Pharmaceuticals containing valsartan have been pulled from the market in 22 countries after contamination by a potential carcinogen N-nitrosodimethylamine (“NDMA”).
On July 9, 2018, Health Canada recalled 28 blood pressure medications from five generic brands that use the ingredient valsartan.
Health Canada advised that the medications were supplied by Zhejiang Huahai Pharmaceuticals of China. The ingredient valsartan used in the products contains an impurity called NDMA, a potential carcinogen that can cause cancer with long-term exposure. NDMA can be toxic for the liver and other organs and has been used by scientists to induce cancer in lab rats.
This recall could affect 4.4 million Canadians who have been prescribed medications.
WHAT IS VALSARTAN?
Drugs containing valsartan are used to treat high blood pressure and help prevent heart attacks and stroke. They are often used by patients who have had heart failure or a recent heart attack.
Canadians are advised to check with their pharmacists to learn if their medication is being recalled. They should not immediately stop taking the medicine unless they have been advised by their doctor or pharmacist.
Nardine Nakhla, from the School of Pharmacy at the University of Waterloo in Ontario, stated:
Patients should contact their pharmacist(s) to see if the drugs they’re taking are indeed the affected, recalled valsartan products. The pharmacist can then figure out alternative medications that are unaffected by the recall.
At this time it is unclear as to the long-term risks posed by the NDMA found in valsartan-containing drugs. The amount of NDMA consumed would certainly affect the risk.
Dr. Erin Michos, an associate professor and associate director of preventive cardiology at Johns Hopkins Medicine, stated:
What we know about the dangers of this impurity comes primarily from laboratory studies. It is a toxin that can affect the liver and cause liver fibrosis or scarring and liver tumors in rats. So, it is assumed to be toxic to humans, as well. In these animal studies, they usually give large quantities, so again, the risk is likely not the same equivalent in humans. …
I am certainly concerned, but I think it is too soon to panic. This recall is a precaution for safety.
Dr. Wassim Saad, Windsor Regional Hospital’s chief of medicine, believes that there may be a risk of getting cancer, but that the risk is relatively low. He stated:
In some animal studies and some very small human studies it caused gastric cancer, so stomach cancer, and colorectal cancer. But we’re talking months and sometimes years and oftentimes decades of exposure. So it’s unlikely that anybody is really going to see any harm from this.
CLASS ACTION LAWSUIT PROPOSED IN QUEBEC
Kenneth Aitchison of Beaconsfield, Quebec has been taking valsartan for nearly two years to help regulate his blood pressure. He received a call from his local pharmacy several days after drugs containing valsartan were recalled in Canada on July 9, 2018.
Aitchison is named as the applicant in a request to proceed with a class-action lawsuit in Quebec, which was recently filed at the Montreal courthouse.
In Quebec, a lawsuit of this nature requires the permission of the court before it may proceed. This is referred to as the authorization stage, which is a screening mechanism to weed out untenable or frivolous claims. In Quebec, the burden is low and the province is viewed as a class action friendly jurisdiction.
Aitchison’s lawsuit alleges negligence against five Canadian pharmaceutical companies that manufactured drugs containing valsartan. It is alleged that these companies did not adequately inspect the ingredients shipped from China and failed to notify Canadians taking the drug that it was contaminated and subject to a recall.
The plaintiffs are seeking damages for personal injury, including increased risk of cancer, anxiety and mental distress, and additional costs for medical monitoring and dispensing fees.
The request to proceed with a class action reads as follows:
The class members have sustained a personal injury because there is a real possibility in the future that the class members will contract cancer because they consumed a drug contaminated with NDMA, which is a carcinogen.
Aitchison anticipates that thousands of Quebecers will join the lawsuit. It is anticipated that a hearing to determine whether the class action will go ahead will take place in six to nine months.
CLASS ACTION LAWSUIT COMMENCED IN ONTARIO
A separate class action lawsuit is being filed in Ontario to represent those individuals affected by the recall of valsartan in the rest of Canada.
This lawsuit is alleging that the following five companies did not adequately test their products:
- Teva Canada Ltd.
- Sandoz Canada Inc.;
- Pro Doc Limitee;
- Sanis Health Inc.; and
- Silvern Pharmaceuticals ULC.
In Ontario, a lawsuit which is started as a class proceeding requires an Order for Certification from the Court certifying it as a class action. In order to certify the lawsuit as a class action, the court must consider the following:
- whether there is a cause of action;
- whether there is an identifiable class;
- whether common issues are raised;
- whether a class action is preferable for the resolution of the common issues; and
- whether there is a suitable representative plaintiff.
Certification does not determine the merits of the case, it is simply a procedural matter to ensure that a case is appropriate to be dealt with as a class proceeding.
If a settlement cannot be reached, a class action lawsuit will proceed in the same manner as a traditional lawsuit with the common issues to be determined by a trial before a judge.
We will continue to follow any developments that occur with both of these class action lawsuits and will provide updates on this blog as they become available.
The personal injury lawyers at Cuming & Gillespie Lawyers have many years of experience litigating claims on behalf of accident victims. We provide free consultations for new clients to review your case and discuss potential options. Contact our office today online or call 403-571-0555 to make an appointment. We look forward to helping you obtain the compensation that you deserve.