Last week, our firm blog posted a short note about how Actos patients with bladder cancer in Kentucky, Louisiana, and Tennessee should move quickly to file because those states have a one-year statute of limitations for personal injury actions. We (and a whole bunch of other lawyers) assume that Takeda Pharmaceuticals will argue that the statute of limitations began to run on June 15, 2011, when the FDA issued an updated warning that one year of Actos use increases the risk of bladder cancer by more than 40%.

As if on cue, the next day Pfizer moved for summary judgment on a whole swatch of consolidated Chantix neuropsychiatric lawsuits (not to be confused with the SSRI birth defect lawsuits), arguing that the statute of limitations for those claims began to run on July 1, 2009, when the FDA mandated the box for the medication warn that the medicine was associated with “serious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide …”  On that day, Pfizer also sent out a “Dear Healthcare Provider Letter” notifying prescribing physicians about the change, and there was also some media coverage. 
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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.”


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A few days ago I reviewed the list of “worst” pharmaceutical and medical device liability court opinions of the last year as chosen by the defense lawyers at Drug & Device Law, so I feel obligated to follow-up on their post on the “best” prescription drug and medical device decisions.

The short version is quite simple: drug and device companies really like activist judges legislating from the bench or overruling juries’ factual findings. How else to explain the love for PLIVA, Inc. v. Mensing, in which the United States Supreme Court couldn’t find a federal statute or regulation in support of granting generic drug manufacturers legal immunity and so contrived an argument the Court admitted “makes little sense,” or Garza v. Merck & Co., in which the Texas Supreme Court held that it was unreasonable for a jury to agree with two cardiologists that Vioxx caused a heart attack?

As with their “worst” list, the “best” list is most interesting for what it reveals about the current state of drug and medical device company liability: heads defendant wins, tails plaintiff loses. In Mensing (#1), a plaintiff’s claim was dismissed because the Court didn’t want to speculate about what the FDA would do if a drug company proposed strengthening a warning label, while in Dobbs (#8) a plaintiff’s claim was dismissed because the Court speculated that the FDA wouldn’t accept a drug company’s proposal for a strengthened warning label. In Williams (#4), a plaintiff’s claim was dismissed because her doctors disposed of the pieces of the device in question, while in Wolicki-Gables (#6), a plaintiff’s claim was dismissed because, even though the plaintiff asked in writing for her doctors to preserve the device, a representative of the device manufacturer slipped into the surgery without the patient’s consent, took the device, lied to the patient about testing it and destroyed it, leaving the plaintiff nothing to examine or to test.

Let’s roll the tape.
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[Update: Drug & Device Law has also released their list of “best” cases, and so I have responded.]

First, a bow to my opponent. I reference the pharmaceutical company defense lawyers from Dechert at Drug & Device Law a lot here on this blog even though, as a plaintiff’s lawyer, I’m always on the other side from them (one might even say they’re on the wrong side of the law) because they write a great blog. They write detailed, passionate arguments about substantive issues of law, and they link liberally, involving others in the conversation. It’s not that I haven’t noticed you folks over at Weil Gotshal with your competing Product Liability Monitor (link nofollowed), but you need to add some hot sauce and link out if you want to roll with the big boys. Maybe it’s because Dechert’s in Philadelphia and Weil Gotshal’s in New York, or maybe it’s because we Philadelphia lawyers punch a little bit harder.

Now, on to the fight. Drug & Device Law has compiled their “Ten Worst Drug/Medical Device Decisions of 2011.” It must have been a Herculean task: from my perspective, you have to look really hard to find court decisions against the pharmaceutical and medical device industry. As I’ve written before, the deck is stacked against innocent people injured by these drugs and medical devices: it’s almost impossible to sue pharmaceutical companies for anything other than inadequate warnings on their labels (a claim that is itself in peril, even as drugs like ActosPradaxa, and Propecia warn of their minor risks but not their major risks), and it’s virtually impossible to sue implant and medical device manufacturers for anything other than violating FDA regulations.

Of course, none of the court opinions on the D&D Law list were really against the drug and medical device companies; no court ever rules that a drug company was negligent or that medical device company has to pay compensation. When a plaintiff “wins” a court decision, that really means the plaintiff gets a chance to prove their case in front of a jury. Instead, when drug and device companies complain about courts, it’s because they think the court should have dismissed the cases entirely, without a trial, without a word of testimony or a shred of evidence shown to a jury. The bulk of the cases cited by Drug & Device Law follow that pattern, with the defense lawyers complaining either that a court didn’t buy some preposterous defense theory or that a court didn’t let a company walk away scot-free after violating FDA regulations and hurting people.

Indeed, the D&D Law list of cases is revealing because of just how reasonable these “worst” court opinions are.  There’s been a lot of press lately about how more Americans are killed annually by prescription medication overdoses than car accidents; coincidentally, D&D Law’s “worst” decision of the entire year, DiCosolo, involved a consumer indisputably killed by a defectively manufactured prescription painkiller patch, and they argue we’re supposed to let the maker of that deadly product walk away from any accountability because the DiCosolo’s weren’t compulsive hoarders that held on to every used disposable product in their house? Because Janssen Pharmaceuticals failed to convince a jury of its ridiculous fentanyl fairy theory? What’s so wrong with letting a jury hear those factual arguments and deciding what’s true and what’s not, the way we’ve settled disputes since ancient times?

Let’s unpack a couple of these “worst” opinions and see just how bad they really are. 
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