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Collections under which this article appears: Family Planning Medicine and the law (incl forensic medicine) Adverse drug reactions

BMJ 2002;324:561 ( 9 March )

News

Claim launched against makers of third generation pill

Clare Dyer, legal correspondent, BMJ

More than 100 womenand the families of seven who have diedlaunched a compensation claim in the High Court in London this week over side effects of third generation contraceptive pills.

Their counsel, Lord Brennan QC, told Mr Justice Mackay that the third generation pill, introduced in the 1980s, carried more than twice the risk of venous thromboembolism as their second generation predecessors. He said that some of the women had sustained "devastating injury which will incapacitate them throughout their lives."

The case, which is scheduled to last five months, has been brought under the little used Consumer Protection Act 1987, which makes the manufacturers of defective products strictly liable for injuries caused, without the need to prove negligence. A material consideration in deciding whether a product is safe is the nature of any warnings given.

The claims are against Schering Healthcare (manufacturer of Femodene), Wyeth (Minulet and Tri-Minulet), and Organon Laboratories (Marvelon and Mercilon).

Lord Brennan said: "The case is that those third generation products carried an increased risk of venous thromboembolism when compared with the previous second generation of products.

"Because of that increased risk, there should have been a warning to prescribers and users. There was no such warning, and the claimants suffered the various conditions I have described." These included deep vein thrombosis, pulmonary embolism, strokes, and cerebral vein thrombosis, he said.

He added: "Had they been warned, it is their case that they would not have taken the third generation pill but either the second or some other form of contraception. A product that carries such a risk, but doesn't carry a warning about it is, we submit, a defective product under that statute."

He said the case appeared complex, but the issues were simple. "The complexity, we submit, comes from the defendants' concerted argument that the mainstream epidemiology is wrong, that the regulatory authorities have over-reacted, and that their group of experts is right."

The claimants' case was that the product they received was defective and that defect caused them injury. Debate has raged for years over the relative risks of the second and third generation oral contraceptives. Studies funded by the manufacturers show little or no increased risk of venous thromboembolism for the third generation pills, whereas independent studies show a higher risk for the newer pills.

The makers argue that doctors tended to choose the third generation pill for women who were more susceptible to clots.

(Credit: JOHNNY GREEN/PA )   Yvonne Berry, whose daughter died after taking the pill for a month

© BMJ 2002
 

PDF of this article Email this article to a friend Send a response to this article Electronic responses to this article PubMed citation Related articles in PubMed Download to Citation Manager Search Medline for articles by: Dyer, C. Alert me when: New articles cite this article

Collections under which this article appears: Family Planning Medicine and the law (incl forensic medicine) Adverse drug reactions

Rapid Response responses to this article:

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Simple association doesn't always mean causation

Anusch Yazdani

bmj.com, 9 Mar 2002 [Response]

Factor V (Leiden) and D-Dimer(ELISA) to assess the risk of thrombosis.

Friedrich Flachsbart

bmj.com, 10 Mar 2002 [Response]

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.