The Most Unfair Prescription Drug And Medical Device Opinions Of 2011
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.
#1: PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011)
Here’s what it looks like when Congress wants to “pre-empt” state law tort claims:
Except as provided in subsection (b) of this section, the provisions of this title and title IV shall supersede any and all State laws insofar as they may now or hereafter relate to any employee benefit plan described in section 4(a) and not exempt under section 4(b).
That’s the pre-emption clause of ERISA, 29 U.S.C. § 1144. Its scope is hopelessly ambiguous — what the heck does “relate to” mean? — but its intent is quite clear: “[federal law] shall supersede any and all State laws” within that scope.
When it comes to prescription drugs, Congress has never passed any law even remotely like the ERISA pre-emption clause. That, however, hasn’t stopped drug-company-backed Supreme Court justices from doing somersaults to dream up ways in which to create that same sort of immunity for drug companies, like in PLIVA, Inc. v. Mensing.
In Mensing, Gladys Mensing was prescribed Reglan in 2001 and received generic metoclopramide from her pharmacist. After taking the drug as prescribed for several years, Mensing developed tardive dyskinesia, as up to one third of patients taking the drug do. In In 2004, the brand-name Reglan manufacturer (Wyeth) requested, and the FDA approved, a label change to add that “[t]herapy should not exceed 12 weeks in duration.” In 2009, the FDA ordered its strongest, “black box” warning to the Reglan package stating, “Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible …. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases.”
As you would expect, a drug manufacturer selling their drugs has to include the same warning labels and descriptions as the brand-name drug does. That set up raises an interesting policy question: when someone is injured by a generic drug that failed to warn of the side effects the drug could cause, then which company bears responsibility for the injury? The generic drug manufacturer? The brand name drug manufacture? No one?
Thankfully, the statutes enacted by Congress and the regulations promulgated by the FDA give us a clear answer. Like I wrote above, at no point did Congress pass any statute even arguably granting brand-name or generic drug manufacturers the sort of immunity envisioned by the ERISA preemption clause. Similarly, FDA regulations do not allow generic drug manufacturers to simply copy the brand name warning label; instead, generic drug manufacturers have to develop their own independent research, evaluation, and reporting systems, are obligated to inform the FDA of any potential safety issues “as soon as there is reasonable evidence of an association of the serious hazard with the drug,” and must recommend to the FDA changes to the warning label when warranted. 21 CFR § 314.80(b); 21 CFR § 201.80(e). Perhaps unsurprisingly, in the case the United States filed an amicus brief noting all of that and arguing in favor of Ms. Mensing. (The American Medical Association and 42 states also filed amicus briefs in favor of Ms. Mensing.)
The correct decision Mensing was obvious: Mensing’s claims should not have been pre-empted. Congress didn’t think pre-emption was appropriate, the FDA didn’t think pre-emption was appropriate, and the state law claim was largely parallel to the FDA’s own requirements, but that’s not what happened. Instead, the Supreme Court invented a brand new rule: if a federal agency has to sign off on what you do, then it’s “impossible” to comply with state law even when state law and the federal agency ask you to do the same thing.
Huh? As Justice Thomas wrote for the 5-4 majority, “We recognize that from the perspective of Mensing and Demahy, finding pre-emption here but not in Wyeth makes little sense.” No, it makes perfect sense: five members of the Court had a result in mind and so made up a reason to get there.
#2: Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068 (2011)
In Bruesewitz, another pre-emption case, Hannah Bruesewitz was born on October 20, 1991, then vaccinated six months later with DTP, which is no longer in use. Within 24 hours, Hannah started to experience seizures, suffered several seizures a day over the next month, and to this date continues to have seizures. The question was if she could bring negligent design claims against the vaccine’s manufacturer. At least in Bruesewitz there was a statute involved:
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
That’s part of the National Childhood Vaccine Injury Act of 1986 (NCVIA), which also established the National Vaccine Injury Compensation Program (VICP), an administrative courts system for evaluating certain vaccine-related injury claims.
Thus, in Bruesewitz we have two elements completing lacking from Mensing: a statute arguably pre-empting the state law claims in question and a compelling legislative reason to believe pre-emption was intended, because Congress has created an alternative means for plaintiffs to pursue relief, just like with ERISA. Under Mensing, plaintiffs injured by generic drugs may never get a day in court. Under Bruesewitz, plaintiffs injured by vaccines at least get an opportunity to prove their case through the VICP.
I’m thus not going to bash Bruesewitz as a blatant example of conservative judicial activism like Mensing was. Indeed, I was complementary of Bruesewitz’s reasoning when the opinion came out, because it respects the important role that state tort law provides in improving medication safety and compensating innocent victims. I would have preferred that Justice Sotomayor’s reasoning had prevailed in Bruesewitz — not least because the NCVIA specifically says “state law shall apply to a civil action brought for damages for a vaccine-related injury or death” (§ 300aa-22(a)), thus implying the pre-emption clause was to be interpreted narrowly — but I don’t think the majority’s opinion was clearly erroneous.
3. Ironworkers Local Union 68 v. AstraZeneca Pharmaceuticals, LP, 634 F.3d 1352 (11th Cir. 2011).
Our health care insurance system is heavily dependent upon trust. There are certainly situations in which health insurance companies will cheat their insureds — like the shocking statistics for health insurance rescission — but in general health insurers, particularly the non-traditional ones like labor unions and their health benefit plans, sign off on the treatments prescribed by the beneficiaries’ doctors, as they should. Who wants their insurance company subjecting every last medical decision to “pre-authorization?”
So what happens when a pharmaceutical company engages in a systematic, blatantly illegal off-label marketing campaign so effective that more than half of the medication’s prescriptions are for off-label uses? The Seroquel debacle gives us an answer. AstraZeneca ended up paying $520 million in a qui tam whistleblower suit over it and $68.5 million in a consumer fraud lawsuit brought by 38 states over it. Unsurprisingly, the unions and their health benefit plans that paid millions of dollars for over-prescribed Seroquel — despite the availability of cheaper and safer alternatives — wanted some of their money back, so they sued.
The unions lost, without even an opportunity to conduct discovery, much less present their case in front of a jury because, as the Eleventh Circuit held, the union plans assumed the risk that a major pharmaceutical company was systematically defrauding them. I wish I was kidding, but here’s the Eleventh Circuit’s actual analysis:
[T]he insurers made the conscious business decision not to require preauthorization review in their policies. The complaint, by suggesting that the insurers could have required preauthorization review for off-label Seroquel … Instead, they voluntarily assumed the risk of paying for all prescriptions of Seroquel, including prescriptions for off-label uses that were medically unnecessary or inappropriate.
… As a consequence, because the insurers consciously chose to assume the risk of paying for all medically unnecessary or inappropriate prescriptions of formulary-listed drugs—like Seroquel—we must further infer that they adjusted their premiums upward to reflect the projected value of claims for these prescriptions. Such estimates, when calculated properly, take into account all known risks that might cause the insurers to pay for medically unnecessary or inappropriate prescriptions.
One such risk is fraud within the health care industry. Fraud is a well-known contributor to increased costs for health care services. ... Thus, the risk that fraud—including fraudulent marketing by drug manufactures—might result in insurers paying for medically unnecessary or inappropriate prescriptions is just another cost to be factored into premiums.
As discussed generally in part II.B.1, supra, the insurers gambled that their estimates would prove sufficient to cover their payments for all medically unnecessary or inappropriate off-label Seroquel prescriptions. … [If] the insurers’ estimates fell short of actual payments, their own business mistakes caused their loss. AstraZeneca cannot be held to reinsure the insurers’ sophisticated actuarial decisions.
That’s right: health insurers like union benefit plans are supposed to make the “actuarial” assumption that drug companies routinely violate federal and state law. The court’s reasoning would be funny if it wasn’t so outrageous.
Let’s try that reasoning on your local Wal-Mart. Wal-Mart, of course, prices every item in the store with a little bit of “loss” — customer theft, employee theft, weather damage, or just plain misplacement — priced into it. Assume a gang of thieves targets Wal-Mart, Wal-Mart finds out, and then sues the gang for racketeering and for fraud. Does anyone really believe the court would dismiss that case as a “business mistake” on Wal-Mart’s behalf for not making its products more expensive?
Of course not: activist judges reserve this sort of sloppy, biased reasoning when trying to save a drug company from responsibility for defrauding millions of Americans and their health benefit plans.
4. Williams v. Mast Biosurgery USA, Inc., 644 F.3d 1312 (11th Cir. 2011)
Apparently, Wanda Williams was abducted by aliens who inserted several pieces of plastic into her lower abdomen and then created false memories about the source of that foreign material in her treating physicians’ brains. At least, that’s what the Eleventh Circuit must have believed when they dismissed her case at summary judgment, because the court chose to exclude the testimony of her gynecologist, gastroenterologist and general surgeon, all of whom thought the plastic came from the SurgiWrap (it’s a bioresorbable barrier used to prevent post-surgical adhesions) implanted in her just one month before. The court also blamed the plaintiff because her physicians discarded the SurgiWrap.
The exclusion of the gynecologist’s testimony was the most egregious part of this opinion: though the gynecologist was the one who implanted the SurgiWrap, the District Court and the Eleventh Circuit both held he wasn’t qualified to testify about how SurgiWrap was supposed to function or if the SurgiWrap had failed in this procedure. Yet, if the tables were turned and the gynecologist was supporting the defense, then the Eleventh Circuit undoubtedly would have considered the gynecologist a “learned intermediary” wholly responsible for determining and communicating the risks and benefits of the SurgiWrap, and would have used that to dismiss any claims against the manufacturer. See, e.g., Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1277-78, 1281 (11th Cir. 2002) (per curiam)(dismissing claim against medical device manufacturer because it had, under the “learned intermediary” rule, adequately warned the doctors and nursing using a pain pump of the risks, and so they were the ones responsible for conveying information about risks to patients).
What’s dispositive proof for the goose is apparently not even admissible evidence for the gander.
5. Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011).
The Supreme Court used to use its power and limited resources for important issues like racial discrimination in the Jim Crow South and the publication of the Pentagon Papers. Now it uses the First Amendment to overturn state laws prohibiting pharmaceutical companies from using confidential prescribing records to target individual doctors for high-pressure marketing. I’m sure that’s what the Framers had in mind when they drafted the First Amendment.
6. Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. 2011)
I’m don’t see why Drug & Device Law crows so much about Twombly and Iqbal on this case, which was decided on summary judgment, but I suppose the opinion has, in dicta, a reference or two to the complaint.
More to the point, remember in the Williams case above how the plaintiff was blamed because her doctor’s lost the device in question? Let’s see what happens when the defendant manufacturer invades a patient’s procedure without her consent, lies about their reason for being there, and then deliberately destroys the evidence before the plaintiff or her doctors can examine it.
Wolicki-Gables involved an implanted pain pump. When the device started causing problems, a removal surgery was scheduled, and on her consent form the plaintiff specifically noted she did not consent to disposal of any tissues or other materials, did not consent to the presence of third parties in the procedure, and then wrote by hand “we want old pump.”
Despite that, a representative for the device manufacturer snuck into the procedure, told the patient’s husband that they were taking the device to test it and would contact them, then promptly destroyed the evidence. The perfect crime!
In a reasonable court, that would be called “intentional spoliation,” and the jury would be instructed that they could infer from the defendant’s destruction of evidence that the device was defective and that examination or testing would have revealed the defect.
Kafka was on the bench that day, so the patient was blamed for the manufacturer’s deliberate spoliation of evidence. The plaintiff’s case was dismissed because their doctors and experts, lacking the actual pump, were ”unable to exclude alternate possible causes” other than a defect in the device.
7. Garza v. Merck & Co., 347 S.W.3d 256 (Tex. 2010).
Garza was a weak, but still meritorious, Vioxx case. The plaintiff had a history of heart disease and only took Vioxx for 25 days prior to his death from a heart attack. Would he have had the heart attack without the Vioxx? Maybe so, maybe not. Sounds like a classic factual question for the jury — particularly because Garza had two cardiologist expert witnesses on his side — but the Texas Supreme Court thought otherwise, and so reversed a jury verdict in favor of the plaintiff.
Let’s start with the obvious: had Garza or his doctor known back in 2001 that Vioxx had the potential to exacerbate cardiovascular disease or cause myocardial infarction — which is what Merck suspected since at least 1997 — there’s no chance whatsoever that Garza would have been prescribed or would have taken Vioxx. It’s a classic “failure to warn” case.
The legal question is one of causation: Merck admitted that Vioxx increases the risk of heart disease after 18 months (although that turned out to be blatantly false, and their own data showed a risk beginning at least as early as 4 months), but there are no studies on heart attacks after 25 days of Vioxx, so the plaintiffs brought in two cardiologists who had reviewed Merck’s own research data on Vioxx to testify that the use of Vioxx nonetheless increased the risk of Garza having a heart attack.
The Texas Supreme Court didn’t care. What do those cardiologists know about heart attacks, anyway? The Texas Supreme Court then created a new rule of law, a rule not followed by any real doctors or medical researchers, that a drug is indisputably harmless unless there are two formal epidemiological studies showing the drug at least doubles the risk of the particular disease the plaintiff suffered.
Even that abomination of medicine and science wasn’t enough for the Texas Supreme Court, which made sure to leave itself some room to arbitrarily dismiss even cases where plaintiffs had those types of studies in hand, noting “statistically reliable studies showing a doubling of the risk might nevertheless be insufficient to prove causation,” and encouraging judges to pretend they’re medical researchers and make factual findings about each study’s “strength of association, consistency, specificity, temporality, biological gradient, plausibility, coherence, experiment, and analogy.”
To put it another way, thanks to the Garza opinion, if you’re injured by a dangerous drug in Texas, you can’t even open the courthouse doors by bringing along two doctors who reviewed piles of research data and concluded the drug caused your injury. Indeed, under Garza you can come to court with two separate peer-reviewed studies showing the drug you took more than doubled your risk of injury, but a judge who hasn’t taken a biology class since ninth grade can nonetheless dismiss your case because he or she questions the “biological gradient” shown by either one of those studies.
8. Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. 2011).
Dobbs arose from the suicide of a 53-year-old man after taking Effexor, an anti-depressant. Like with Bruesewitz, I think Dobbs was a fair and appropriately reasoned decision. I don’t agree with it, but I do think Judge Friot honestly and fairly evaluated the case and reached the decision he thought was required by Levine.
Under Wyeth v. Levine, 555 U.S. 555 (2009), FDA labeling regulations do not preempt state law failure-to-warn claims against brand name drugs unless the manufacturer presents “clear evidence that the FDA would not have approved a change” to the drug’s label, thereby making it “impossible” for the manufacturer to comply with “both federal and state requirements.” Levine, 129 S. Ct. at 1198. (Mensing held that this same rule didn’t apply to generic drug manufacturers.)
Ordinarily, the issue of “impossibility” requires such extensive evidence that it goes to a jury. See, e.g., Mason v. Smithkline Beecham Corp., 596 F. 3d 387, 396 (7th Cir. 2010)(“[I]n light of the extensive showing required by Levine, we conclude that GSK did not meet its burden of demonstrating by clear evidence that the FDA would have rejected a label change warning about the risk of suicide by young adults before Tricia’s life came to an end at 23. Consequently, the plaintiffs’ claims are not preempted.”). But Dobbs made a strong case that the FDA would indeed have rejected a warning label for Dobbs’ age group:
First, the record reflects the FDA’s ongoing study and analyses regarding the propriety of enhancing SSRI warnings to include the association between SSRIs and suicidality. That history is in contrast to the facts in Levine, in which the Court noted that the trial court found the record reflected that, during the time period relevant to the claims asserted, neither the manufacturer or the FDA “gave more than passing attention” to the issue of the proper method for intravenous administration of Phenargen. Levine, 129 S. Ct. at 1199. Second, the record reflects that, despite the ongoing analyses from as early as 1993 through 2007, the FDA has yet to find scientific evidence to support the addition of a suicidality warning for patients in Mr. Dobbs’s age group. After many years, the FDA concluded that scientific studies supported the issuance of a warning regarding pediatric patients; a few years later, it reach the same conclusion with respect to adults age 24 and younger. It did so only after numerous studies and, ultimately, an extensive analysis. Despite the scope of the 2006 analysis, however, it found no support for a suicidality warning applicable to the age group of which Mr. Dobbs was a member. To date, it has not done so. In fact, it has opined that the evidence suggests a neutral connection between SSRIs and suicidality in his age group [i.e., 53-years-old].
I personally agree with Mason on this point, but Judge Friot evaluated Mason and distinguished it honestly and fairly. I don’t expect every judge to agree with me, just that they be honest and fair, and the Dobbs opinion was.
9. Smith v. Wyeth, Inc., 657 F.3d. 420 (6th Cir. 2011), and Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2011).
Remember how the Supreme Court held in PLIVA v. Mensing (#1) that plaintiffs who took generic drugs can’t sue the generic drug manufacturer because the generic warning label had to match the label on the brand name drug? That’s the heads defendant wins. The Smith v. Wyeth and Mensing v. Wyeth cases are the tails plaintiff loses: they can’t sue the brand name manufacturer either. They can’t sue anybody.
10. Kowalski v. Rose Drugs of Dardanelle, Inc., ___ S.W.3d ___, 2011 WL 478601 (Ark. Feb. 9, 2011)
You know how pharmacists have to go to special schools, go through special training, and then are licensed by the state to dispense medicines and give advice? At least in Arkansas after Kowalski, that’s all just marketing, because pharmacists have no duties whatsoever to customers. They can dispense you Norflex, Zoloft, Effexor, Valium, Ambien, Trazodone, Oxycontin, Percocet, Lorazepam, Methadone, Propoxyphene, and Doxepin all at once (like they did with Kevin Allen Curry, who had “generalized facial pain resulting from a blast to the face”) without bothering to tell you or put on your medication instructions the fact that their own medication database lit up like a Christmas tree with warnings and contraindications and that mixing even just a few of those, or mixing any of them with alcohol, can be fatal. Under the Kowalski court’s reasoning, pharmacists are just glorified vending machines.
* * *
Some of these cases are examples of “bad cases make bad law.” I’m surprised the plaintiff in Bruesewitz didn’t win compensation from the VICP (which would have stopped the claim from going so far), and I can see why a court would be skeptical of Kowalski’s claims given the strong contributing role of his own alcohol use, but in most of these cases a court either invented a new law that Congress didn’t pass or made huge factual assumptions on the way to closing the courthouse doors to people who had quite plainly been injured by dangerous drugs or medical devices. I don’t know what the Framers would have thought about the First Amendment protecting pharmaceutical companies’ “right” to use confidential patient prescription records to target physicians for high pressure marketing campaigns (as in Sorrell), but I do know what they thought about jury trials. They loved them, and even gave them their own Amendment:
In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law.
As Thomas Jefferson wrote, “[the people] are not qualified to judge questions of law; but they are very capable of judging questions of fact,” and that inherent power of the people was intentionally preserved in the Constitution. Unfortunately that right has become meaningless, such that courts routinely feel empowered to decide the disputed facts in front of them — sometimes before any evidence has been collected in discovery, like when Ironworkers Local Union 68 concocted an entirely new reality to protect a drug company that admittedly broke the law.
There are solutions, of course. Congress doesn’t have to let Mensing stand and can easily amend the Hatch-Waxman Act to bring it into line with the Levine opinion, i.e. clarifying that state law tort claims can proceed unless the drug manufacturer can show clear evidence that the FDA would not have approved a change to the drug’s label, making it impossible for the manufacturer to comply with both federal and state requirements. State legislatures always have the power to eliminate unfair games like the “learned-intermediary rule” by passing new product liability statutes. It’s not like these issues are rare: for example, millions of people took Actos or Pradaxa, both of which have killed consumers.
Will they? Whose side are your legislators on?