The generic drug industry is heatedly battling attempts by the Food & Drug Administration to make generic drug use safer for the U.S. consumer.  Interviewed in the market journal, Law 360, Levin Papantonio shareholder Tim O’Brien had this to say about generic drug lobby:  “They just want to punch out pills and rake in money.”  This astute observation – as well as a nearly perfect “capsule” description of the unique, profit-driven, corporatized U.S. health care system – was made by O’Brien, a top trial lawyer who is no stranger to product liability involving prescription drugs. He points out that drug makers who manufacture and market generics “are really enjoying this anti-competitive position: they have done nothing to invent the drug, and they don’t want to take any liability for warnings.”

What is Mr. O’Brien talking about?

To understand what’s going on, we need to go back a few years to a Supreme Court decision rendered in the case of Pliva, Inc. v. Mensing. The “Inc.” in that case name should give you a good idea as to where this is going, if you know anything about the current makeup of the U.S. Supreme Court – consisting of four honest, thoughtful, dedicated jurists and five corporate toadies.

Therein lies the tale.

The Background

Several years ago, Gladys Mensing and Julie Demahy were prescribed a medication known as metoclopramide, originally developed by a Belgian pharmaceutical firm, UCB. The drug was marketed in the U.S. by Schwarz Pharma as Reglan. This medication is commonly prescribed for the treatment of nausea, diabetic gastroparesis (a condition in which food remains in the stomach for an abnormally extended period), and acid reflux. It has also been used off-label to treat migraines.  As of 2012, metoclopramide was among the 100 most-commonly prescribed medications in the U.S.

When Ms. Mensing was first prescribed metoclopramide in 2001, the patent on the drug had run out, making it available in generic form. It was the generic version that her physician prescribed.

By 2004, Ms. Mensing began experiencing “severe neurological disorders” – specifically, a condition known as tardive dyskinesia. This condition manifests itself gradually as spasmodic, involuntary repetitive movements that have no purpose. These movements can include facial tics (grimacing, excessive movements of the lips and tongue and frequent eye-blinking) as well as rapid, uncontrollable movement of the limbs, torso and extremities. The condition can be serious enough to interfere with mobility.

What They Knew (Or Should Have Known)

During that period, increasing evidence of the potential side effects was coming to light. However, early warning labels downplayed the risk. In the original lawsuit filed in a Minnesota district court in 2008, Mensing v. Wyeth, Inc., the plaintiff argued that “despite mounting evidence that long term metoclopramide use carries a risk of tardive dyskinesia far greater than indicated on the label, no metoclopramide manufacturer took steps to change the label warnings.”  In other words, the manufacturer knew that taking metoclopramide for an extended period was likely to result in Mensing’s condition – and failed to issue a proper warning. In fact, the company allegedly did the opposite, actively promoting the drug as a long-term treatment for Mensing’s condition.

The district court granted summary judgment to the corporate defendants – in other words, dismissed Mensing’s case. Their reasoning: Mensing’s claim against the manufacturers of the generic drug she actually took was in conflict with federal statute. Under federal law, generic manufacturers (Pliva and Actavis) are not required to have any warning on the packaging other than what was required of the original name brand company (Schwarz and Wyeth). In fact, these warning labels are mandated by law to be identical – even if the information is outdated or inaccurate. Furthermore, the judge dismissed Mensing’s case against Schwarz and Wyeth because she had never actually taken their name-brand product, Reglan.

In the fall of 2009, Mensing took her case to the Eighth Circuit Court of Appeals, which upheld the original court’s decision. Eventually, the case caught the attention of the U.S. Supreme Court, which agreed to hear Mensing’s case in 2011.

The Roberts Court Weighs In

The outcome should have been predictable. The decision was in favor of the corporate defendants, 5-4 – and regular listeners of Ring of Fire know good and well who the “five” were. Just in case you don’t, they are the usual suspects: Chief Justice John Roberts, who has never met a Corporate Person whose ring he wouldn’t kneel down and kiss, followed in lockstep by Justices Clarence Thomas, Antonin Scalia, Anthony Kennedy and Samuel Alito.  The dissent, in favor of natural humans, was filed by Justice Sonya Sotomayor, along with Justices Stephen Breyer, Ruth Bader Ginsburg and Elena Kagan.

According to the corporatist majority, the manufacturer of a generic drug bears no liability in a state court simply because it fails to inform the Food and Drug Administration (FDA) that the warning label is inadequate and outdated. After all, federal law requires that the generic label be identical to that of the brand-name version. Under federal law, a generic drug maker cannot even make changes to a warning label. On the other hand, a state law may require them to do so – putting the drug maker in an “impossible” situation.

In any event, federal law – in this case, provisions of the Hatch-Waxman Act (aka The “Drug Price Competition and Patent Term Restoration Act of 1984, which amended the Federal Food, Drug and Cosmetic Act) – trumps state law under the “Supremacy Clause” of the U.S. Constitution.  Among other things, the Hatch-Waxman Act ties the hands of the FDA, prohibiting the agency from doing much more than asking for “bioavailability studies” (bioavailability is a term referring to the amount of the drug that actually enters the system and how long it takes).

Bottom line: if the drug is generic but the warning label is outdated and inadequate, the generic manufacturer is shielded from liability.

The Dissent

Justice Sotomayor, as usual, disagreed with the corporatist majority, stating that it “invents new principles of pre-emption law out of thin air to justify its dilution of the impossibility standard.” She also called the majority’s interpretation of the Supremacy Clause a “direct assault” on earlier precedent under which any defense based on “federal preemption” of state law must clearly demonstrate that a major conflict exists in order to prove that “state and local regulation can constitutionally coexist with federal regulation.”

In short, when it comes to human health and safety, a drug maker has no excuse simply because its product is a generic.

Unintended “Absurd Consequences”

Justice Sotomayor also points out three “absurd consequences” of the ruling:

  • Consumers of generic drugs will have no recourse if they are injured because of inadequate label warnings
  • Manufacturers of generic drugs will no longer be held to the same standards as brand-name manufacturers when it comes to safety warnings
  • The ruling virtually undoes the primary goal of the Hatch-Waxman Act, which was to encourage and expand the use of less-expensive generic prescriptions; since strong and current safety warnings are not required, physicians will think twice about prescribing them – and patients will think twice before using them.

As is often the case, this decision has opened up a proverbial legal can of worms – which brings us to the present.

“There is a Little Good in All Evil

Some will recognize that line from the classic novel Where The Red Fern Grows. It is hopefully applicable to the current case, which, despite everything else, puts the spotlight on a serious problem. It is a problem that the FDA has been attempting to resolve.

It’s not going to be resolved without a fight. Generic drug makers realize they could finally be unequivocally held accountable for the harmful side effects of their products – regardless of what the original brand-name warning label said (or didn’t say).

The FDA originally made a proposal that would allow generic drug manufacturers to change the warning labels on their products when new safety information becomes available. The problem – for the generic drug makers – is that such power to make changes means they would no longer be able to hide behind the current federal law when an injured patient brings legal action.

Of course, this is not what the industry is saying. Instead, they are whining about how being allowed (in essence, obligated) to change warning labels independently would add burdensome costs (oh, horrors!). According to the Generic Pharmaceutical Association (GPhA), that price tag might go as high as $4 billion a year (this, from an industry with annual revenues in the tens and even hundreds of billions).

Oh…and incidentally, it would also confuse patients, because those warnings might be different from those on the original brand name (news flash: most brand-name manufacturers discontinue their drug once the patent expires), or even from one generic version to another. San Diego attorney Erin Bosman, who is representing a manufacturer of metoclopramide in current litigation, says, “We cannot have a situation where you could have upwards of 10 different labels, if you have nine generics on the market…labels would need to stay the same in order to maintain the [federal] sameness requirement.”

Of course, attorneys for the generic drug industry are also worried that the FDA proposal would undo the U.S. Supreme Court’s wonderful corporate gift, presented in the 2011 Pliva v. Mensing decision.

In any case, the GPhA has announced that it will file a lawsuit against the FDA if the federal regulatory agency attempts to implement the new rule.  Ironic, that the industry group that enjoys near-immunity from litigation is now threatening to litigate against the underfunded agency charged with safeguarding U.S. consumers’ health.

So…what is their solution?

The GPhA has proposed a system of “expedited agency review,” (“EAR”) which assumes that the FDA has the information and data needed in order to make decisions about safety labels. On the face of it, such a proposal bears a chilling resemblance to another “expedited” process the FDA employs, known as 510(k) Clearance. This now-infamous process allows a medical device manufacturer to bypass clinical studies if it can be demonstrated that the new product is “substantially equivalent” to one already given approval and currently on the market. Many health care and medical products approved under 510(k) Clearance have caused thousands of injuries and deaths (but that’s another story).

Further, the GPhA solution would draw in to the EAR process manufacturers of branded-drugs and relieve those branded manufacturers of their duty to quickly update drug label warnings under the changes-being-effected provisions of Title 21 of the Code of Federal Regulations.  The American consumer should be very concerned about cloaked effort to radically undermine the fundamental precepts of pharmacovigilance:  monitor safety signals and warn consumers and physicians quickly.

Corporate “People” vs. Natural Persons

Ms. Bosman says that the FDA needs to “recognize that this is something that needs to be dealt with

by Congress.” Of course, given that most members of Congress are as much in the pocket of Corporate America as its five pet judges on the SCOTUS, we know how that would play out.

Ralph Neas, CEO of GPhA, was not shy about it when he told his organization in a recent keynote address that “Our influence in the nation’s capitol and in state legislatures has never been greater.” He added that the industry has “never worked as closely with regulators at the FDA, especially with the office of generic drugs, as we do today.”

Indeed, they are…and more’s the pity for consumers. Lawyers for the plaintiffs are likely to be facing a long, hard battle against powerful corporate interests whose money speaks far, far louder than the voices of natural humans.

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K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues.