Filed 5/30/03 by Clerk of Supreme Court
SUPREME COURT OF NORTH DAKOTA
| Amy Jo Kjolsrud f/k/a | ||||||||
| Amy Jo Mattson | Supreme Court No. 20030023 | |||||||
| Cass Co. No. 99-C-03734 | ||||||||
| Plaintiff-Appellant/Cross-Appellee, | ||||||||
| v. | ||||||||
| Appeal from Final Judgment Entered | ||||||||
| MKB Management Corporation | by Cass County District Court | |||||||
| d/b/a Red River Women's Clinic, | ||||||||
| Defendant-Appellee/Cross-Appellant. | ||||||||
REPLY BRIEF FOR PLAINTIFF-APPELLANT/CROSS-APPELLEE
| John Kindley (Non-Resident) | Gregory L. Lange #03491 | |||||
| P.O. Box 1406 | P.O. Box 488 | |||||
| Mishawaka, IN 46546 | Hazen, ND 58545 | |||||
| (574) 514-5528 | (701) 748-2206 | |||||
ATTORNEYS FOR PLAINTIFF-APPELLANT/CROSS-APPELLEE | ||||||
TABLE OF CONTENTS
I. Plaintiff's standing is clear. ¶1
II. The testimony of the Clinic's own experts demonstrates that there is evidence
of a causal relationship between abortion and breast cancer. ¶4
III. The evidence of a causal relationship exists independently of its recognition
by the National Cancer Institute. ¶15
TABLE OF AUTHORITIES
Allen v. United States, 588 F. Supp. 247 (D. Utah 1984) ¶5
Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974) ¶16
State Board of Architecture v. Kirkham, Michael & Associates,
179 N.W.2d 409 (N.D. 1970) ¶1
Stop Youth Addiction, Inc. v. Lucky Stores, 71 Cal.Rptr.2d 731 (Cal. 1998) ¶2
False Advertising Statute, NDCC 51-12-14 ¶1
Stephen Breyer, Breaking the Vicious Circle: Toward Effective Risk Regulation (1993) ¶16
Theodore J. Schneyer, "Informed Consent and the Danger of Bias in the
Formation of Medical Disclosure Practices," 1976 Wis. L. Rev. 124 ¶16
http://www.capitol.state .tx.us/tlo/78R/billtext/HB00015H.HTM ¶15
1. North Dakota's False Advertising Statute provides that "[a]ctions for injunction under this section may be prosecuted . . . by any person acting for the interests of itself, its members or the general public." NDCC 51-12-14. This Court has previously recognized that this provision means just what it says:
Surely the Legislative Assembly intended this latter provision to have some meaning, even though the language of the statute is not clear or concise and certainly is not the best. The only meaning that this language can possibly be given is that, in addition to allowing such action to be brought by the Attorney General or by one of the State's attorneys, upon complaint of the parties mentioned, it might also be brought by any person acting for his own interests or by any board or association for its own interests or for the interests of its members or the interests of the general public.
State Board of Architecture v. Kirkham, Michael & Associates, 179 N.W.2d 409, 411 (N.D. 1970).
2. California's false advertising statute has an identical remedy passage which the California Supreme Court has likewise repeatedly interpreted as conferring standing upon individuals and organizations who have "suffered no injury at all" to sue for injunctive relief on behalf of the general public. Stop Youth Addiction, Inc. v. Lucky Stores, 71 Cal.Rptr.2d 731, 736 (Cal. 1998).
3. Plaintiff was entitled to rely on the plain meaning of the statute and this Court's decision in State Board when she in good faith brought this lawsuit to serve the public interest. The Clinic's arguments on this point are patently contrary to the settled law.
4. Dr. Julie Palmer at least once in her cross-examination admitted the obvious: that an association found in an epidemiological study provides "one piece of evidence" of a causal link, and that a number of epidemiological studies have provided support for a causal relationship between abortion and breast cancer. T. 518:5-12, 538-39. This admission directly contradicts the sentence which the Clinic took from an outdated 1996 NCI fact sheet and continues to quote in its Current Brochure that "[t]here is no evidence of a direct relationship between breast cancer and either induced or spontaneous abortion." Plaintiff's Exhibit No. 4. (Dr. Palmer, in agreement with Plaintiff's expert, Dr. Brind, elsewhere defined the phrase "direct relationship" as simply meaning "causal relationship." T. 537-38.) That this sentence was clearly a mistake on the part of whoever wrote the 1996 NCI fact sheet is demonstrated by the very same fact sheet, which, inter alia, two paragraphs later quotes a commentary that described a 1994 study published in the Journal of the National Cancer Institute as "add[ing] to the limited evidence that induced abortion increases the risk of breast cancer," and five paragraphs later states, "In summary, as stated above, evidence of a direct relationship between breast cancer and either induced or spontaneous abortion is weak." The evidence can't be "weak" or "limited" if it doesn't even exist.
5. Dr. Palmer ostensibly disagreed with Dr. Brind's testimony that most of the published studies have found a positive association between induced abortion and increased breast cancer risk. T. 485. However, Dr. Palmer apparently only included in her count those studies which achieved statistical significance, despite acknowledging on cross-examination that positive associations not reaching statistical significance still constitute probative evidence. T. 454:3-8, 479-80, 492-93, 545-46. Dr. Palmer never directly disputed Dr. Brind's testimony that as of the date of trial twenty-eight of the thirty-seven studies published worldwide reported an overall positive association, including those that did not reach statistical significance. T. 147:22-23. "The cold statement that a given relationship is not 'statistically significant' cannot be read to mean 'there is no probability of a relationship.'" Allen v. United States, 588 F. Supp. 247, 417 (D. Utah 1984). The inconsistency of Dr. Palmer's position is further demonstrated by the fact that her lowest estimate of the number of positive studies linking abortion with increased breast cancer risk ("[a]t most 7 or 8 or possibly 9") is higher than the number of studies which have convinced her that a full-term pregnancy is associated with a short-term increase in breast cancer risk and a higher risk of heart attack. T. 482-85.
6. One of the studies which Dr. Palmer counts as a "null" study is the 1997 Melbye study. Dr. Palmer considers this study "the reason that [she] now feel[s] certain" that recall bias is significant in other epidemiological studies on the issue of induced abortion and breast cancer, because it was immune by virtue of its methodology from any possibility of recall bias and reported no overall association. T. 458-59. If anything, however, the findings of this study provide evidence against the recall bias hypothesis and in favor of the causal hypothesis.
7. Although the study reported an overall relative risk of 1.00, it also reported that "with each one week increase in the gestational age of the fetus there was a 3 percent increase in the risk of breast cancer," a trend which was statistically significant. T. 549:13-22. The study reported a biologically-inexplicable reduced relative risk of 0.81 associated with abortions performed before 8 weeks, while abortions after 18 weeks were associated with a statistically significant 1.89 relative risk. T. 469:15-20, 549:22-23. These statistically significant positive findings cannot possibly be explained by recall bias, and are evidence against the hypothesis that recall bias could be behind the positive associations found in other studies.
8. Dr. Brind testified that the trend of increasing risk with gestational age of the fetus reported in the Melbye study
would be the best evidence really of a dose affect which is one of the criteria that epidemiologists also use to infer causation. That is to say well if one abortion increases your risk of breast cancer, some level, shouldn't two abortions increase it more. It's difficult however to find that in lots of studies. In the literature some studies show it, some don't, because an abortion is not really a very good direct measure of exposure to estrogen. But gestational age is a better measure.
T. 184:8-18.
9. Dr. Palmer, on the other hand, professes agnosticism on this point: "We don't know that an induced abortion is a surrogate for estrogen exposure. If it were, if we knew that was a really close surrogate, you might be able to say" that the duration of exposure to pregnancy estrogens is a more appropriate measure of a dose-response effect than number of abortions. T. 552:2-8.
10. The Melbye study itself describes its own findings as follows:
Induced abortion had no overall affect on the risk of breast cancer but we found a statistically significant increase in risk among women with a history of second trimester abortion. . . . The increased risk among women who had had second trimester abortions finds biologic support in experiments in rats and is in line with the hypothesis of Russo and Russo. . . . We cannot explain why a very early induced abortion was associated with a slight although insignificant decrease in risk.
T. 552-53.
11. Dr. Brind testified that the Melbye study's calculation of an overall 1.00 relative risk is explained by several serious methodological problems in the study, and that the real overall relative risk in this study population is probably somewhere between 2.0 and 3.0. T. 160-61, 182-83. Although Dr. Palmer disputed Dr. Brind's criticisms, a review article moved into evidence by the Clinic and characterized by Dr. Palmer as a "very good review" acknowledged that the 1997 Melbye study has "several [methodological] limitations," and is "not definitive." T. 500:21; Def. Exh. No. 26, 4-5.
12. Other studies cited by Dr. Palmer as support for the recall bias hypothesis also call into question her objectivity and credibility. She describes as "evidence" of recall bias the fact that her 1997 study and Dr. Newcomb's 1996 study found a slightly stronger association for women who had pre versus post 1973 abortions, a difference which was not statistically significant. T. 540-41. When asked whether she could think of any explanation other than recall bias for why those points might be different, she offered "chance" as an explanation. T. 546. Dr. Palmer was then referred to the following statement on the last page of Dr. Newcomb's 1996 study: "Compared with spontaneous abortion the duration of pregnancies electively terminated has decreased since 1972 with the majority now performed at less than 8 weeks gestation. If longer gestation is associated with greater mammary cell proliferation induced terminations in past decades might be associated with greater risk." T. 546. When asked whether this was a plausible explanation for why women who have abortions prior to 1972 might wind up with a higher risk of breast cancer, Dr. Palmer replied, "I don't know how plausible it is but it's a possible explanation." T. 547. This explanation, of course, is also the explanation for why the statistically significant trend of increasing risk with gestational age in the Melbye study constitutes evidence of a dose-response relationship.
13. Dr. Palmer also offered as evidence of recall bias a 1991 study by Lindefors-Harris, in which the investigators were able to compare what women reported in an interview about their abortion history to abortion registry records. T. 460-61. The authors calculated from discrepancies they found between the interviews and the records a spurious 50 percent increase in risk, a figure cited in an affidavit filed by Dr. Palmer in this case and in her direct testimony at trial. T. 461, 558. When Dr. Palmer was asked on cross-examination whether this figure was based on the observation that a number of women had "over reported" abortions of which the registry had no record, coupled with the assumption that the registry was correct and these women had made up abortions they in fact did not have (as opposed, for example, to having had the abortions outside the country), Dr. Palmer answered: "Well, I read the Lindefors-Harris and they don't actually say that it was based on over reporting. Dr. Daling says it here but when I looked at that they I couldn't find in their original paper that they talk about over reporting." T. 559. However, when Dr. Palmer was asked to read the very first page of the Lindefors-Harris paper, which actually uses the word "over-reporting," she admitted that the authors had indeed in calculating the 50 percent figure made the unreasonable assumption that a number of women made up abortions they had never had, and that she herself "would never make that assumption." T. 580. This study, based on an absurd assumption, was also cited by both the 1996 and 1999 NCI fact sheets on abortion and breast cancer as support for the recall bias hypothesis. Pl. Exh. Nos. 4, 5.
14. Dr. Palmer testified on cross-examination that she knew of only one study that provides evidence against the recall bias hypothesis the 2000 study by Tang et al., published in the American Journal of Epidemiology by scientists whom Dr. Palmer knows and respects, which directly examined the issue and found no evidence of recall bias. T. 562-64. However, a number of other studies, including the Melbye study discussed above, also provide evidence against the recall bias hypothesis. See cross-examination of Dr. Palmer concerning the 1989 Howe study, T. 567-68; the 1995 Bu study, T. 576-77; the 1995 Lipworth study, T. 569-574; and the 1994 Daling study, T. 564-567. All of these studies reported statistically significant positive associations even though recall bias was either impossible or highly unlikely because of the studies' methodology or population.
III. THE EVIDENCE OF A CAUSAL RELATIONSHIP EXISTS INDEPENDENTLY OF ITS RECOGNITION BY THE NATIONAL CANCER INSTITUTE.
15. The legitimacy of the scientific evidence supporting the abortion-breast cancer link has been recognized by the public health departments of four states and evidence of that fact was offered and should have been received and considered by the trial court. T. 267-68, 632. Moreover, this Court may take judicial notice of the recent passage by the Texas House (April 30, 2003) and Senate (May 21, 2003) of H.B. 15, which provides that consent to an abortion is voluntary and informed only if the woman is informed of, inter alia, "the prospect of increased risk of breast cancer following an induced abortion and the natural protective effect of a completed pregnancy in avoiding breast cancer." See www.capitol.state.tx.us/tlo/78R/billtext/HB00015H.HTM.
16. Why the leadership of the NCI, a government agency charged with the prevention and eradication of cancer, has excessively downplayed and censored the evidence linking abortion and breast cancer is unclear, but such paternalism is not unprecedented. In Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), discussed in Theodore J. Schneyer, "Informed Consent and the Danger of Bias in the Formation of Medical Disclosure Practices," 1976 Wis. L. Rev. 124, 158-60, the Fifth Circuit held the manufacturer of a polio vaccine liable for its failure to warn a child's parents of the less than one in a million chance that the vaccine would cause polio in the child. The court rejected a policy judgment by the state department of health that disclosure of the remote risk might be significant to some patients, and for that very reason, should be withheld to ensure the success of public health efforts to immunize the population against polio. This policy judgment by state public health officials had formed the prevailing practice among physicians of not informing their patients of the risk of polio. A similar policy judgment by policy makers at the NCI may be driving the NCI's "spin" on the evidence linking abortion and breast cancer. Justice Stephen Breyer has observed that "the very fact that the many assumptions required by uncertainties are not clearly derivable from science can make them a lightning rod for contending political forces. Regulatory bodies, after all, are politically responsive institutions . . . . Their choices of default assumptions, to a degree, can respond to the desire of the President, Congress, Congressional staffs, interest groups, or the agencies themselves to appear especially careful to err on the safe side or alternatively to show sensitivity to economic costs." Stephen Breyer, Breaking the Vicious Circle: Toward Effective Risk Regulation 49 (1993).
17. Contrary to the Clinic's commercial brochures, there is evidence in fact an overwhelming preponderance of evidence that induced abortion is causally related to an increased risk of breast cancer in later life. This evidence is of vital importance not only to the public health but to the individual woman who next month may be considering an abortion at the defendant's Clinic. The politics of abortion has obscured and distorted what would be beyond debate in any other context patients have a right to be informed about material risks associated with a medical procedure they are about to undergo. This Court should recognize and acknowledge what other institutions may now be unwilling or unable to see.
Respectfully submitted this 29th day of May, 2003,
| /s/ John Kindley | |
| John Kindley (Non-Resident) | |
| P.O. Box 1406 | |
| Mishawaka, IN 46546 | |
| (574) 514-5528 | |
| Gregory L. Lange #03491 | |
| P.O. Box 488 | |
| Hazen, ND 58545 | |
| (701) 748-2206 | |
| ATTORNEYS FOR PLAINTIFF-APPELLANT/CROSS-APPELLEE | |