In a 5-4 ruling today the Supreme Court ruled that generic drug manufactures can not be held liable for failing to properly warn about known adverse reactions to their generic versions of brand name drugs.
The ruling was prompted by a lawsuit from two women (Gladys Mensing and Julie Demahy) who developed tardive dyskinesia after taking a generic form of Reglan(metoclopramide). Tardive dyskinesia is a severe neurological disorder that causes degradation of motor skills & tremors. The symptoms are similar to those found in Parkinson’s Disease. Reglan is a motility drug that goes beyond the blood brain barrier & is used in the USA for treatment of things like Gastroparesis & acid reflux. While safer alternatives are available outside the USA, such as Domperidone, there aren’t really any viable alternatives in the USA besides the herbal Iberogast or Erythromycin(which has it’s own risks).
Back in 2000 & 2001 when the plaintiffs were prescribed Reglan, the labeling consisted of the following:
“tardive dyskinesia . . . may develop in patients treated with metoclopramide,”
…and the drug’s package insert added:
“[t]herapy longer than 12 weeks has not been evaluated and cannot be recommended.”
Which is wrong, because for almost as long as Reglan has been available, tardive dyskinesia has been associated with it & the longer you take Reglan, the likelier the chances are that you’ll experience side effects. Merely saying it hasn’t been evaluated & cannot be recommended doesn’t correctly express the risks to the patient. In other words, putting your head in the sand doesn’t make the risk any less or lessen your requirements to properly inform those taking your drug.
The plaintiffs felt that this labeling was inadequate in describing the danger & risk associated with taking the generic form of Reglan. They sued Pliva Inc, the manufacturer of the generic Reglan they were prescribed under their state’s tort laws. Under the plaintiff’s state laws, drug manufacturers must have adequate & accurate labeling that does not downplay the serious risks of taking the drug.
The plaintiffs had a point because in 2004, Schwarz Pharma, the manufacturer of the brand name version of Reglan, requested the FDA to allow for the labeling to include:
“[t]herapy should not exceed 12 weeks in duration.”
In 2009 the FDA acted on it’s own in giving Reglan a much more stern & less ambigious “black box” warning of:
“Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. . . . Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases.”
Basically the dangers of Reglan have been known for over two decades & the warning labels have always been inadequate as far as relating the serious possibility & consequences of developing of tardive dyskinesia.
Pliva, Inc’s defense to the accusation that they were not meeting the requirements of the state laws was that they were bound by FDA regulations stating they must have the exact same labeling as the brand name manufacturer. Thus they cannot comply with the state laws, even if they know the labeling is inadequate because they do not have the ability to change the labeling.
The court majority essentially agreed with this stating that the conflicting state & federal laws created a situation that made it impossible for generic manufacturers to carry proper labeling.
However, the dissenting opinion offers a very different picture. Writing for the minority, Sonia Sotomayor makes many good points to the contrary of the court’s decision.
“[The court’s decision] effectively rewrites our decision in Wyeth v. Levine, 555 U. S. 555 (2009), which holds that federal law does not pre-empt failure-to-warn claims against brand-name drug manufacturers.”
Under federal law, generic manufacturers must “develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences”
Generic manufacturers must also submit to the FDA an annual report summarizing “significant new information from the previous year that might affect the safety, ef-fectiveness, or labeling of the drug product,” including a“description of actions the [manufacturer] has taken or intends to take as a result of this new information.”
According to the FDA, however, that generic manufacturers cannot disseminate additional warnings on their own does not mean that federal law permits them to remain idle when they conclude that their labeling is inadequate.
The Manufacturers contend that it was impossible for them to provide additional warnings to respondents Mensing and Demahy because federal law prohibited them from changing their labels unilaterally. They concede,however, that they could have asked the FDA to initiate a label change.
She also brought up the FDA “changes being affected” labeling regulation that played a large part in the Wyeth v. Levine trial. Basically the “changes being affected” regulation allows for manufacturers of drugs to update their labeling in certain ways before the FDA officially approves it. This allows manufacturers to properly disclose new found dangers to the public in a timely manner, without having to wait on the FDA.
What’s really odd here is that the court’s decision & the argument by the manufacturer seems to be stating that the generic drugs must be exactly like the brand name as far as bio-availbility & labeling goes, but not as far as legal liability goes. They have to be so equal that they’re not equal… Huh?
The ruling has big implications because it essentially tells generic drug manufacturers that they can make money off of drugs they know to be unsafe, with inaccurate labeling, without fear of being held liable. By going with the cheaper generic you are now essentially waiving your right to sue the manufacturer for harm caused to you by their product.
What with many states allowing pharmacies to substitute brand name drugs for generics without consent or with merely a small sign on the wall stating the policy, this decision seems entirely misguided & a major win for unethical drug manufacturers