Judge dismisses test case on third generation pill
Clare Dyer, legal correspondent, BMJ
Third generation contraceptive pills, whose sales plummeted after the
1995 "pill scare," carry no higher risks of venous thromboembolism
than second generation pills, a high court judge ruled thisweek.
Mr Justice Mackay made his ruling in a group action by 99 women against three
manufacturers of third generation oral contraceptivesScheringHealth Care, Organon Laboratories, and John Wyeth and Brother.
The women, who had strokes, pulmonary embolisms, and deep vein
thromboses, argued that the newer pills were defective productsas
defined by the Consumer ProtectionAct.
The judge described the 42 days of expert evidence as "almost certainly the
most exhaustive examination that this questionhas yet received." The
judgment is unlikely to resolve the controversy,which has raged
since the United Kingdom's Committee on Safetyof Medicines issued
its warning in October 1995. The warning letterfollowed three
epidemiological studies showing that the newerpills were associated
with a twofold increase in the risk of venousthromboembolism
compared with the olderproducts.
Mr Justice Mackay halted the trial at the end of May, with eight weeks still
to go. Both sides had agreed that the case wouldfail unless the
women could prove a more than twofold risk forthe newer products
compared with the older ones, and the judgedecided to resolve that
issuefirst.
After reviewing all the studies, with the help of 10 expert witnesses, the
judge decided that the "most compelling evidence"in the case was the
Cox regression analysis carried out by KennethMacRae and Michael
Lewis on the data from the study by the TransnationalResearch Group
on Oral Contraceptives (Human Reproduction 1999;14:1493-9.)
The original transnational study, by Walter Spitzer and colleagues and
published in the BMJ in 1996 (1996;312:83-8), founda relative
risk of about 1.7. The 1999 paper in Human Reproduction
included full lifetime oral contraceptive exposure for over 90%of
the subjects and found no association between third generationpills
and any increased risk of venousthromboembolism.
"Based on that evidence, I find that there is not as a matter of probability
any increased relative risk of VTE [venous thromboembolism]carried
by any of the third generation oral contraceptives suppliedto these
claimants by the defendants as compared with second generation
products containing levonorgesterel," said the judge. If he hadhad
to decide the case without the Cox regression analysis, hesaid, he
would still not be satisfied that the relative risk wasmore than
2. The most likely figure was around 1.7.
The claimants' solicitor, Martyn Day, said that he was "astonished" that the
judge had come to the conclusion that there wasno increased risk.
The legal team would be considering an appeal,but "the court of
appeal has shown itself to be very unenthusiasticabout appeals in
these sorts of actions following a lengthytrial."
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