The Alabama Supreme Court recently reaffirmed that patients are allowed to sue drug makers who mislead doctors into believing that prescription medicines the companies market do not cause harmful side effects. The case is Weeks v. Wyethand the same decision came again this year after the Supreme Court was asked to revisit the case from last year. We represent the injured patient, Danny Weeks.
The ruling of our Supreme Court protects both doctors and patients in Alabama from using outdated drug labels.
It is important to know why this ruling is important to doctors and patients, why it is not a departure from long standing Alabama law, and why the overreaction from the pharmaceutical industry is a fear tactic with no merit.
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Here is how this works. Prescription drugs have a label or package insert, which is a critical document for doctors and required by the FDA. The label should include all dangers and risks that the drug company knows about the drug so that doctors will know these risks to be able to decide if a drug is right for the patient.
The brand company which manufactures and develops the drug is, by law, responsible for the drug label contents. This means that any new dangers and risks the drug company learns over time should be updated in the drug label to inform doctors.
After the patent for a brand drug expires, generic drug makers may enter the market. Generic drug makers are not required to test the drug; they must simply convince the FDA that their product is the same and bio-equivalent to the brand drug. If the generic is not the same as the brand drug, the FDA will not approve it.
By law, generic drug companies cannot alter, update or modify the drug label. By law, the brand maker continues to be responsible for the drug label.
Our client, Danny Weeks, was prescribed the drug Reglan to treat his acid reflux. A pharmacist filled the prescription substituting a generic, bioequalivent, lower cost version for Reglan, the brand drug prescribed. Alabama law allows pharmacists to substitute generics because they are the same drug as the brand. The Alabama Legislature and insurance companies support this because generics save money and are allowed on the market only after years of the brand manufacturer holding a monopoly on the drug and charging prices to profit from the drug development.
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At the time Reglan was prescribed, the owner of the drug label, Wyeth (now Pfizer) had not updated the label to warn against tardive dyskinesia. Reglan is known to cause this crippling and permanent disease, similar to Parkinson’s disease. After taking the drug, Danny Weeks was diagnosed with tardive dyskinesia.
Long-standing Alabama law allows a person who has been injured by the fraud of another to sue for damages. By law in Alabama, the manufacturer of a drug has a legal duty to warn doctors of all dangers and risks of the drug by putting information in the label or by other means. In this case, the failure of Wyeth to update the drug label is fraud under Alabama law.
Regardless of what some alarmists claim, this decision is not an obstacle to business coming to Alabama. What this decision should do is tell pharmaceutical brand makers that they cannot stop informing doctors about risks of the drug they developed when the drug goes generic.
The Alabama Supreme Court, not the legislature, is responsible for enforcing the law and it did so by applying legal principles that have existed for more than 80 years to the facts of this case to the benefit of doctors and their patients.