Will Blood Pressure Medicine Recall Lead to Lawsuits?

An impurity in common heart and blood pressure medications has prompted massive drug recalls. The impurity places patients at risk of developing cancer.

The recalls began in 2018 and have consistently expanded throughout January and February 2019. They are focused on three drugs that account for over 77 million prescriptions annually.

Pharmaceutical companies often face lawsuits when they market products that harm patients. Those lawsuits are not easy to win, as it is often difficult to prove that a particular harm (in this case, cancer) was caused by a particular drug. Since cancer is often slow to develop, it may be years before the legal liability of drug companies that sold cancer-causing blood pressure medication becomes clear.

Recalls Announced

The most common blood pressure medication that places patients at risk of cancer is valsartan. Only certain batches of valsartan are contaminated. The contaminated drug is marketed by at least ten companies and is often combined with other drugs, such as amlodipine and hydrochlorothiazide (HCTZ). The Food and Drug Administration (FDA) has created and periodically updates a list of all the valsartan medications that have been recalled.

Recalls of losartan (typically marketed as losartan potassium, sometimes in combination with HCTZ) have been announced by Torrent Pharmaceuticals and Macleods Pharmaceuticals. Anoter drug, irbesartan, has been recalled by ScieGen Pharmaceuticals (d/b/a GSMS and Westminster Pharmaceuticals) and Prinston Pharmaceutical (d/b/a Solco Healthcare).

The recalled drugs have been contaminated with either NDMA or NDEA, chemicals that are typically produced as industrial manufacturing byproducts. Humans are not often exposed to either chemical, but animal studies provide persuasive evidence that both chemicals are carcinogenic. Studies of NDMA have linked the chemical to colorectal cancer as well as cancer of the liver, lungs, and kidneys.

The affected medications all appear to have originated with a Chinese manufacturer, Zhejiang Huahai Pharmaceuticals. The contamination seems to be related to a change in the manufacturing process that was implemented in 2012.

Cancer Risks and Contaminated Blood Pressure Medication

While the FDA notes that the chance of acquiring cancer by ingesting any of the recalled products is small, minor risks produce large numbers of cancer patients when the risk is multiplied by a drug that is consumed by millions of people. The FDA’s scientists believe that one out of every 8,000 people who take the contaminated drug will acquire cancer. That seems like a small risk, but if 77 million people took one of the recalled drugs in just one year, the FDA’s calculations suggest that 9,625 of those people will acquire cancer from the contaminated medications.

A study in Denmark that examined individuals who took contaminated valsartan found no “markedly increased short term overall risk of cancer.” However, valsartan is not widely prescribed in Denmark, and the authors acknowledged that they were unable to follow patient populations for more than a few years. The long-term risk of developing cancer should be significantly higher than the short-term risk.

The FDA claims that it is unaware of any patient acquiring cancer from the contaminated blood pressure drugs. However, the FDA is extraordinarily reluctant to link any individual’s health condition to a recalled drug.

The FDA’s data makes a convincing case that the contamination is likely to cause thousands of people to develop cancer. Will patients be able to sue the companies that marketed the carcinogenic drugs?

Legal Liability

Federal laws and court decisions can make it difficult to bring a successful lawsuit based on a dangerous drug that has been approved by the FDA. Product liability claims are often based on a drug company’s failure to warn patients about the risks of using a medication. Those lawsuits have spawned confusing and conflicting court decisions about the circumstances under which FDA approval of a drug label preempts “failure to warn” lawsuits.

As a general rule, drug companies have an obligation to change their warnings after they learn of information that makes a drug dangerous, provided that the information was not known when the FDA approved the drug label. That rule may overcome preemption defenses to “failure to warn” lawsuits against companies that marketed contaminated blood pressure medication.

More importantly, the FDA did not approve valsartan or other blood pressure medications that contained NDMA or NDEA. Since the FDA did not approve the sale of contaminated drugs, FDA approval should not be the basis for a preemption defense.

Companies that purchased contaminated drugs from a manufacturer in China and failed to detect the contamination were likely negligent. That negligence would probably support a lawsuit against the responsible drug company under the law of every state.

Proof Problems

The larger roadblock to successful lawsuits will be the difficulty of proving that any particular patient’s cancer was caused by a contaminated blood pressure medication. Drug company lobbyists have convinced most state legislatures to adopt strict rules governing the kind of expert evidence that can admitted at a trial to prove the causal link between a dangerous drug and a patient’s disease. If experts cannot rule out every other possible cause of cancer, many judges will refuse to admit the testimony of an expert who concludes that a particular drug was the most likely cause of cancer.

Cancer patients who took a contaminated blood pressure medication should seek legal advice. The likelihood that they can bring a successful lawsuit will depend upon a number of facts, including the kind of cancer they acquired, other risk factors that may have produced that cancer, further medical research about the effects of taking drugs contaminated by NDMA or NDEA, and the law of the state in which the cancer patient was living when the contaminated drugs were consumed.

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