Thalidomide Litigation Lawsuit

Thalidomide Litigation

The product

Thalidomide was developed by the German pharmaceutical company Chemie Grünenthal and launched in West Germany on 1 October 1957 under the brand name Contergan. Promoted as a sedative and antiemetic for insomnia, "tension," and morning sickness, it was sold over the counter in West Germany at first. The drug was also marketed under license by other firms: The Distillers Company (Biochemicals) of Britain sold it as Distaval across the UK, Australia, and New Zealand, with advertising that claimed it could be given "with complete safety to pregnant women and nursing mothers." In all, thalidomide was available in 46 countries under many different brand names.

In the United States, Smith, Kline & French had conducted animal testing and a clinical trial of the compound and declined to commercialize it. In 1958, Chemie Grünenthal agreed to let the William S. Merrell Company of Cincinnati, later Richardson-Merrell, market and distribute the drug in the U.S. Richardson-Merrell applied for FDA approval in September 1960. The FDA reviewer in charge, Frances Oldham Kelsey, refused to rely on the company's submitted data, demanded further testing including studies of the drug's effects in pregnancy, and denied approval each time the company petitioned — six times in all. The drug was never approved for sale in the United States, though unapproved "testing" distribution did take place, resulting in 17 U.S. children born with thalidomide-induced malformations.

The harm

A cluster of infants born with severe limb deformities, including phocomelia, in the late 1950s and early 1960s was traced to maternal use of the drug. In November 1961, pediatrician Widukind Lenz presented evidence linking the deformed births to thalidomide, and under pressure from the press and the public the drug was withdrawn from markets in 1961. Estimates place the number of children seriously harmed worldwide above 10,000, with roughly 2,000 deaths and about 40 percent of affected infants dying around the time of birth. Survivors carried lifelong limb, eye, heart, and urinary problems. The disaster prompted major regulatory reform, including the U.S. Kefauver-Harris Amendment of 1962, which required proof of efficacy and disclosure of side effects, and the UK Medicines Act of 1968.

Claims and compensation

Affected claimants and survivors pursued the drug's manufacturers for decades. Compensation was channeled through trusts and national schemes, including the UK Thalidomide Trust, and U.S. litigation continued far beyond the 1990s. The record does not document a single final global resolution of all thalidomide claims; claims processing through trusts and courts ran for generations after the withdrawals.

Later history

In 1998, the FDA re-approved thalidomide in the United States for a leprosy complication, marketed by Celgene under the name Thalomid and distributed only through the tightly controlled STEPS program, with mandated contraception and pregnancy testing. Accelerated approval for multiple myeloma followed in 2006, and later analogs such as lenalidomide and pomalidomide entered the market under similar risk controls.

Outcome

The case is recorded as a market withdrawal, resolved in 1961. The downstream compensation and litigation that followed was long-running, with no final global settlement documented in the archived record.