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Collections under which this article appears: Family Planning Venous Thromboembolism Adverse drug reactions

BMJ 2002;325:237 ( 3 August )

News

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 this week.

Mr Justice Mackay made his ruling in a group action by 99 women against three manufacturers of third generation oral contraceptivesSchering Health 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 products as defined by the Consumer Protection Act.

The judge described the 42 days of expert evidence as "almost certainly the most exhaustive examination that this question has yet received." The judgment is unlikely to resolve the controversy, which has raged since the United Kingdom's Committee on Safety of Medicines issued its warning in October 1995. The warning letter followed three epidemiological studies showing that the newer pills were associated with a twofold increase in the risk of venous thromboembolism compared with the older products.

Mr Justice Mackay halted the trial at the end of May, with eight weeks still to go. Both sides had agreed that the case would fail unless the women could prove a more than twofold risk for the newer products compared with the older ones, and the judge decided to resolve that issue first.

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 Kenneth MacRae and Michael Lewis on the data from the study by the Transnational Research 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), found a 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 generation pills and any increased risk of venous thromboembolism.

"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 supplied to these claimants by the defendants as compared with second generation products containing levonorgesterel," said the judge. If he had had to decide the case without the Cox regression analysis, he said, he would still not be satisfied that the relative risk was more 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 was no increased risk. The legal team would be considering an appeal, but "the court of appeal has shown itself to be very unenthusiastic about appeals in these sorts of actions following a lengthy trial."

Footnotes

The judgment is accessible at www.courtservice.gov.uk

© BMJ 2002
 

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Collections under which this article appears: Family Planning Venous Thromboembolism Adverse drug reactions

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BMJ 2002 325: 0. [Full text]  

 

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