Smallpox has been eradicated from the global population. Polio hasn’t appeared in America in over 34 years. Glasses and contacts sharpen blurry vision to crystal clarity in an instant, while cochlear implants return sound to the hearing impaired. We can move organs between bodies, substitute limbs, even transplant entire faces. Yet for all the awe-inspiring medical advancements we have wrought as a species, there’s a dark side to making such rapid progress.
Sometimes, our pharmaceutical companies release “wonder-drugs” prematurely. Whether the root cause can be traced back to earnest error or sheer greed for maximum profits, multiple drugs have been allowed onto the market… only to be retracted in horror when their grisly side effects become apparent later down the road. In this blog post, our pharmaceutical drug litigation attorneys revisit a troubled international history with pills that kill: deadly drug recalls.
5,000 Babies Die From Thalidomide
In the laundry list of bothersome effects caused by pregnancy, one of the most well-known (and unpleasant) is morning sickness. Morning sickness, technically known as nausea gravidarum, is exactly what it sounds like: nausea during the A.M. hours. According to Dr. Jessica Niebyl, head of obstetrics and gynecology at University of Iowa College of Medicine, as many as 90% of pregnant women experience morning sickness. In the most severe cases, it can lead to vomiting, dehydration, decreased levels of potassium, and weight loss.
Needless to say, no expectant mother wants to deal with these nasty symptoms if she doesn’t have to. That’s where German drug company Grunenthal came in.
Grunenthal wanted to develop a drug which would eliminate the effects of morning sickness, while still being safe for pregnant mothers and their growing babies. By the early 1950s, Grunenthal had passed such a drug through preliminary testing, and by 1957, it was approved for over-the-counter use in West Germany. In 1958, it was approved in the U.K. Usage of Grunenthal’s new “wonder-drug” spread as far as Australia, Canada, Japan.
The drug was called thalidomide — but it wouldn’t be available for long.
In 1961, an Australian doctor named William McBride noticed an alarming increase in the rate of birth defects at his hospital. His next realization was even more troubling: all of the deformed babies had been born to mothers who took thalidomide during their pregnancies. The defects presented themselves as malformed limbs, damaged hearts, deafness, blindness, misshapen eyes. Sometimes, the babies didn’t survive.
Disturbed, McBride wrote to renowned medical journal Lancet with his findings. By the end of 1961, just a few short years after its initial release, thalidomide had been banned in countries around the world. Canada was the last country to apply the ban, in 1962.
But the damage had already been done. During the late ’50s and early ’60s, some 10,000 “thalidomide babies” were born across 46 countries. Among these 10,000, only 50% survived past one year.
In other words, approximately 5,000 infants were killed by thalidomide.
By 1968, U.K. pharmaceutical company Distillers Company was entangled in a massive lawsuit with the families of British victims, while officials at Grunenthal were facing charges of negligent homicide in Germany. While the trial ultimately returned a verdict of not guilty, in 1970 Grunenthal paid 100 million Deutsche Marks to settle with German victims. Distillers Company, which has since been absorbed by Diageo, paid out 20 million pounds in the U.K.
Even today, thalidomide lawsuits continue. In July 2012, Australian Lynette Rowe, who was born without limbs, brought a class-action lawsuit against Grunenthal. The case settled out of court for millions of dollars.
Thalidomide was never approved for sale in the United States.
Vioxx Linked to Nearly 30,000 Deaths and Heart Attacks
It’s certainly true that — largely thanks to thalidomide — the standards for drug testing have come a long way since the mid-20th century. But, nothing is perfect, and even fifty years of scientific advancement can’t block every danger.
In 1998, American pharmaceutical giant Merck unveiled a new and improved sort of painkiller. Older painkillers had a tendency to cause bothersome gastrointestinal issues, but Merck’s newest creation promised improvements.
To doctors, it was known as Rofecoxib. To the buying public, it would be marketed as Vioxx.
Unlike thalidomide, which was tested primarily on animals, Vioxx was tested on 5,400 people in no fewer than eight initial studies. After that, Vioxx was tested on a further 4,000 individuals in an 8,000-participant study comparing Vioxx against naproxen, an older painkiller Merck hoped Vioxx would outperform.
Satisfied with Merck’s extensive testing program, the FDA approved Vioxx for sale in the United States in May of 1999.
By October, nearly half a year later, the results of the ongoing Vioxx tests were beginning to trickle in — and they seemed completely positive. Just as intended, patients taking Vioxx experienced reduced stomach bleeding and fewer ulcers compared to those taking the older class of painkillers.
But in 2004, the drug was recalled from the market. What happened in between?
Merck may be “Big Pharma,” but in the era of Vioxx, the company was hurting for money. “In the late 1990s Merck was facing the loss of patent protection on several top drugs and needed a big hit,” wrote the Wall Street Journal.
That’s why Merck distorted the results of Vioxx safety testing.
By November of 1999, nearly 80 Vioxx patients in the test against naproxen had either developed serious heart conditions, or died. Merck decided to continue testing, with company meeting notes saying, “…while the trends are disconcerting, the numbers of events are small.”
But as more and more prescriptions for Vioxx were filled, and as testing dragged on longer and longer, the incidence of heart attack among users continued to grow.
In 2000, Merck submitted the completed results of their testing to the New England Journal of Medicine — with many of the negative findings carefully omitted.
In 2001, the FDA conducted an advisory meeting to further probe the realities of Vioxx’s safety. The same year, the FDA published the real data on their website, including the heart attacks and cardiovascular issues Merck had conveniently left out.
By 2004, Vioxx — which had been prescribed to over 20 million Americans — had been linked to nearly 30,000 heart attacks and sudden deaths from cardiac problems.
Numerous personal injury and wrongful death lawsuits have been filed against Merck in Vioxx’s deadly wake: over 10,000 as of early 2006, plus an additional 190 class action suits.
Vioxx is no longer available in the United States, but continues to be sold in other countries around the world.
If you or someone you love has been hurt by dangerous pharmaceutical drugs, such as AndroGel, you may have a case for a product liability lawsuit. Contact the personal injury law firm of The Reiff Law Firm online, or call us today at (215) 246-9000.