Ordinarily, American law says that you can sue a company only if you used the company’s product and that product injured you. Due to an odd quirk of pharmaceutical law, people who live in several of the United States are about to learn whether that fundamental principle remains true.
The United States Food and Drug Administration tells pharmaceutical manufacturers what the manufacturers can say on a drug’s labeling. For the innovator-manufacturer – the company that discovered a new molecule and turned it into a drug – the FDA occasionally lets the manufacturer make changes to the labeling without first obtaining FDA approval. But the labeling on the generic version of the drug – a copycat of the original molecule, allowed on the market several years after the innovator drug appears – cannot be changed at all. The labeling on the generic must be exactly the same as the labeling on the innovator’s version of the product.
This difference in regulation has led to a quirk in American law. Because innovators have some control over their products’ labeling (innovators can occasionally make unilateral labeling changes) patients who allege that they were injured by an innovator’s product are permitted to sue the innovator for having “failed to warn.” Patients can say that the manufacturer didn’t tell the patient all of the risks of the product. But because generic manufacturers have no control over the content of the labeling (the labeling must be precisely the same as on the innovator’s product) people who allege that they were injured by a generic’s product are not permitted to sue the generic manufacturer for failure to warn.
What’s an injured patient to do?
Many patients allegedly injured by the failure of a generic drug’s labeling to give adequate warnings have now sued companies that did not manufacture the product. Instead of suing the manufacturer of the product that the patients took – the generic company – these patients have sued the innovator instead. The theory is that although the innovator didn’t manufacture the product, the innovator controlled the labeling. The innovator is therefore responsible for a failure to warn even though the innovator didn’t manufacture the drug that the patient took and had no other relationship with the patient.
Innovator-manufacturers of course insist that this is an outrage. Centuries of tort law hold that a consumer can sue only the company that manufactured the product that the consumer used. If innovator-manufacturers are responsible for the damages caused by generic versions of a drug, innovators will face limitless liability and lose the incentive to develop new drugs. And innovators, of course, have spent huge sums of money researching and developing new drugs, while generic-manufacturers have invested comparatively little.
Injured patients, however, say that they shouldn’t be left without a remedy: suppose a patient was hurt by a failure of a generic drug’s labeling to warn of a risk. The patient can’t sue the generic manufacturer. And the patient surely shouldn’t be left without a remedy. The only solution is to let the patient sue the innovator-manufacturer, which controls the labeling, even though the innovator didn’t manufacture the product that injured the patient.
To date, the innovator-manufacturers have won most of the cases on this issue. Courts have generally reasoned that a patient cannot sue a company that didn’t manufacture the product the patient used.
But the year 2018 is likely to see this issue finally resolved. The supreme courts of three different states – California, Massachusetts, and West Virginia – all currently have cases on their dockets that present precisely this issue.
If all three states rule that patients who took generic drugs cannot sue manufacturers of innovator drugs, it’s likely that this issue will wither on the vine. Other states will probably follow the lead of the first three states to rule.
On the other hand, if all three states rule that the patients are able to sue the innovator manufacturers, then the floodgates of liability for innovators will have opened.
If the courts split two to one, however, then two things will happen: First, every patient allegedly injured by a generic drug will struggle to find a justification to sue the innovator-manufacturer in the state that allows innovator liability to exist.
And the fight over this issue will go on into the future, as more state courts are faced with this issue and must decide whether to allow a novel theory of liability in unusual circumstances.
Featured image credit: Meds by Charles Williams. CC BY 2.0 via Flickr.