This week’s U.S. Supreme Court argument in Bartlett v. Mutual Pharmaceutical (link goes to my thoughts on the case, which I posted back in December) has taken the issue of “impossibility preemption” for a brief stroll through the rest of the legal world, crossing paths with some major news outlets. Karen Bartlett was given a shot of a pain reliever, sulindac, which caused her to develop Stevens-Johnson Syndrome and toxic epidermal necrolysis so severe her burn surgeon called it “hell on earth.” There would be a handful of legal avenues available to her if she had received the brand-name drug, but, because she received a generic, there’s the looming question as to whether her State tort law lawsuit is “preempted” under the Supreme Court’s 2011 case, PLIVA v. Mensing.

A brief refresher. There are four types of “preemption,” so named when federal law trumps — i.e., “preempts” — state law.

1. Express Preemption is when Congress and the President pass a law that says States’ law on the issue are unenforceable. For example, the preemption clause of ERISA, 29 U.S.C. § 1144, “the provisions of this title … shall supersede any and all State laws insofar as they may now or hereafter relate to any employee benefit plan …”

2. Impossibility Preemption is when Congress has not passed any law preempting State law, but “where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce.” Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963).

3. Conflict Preemption occurs where Congress hasn’t passed a law preempting State law, and where it’s possible to comply with both, but “under the circumstances of [a] particular case, [state] law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Hines v. Davidowitz, 312 U.S. 52, 67 (1941).

4. Judicial Activism Preemption happens when a judge, or the majority of judges on a federal appellate court, don’t like a particular State law and so make up a reason to get rid of it. No, the courts themselves don’t call it that, they typically call it “impossibility preemption.” This is my term for it.

In the Bartlett case, just like in every other pharmaceutical liability case, there’s no express preemption. In the 80 years since the passage of the Federal Food, Drug, and Cosmetic Act in 1938, Congress has never once saw fit to preempt State law lawsuits against brand-name or generic drug manufacturers.

In 2011, a slim majority of the Supreme Court in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) applied what I call Judicial Activism Preemption under the guise of impossibility preemption, and made up a reason to blow up the majority of lawsuits against generic drug manufacturers. I wrote more about it here. Law professor Leslie Kendrick recently wrote about how problematic impossibility preemption is in the conduct of pharmaceuticals in general.

Mensing involved a “failure to warn” claim — i.e., an allegation that the drug’s warning labels didn’t adequately disclose the drug’s real risks — and the Supreme Court held those claims were preempted. Bartlett on the surface involves a pure strict liability claim — i.e., a claim that the drug is simply unreasonably dangerous given the minor benefits it has compared to the serious risks — and then in the details involves a number of complicated factual and legal issues, including the strange decision by the defendant to waive most of its defenses, complicated issues that, to me, should have caused the Supreme Court to decline the case for consideration.

Be that as it may, the oral argument (transcript here) revealed a lot about the true nature of preemption and the Justice’s thoughts.
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It’s déjà vu all over again. Remember how, three years ago, Pfizer paid $2.3 billion to the Department of Justice to settle off-label claims relating to Bextra and other drugs, and Eli Lilly paid $1.4 billion for Zyprexa marketing?

If so, then last week was no surprise: GlaxoSmithKline agreed to pay a whopping $3 billion to settle criminal and civil charges brought against it by the Department of Justice. Quoting from the DOJ press release, GlaxoSmithKline was accused of:

  • distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18,
  • GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18.
  • GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents.
  • GSK paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wellbutrin for these unapproved uses.
  • GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends.   The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia.
  • GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile … GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks.
  • GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs [Paxil, Wellbutrin, Avandia, Advair, Lamictal, and Zofran] as well as the drugs Imitrex, Lotronex, Flovent and Valtrex.

Let’s call GlaxoSmithKline what it is: a criminal enterprise. GSK didn’t miss the finer points of a couple red-tape regulations: the DOJ alleged they tampered with scientific studies, concealed safety data, then lied to doctors and patients and, if that didn’t work, outright bribed the doctors. Why?
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Have you ever seen a commercial on TV, or heard a commercial on the radio, or read an advertisement in a magazine, or saw a commercial on a website, for a prescription drug?

Of course you have, if you’re in the United States (or New Zealand — the rest of the modern world bans the practice). You see them all the time. Why? Because, as io9 profiled extensively, “For every dollar spent on ads for drugs, over four dollars in retail sales are garnered. A May 2011 study showed that new drugs that feature direct-to-consumer advertising are prescribed nine times more than their new counterparts that lack consumer advertising.” Billions of dollars are spent on ads to patients to convince them (1) to “ask your doctor about” whatever medication is most profitable and lobby for it based on the advertising and (2) to choose the medication over other available options.

There’s nothing novel or even disputable about that, but try pointing out the purpose and effect of prescription drug advertising to the Supreme Courts of the three dozen or so states — including most of the large population states like California, New York, Florida, Illinois, Pennsylvania, Ohio, Michigan, and so on — that have followed some version of the “learned intermediary doctrine.” (Only one court, West Virginia, has expressly rejected the doctrine, in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 913–14 (W. Va. 2007)). Texas formally joined the ranks of learned intermediary courts about two weeks ago. LexisNexis summarizes here, there’s some defense oriented coverage here and here and here, and I haven’t seen any plaintiff’s comment (but feel free to email me).

Under the most basic version of the learned intermediary doctrine, prescription drug users are considered by law to be lab rats who have no say in what their doctor prescribes and have no ability to turn the medication down. More formally, the doctrine provides:

 (1) that manufacturers of prescription drugs and medical devices discharge their duty to of care to patients by providing adequate warnings to prescribing physicians, and (2) that any failure to warn cannot be considered a proximate cause of a subsequent injury if the physician was fully aware of the dangers that would have been included in an alternative warning.

Greaves v. Eli Lilly, 2011 U.S. Dist. LEXIS 129443 (E.D.N.Y. Nov. 8, 2011). In Greaves, a man developed diabetes as a result of 9 years of Zyprexa use. Six years into his Zyprexa use, the doctor learned Zyprexa could cause diabetes, and continued prescribing it. When the doctor was later asked if knowing Zyprexa could cause diabetes would have changed anything about his interactions with the patient or his prescription, the doctor said no, he would have prescribed it just the same, regardless of the warning and regardless of how his patient felt about that, even though Abilify — which the patient was eventually moved to once he was diagnosed with diabetes — would have worked just as well. That’s when the learned intermediary rule came into play: because the doctor said he wouldn’t have done anything different if the doctor had known about the risk of diabetes, the plaintiff’s testimony was irrelevant, and so the plaintiff’s claim was dismissed.

There are thousands of cases like Greaves. Consider Wendell v. Johnson & Johnson,  2011 U.S. Dist. LEXIS 144437 (N.D. Cal. Dec. 15, 2011), where a young man developed hepatosplenic T-cell lymphoma (and died from it) as a result of irritable bowl syndrome medications. When the young man was diagnosed with lymphome, his treating doctor didn’t even suspect the medications — but not long after the man’s death, the doctor stopped giving that therapy to patients. Under the learned intermediary doctrine, it didn’t matter: the doctor didn’t emphatically state that he would have changed everything in response to an adequate warning, and so “Plaintiffs lack evidence that any further warning regarding the use of 6-MP, such as a warning about its use in combination with Humira, would have changed the manner in which Dr. Rich treated Maxx.”

It’s a bad rule, a sleight of hand that allows the prescription drug company to avoid liability for misleading prescription drug users by pointing the finger at their doctors. All a doctor has to say — and we’ll get to why they would say this in a moment — is, “a better warning wouldn’t have changed my prescribing decision” and, poof!, the plaintiff’s case vanishes. The whole case is decided without even considering whether the defendant drug company had warned the patient — the one who, at all times, had the final say on whether or not they actually took the medicine — about the real risks. 
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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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If you were diagnosed with bladder cancer after using Actos and are reviewing your legal options, please see my Actos Bladder Cancer Lawyers page for patients. 

I wrote this post for my legal blog, which is ordinarily read by other lawyers. Patients looking for legal help should read the Actos page linked above. 

Personal injury law isn’t like running an ordinary business, not even an ordinary law practice, because of the risk involved in taking cases. Defective drug and consumer products lawsuits exemplify both extremes of our work: the cases are enormously expensive to pursue and require a tremendous amount of attorney time, but they also have the potential to be lucrative blockbusters.

Problem is, once a drug or product is shown to be unreasonably harmful by a study or a recall, there’s no way for us to know for certain what the courts will do with the lawsuits. We don’t roll the dice — it’s much more rational and systematic than that — but we have to play the odds. So it will be with Actos lawsuits: we believe the drug was inadequately tested and didn’t warn patients of the risks, and will vigorously pursue cases against their manufacturer, but the cases aren’t without considerable risk.

Consider the denture cream lawsuits. To paraphrase what I wrote last week while discussing asbestos lawyers, GlaxoSmithKline settled the vast majority of Super Poligrip claims, but Proctor and Gamble fought the Fixodent cases, resulting a judge dismissing one of the bellwhether cases on Daubert grounds.

One of the drug cases trial lawyers are pursuing these days involve Actos (pioglitazone), the best-selling Type 2 Diabetes drug in the world. The Associated Press recently wrote about the “wave of lawsuits” filed against Takeda Pharmaceuticals:

TRENTON, N.J. — The maker of the world’s best-selling diabetes drug is facing hundreds of lawsuits and likely a big sales drop as suspicion grows that taking the pill for more than a year raises the risk of bladder cancer. …

both the U.S. Food and Drug Administration and the European Medicines Agency have issued warnings about the cancer risk based on new research, but they have allowed sales to continue. Doctors are being told not to prescribe Actos for people who have or have had bladder cancer.

The warning will limit patient choices and could spell the end for a once-promising class of Type 2 diabetes drugs that debuted more than a decade ago amid heavy promotion.

An FDA warning that a popular drug increases the risk of any type of cancer or heart disease virtually guarantees the filing of thousands of lawsuits, and pioglitazone is no exception: it raises the risk of bladder cancer by more than 40%, or an “extra 28 cases a year for every 100,000 people taking it.” The irony is why Actos is so popular:

Actos, despite links to heart failure risk and other serious side effects, became the No. 1 diabetes pill after Avandia, the only other drug in that class, was found in 2007 to sharply increase risk of heart attacks. Avandia’s use was banned in the EU and sharply restricted here. Actos sales jumped from about $2.9 billion in 2006 to more than $4.3 billion last year.

Avandia’s restriction, of course, prompted its own wave of lawsuits, and GlaxoSmithKline has settled about 12,000 of them for around $700 million. Assuming the clients are on one-third contingent fee agreements, that’s over $200 million for the lawyers. I don’t say that to be critical; one of those firms, for example, recently spent hundreds of thousands of dollars on an antitrust action just to lose and then also get hit with almost $600,000 in costs. It’s a big-risk, big-reward kind of business, and one of the few elements of society keeping medical products safe in light of the broken clearance processes we have for new drugs and devices.

Which brings me to one of the lessons this episode has for lawyers trying to build a personal injury or product liability law practice.
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