Anything but Generic: Supreme Court Preemption Opinion Calls for Correction from Congress and the FDA

Lost among the high-profile opinions that the Supreme Court issued during the past two weeks was a case that attracted little media attention, but is of great importance to the millions of Americans who take generic drugs.

Karen Bartlett, a secretary for an insurance company filed the lawsuit against generic drug manufacturer Mutual Pharmaceutical Company.  When Karen visited her doctor complaining of shoulder pain, he prescribed Clinoril, one of many non-steroidal anti-inflammatory drugs (NSAID) that are commonly used to treat arthritis, bursitis, and other painful conditions.  When Ms. Bartlett’s pharmacist filled the prescription, however, he gave her the generic version of the drug sulindac, rather than the brand-name drug.

Soon after taking the drug, Ms. Bartlett developed a horrific disease called SJS/TEN, which caused massive burns on over 60-65 percent of her body.  For the next year, her life was, in the words of her surgeon, a “hell on earth” as she spent 100 days in five hospitals and several months in a medically induced coma.  During this time she was fed by tube, suffered two septic shock episodes, endured twelve eye surgeries, and became legally blind.  Although she survived, she is severely disfigured, cannot eat normally due to esophageal burns, cannot have sexual relations, and cannot engage in aerobic activities because of burns to her lungs.  

In a clear concession that it had made a grave mistake, FDA several months later required manufacturers of all NSAID drugs to include an additional warning on their labels concerning the risk of adverse dermatological effects, including SJS/TEN.  But that was too late for Ms. Bartlett.

As I related in a previous blog, Ms. Bartlett’s attorneys made a powerful case for the proposition that the risks posed by sulindac far outweighed its very modest painkilling benefits and that numerous less dangerous alternatives were available for patients, like Ms. Bartlett, who suffered from shoulder pain. 

Mutual Pharmaceutical did not put on a single witness to defend its product.  Instead, it argued that Ms. Bartlett’s claim was impliedly preempted by the Federal Food, Drug and Cosmetics Act (FDCA) as amended by the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch/Waxman Act”).  The former statute requires drug manufacturers to obtain FDA approval of their products by demonstrating that they are safe and effective.  The latter requires the FDA to approve generic versions of approved drugs upon a showing that the active ingredient in its drug is chemically and biologically equivalent to the active ingredient in the previously approved brand-name drug and that the label is identical to the brand-name label.

Although neither statute mentions preemption, Mutual’s attorneys argued that Ms. Bartlett’s lawsuit was impliedly preempted because it was impossible for Mutual to comply with both the federal requirements and the duty that New Hampshire common law implicitly put on drug manufacturers to market non-defective products.  In short, they argued that since the characteristics of its generic drug had to be chemically and biologically equivalent to those of Merck’s brand-name version of the drug, it was impossible for it to market a safer version of the drug that would have met its duty under New Hampshire common law without violating the federal law.

In an opinion written by Justice Alito for a 5-justice majority, the Supreme Court agreed with Mutual Pharmaceutical that Ms. Bartlett’s claim was preempted because it was impossible for Mutual to design a safer drug consistent with federal law.  Federal law required Mutual’s version of sulindac to have the same active ingredients, route of administration, dosage form, strength, and labeling as Clinoril.  The majority further found that because of sulindac’s simple composition, it was chemically incapable of being redesigned.  Since redesign was legally (and apparently physically) impossible, Mutual’s only option was to strengthen its warnings.  That route, however, was precluded by the Court’s recent opinion in PLIVA, Inc. v. Mensing, in which the court held that common law failure to warn claims against generic drug manufacturers were preempted because the generic drug manufacturer did not have a legal right to use a label that varied in any respect from the original manufacturer’s FDA-approved label.

As court of appeals and Justice Sotomayor’s dissenting opinion made clear, it was not at all impossible for Mutual to comply with both the federal statute and the state common law.  It could have complied with both by not marketing sulindac in New Hampshire.  Justice Alito, however, dismissed that obvious point with the observation that it was “incompatible with our pre-emption jurisprudence.” 

The problem with that argument is that the Supreme Court’s pre-emption cases do not consist of a coherent body of law to which one might reasonably assign the label “jurisprudence.”  As I point out in my 2008 book, The Preemption War, the notion that a federal regulatory program could preempt a common law duty was foreign to the Supreme Court’s preemption “jurisprudence” until the last quarter of the twentieth century.  And the cases decided since then are very hard to reconcile with one another.  The “presumption against preemption,” that the Court says it applies to such cases is frequently ignored when the majority is inclined to hold for the defendant.

Unfortunately, too much water has by now flowed under the bridge to allow the Court to distinguish between common law obligations to pay damages caused by marketing a defective product and a statutory obligation to comply with statutory and/or administrative directives.  That being the case, the law is now in the anomalous position of allowing failure to warn and (presumably) design defect claims against the manufacturers of brand name drugs, but not against the manufacturers of generic drugs. 

Knowing this, it behooves the consumer who has a choice in the matter to demand the brand name drug.  If she chooses the less expensive generic drug, she is giving up her right to sue the manufacturer for designing a defective product or providing an insufficient warning on the label.  Since all or a substantial portion of most prescription drug purchases are ultimately paid for by Medicare, Medicaid or insurance companies, the unintended consequence of the Court’s holding may well be to drive up medical costs for all of us.

Before we go any further down that road, we should demand that FDA fix the problem by amending the its regulations to allow generic drug manufacturers to change the labels on their drugs.  To eliminate any doubt about FDA’s authority to promulgate such a regulation, Congress should amend the statute to clarify its authority to allow generic drug manufacturers to amend their labels to include more stringent warnings.  Better still, Congress could eliminate a lot of future preemption litigation by simply adding a provision stating that nothing in the statute shall abrogate the right of an injured party to file a claim for damages under state common law.

Through crocodile tears, Judge Alito ended his opinion with the observation that Ms. Bartlett’s “situation” was “tragic” and “evoked deep sympathy,” but a “straightforward application of pre-emption law” required that she not be compensated for her enormous loss.  Since the current majority on the Supreme Court is unwilling to correct the grave injustice in a dual system of recovery for drug-caused damages, it is now up to FDA and Congress to set things right.