FAQs About Thalidomide in the US

Frequently Asked Questions

How many Thalidomide Babies were born in the United States?

In 1962, the Food and Drug Administration (FDA) informed the public that only 17 babies were born with thalidomide injuries in the U.S.

A less known fact is that, of the 17 mothers they counted, only 9 got thalidomide samples from U.S. doctors. The other 8 got thalidomide while visiting Europe or from a spouse or other person who had visited there.

But records from the FDA’s long and thorough investigation suggest there were many more than 9 mothers who got thalidomide from U.S. doctors and gave birth to babies with shortened limbs, missing digits and/or other injuries.

Many factors combined to ensure the FDA would never know the exact number. 

  • Many doctors refused to allow the FDA to access their patient’s records. 
  • Some mothers of children born with birth defects denied having taken medication in spite of circumstantial evidence.
  • Some mothers took thalidomide years before the drug’s devastating effects finally became public. If she didn’t come forward on her own, due to shame and guilt, the FDA had few ways to find out about her baby. In 1962, few states kept track of children born with disabilities and the only clue might be a short note entered in the medical chart regarding the child’s injuries.
  • FDA investigators combed through as many patient records as they could, looking for any baby born with birth defects. In very large hospitals, trying to find this information among hundreds of boxes of paper records was like finding a needle in the proverbial haystack.

Why would a woman deny having taken the medication? For one thing, mothers were shamed by other women for having taken a sleeping pill while pregnant even if they got the medication from their doctor. 

The FDA investigation discovered that some of the samples ended up in pharmacies or even donated to a charity clinic. Once the recall began, an unknown number of the 250,000 doses of medication distributed were never accounted for.

Although many journalists, legislators and private citizens demanded more details, FDA records reveal that Dr. Frances Kelsey was threatened by a Richardson-Merrell executive with a libel suit, causing FDA leaders to tighten the release of information.

In the end, the U.S. Justice Department declined to prosecute the company or its leaders. In the wake of the Kennedy assassination and other issues of the day, the Thalidomide tragedy soon faded from public view.

As of March 22, 2019, a number of US Thalidomide Survivor members are still waiting for their Freedom of Information Act (FOIA) requests to be decided by the FDA. Although we have obtained more than 1,500 pages of the final document, additional pages have never been released. In addition, many names and other identifying information has been redacted while other names are not. We are waiting for FDA officials to justify their reasoning for redacting the names of some doctors and patients while releasing others.

 

When was thalidomide available in the United States?

FDA records indicate that thalidomide was manufactured and tested in the United States from 1957 until some time in 1962. Thousands of doses distributed as samples were never accounted for, leaving open the possibility that some babies could have been born in 1963 and beyond. 

More than 2.5 million doses of thalidomide were distributed to more than 1,300 U.S. doctors by Smith Kline and French (now GlaxoSmithKline), Richardson-Merrell (now Sanofi-Aventis) and several Richardson-Merrell subsidiaries to be used in clinical trials. The American pharmaceutical companies had been licensed to manufacture and distribute the drug by its patent owner, German pharmaceutical company Chemie Grünenthal (now known as Grünenthal).

Did thalidomide survivors sue the pharmaceutical companies?

A few of the parents did attempt to sue the drug companies in the 1960s and 70s. One California plaintiff was awarded $2.5 million by a jury but the judge reduced the award to $500,000 for her and $250,000 for her mother. A few others that we know of reached a confidential settlement prior to their case being delivered to a jury.

Experts of the day speculated that the settlements won in England and elsewhere were woefully inadequate to address the survivors’ lifelong needs. And they were right.

Today, many survivors struggle with crushing medical expenses and suffer from chronic pain and other conditions that worsen as they age. Many of those who received inadequate settlements are no better off than those who did not.

What happened with the lawsuit that was filed in the United States in 2011?

The lawsuit filed on behalf of 52 plaintiffs in 2011 is still pending a decision by the United States Court of Appeals for the Third Circuit in Philadelphia.

Is there a list of injuries thought to be caused by in utero thalidomide exposure?

Yes. The Thalidomide Victims Association of Canada website has a thorough explanation of malformations and conditions known to be caused by thalidomide exposure.

How can I find out if I am a thalidomide survivor?

Contact us to schedule a private phone conversation. We can provide more information about how to determine the likelihood that your injuries were caused by your mother taking thalidomide during pregnancy. 

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