Government Urged To Investigate Health Effects Of 1960s Pregnancy Test

Legal experts at national law firm Irwin Mitchell have called for a public inquiry into Primodos, a hormone pregnancy test used in the 1960s that may have caused malformations and deaths to babies in the womb.

The calls follow the airing of the Sky documentary, Primodos: The Secret Drug Scandal, which was shown in Parliament earlier this month.

Lord Alton of Liverpool wrote to the Government, after the screening, to ask whether it will consider establishing a public inquiry into the alleged failure of the regulator at that time to protect public safety.

An expert working group has been set up by the Government to examine hormone pregnancy tests such as Primodos, which was manufactured by Schering used in the 1960s by women to diagnose pregnancy.

In 1967 a study raised concerns that use of hormone pregnancy tests may be associated with birth defects. During the documentary, it was revealed that a further study conducted in 1975 reported a 5:1 risk of a mother giving birth to a baby with birth defects.

In 1975 the Committee on Safety of Medicines recommended that doctors should not use hormone pregnancy tests. A warning was placed on the labelling of the drug. However, Primodos continued to be available for prescription in this country until 1978.

Manufacturers are under a duty to the public to ensure that the drug they market is fit for purpose and safe for the intended use prescribed. The regulatory framework in relation to drugs was overhauled following the Thalidomide disaster. Thalidomide was a drug prescribed to pregnant women to alleviate symptoms of morning sickness, some of whose babies in the 1960s were born with life changing deformities.

The outrage in relation to the Thalidomide investigation prompted a number of changes in which drug companies were allowed to operate. One of the recommendations was that all new drugs should be submitted for approval.  The Committee on Safety of Drugs began work in the mid 1960s and established a voluntary scheme for the pharmaceutical industry to develop a system for reporting adverse reactions to any drug.

Further supervision was introduced following the enactment of The Medicine Act 1968 as prior to that, there were no comprehensive laws governing the safety of drugs. All medicines already on the market had at this point to be reviewed by peers and approved or withdrawn from sale. From 1971, all new medicines were subject to pre-market assessment for safety and quality by the licensing authority.

The position now is that the Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for the regulation of all medicines and medical devices. The MHRA launched a call for evidence relating to the use of hormonal pregnancy tests and adverse effects relating to pregnancy including possible birth defects on 25 March 2015.

Expert Opinion

Through our work we see the long lasting emotional and physical effects that using defective drugs and medicines can have. We invite the Department of Health to finally establish a public inquiry into the use of Primodos. After concerns have been expressed for around 50 years something surely must now be done? Catherine Slattery - Associate Solicitor

The Defective Product team at Irwin Mitchell have in the past supported clients through claims involving a number of different types of drug, causing injury, including: Human growth hormone, Lariam (Mefloquine), Dietary supplements, Antihistamines, Vioxx, Contaminated blood products, Levothyroxin, Myodil and dealt with claims brought under the Association of the British Pharmaceutical Industry (ABPI) clinical trial compensation guidelines.

The team has a great deal of experience and is ranked in the top band of law firms for defective product compensation claims by Chambers & Partners.