose whether Ms. Banner suffered from severe disfiguring nodular acne or some lesser form of acne. In any event, Ms. Banner's doctor wrote her a prescription for Accutane.
Because of the risks involved if a woman of child-bearing age were to take Accutane, Roche had developed a Pregnancy Prevention Program for physicians to use while discussing with their patients whether Accutane would be an appropriate therapy. Part of this Pregnancy Prevention Program involved having the patient complete a document titled in large, bold type "Patient Information/Consent and Survey Enrollment Form." Roche's protocol called for a physician to review this consent form with the patient and have the patient complete it prior to writing a prescription for Accutane. Ms. Banner's physician utilized this form in connection with reviewing with her the risks attendant to the use of Accutane.
On the top right-hand corner of this form is the silhouette of a pregnant woman, upon which is superimposed a circle, with an angular line descending to the right, the universal pictograph to depict a warning, together with the words, "Pregnancy Prevention Program for Women on Accutane." These words are in bold type and all capital letters. Beneath that, in large italic type, is written "Accutane must not be used by females who are pregnant or who may become pregnant while undergoing treatment."
We set forth the pertinent provisions of this consent form in detail.
My treatment with Accutane has been personally explained to me by Dr. _____. The following points of information, among others, have been specifically discussed and made clear:
1. I, ______, understand that Accutane is a very powerful medicine used to treat severe nodular acne that did not get better with other treatments, including oral antibiotics.
2. I understand that I must not take Accutane if I am or may become pregnant during treatment.
3. I understand that severe birth defects have occurred in babies of women who took Accutane during pregnancy. I have been warned by my doctor that there is an extremely high risk of severe damage to my unborn baby if I am or become pregnant while taking Accutane.
4. I have been told by my doctor that effective birth control (contraception) must be used for at least 1 month before starting Accutane, all during Accutane therapy and for at least 1 month after Accutane treatment has stopped. My doctor has recommended that I either abstain from sexual intercourse or use two reliable kinds of birth control at the same time. I have also been told that any method of birth control can fail. I must use two forms of reliable birth control simultaneously even if I think I cannot become pregnant, unless I abstain from sexual intercourse or have had a hysterectomy.
5. I know that I must have a blood or urine test done by my doctor that shows I am not pregnant within 1 week before starting Accutane, and I understand that I must wait until the second or third day of my next normal menstrual period before starting Accutane.
6. My doctor has told me that I can participate in the "Patient Referral" program for an initial free pregnancy test and birth control counseling session by a consulting physician.
7. I also know that I must immediately stop taking Accutane if I become pregnant while taking the drug and immediately contact my doctor to discuss the desirability of continuing the pregnancy. I also know that I must immediately contact my doctor if I become pregnant during the month after stopping Accutane.
8. I have carefully read the Accutane patient brochure, "Important Information Concerning Your Treatment With Accutane (isotretinoin)," given to me by my doctor. I understand all of its contents and have talked over any questions I have with my doctor.
9. I am not now pregnant, nor do I plan to become pregnant for at least 30 days after I have ...