[Update, June 24, 2013. The Supreme Court ruled against Karen, holding, in essence, that generic drug companies have no responsibilities whatsoever to patients.]


I’ve written before about the United Supreme Court’s dismal PLIVA v. Mensing opinion. Although Justice Scalia recently co-wrote a book on legal interpretation that admitted that a basic principle of federalism is that “a federal statute is presumed to supplement rather than displace state law,” he had no trouble joining Justice Thomas’ opinion finding “implied” pre-emption of all state tort lawsuits that alleged  generic drug manufacturers failed to adequately warn about their product’s risks.


Nevermind that Congress had never passed any statute restricting state torts against generic drug manufacturers; the FDA itself had no problem with the state tort lawsuits, and indeed filed a brief in favor of the injured plaintiff; that the American Medical Association and 42 States supported the plaintiff. The case was, to put it mildly, “result-driven.”


That’s old news (Professor Bernabe’s Torts Blog has been following the fallout), but PLIVA v. Mensing is back in the spotlight: the Supreme Court has granted certiorari in Bartlett v. Mutual Pharm. Co., Inc., a First Circuit Court of Appeals opinion in a generic drug case from earlier this year that was one of the very few bright spots in the darkness created by PLIVA v. Mensing. Pharmaceutical defense lawyers have written endlessly in the abstract about Bartlett (like here and here and here), claiming that it conflicts with PLIVA and that the Supreme Court would reverse. I, of course, don’t agree with PLIVA and so, of course, don’t think Bartlett’s claim should be pre-empted; whether the Court in Bartlett mis-applied PLIVA is another matter.


But before we get there, I frankly think that no discussion of the case is complete without talking about the extraordinary facts of the case. Cases aren’t just names on a page, they’re real people, often with real injuries.  From the First Circuit’s opinion:

This products liability case arises out of severe and permanent injuries sustained by plaintiff Karen Bartlett after taking sulindac, a generic non-steroidal anti-inflammatory drug (“NSAID”) manufactured by (among others) defendant Mutual Pharmaceutical Company (“Mutual”). Sulindac is known to cause, in rare instances, a hypersensitivity reaction called Stevens-Johnson Syndrome and its more generous cousin toxic epidermal necrolysis (“SJS/TEN”). In December 2004, Bartlett’s doctor prescribed (for her shoulder pain) sulindac under the brandname Clinoril made by the original provider, and her pharmacist dispensed generic sulindac.

The consequences were disastrous. Bartlett developed SJS/TEN early in 2005. TEN is diagnosed when 30 percent or more of the outer skin layer on a patient’s total body surface area has deteriorated, been burned off or turned into an open wound. In Bartlett’s case, the percentage rose to 60-65 percent of her body; she spent 70 days at Massachusetts General Hospital–including over 50 in its burn unit. Both her suffering and permanent injury, including permanent near-blindness, are described below in connection with the award of damages.

We typically refer to plaintiffs by their last names, because the cases are referred to that way, but that tends to further dehumanize the issue. The case isn’t about “Bartlett.” She has a name, a name you or I would call her if we met her, and that name is Karen.


Karen took a basic pain reliever her doctor prescribed for shoulder pain, and what she got was torment worse than any level of Dante’s Inferno. Either you know what Stevens-Johnson and toxic epidermal necrolysis are or you don’t; if you do know, you probably gasped when you saw the words. Karen’s burn surgeon — someone well accustomed to the kind of pain and bodily destruction we try to forget exists in this world — described her condition as “hell on earth.” As the First Circuit recounted,

She spent almost two months in MGH’s burn unit, spent months in a medically-induced coma, and suffered burns over nearly two-thirds of her body.  Her burn surgeon described the experience as “hell on earth.” She spent a year being tube fed and endured two major septic shock episodes. She suffered through 12 eye surgeries and has many more ahead of  her.  This is a brief summary of the suffering detailed for the jury.

In addition, the permanent damage is severe.  Bartlett cannot eat normally due to esophageal burns, cannot have sexual relations due to vaginal injuries, and cannot engage in aerobic activities due to lung injuries.  She is almost blind now and faces some likelihood of complete and permanent blindness.  She cannot read or drive or work.  And she is seriously disfigured in face and body.  In sum, the jury’s award is not so clearly disproportionate to the harm suffered that a court must set it aside.

Imagine enduring any one of those symptoms. So blind you cannot read at all. Never eating a normal meal again, or never having sex, or burned over your whole body, or burned inside your lungs. Put them all together, and that’s Karen’s life now, all because she had some shoulder pain, and so her doctor prescribed her a routine generic pain reliever.


As I’ve argued before, if I were writing the laws, I’d say Karen’s situation was enough to prove strict liability. The doctrine of strict liability was created for this very circumstance: to spread the cost of unreasonable dangers in a product across the manufacturers and consumers of that product. Over 30 million Americans regularly use NSAIDs, spending well over $10 billion annually on them. Would you mind chipping in to help the people like Karen who, through nothing but bad luck doing something the rest of us do all the time — take a pain reliever — end up living in “hell on earth.” We can chip in to help people like Karen; the drug companies can certainly do so.


I don’t write the federal drug laws, however, Congress does, and the FDA enforces them. Congress and the FDA didn’t have a problem with state tort lawsuits against generic drug manufacturers, but those five conservative Justices of the Supreme Court did. If Karen had been dispensed brand-name Clinoril — like her doctor had prescribed — she’d undoubtedly have a viable legal claim, because her claim would fall under the Supreme Court’s Wyeth v. Levine opinion, which allows “failure to warn” lawsuits against brand-name drug manufacturers. But, because her pharmacist dispensed generic sulindac without her knowledge, she has to battle with the “implied” law of PLIVA v. Mensing.


The First Circuit, however, took PLIVA v. Mensing’s reasoning seriously, as the case itself was focused on failure to warn claims, not on typical strict liability claims. The First Circuit, too, took seriously those “canons of interpretation” that Justice Scalia claims to follow, and held that PLIVA v. Mensing applied only to “failure to warn” claims. To put it another way, Karen was precluded from arguing the label was inadequate, much as the plaintiff in PLIVA was, but that ruling said nothing about strict liability as applied to the claim that a manufacturer wasn’t required to sell the product at all, and so is held responsible for its unreasonable dangers. Indeed, as the First Circuit elegantly reasoned:

Mutual argues with some force that the generic maker also cannot alter the composition of the drug and so PLIVA’s policy of encouraging generics by preempting state tort claims should extend to design defect as well as claims based on inadequate warning. But although Mutual cannot legally make sulindac in another composition (nor is it apparent how it could alter a one-molecule drug anyway), it certainly can choose not to make the drug at all; and the FDCA might permit states to tell Mutual it ought not be doing so if risk-benefit analysis weights against the drug, despite what the Supreme Court made of similar arguments in the labeling context.

This reasoning is of course entirely correct: the FDA certainly doesn’t require any generic drug manufacturer to sell anything at all. There plainly isn’t any “conflict” between federal law describing what a generic drug’s warning should say (the issue in PLIVA) if a generic drug manufacturer chooses to sell a pain reliever and a state court holding that a pain reliever is “unreasonably dangerous” because it causes “hell of earth” and so holding the company liable for those damages.


I must admit I am usually dismayed when the Supreme Court grants petitions for certiorari, because the Court has had a dismal record as of late, with a slim majority of Justices following a simplistic might makes right formula. I’m thus never happy to see the Supreme Court take up review of a case in which a drug or medical device injury victim won, because the Supreme Court is aking up the case to reverse it, to deny the plaintiff and everyone like them their legal right to compensation.


But the grant of certiorari in the Bartlett case gives me even more reasons to be upset. As pharmaceutical defense lawyers admit, the case is unusual for a variety of a reasons unrelated to the PLIVA issue. The defendant, for example, waived its “comment k” defense — essentially, an argument that their drug was “unavoidably unsafe” — which is normally the first line of defense in this sort of case alleging a drug was defectively designed. As a general rule, the Supreme Court is supposed to avoid cases that don’t present issues in a straightforward manner, or cases that seem to fall on issues mostly unique to the case, which makes me suspicious of their reasons for taking this case: I suspect those five Justices grabbed the first case they could that presented another issue on generic drug liability, so they could further extend PLIVA v. Mensing to deny victims’ compensation.


Which is the part that bothers me most deeply about Bartlett, or should I say, Karen’s case. Confidentiality rules (plus common sense and respect for my client’s privacy) preclude me from talking about my own cases much, so on this blog I spend a lot of time discussing other cases in the abstract. But that’s not how the practice of law is for a plaintiff’s lawyer. To us, the daily experience is one of handling the aftermath of real people’s tragedy and pain. On Monday, a paralegal asked me to finish proofing something because she “couldn’t look at it anymore.” It was our client’s draft discovery response to a standard interrogatory asking them to “describe your version of the accident.” The client’s description of the accident made me cry. It would make you cry, too.


Those five Justices on the Supreme Court inevitably have on their dockets many, many opportunities to extend PLIVA v. Mensing to the small portion of generic drug lawsuits that have remained. The defendant in Karen Bartlett’s case is part of a huge pharmaceutical conglomerate with nearly $20 billion in annual revenues, and annual profit margins between 10% and 25%; when those five Justices were looking for a case to further cut off drug injury victims’ legal rights, did they have to start with the woman living in “hell on earth”?