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Litigation concerning injuries from the heparin recall, a prescription injectable blood coagulant often used in hemodialysis (the filtering of blood) and cardiac invasive procedures, has begun. To find out what causes of action are being alleged, we asked Douglass Kreis, a Florida attorney whose firm protects the rights of consumers who are seriously injured due to defective drugs such as heparin. He explained that the following causes of action are typical and that most of these would be viable in heparin lawsuits:

Strict liability / negligence / fraud / warranty. We believe strict liability would apply here as it does to most pharmaceutical product defect cases that were defectively designed, manufactured or where they failed to warn consumers of the dangers associated with the product. You could also bring a negligence claim or a negligent misrepresentation claim – as well as a fraud-based claim such as fraudulent misrepresentation. There are also warranty claims, both express and implied, as well as a statutory state based unfair and deceptive trade practice cause of action.

Manufactures were clearly negligent

Kreis says that he believes manufacturers are going to have a difficult time defending this litigation and that the preemption impediment isn’t something they can claim. He continued:

Manufacturers were clearly negligent from the standpoint of not inspecting plants and not doing presale routine analysis of the product that was being sold. I really think there was a breakdown in the post marketing surveillance. But, we have to remember that this is really an acute event relative to some of the other litigation that we’ve been involved in. Instead of a pill that’s ingested, there is a disease process here that starts after a long duration of use or based on a certain amount of dosage. Here we have something that is being injected directly into the bloodstream and you have a very close relationship between the introduction of heparin to the bloodstream and the symptomology that stems from it.

We think that Baxter not only failed to inspect the plants, but they were apparently getting a product that was entirely unregulated and unscreened. We believe that they were likely playing games with the recall and trying to make it smaller in scope and broadening the net gradually. So, the question remains: how many people were hurt between the January recall and the late February recall. I recall that Baxter had been selling the product at the rate of about 100,000 vials a day.

Heparin cases are ‘preemption proof’

Kreis says that preemption isn’t a defense that manufacturers can claim here. He explained why:

We believe that this case is preemption proof for various reasons. Number one, it’s a pharmaceutical and not a medical device. The recent case of Reigel vs. Medtronic does not affect this litigation. There is an upcoming Supreme Court decision that may have some implications but given another pharmaceutical case decision, which resulted in a 4-4 tie, we think that the court understands the difference between medical devices, which undergo a complete 360 evaluation, and a pharmaceutical, which does not undergo a heightened scrutiny. But there’s really no legal impediment from where we stand right now.

Even assuming that the holding in Reigel is applied to pharmaceuticals and the Supreme Court essentially says that the process of a product getting to market is sufficiently scrutinized by the FDA such that a person doesn’t have a private civil right of action that invades the province of the FDA, it probably still won’t fly. Justice Scalia, in an eight to one opinion, talked about what we call parallel requirements in the Reigel decision. That means that you can still bring a state cause of action under negligence or strict liability as long as it doesn’t regulate any more than what was regulated within the PMA or the FDA. That leads us to Number two: that Baxter clearly violated federal regulations. That meets the parallel requirements test of Riegel were it to ever apply to a pharmaceutical (which it should not as the cross application of Riegel would bastardize preemption law and its main thrust).

Every case has three legs

According to Kreis, every case has three legs. “You’ve got liability, damages and causation in which the liability gave rise to the damages. Within causation, you’ve got specific causation and general causation. I don’t think that it’s going to be difficult for us to find experts that can testify about how the adulterated product would cause the symptoms that we’re seeing. But specific causation will be interesting because there is such a short temporal span. There won’t have been other products or agents introduced into the person’s body that could have caused this and there may be a question as to whether or not you’ve got possible physician liability and medical malpractice as well. “

If you’ve been injured due to heparin use, contact an attorney to discuss your situation. The consultation is free and without obligation. To contact a qualified attorney whose practice focuses in this area of law, please click here.