Thalidomide, Frances Oldham Kelsey, And The Pharmaceutical Industry

By Michael A. Lesser, Esq.

Posted on Sep 25, 2013

 

 

 

 

 

 

 

Dr. Frances Oldham Kelsey

Released in Germany in 1957 as an all-purpose sedative, but later widely used as a preventative treatment for “morning sickness,” Thalidomide caused an estimated 10,000 – 20,000 severe birth defects worldwide. The injuries associated with a mother’s ingesting Thalidomide while pregnant included birth without limbs, shortened limbs, deformed hearts and eyes, and blindness and deafness. It is estimated that 39-50% of babies born with Thalidomide-related birth defects died within a few months of birth. Thalidomide’s use increased after the drug became available over-the-counter in 1960. Before its use was banned, however, Thalidomide had been linked to birth defects in more than 39 countries.

The pharmaceutical company Richardson-Merrell (now Marion Merrell Dow) sought approval for sale of Thalidomide in the United States in June 1960. Because of a loophole in the approval process, however, Richardson-Merrell was able to distribute millions of doses of Thalidomide to more than a thousand doctors in the United States while the drug was being investigated. About 20,000 patients in the United States took Thalidomide as a result. Despite efforts to win quick approval from the Food and Drug Administration, Richardson-Merrell ran into an immovable force in the person of Frances Oldham Kelsey. Dr. Kelsey, who had only recently joined the FDA as a reviewing pharmacologist, resisted the requests for approval to market the drug and instead asked for more controlled studies related to Thalidomide’s risks. When studies showed that the drug’s use had lead to more than 10,000 severe birth defects worldwide, Richardson-Merrell pulled their application for approval. In 1962, Thalidomide was banned worldwide. Compared to other countries, only a relative handful of children in the United States were born with Thalidomide-related injuries. For her efforts, Frances Oldham Kelsey received the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy in 1962 and continued her work at the FDA.

As a result of the Thalidomide tragedy, many new regulatory reforms were enacted in order to better protect American consumers. Congress passed new rules related to testing and licensing of drugs.

Unfortunately, the potential for birth defects resulting from a mother’s use of pharmaceutical drugs is still present today. A new, peer-reviewed study has found that children born to mothers who took common prescription painkillers, like Vicodin, Oxycontin, or Percocet, at or near the time of conception were more than twice as likely to be born with neural tube defects such as spina bifida. The scientists found a strong association between mothers who took these prescription opioid painkillers and a significantly increased risk of having a child with one of these serious neural tube birth defects.

If you took an opioid painkiller around the time of conception and your child was born with a neural tube birth defect, please contact attorneys David Strouss or Marilyn McGoldrick at 888-341-1405 to discuss your legal rights with our experienced team of birth defect lawyers.

Depuy Hip Recipients Prepare For More Trials In Hip Implant Litigation

By Marilyn T. McGoldrick, Esq.

Posted on Sep 3, 2013 

The first bellwether trial in the federal court Multi-District Litigation over Johnson & Johnson’s DePuy Unit’s metal hip implants is scheduled to begin on Monday, September 9, 2013. The plaintiff is Ann McCracken, a woman from Rochester, New York who underwent a DePuy ASR XL Acetabular Hip System replacement in 2009. She , in 2011. While this is the first trial of the federal MDL cases, 2 other cases have already been tried to verdict in the state courts and other cases have trial dates scheduled for later this fall. These other cases include the New Jersey Multi-County Litigation (MCL) Bergen County Superior Court, bellwether case set for trial on October 21, 2013; the San Francisco Superior Court, coordinated California proceedings, bellwether case set for trial in October of 2013, and the case scheduled for trial on November 8 in West Palm Beach, Florida.

J&J’s DePuy unit began manufacturing the metal-on-metal hip implants – the ASR XL Acetabular System, and the ASR Hip Resurfacing System – less than a decade ago. The ASR XL Acetabular System was submitted to the FDA for so-called 501(k) approval, meaning that J&J claimed that the product was substantially similar to products already on the market so did not require clinical trials before being sold to the public. [The ASR Hip Resurfacing System was submitted to the FDA in 2007, but that application was withdrawn and it was never sold in the U.S. However, Americans who went abroad for a hip resurfacing procedure could have gotten an ASR Hip Resurfacing System, as it was sold in other countries.]

Unfortunately, for the 93,000 people in the United States who did receive an ASR metal-on-metal hip implant, the change from the older hip implant sold by DePuy was not a minor change but a major change and, ultimately, a major defect which render the devices dangerously unsafe. J&J recalled the ASR hip implants in 2010, but at that point the damage was already done.

At the time of the recall, DePuy cited revision rates double what was expected. Unfortunately, more recent studies in the United Kingdom have shown a failure rate as high as 49%, an astonishingly high failure rate for a device that was meant to be better than the old conventional hip replacements that failed 1% to 2% of the time.

The ASR was recalled on August 24, 2010. If you received one of these hip implants and have not seen a doctor recently, we urge you to see your doctor and have your hip implant evaluated. You should ask the doctor to perform a metal ion test to see if you have elevated levels of chromium or cobalt in your blood.

Call the Boston hip implant lawyers at Thornton Law Firm for a free and confidential evaluation of your case. Ask for attorney Marilyn McGoldrick when you call 888-341-1405 and we will put our hip implant legal team to work for you.

Contact Us