As I’ve written before, anti-consumer legislators and judges have so thoroughly eviscerated claims against pharmaceutical companies that in most states there’s only a single claim left: the claim that brand-name drug manufacturers failed to warn about the risks of the drug. For example, the IUD Mirena causes pseudotumor cerebri, but the label says nothing about that.
As long as the company warned about the risks of the drugs, they’re essentially immune from liability, even if the drugs weren’t properly tested, even if they were deceptively marketed, and even if the drug didn’t perform as promised. (Sometimes state and federal attorneys general can sue over drugs that were falsely marketed, like how Johnson & Johnson was just walloped for $1.2 billion in Arkansas for improper marketing of Risperdal, but consumers can’t, because those same legislators and judges have delivered mortal wounds to most consumer class actions.)
A slim 5-4 majority of the Supreme Court disappointingly killed the vast majority of generic drug liability last year with PLIVA, Inc. v. Mensing (#1 on my list of most unfair drug and medical device court opinions). Manufacturers of the brand-name drugs that are still under their patents could kill almost all of the rest the litigation if they just bothered to warn consumers about the real side effects of their drugs. But they won’t. As I wrote in November about Propecia, the pharmaceutical industry is simply too dependent on blockbusters and marketing, and so try to squeeze every penny out of each drug, patient safety and lawsuits be damned.
That is, of course, until the FDA awakens from its slumber every now and then and makes the companies fix their labels. Just last week, the FDA released two prescription drug label changes, one for Propecia, another for Beyaz, Safyral, Yasmin and Yaz.
Propecia (new label here, FDA release here) will warn about “libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug” with the patient insert noting “reports” of “difficulty in achieving an erection that continued after stopping the medication,” the same sexual side effects in the consolidated lawsuits in New Jersey.
Yasmin / Yaz (new label here, FDA release here) will warn about blood clots or, in the uniquely hand-wringing way drug labels describe deadly risks, it will warn that:
[S]ome epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.
Yasmin’s patient insert is more informative than the warning label itself, noting, “Like pregnancy, birth control pills increase the risk of serious blood clots … Women who use birth control pills with drospirenone (like Yasmin) may have a higher risk of getting a blood clot.”
What Bayer, Merck, and the FDA expect consumers to do with that sort of equivocation is anybody’s guess. (At least it’s better than NuvaRing, which has those same blood clotting risks only they’re twice as likely, not that the prescribing information mentions that.) Given the financial incentive drug companies have to conceal risks, and how slow the wheels turn at the FDA’s bureaucracy, it usually takes a long time for labels to be updated to show their true risks. Hundreds of Actos lawsuits have been filed, but the Actos warning label still only admits “There may be an increased chance of having bladder cancer when you take Actos,” and hundreds of Pradaxa deaths have been reported, but the Pradaxa patient medication guide says only “Pradaxa can cause bleeding which can be serious, and sometimes lead to death,” without a word discussing the lack of a reversal agent or the comparative risk to warfarin.
I raise the actual text of the labels not to address their adequacy per se, but to address another issue near and dear to my heart as a plaintiff’s lawyer: whether or not a FDA labeling change is a “subsequent remedial measure.”
Continue Reading Yaz and Propecia Labels Updated; Are They Subsequent Remedial Measures?