In the appeal of the Karen Bartlett case, recently accepted for review by the U. S. Supreme Court, the issue to be determined is whether the makers of generic pharmaceutical products can ever be held liable for the injuries caused by their drugs.
The court will talk in terms of “preemption” (one form of Federal intrusion favored by the far-right wing of the Court), but the real effect of their decision could be complete immunity for the generic manufacturers.
The high court has already given such immunity to generic manufacturers when the warning label is defectively insufficient, but now the Bartlett case will decide whether that immunity will be extended to drugs that are defectively designed.
While the Court considers this grant of blanket immunity to companies that don’t deserve it (as they are profiting from drugs they didn’t even bother to develop and test themselves), one would hope that the Justices realize that Ms. Bartlett suffered one of the worst fates that can befall any human being – toxic epidermal necrolysis.
Aside from being burnt alive over 60% of her body surface area, the burning reaction to the drug also attacks the mucosal linings of the eyes, mouth, esophagus, rectum and vagina. Her permanent injuries include blindness and difficulty swallowing, in addition to horribly disfiguring scars.
It is not uncommon in a TENS reaction for patients to be put in a humanitarian coma for months at a time as the only possible relief from the searing unrelenting agony. Unlike being burnt from an actual fire, the nerve cells of TENS patients remain intact and transfer all the pain that anyone could imagine.
Ms. Bartlett’s doctor testified that her condition was “hell on earth.” TENS patients are sent to burn units, the only places able to treat them (where they amputate limbs and then strip away the living skin and replace it with cadaver skin), since pharmaceutical companies have invested nothing in special treatments for these victims. Nor have they as an industry developed any testing that would help identify those individuals who might be prone to suffer such reactions to certain drugs.
As a whole, the industry has shirked any responsibility because they rarely face consequences in court due to a variety of tort reform and “FDA defenses.”
In Ms. Bartlett’s case the drug was a non-steroidal anti-inflammatory known as Suldinac. However, Suldinac does not work the way other drugs in this class do; it first has to be transformed by the patient’s liver into the substances that inhibit inflammation. This makes Suldinac more dangerous for the liver itself.
The original maker of the drug suggested intestinal benefits from this approach, but there are other non-steroidal anti-inflammatories on the market known as COX-2 inhibitors that already do a better job in that regard. So here we have a company putting out an unnecessary generic drug that foreseeably caused a great injury, and they don’t want to bear any responsibility. Shame on them and any court that would go along with such a federalized scheme. The First Circuit Court of Appeal did not agree with such a result and said there would be no preemption where the drug has a defective design. Let’s hope a majority of the U.S. Supreme Court agrees.
M. Robert Blanchard is a former prosecuting attorney, trial lawyer and writer living in Gulf Breeze, FL.
More information on defective drugs.