We’ve all been in the situation where we do something – crash a bike, step wrong on thawing ground, trip over a damnedbeloved pet – that leaves us with a painful injury that doesn’t go away. And when that happens, we go to the doctor to verify we’re not badly injured, and possibly pick up some anti-inflammatories. For most of us, when this happens, our skin won’t slough off, we won’t end up in a burn unit for treatment, and we won’t be in a medically induced coma for months.
Most of us aren’t Karen Bartlett, who suffered a rare side effect of NSAIDs when she took sulindac: toxic epidermal necrolysis. Aside from the extreme trauma of seeing your skin shed off you like wet tissue, Ms. Bartlett suffered permanent damage to her esophagus and lungs, and was left legally blind.
Rather understandably, Ms. Bartlett sued the manufacturer of sulindac, Mutual Pharmaceutical Company, the manufacturer of the generic formulation she took. She argued the drug design was defective and dangerous, and she won both the case and the appeal. Mutual Pharmaceutical Company, apparently attempting to live up to the reputation of pharmaceutical companies everywhere, has continued to appeal the decision against them, and this month the Supreme Court of the United States will hear the case.
At crux, Mutual Pharmaceutical Company is arguing that because they have no control over the design of the drug, they are not liable for any injuries sustained from taking it; they say this is the same as a recent SCOTUS ruling that does not allow patients to sue generic manufacturers for warning labels, as the company has no control over that information.
The problem I have with this argument is that we know that this is patently false. In October of 2012, the FDA removed approval of Budeprion XL 300, a generic version of Wellbutrin XL 300 manufactured by Impax and marketed by Teva. Why? Because their formulation was not therapeutically equivalent, and likely never had been.
The Impax/Teva Budeprion XL 300 was approved in December 2006; given that 80% of prescriptions filled in the United States are generic, it’s safe to say that quite a few generic prescriptions for Wellbutrin XL 300 were filled in that time. Almost immediately, the FDA began receiving reports that the generic form of the drug was not therapeutically equivalent; patients experienced reduced efficacy. Reduced efficacy is a polite way of saying that patients, many of whom were severely depressed, weren’t receiving any benefit from taking the drug, something I think we would all agree is a harm. And yet patients were taking this ineffective drug for six years, because the FDA was unable to quickly move to investigate the bioequivalence of Budeprion XL 300 to Wellbutri XL 300.
Clearly, generic manufacturers have the ability to change formulations, whether they should or it’s legal aside.
Generic manufacturers say that allowing juries to award damages to patients harmed by generics trumps the authority of the FDA, and the FDA is grudgingly siding with manufacturers on this. The problem here is that this argument presumes two things:
- that the FDA always has all information regarding a pharmaceutical, something that Vioxx alone clearly indicates isn’t true;
If you want to read more about pharma behaving badly, hiding clinical trial results, etc, check out Carl Elliott’s White Coat Black Hat and Ben Goldacre’s Bad Pharma. - that the FDA has the ability to move quickly to protect patients, something the Budeprion XL 300 example shows is not the case.
Lawsuits are one of the few ways it seems that patients have any ability to advocate for themselves – and, as Ms. Bartlett’s lawyer notes, force pharmaceutical companies to reveal information that they often take effort to squelch. Hopefully SCOTUS recognizes both the limitations of the FDA and the need to give patients a venue wherein they can hold manufacturers accountable for damages inflicted by the product they produce.