A recent study on UK patients conducted by the researchers at the University of Pennsylvania* could have an impact on Accutane lawsuits. As most know, class actions as well as individual lawsuits have attempted to hold the manufacturer of Accutane, Hoffman-LaRoche, accountable. The Vitamin-A drug has been linked to inflammatory bowel disease, or IBD.
But wait a minute—so too are tetracycline drugs, say the U of P researchers.
So how does that impact an Accutane lawsuit?
Accutane (isotretinoin) has always been considered a last resort for problematic acne, which is the scourge of adolescents and, if left untreated, could scar the face for life.
Dermatologists will almost always start with more natural ways in which to control acne, such as diet and hygiene—or perhaps an OTC benzoyl peroxide or salicyclic acid solution.
If that doesn’t work, then they turn to tetracycline, which is an antibiotic and thought to carry minimal risk. How can you go wrong with an antibiotic, a microbial? Are they not the magic bullets of our society?
Antibiotic resistance notwithstanding, there’s now a fly in the ointment, if you will. That’s because the large cohort study on British patients conducted by U of P researchers found a link between tetracycline-classed drugs and IBD.
Some tetracyclines were worse than others, but the fact remains: IBD may not be isolated to isotretinoin.
Thus, did an Accutane patient’s IBD have its roots in the tetracycline the patient may have been prescribed before being advanced to isotretinoin?
Dermatologists attending the annual general meeting of the American Academy of Dermatology earlier this year agree that more research has to be done.
However, if the U of P tetracycline research is given any credence in the courts, it may pose a sticky wicket for Accutane plaintiffs. An isotretinoin lawsuit would have to be tempered according to whether, or not, the Accutane plaintiff had been on tetracycline therapy before starting Accutane. Chances are good that would have been the case.
And what does this say about tetracycline? Did manufacturers of tetracycline drugs know about the possibility of IBD prior to this, but kept mum?
As discovery continues to wind along a complicated path, could the new complexity with regard to Accutane lawsuits be offset by a new ‘market’ for tetracycline litigation?
The fallout could be huge. Antibiotics are used by the masses. And with acne a common scourge of teens, tetracycline is a common response. Isotretinoin (still available in generic form, even though Accutane has been pulled) is only used for problem cases, whereas tetracycline is available, and is used by a vast number of patients.
Dermatologists are watching this one. But so too, will be the legal community.
*The U of P research was published in the American Journal of Gastroenterology, 2010; 105:2610–2616; doi:10.1038/ajg.2010.303; published online 10 August 2010. “Potential Association Between the Oral Tetracycline Class of Antimicrobials Used to Treat Acne and Inflammatory Bowel Disease“; Authors: David J Margolis MD, PhD, Matthew Fanelli MD, Ole Hoffstad MA and James D Lewis MD, MSCE.