Yaz and Propecia Labels Updated; Are They Subsequent Remedial Measures?
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.
[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.”
As every law student learns either in their Torts class or Evidence class or both, Federal Rule of Evidence 407 says:
When measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove:
- culpable conduct;
- a defect in a product or its design; or
- a need for a warning or instruction.
But the court may admit this evidence for another purpose, such as impeachment or — if disputed — proving ownership, control, or the feasibility of precautionary measures.
Lawyers refer to this in shorthand as “subsequent remedial measures,” even though that phrase is no longer in the Rule itself. As the notes to Rule 407 say, the primary purpose of the Rule is to further “a social policy of encouraging people to take, or at least not discouraging them from taking, steps in furtherance of added safety.” The notes also say that Rule 407 is limited in its application: “Exclusion is called for only when the evidence of subsequent remedial measures is offered as proof of negligence or culpable conduct.” I.e., even if something a defendant did qualifies as a “subsequent remedial measure,” plaintiffs can still introduce it as evidence at trial to prove issues like notice, control, and causation.
In every drug injury case I’ve seen, the drug makers argue that every change to a drug’s warning label is a “subsequent remedial measure,” and so Rule 407 always prevents plaintiffs from showing those updated warning labels to the jury, regardless of circumstances. Here’s the defense lawyers at Drug & Device Law arguing exactly that. I don’t give too much stock to any of their three arguments, because I think they miss the point: the updated warning labels are undeniably relevant to a host of issues other than proving “negligence, culpable conduct, a defect in a product or its design, or a need for a warning or instruction.”
Truth is, drug injury plaintiffs aren’t the ones who bring the FDA warning labels into these cases, drug companies are. And they beat the issue to death. You can’t go ten minutes in a drug injury trial without a defense lawyer referencing the FDA’s approval of the warning label, or claiming that the drug manufacturer had no power to modify the warning label without FDA approval.
Judge Laplante saw through the drug companies’ shell games and got it exactly right in Bartlett v. Mut. Pharm. Co., 2010 DNH 131, 2010 U.S. Dist. LEXIS 111259 (D.N.H. 2010):
Given that Mutual intends to use the FDA’s approval of Sulindac’s label as evidence of the label’s adequacy (which is an element of Mutual’s ‘comment k’ defense, see Bartlett, 731 F. Supp. 2d 135, 2010 DNH 112, at 25-26 (discussing Restatement (Second) of Torts § 402A, cmt. k (1965))), this court does not consider it unfairly prejudicial for Bartlett to counter with evidence that the FDA changed that label less than two years later, especially to the extent that the FDA relied on information available to Mutual at the time of Bartlett’s prescription. One might even argue that it would be unfairly prejudicial to prevent Bartlett from responding in kind.
I previously discussed Restatement of Torts 402A Comment k. You don’t have to look far to find a drug company claiming FDA approval is the end-all, be-all of the case. Take a look again at my list of the most unfair prescription drug and medical device opinions of last year, and look at #8, Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. 2011). It was an Effexor suicide case, and the court dismissed the plaintiff’s claims entirely because it concluded as a matter of law that the FDA would have rejected the warning label proposed by the plaintiffs.
What’s good for the goose is good for the gander: if defendants can make the whole trial about FDA approval of their warning labels, then plaintiffs should be able to rebut that argument by showing how the FDA eventually mandated a strong warning label — just like what just happened with Propecia and Yasmin / Yaz.
Moreover, considering how defendants routinely also deny their drugs caused the plaintiffs’ injuries, plaintiffs should be able to tell the jury that the defendants and the FDA both agree that the drugs can indeed cause those injuries.
Excluding the labeling changes wouldn’t be bad news for the 60 or so Propecia plaintiffs and the over 11,000 Yaz / Yazmin / Ocella plaintiffs — because their claims are already in my humble opinion quite strong — but the plaintiffs’ lawyers would certainly prefer to introduce at trial evidence that the drug company eventually conceded the exact risk the plaintiffs are suing over, and now do indeed warn their consumers about it.