Nullification of $21m judgment shields generic pharmaceutical manufacturers from liability for unreasonably dangerous drugs...
By Ernest A. Canning on 7/15/2013, 7:35am PT  

Amidst the understandable sound and fury of the U.S. Supreme Court's recent decisions on marriage equality and their activist zeal to gut the Voting Rights Act in their determination to legislate from the bench that which is specifically mandated by the Constitution to be legislated by Congress, a number of their other end-of-term decisions managed to fly largely beneath the radar.

One of those decisions came late last month when the five right-wing members of the Court ruled that citizens who are severely injured, maimed or even killed by FDA-approved --- but unreasonably dangerous --- generic prescription drugs, have no right to seek compensation from the giant pharmaceutical companies which manufacture and market them to unsuspecting consumers.

In its 5-4 decision in Mutual Pharmaceutical Co., Inc. vs. Bartlett [PDF] ("Bartlett"), the Court annulled a $21 million judgment that had been awarded to New Hampshire resident Karen L. Bartlett. Her use of the generic drug, Sulindac, in 2004, produced catastrophic injuries when she suffered an acute toxic necrolysis (aka Stevens-Johnson Syndrome).

In his majority opinion, Justice Samuel Alito described her injuries as "tragic" and acknowledged that over 65% of Bartlett's body "was burned off, or turned into an open wound. She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube fed for a year. She is now severely disfigured…and is nearly blind."

For Alito, and the rest of the Court's right-wing majority, the severity of Bartlett's injury proved inconsequential when measured against Big Pharma's bottom line and their interest in selling generic drugs, which account for 75% of the prescription drugs sold in the U.S.

As a result, as it applies to generics, for the first time in our nation's history, FDA permission to market has been treated as a final stamp of approval as to the generic drug's safety, irrespective of the scope of subsequently obtained scientific evidence that reveals otherwise.

Anyone who is now injured, maimed or killed by what turn out to be generic, poison pills are S.O.L....

Laying the ground work

The rationale (or what cynics might describe as the "sophistry") the Court applied to shield Big Pharma from having to pay damages for catastrophic injuries wrought by unreasonably dangerous generic drugs is derived from the legal concept of preemption --- a doctrine that is based upon the Constitutional limits placed upon the power of the individual states by the Supremacy Clause: That portion of our founding document that declares the "Constitution and the laws of the United States...shall be the supreme law of the land." Just as an Act of Congress becomes null and void if the Court determines that it is unconstitutional, when the Court determines that a state law has been preempted by a federal statute, the state law is deemed null and void.

Critical issues in preemption cases center upon the intent of Congress and whether state laws conflict with the federal statutory scheme. Historically, our courts have presumed that Congress did not intend to preempt state laws that were enacted pursuant to a state's "police power" --- the phrase used to describe laws that promote the health, safety, or welfare of a state's citizens or its communities. Indeed, when it comes to state police powers, Congress often enacts laws that are intended to supplement a state's exercise of those powers.

The issue arose just four years ago in Wyeth v Levine (2009). The Court examined the history of federal legislation pertaining to name-brand pharmaceuticals dating back to 1906. It concluded that Congress had passed laws that were intended to supplement the protections afforded to consumers by state regulations and common law liability.

The Court, in Wyeth, expressly rejected Big Pharma's claim that it was "impossible" to simultaneously comply with both state and federal regulations pertaining to the need for adequate warning labels, noting that, in a 2007 amendment to the Federal Food, Drug & Cosmetic Act (FDCA), Congress "granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug's initial approval."

A scant two years after the Court handed down its decision in Wyeth, a sharply divided U.S. Supreme Court handed down a 5-4 decision in Pliva, Inc. v. Mensing (2011) ("Mensing").

The Mensing majority, whose opinion was written by Justice Clarence Thomas, pointed to a separate federal statute that is designed to permit "manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug." Where a "brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label...[the] manufacturer seeking generic approval...is responsible for ensuring that its warning label is the same as the brand name’s."

Thomas reasoned that since a manufacturer of generic drugs cannot unilaterally strengthen the warnings offered on a generic drug's label, it was impossible for the generic manufacturer to simultaneously comply with both FDA labeling requirements and a state law which "requires a manufacturer that is, or should be, aware of its drug’s danger to label it in a way that renders it reasonably safe."

Thus, Thomas concluded that state tort laws imposing a liability upon pharmaceutical companies to pay damages to consumers for a failure to provide adequate warnings on a drug's labels are preempted by federal law. In other words, he wrote for the court's majority in 2011, even if state law requires more stringent labeling, the federal FDA laws take precedence --- or preempts --- that state law, effectively nullifying it.

Bait-and-switch

In both the 2011 decision in Mensing and in last month's ruling in Bartlett, the four dissenting Justices offered up a stinging rebuke to the majority's claim that it's impossible for manufacturers of generic medications to comply with both FDA labeling requirements and state tort laws based upon a company's failure to properly warn about the dangers of its drugs. It is, for example, clearly "possible" for any pharmaceutical manufacturer to temporarily remove a dangerous generic drug from the market, while waiting for FDA approval of a more adequate and appropriate warning label. One dissenting Justice, Stephen Breyer, noted that it would also be possible for a manufacturer to leave the generic with its FDA-approved label on the market and then pay damages to those who were injured by the unreasonably unsafe drug.

Irrespective of the merit, or lack thereof, of Thomas's rationale in the 2011 Mensing case --- a rationale that Justice Alito simply repeated in last month's Bartlett decision --- Thomas's reasoning had absolutely no bearing on the issue presented in Barlett. Karen Bartlett's $21 million judgment meant as recompense for her horrific injuries was not based upon the content or deficiencies --- or a "failure-to-warn" --- on Sulindac's label. It was based upon the fact that, with or without an adequate warning label, Sulindac was unreasonably unsafe.

That point was central to Justice Sonia Sotomayor's Bartlett dissent. She argued that whatever was or wasn't on the label of the drug had absolutely nothing to do with the case before the U.S. Supreme Court.

"New Hampshire recognizes strict liability for three different types of product defects: manufacturing defects, design defects, and warning defects," she wrote. "Because the District Court granted Mutual [Pharmaceutical Co.] summary judgment on Bartlett's failure-to-warn claim, only New Hampshire's design-defect cause of action remains at issue."

In other words, contrary to the majority's bait-and-switch argument, it was the defectiveness of the drug itself, rather than the inadequacy of the warnings on its label, which resulted in the case coming before the court.

"A product has a defective design under New Hampshire law if it 'poses unreasonable dangers to consumers," Sotomayor added. "New Hamshire's design-defect law did not require Mutual to change its warning label...and an adequate label is...neither a necessary nor a sufficient condition for avoiding design-defect liability."

Sotomayor described the majority's further expansion of its poorly reasoned 2011 decision in Mensing as unnecessary, inappropriate and unwise, observing:

The fact that imposing strict liability for injuries caused by a defective drug design might make a drug manufacturer want to change its label or design (or both) does not mean the manufacturer was actually required by state law to take either action. And absent such a legal obligation, the majority’s impossibility argument does not get off the ground...

Profits before people

The tortured decision by the majority in the Bartlett case is one which, once again, places profits before people, or, more to the point, the health of the bottom line of fictional corporate "persons" over the health and general welfare of actual people in this nation.

There is no escaping the fact that the radical right-wing, five-member Supreme Court majority, four of whom are connected with the Robert Bork-founded, Koch Brothers-funded Federalist Society, engaged in nothing less than legal gymnastics to place the profit margins of giant pharmaceutical companies above the health, safety and very lives of our citizens.

More than a century's worth of federal legislation designed to supplement the protections provided by state regulations and common law with respect to the dangers of prescription medications has now been gutted in favor of protecting the generic pharmaceutical industry's bottom line.

Uninformed consumers who are injured, maimed or even killed by what may prove to be poison pills are are now left with no remedy whatsoever.

This case, like the sad saga of my client, Charles Romano, described in "Schwarzenegger's Workers' Comp 'Reform' Killed My Client", underscores the true meaning behind the dog-whistle in the Republican code words, "tort reform."

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Ernest A. Canning has been an active member of the California state bar since 1977. Mr. Canning has received both undergraduate and graduate degrees in political science as well as a juris doctor. He is also a Vietnam vet (4th Infantry, Central Highlands 1968). Follow him on Twitter: @Cann4ing.