Drugs and medications are often the source of product liability claims that stem from patient injury or illness. Although all pharmaceutical companies have a duty to make sure their products are properly tested under U.S. Food and Drug Administration guidelines, the fact that a drug is approved does not shield the manufacturer from liability if the drug proves defective.
Many of these cases involve failure to warn. That is, while some products may be unavoidably unsafe (the drug is unsafe no matter how carefully its made, but it still has benefits), the company has a duty to adequately warn users of those dangers. This can be accomplished by directing warnings to “learned intermediaries,” such as the doctor or pharmacist.
Product liability lawsuits are often complex and challenging. Recently, the Arizona Supreme Court issued a ruling that may make it somewhat easier for victims of defective drugs in that state to bring claims against drug companies that fail to make safe drugs or adequately warn of the risks.
In Watts v. Medicis Pharmaceutical Corp., the court ruled that prescription drugs may be considered “merchandise” for the purposes of bringing action under the state’s Consumer Fraud Act. Further, the court held that state law does not require a direct merchant-consumer transaction in order to support a patient’s claim against a drug manufacturer.
Defendant is manufacturer of a drug called Solodyn, which contains a substance called minocycline. In the full prescribing materials issued to doctors, the manufacturer warns that long-term use of the drug may result in “lupus-like syndrome,” vasculitis and autoimmune hepatitis. It cautioned that patients experiencing rash, fever, malaise or arthralgia should stop taking the drug immediately.
In 2008, plaintiff was a minor who sought medical treatment for acne and was prescribed this drug by her doctor. Patient was not informed of the specific information above, but she did receive packets of information indicating the safety of the drug’s use for longer than 12 weeks wasn’t known and that she should consult a doctor if her symptoms hadn’t improved within that time frame. She was prescribed the drug for 20 weeks.
Two years later, she received another prescription for the drug and again was prescribed to take it for 20 weeks. She was ultimately diagnosed with lupus and hepatitis and had to be hospitalized. Doctors say she will live with lupus for the rest of her life.
She filed a product liability lawsuit against defendant manufacturer, alleging product liability and consumer fraud. She sought both compensatory and punitive damages. As far as her consumer fraud claim, she asserted the company advertised the drug in a way that misrepresented and omitted critical facts and that the company did not adequately warn her of the risk of long-term use.
A superior court granted defense motion to dismiss. Appeals court vacated that judgment and remanded the case. The state supreme court granted review.
The court noted that most claims of strict product liability have to be based on some informational defect regarding the instructions or warnings that cause the drug to be unreasonably dangerous or defective. In some situations, though, the manufacturer/ supplier duty to warn end users can be limited if proper warnings are given to an intermediary, and that person has a duty to then pass the information on to the end user. This is the learned intermediary doctrine.
This doctrine is not a blanket immunity, and drug makers do still have a duty to inform prescribing doctors of the risk. In that situation, the patient could claim damages from the doctor. The state supreme court rejected plaintiff’s assertion that the learned intermediary doctrine was no longer viable.
However, the court rejected the manufacturer argument that prescription drugs are not “merchandise” because there isn’t a direct merchant-to-consumer transaction between the maker of the drug and the end user. The court held the statute doesn’t directly require this, and what’s more, the court found plaintiff’s argument on misrepresentation persuasive. Although the company told learned intermediaries there were known severe side effects if the drug was taken longer than 12 weeks, it told patients the effects of use longer than 12 weeks was “unknown.”
Contact the Carolina injury lawyers at the Lee Law Offices by calling 800-887-1965.
Watts v. Medicis Pharmaceutical Corp., Jan. 21, 2016, Arizona Supreme Court
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