A lawsuit accusing Medtronics of covering up negative side effects of its Infuse bone graft has been revived by an appeals court.
A lawsuit accusing Medtronic of misleading shareholders by concealing the adverse effects of its Infuse bone graft, has been revived by the The 8th U.S. Circuit Court of Appeals in St. Paul, Minnesota.
The Infuse bone graft has been used in more than 1 million surgeries. In 2002, the FDA approved the Infuse bone graft for use in specific types of spinal fusion surgeries. The Infuse bone grafts variety are“synthetic, concentrated proteins…mixed with collagen from cows and injected into the spine to alleviate pain.”
The Spine Journal found, in 2011, that the risks of the product had been understated by medical professionals.
In 2012, the U.S. Senate Finance Committee stated that Medtronic, Inc., the manufacturer of the Infuse bone graft, had paid doctors hundreds of millions of dollars to write favorable articles and manipulate studies on the popular product.
In 2013, Medtronic shareholders sued the company claiming that the company’s stock had been inflated due to these unethical activities. As the truth about the product emerged, they have alleged hundreds of millions of dollars in losses.
In 2014, Medtronic agreed to settle its Infuse bone graft lawsuit for $22 million that involves 950 people. Around 2,300 surgeons had used Medtronic products in the US prior to any serious side effects being reported.
An earlier decision in the case judged that shareholders had waited too long before seeking legal action. As 2016 came to a close an appeals court found that the case could still be brought forward.
The case will now be returned to the lower court for further proceedings.
The story is a pretty well-known one by now: Zofran was created in 1991 by medical manufacturing giant GlaxoSmithKline and grew to become one of the most popular drugs ever. The actual medication works by limiting the amount of serotonin that gets to the part of the human brain that triggers nausea and vomiting. Obviously this is the kind of thing that a pregnant mother would love. Unfortunately the FDA only permitted the use of Zofran to surgery and cancer patients—not pregnant women. Additionally, reports now allege that GlaxoSmithKline knew the product could be potentially hazardous to pregnant mothers and could cause birth defects. The reality is pregnant women did take the medication and sadly many birth defects occurred, including musculoskeletal abnormalities, club foot, cleft lip, cleft palate, jaundice and heart deficiencies. This has caused a number of Zofran lawsuit claims to be filed.
Similar charges were brought by the Department of Justice, in one of the largest alleged health care fraud in history, a case GlaxoSmithKline settled for $3 billion. What is more stunning is additional plaintiffs have come forward now claiming the company has hid evidence of Zofran’s alleged link to major birth defects for more than two decades.
If you are interested in the December 2014 study that showed the impact of the drug on young mothers from Dr. Gideon Korenin in the American Journal of Obstetrics and Gynecology you can find that here.
The U.S. Food and Drug Administration [FDA] issued their formal warnings and instructions on Zofran here.
When lawsuits are brought against a pharmaceutical manufacturer such as GlaxoSmithKline, they either end in a financial settlement for the plaintiff or the lawsuits go to trial. Generally, zofran lawsuit claims are settled prior to a trial. Medical Claim Legal and its experts have assisted Zofran lawsuit plaintiffs in similar claims.