Myers v. Hoffman-la Roche Inc.

• Decision Date: 05 October 2008
• Docket Number: 1 CA-CV 06-0137
• Parties: KRISTEN-MARIE LYNETTE MYERS, by and through her Guardian Ad Litem, HEIDI MYERS, Plaintiff/Appellant, v. HOFFMAN-LA ROCHE, INC.; ROCHE LABORATORIES, INC.; MARY F. FREDENBURG, M.D., Defendants/Appellees
• Court: Arizona Court of Appeals

KRISTEN-MARIE LYNETTE MYERS, by and through her Guardian Ad Litem, HEIDI MYERS, Plaintiff/Appellant, v. HOFFMAN-LA ROCHE, INC.;

ROCHE LABORATORIES, INC.;

MARY F. FREDENBURG, M.D.,

Defendants/Appellees

1 CA-CV 06-0137

COURT OF APPEALS STATE OF ARIZONA DIVISION ONE DEPARTMENT A

Dated: Oct. 5, 2008

OPINION

(Amended by Order filed 10-5-08)

Appeal from the Superior Court in Maricopa County

Cause No. CV 2005-006573

The Honorable Paul J. McMurdie, Judge

REVERSED AND REMANDED

Bellah & Harrian PLLC

By Richard Bellah

Sheila E. Harmer

Glendale

McNulty Law Firm

By Peter J. McNulty

Attorneys for Plaintiff/Appellant

Los Angeles

Peabody & Arnold LLP

By Colleen M. Hennessey

Elizabeth A. Houlding

Pro Hac Vice

Boston

Lewis and Roca LLP

By Susan M. Freeman

Stephen M. Bressler

Phoenix

Attorneys for Defendants/Appellees

Hoffman-La Roche, Inc. and Roche Laboratories

Jennings Strouss & Salmon PLC

By Jay Fradkin

John J. Egbert

Attorneys for Defendant/Appellee Fredenberg

Phoenix

JOHNSEN, Judge

¶1 Through her mother, Kristen-Marie Lynette Myers sued Hoffman-La Roche, Inc. and Roche Laboratories, Inc. (together "Roche") and Mary F. Fredenberg, M.D., seeking damages for personal injuries she sustained after her mother took Accutane, a drug manufactured by Roche, while she was pregnant with Kristen-Marie. The complaint alleged claims of negligence, strict products liability and breach of express and implied warranty against Roche and a claim of medical negligence against Fredenberg, who prescribed Accutane to Kristen-Marie's mother. Each defendant moved to dismiss, asserting that Kristen-Marie's complaint constituted a claim for "wrongful life," for which Arizona permits no relief. See Walker v. Mart, 164 Ariz. 37, 790 P.2d 735 (1990). Roche also asserted that its warnings about the dangers of Accutane were adequate as a matter of law pursuant to the "learned intermediary" doctrine. After the superior court granted defendants' motions to dismiss, Kristen-Marie brought this appeal.

¶2 We hold the claims Kristen-Marie alleges are not barred by the "wrongful life" doctrine because she sues not for a "wrongful life" but rather for the damages she sustained in utero, allegedly as a result of defendants' tortious acts. We also hold that her allegations were sufficient to state claims against Roche, notwithstanding the "learned intermediary" doctrine. Accordingly, we reverse the superior court's entry of judgment in favor of defendants and remand for further proceedings.

I. THE ALLEGATIONS OF THE COMPLAINT

A. Allegations About Accutane and Roche's Purported Failure to Properly Instruct Prescribing Physicians.

¶3 Kristen-Marie filed her complaint on April 19, 2005, and an amended complaint on August 16, 2005. According to the amended complaint, Roche manufactured Accutane for treatment of severe cystic acne.¹ The amended complaint alleged that the drug is a teratogen in that it can cause catastrophic physical and cognitive birth defects and abnormalities in children who are exposed to it during gestation. Fetal exposure to Accutane has been linked to significantly decreased cognitive abilities, premature births and stillbirths. Ingestion of Accutane during gestation is known also to cause abnormalities in the fetus's central nervous system, cardiovascular system and in the skull, external ear and eye.

¶4 According to the amended complaint, as it brought Accutane to market in the United States in the early 1980s, Roche was aware the drug was associated with birth defects in children whose mothers took Accutane during pregnancy. According to the amended complaint, Roche at the time advocated abortion in all Accutane-affected pregnancies. As Kristen-Marie further alleged, Roche "chose to emphasize abortion over a comprehensive and adequate pregnancy prevention program because Roche feared that such asuch a program would substantially reduce sales" of the drug. Ultimately, according to the amended complaint, the United States Food and Drug Administration ("FDA") disproved the notion that each exposure of Accutane to a pregnant woman would result in birth defects. According to the amended complaint, the "current judgment" is that 25 percent of women who take Accutane while pregnant bear children impaired by catastrophic birth defects.

¶5 In 1988, in the face of recommendations from senior FDA officials that Accutane be removed from the market, Roche implemented a "Pregnancy Prevention Program," by which, according to the amended complaint, it purported to give "family planning and contraceptive counseling to female Accutane users of child-bearing potential." Roche's Pregnancy Prevention Program included instructions to the prescribing physician and the patient that were printed in a Patient Information/Consent and Enrollment Form ("Patient Information Form"), package inserts, other labeling, and scripts to be read by treating physicians to patients.

¶6 According to the amended complaint, Roche's Pregnancy Prevention Program "failed in its essential purpose." Roche gathered "substantial evidence of incomplete use and understanding of the program, causing Roche to conclude that the program contained serious weaknesses." According to a study conducted in the 1990s, "unacceptably high percentages of physicians and patients were not complying with core components of the pregnancy-prevention program." By 2000, according to the amended complaint, Roche was aware ofRoche was aware of 1,995 cases of Accutane-exposed pregnancies, of which 70 percent occurred after Roche implemented its Pregnancy Prevention Program. The amended complaint alleged that in hearings before an FDA committee in September 2000, Roche admitted that its Pregnancy Prevention Program was flawed because "patients were often not able to comprehend its instructions and follow the core concepts" of the program.

¶7 According to the amended complaint, Accutane also has been linked to "depression, psychosis and other psychiatric and psychological disturbances" in women who take the drug. Depression affects one's "capacity to consider, appreciate and follow instructions and warnings in general." According to the amended complaint, depression "also affects a person's attitudes relating to complicated social issues like sex" and Roche knew throughout the 1990s "that depression caused by Accutane had a substantial likelihood to undermine a patient's ability to comprehend its pregnancy-prevention instructions." The amended complaint alleged that "Roche was negligent in failing to warn, instruct and educate dermatologists regarding depression and its effects on patients' ability to comply with pregnancy prevention procedures."

¶8 Because of the substantial risk of birth defects linked to Accutane, Roche required dermatologists to question and counsel patients with respect to any potential pregnancy. For example, according to a FDA briefing document (as quoted in the amended complaint), Roche directed that prescribing physicians must:

1. question the patient thoroughly relative to sexual activity and contraceptive use[.]

2. carefully assess the patient's responses.

3. effectively guide, counsel and motivate them in sound contraceptive practice and continue to monitor and reinforce this throughout treatment.

4. assure that patients are not pregnant before they start their Accutane treatment.

¶9 The amended complaint alleged that Roche had a duty not only to warn of the danger of birth defects posed by Accutane "but also to provide adequate instructions and information essential to make the use of Accutane as safe as possible." The amended complaint continued, "In this case, safe use requires adequate, safe and competent instructions and advice concerning regular pregnancy testing to ensure that a child, once conceived, is not regularly exposed to Accutane over a number of days in an amount sufficient to cause severe and debilitating birth defects." The amended complaint alleged that Roche's instructional program was "defective and inadequate [and] fails to prevent fetal exposure to Accutane and resulting birth defects." "It is specifically contrary to reasonably prudent practice and to the standard of care," the amended complaint alleged, "not to have an instructional regime in place that ensures that female Accutane patients do not expose unborn children to this dangerous drug."

¶10 It was not until 2001 and 2002, the amended complaint alleged, that Roche implemented a "Targeted Pregnancy Prevention Program," which "emphasized contraceptive counseling by increasingpregnancy prevention education for likely treating physicians, including dermatologists." The same program also included "additional efforts to educate patients regarding compliance strategies and the consequences of failure."

¶11 The amended complaint asserted that due to the severe risks posed by Accutane and the flaws in its Pregnancy Prevention Program, Roche should have instituted a "national registry" that would have permitted "only those treating physicians and pharmacists who have completed extensive instruction and training programs in pregnancy prevention to prescribe and distribute the drug." According to the amended complaint, under the registry program that Roche eventually did put in place, a pharmacy may not fill a prescription for a woman unless she presents a record of a negative pregnancy test within the previous seven days. If the registry system had been in place in 1996, the amended complaint alleged, the pharmacy could not have given Accutane to Kristen-Marie's mother.

B. The Accutane Prescriptions Given to Kristen-Marie's Mother, and Kristen-Marie's Condition Upon Her Birth.

¶12 According to the amended complaint, Fredenberg prescribed Accutane for Kristen-Marie's mother beginning in late May 1996. Her mother underwent pregnancy tests, each of which was negative, on May 31, July 2 and August 7. No pregnancy test was performed in September. On September 3, Fredenberg prescribed four more weeks ofmore weeks of Accutane,...