Drug Liability
Overview
Drug Liability Attorneys
We represent consumers and their families in lawsuits against manufacturers of drugs that cause illness, including cancer, or even death.
We are passionate advocates for consumers who should be able to trust that the drugs they are taking for an illness are safe. We have filed lawsuits against some of the biggest manufacturers of prescription drugs and over-the-counter medication, including ondansetron (Zofran) and Actos. Most recently, we are representing families impacted by ranitidine (Zantac).
RANITIDINE (Zantac)
Ranitidine and Cancer
Corboy & Demetrio represents consumers who took ranitidine, either as Zantac or in generic form under other names, either by prescription or over the counter, who developed cancer. Potential cancers include:
- Liver cancer
- Kidney cancer
- Stomach cancer
- Colorectal cancer
- Prostate cancer
- Esophageal cancer
- Pancreatic cancer
- Bladder cancer
- Other digestive tract cancers
What is Ranitidine?
Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease, according to the FDA.
Ranitidine Recall
On April 1, 2020, the U.S. Food and Drug Administration announced it requested manufacturers withdraw all prescription and over-the-counter ranitidine drugs from the market immediately.
This was the latest step in its ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac).
The FDA said it determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity.
“As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.,” the FDA said in its news release. The FDA is also urging consumers to dispose of any ranitidine they may have currently stored in their homes.
Read the full April 1, 2020 FDA News Release
The History of Zantac (Ranitidine)
1983
Glaxo Holdings Ltd received its first U.S. FDA approval for Zantac as a short-term treatment of a common form of ulcers. The drug was already approved in 31 different countries.
1988
Zantac became the world’s best-selling drug and one of the first-ever drugs to top $1 billion in annual sales.
1997
Glaxo’s U.S. patent for ranitidine expired and competitors launched generic alternatives to the drug.
2004-2017
Pfizer received FDA approval for an over-the-counter version of Zantac in the U.S. The brand later moved in various transactions to Johnson & Johnson, Boehringer Ingelheim Pharmaceuticals and Sanofi SA. Other companies also launched generic over-the-counter competitors.
July 17, 2018
The FDA announced a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall was due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products.
Read the full FDA news release.
Sept. 13, 2019
The FDA issued a Statement that it found “low levels’ of a nitrosamine impurity called N-nitrosodimethylamine (NDMA) in some ranitidine medicines, including some products commonly known as the brand-name drug Zantac. The FDA said that NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests but also that NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Read the full FDA news release.
Dec. 4, 2019
The FDA announced it required additional testing of ranitidine and nizatidine as part of its ongoing effort to help ensure product safety for patients and consumers. It asked manufacturers to conduct their own testing and to report if NDMA levels exceed safe levels.
Dec. 12, 2019-April 2020
The FDA announced various voluntary recalls by some manufacturers of ranitidine.
April 01, 2020
The FDA Requested removal of all ranitidine products (Zantac) from the market immediately after new FDA studies showed risk to public health. Consumers were urged to dispose of all ranitidine stored in their home.
ONDANSETRON (Zofran)
Ondansetron and Birth Defects
Ondansetron (Zofran) is manufactured by GlaxoSmithKline and was granted FDA approval for use as an anti-nausea medication for cancer patients enduring chemotherapy treatments when it first came on the market in 1991.
Zofran was later marketed and promoted as a morning sickness remedy for pregnant women. This was done in spite of GSK’s knowledge that the drug could have detrimental effects on the mother’s unborn child. The Department of Justice has brought criminal charges against GSK for this behavior and now the corporation must respond for its actions in civil lawsuits filed on behalf of the innocent children allegedly harmed by the drug, including those filed by Corboy & Demetrio.
Although not FDA approved for treatment of morning sickness, ondansetron (commonly known as Zofran) is widely prescribed for pregnant women experiencing nausea and vomiting. Lawsuits allege use of ondansetron by pregnant women results in increased risk of birth defects.
What is Ondansetron?
Ondansetron is a drug used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. It is in a class of medications called 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.
Has Ondansetron (Zofran) been Recalled?
No. The FDA has not issued a recall. The FDA does, however, provide consumers with the opportunity to report any adverse reactions/illness:
“Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program…”
Here is the link to the FDA’s webpage.
The History of Ondansetron (Zofran)
1991
The U.S. Food and Drug Administration (FDA) approved Zofran in 1991, making it the first in a class of new drugs called 5-HT3 receptor antagonists to hit the market. The FDA’s approved use of the drug was to treat nausea and vomiting in certain types of cancer patients. It was not approved to treat morning sickness in pregnant women.
2006
GlaxoSmithKline developed, manufactured and sold the drug exclusively until 2006, when the company’s patent for Zofran expired. The FDA approved generic versions of ondansetron from several vendors shortly after.
Sept. 15, 2011
The FDA Issued a safety warning that abnormal heart rhythms may be associated with use of Ondansetron (Zofran). The FDA informed the public of an ongoing safety review of the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and their generics), specifically, that ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.
Here’s the link to the full FDA Safety Warning.
June 29, 2012
The FDA announced that it was informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes. Here’s the link to the full FDA Safety Warning.
ACTOS
Actos Settlement
Corboy & Demetrio obtained settlements for clients in three lawsuits it filed against Takeda Pharmaceuticals on behalf of patients who took the drug Actos for diabetes and later developed bladder cancer.
The lawsuits alleged that for more than 10 years, Takeda concealed and failed to completely disclose its knowledge that Actos was associated with or could cause bladder cancer or to disclose its knowledge that it had failed to fully study and test regarding that risk.
The lawsuits claimed Takeda and researchers of a 2005 study, which looked at the impact of Actos in high-risk patients, intentionally skewed the findings and failed to disclose that it showed “statistically significant increases of bladder cancer.”
In one of Corboy & Demetrio’s lawsuits, a 63-year-old man from Plainfield, IN, took Actos for seven years until he was diagnosed with bladder cancer in 2012.
The lawsuits claimed Actos is a defective product because it was unreasonably dangerous and more dangerous than an ordinary consumer would expect; that the Defendants failed to adequately test Actos before making and marketing it to the public; that the Defendants knew Actos to be defective and unreasonable safe yet failed to warn the public about is defects; and failed to stop marketing Actos after discovering it was defective.
That lawsuits also claimed the Defendants acted fraudulently in representing to the plaintiffs, to the medical community and to the general public that Actos was safe and effective, more so than other diabetes drugs, and that Actos posed “no statistically significant risk of cancer to bladders in humans.”
