Patients Take Generic Drugs at Their Own Risk

 Posted on February 05, 2015 in Uncategorized

By Timothy S. Tomasik

When a generic prescription drug causes injury to a patient – even permanent neurological injury or death – the patient cannot sue the maker of the generic drug, even if the patient could have sued had he or she been administered the name brand drug instead.

Why Are Generic Drug Manufacturers Essentially Immune From Suit? 

Two Supreme Court product liability cases have slammed closed the courthouse doors to injured patients while protecting the manufacturers of generic drugs, no matter how horrific the harm to the patient.

Historically, the Supreme Court of the United States has permitted brand name drug companies to be sued for failing to adequately warn consumers furthers Congress goals of safer drugs and better informed patients.  Wyeth v. Levine, 555 U.S. 555 (2009); Erwin Chemerinsky, The Case Against the Supreme Court (2014).  Chereminsky’s book is a must read for anyone who cares about protecting consumer rights.  Chemerinsky’s take in The Case Against the Supreme Court is dead on, so let’s discuss how he got it right.

The question to ask is, how did the Supreme Court get it so wrong just two years after Wyeth when it ruled that a patient can’t sue a generic manufacturer for failing to adequately warn of side effects, even if a patient could have brought suit against the name brand company instead?  How can the law possibly allow name brand drug companies to be liable and give generic drug manufacturers of the same drug a break? The answer lies in two Supreme Court cases from 2011 and 2013 that diverge radically from the precedent set in Wyeth.

In two landmark decisions Pliva, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett in 2011 and 2013, respectively, generic drug manufacturers were essentially handed blanket immunity from negligence for failure to warn.

In the first case, Mensing, patients were administered Metoclopramide, a drug designed to increase how quickly patients digest food and is often provided to patients who are treating for diabetes.  The FDA approved the drug originally in 1980 under the brand name of Reglan.  Generic drug manufacturers began marketing Metoclopramide five years later.  Sadly, research demonstrated that the drug caused an irreversible and severe neurological disorder in up to 30% of patients who ingested the drug for a significant amount of time.

Gladys Mensing, and others, ingested the generic drug.  The original warnings in 1985 said that “Tardive Dyskinesia…may develop in patients treated with Metoclopramide,” and the package insert simply stated that therapy longer than 12 weeks has not been evaluated and cannot be evaluated and cannot be recommended.

Later in 2009, after Gladys Mensing had ingested the drug, the FDA ordered a new, stronger warning that made it clear that the drug could cause irreversible neurologic damage.  The drug company argued that they were insulated from liability for failing to adequately warn patients because the drug label had originally been approved by the FDA.  The generic pharmaceutical company said that any state law claim for failing to warn was “preempted” by federal law.

The constitution says that the constitution and laws and treaties made pursuant to it are the supreme law of the land.  Thus, if there’s a conflict between federal law and state law, federal law wins out; this is termed “preemption.”  The drug company said that its compliance with federal law – obtaining FDA approval – meant that it could not be held liable.  See Chemerinsky.

Generic Drug Manufacturers Granted License to Harm

Shockingly, the Supreme Court concluded in Mensing that the manufacturers of generic drugs could not change these warnings because the verbiage of the warnings for generic drugs must be the same as the warning that had been previously approved for the non-generic name brand drugs.  Nor could generic drug manufacturers send notices to doctors and hospitals informing them of the harm.  This decision led to an unjust outcome wherein the court, contrary to Wyeth, concluded that suits against makers of generic drugs for failing to adequately warn consumers of harmful side effects are preempted by state law.

It is fundamentally unjust that if someone is injured after taking a brand named version of a drug, the injured patient can sue the drug company; however, if a patient is injured after taking the generic version of the identical drug, the Supreme Court determined that the patient cannot sue the generic manufacturer.  Of course, the victim cannot sue the company that named the brand-name version of the same drug, because the patient did not ingest that company’s product, despite having ingested a drug made of identical design and compounds.

The Mensing decision is poorly reasoned on many levels.  The Supreme Court recognized the injustice, stating:

We recognize that from the perspective of Mensing… finding preemption here but not in Wyeth makes little sense.  Had Mensing taken Reglan, the brand name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be preempted.  But because pharmacists, acting in full accord with state law, substituted generic Metoclopramide instead, federal law preempts these lawsuits.

The Supreme Court recognizing the irrational outcome, yet inexplicably dumped responsibility on Congress:

We acknowledge the unfortunate hand that Federal Drug Regulation has dealt Mensing… and others similarly situated.  But ‘it is not this Court’s task to decide whether the statutory scheme established by congress is unusual or even bizarre.’

The Supreme Court reached even further to protect generic-drug manufacturers two years later in Mutual Pharmaceutical Co. v. Bartlett, when it concluded that manufacturers of generic drugs cannot be sued for design defects either.

The unjust reality of these cases results in generic drug manufacturers enjoying broad immunity to suit while innocent consumers are severely injured.

How About Walgreens, CVS, and Wal-Mart?

How popular are generic drugs with the big players – Walgreens, CVS, and Wal-Mart?

According to the FDA, nearly 80% of all prescriptions are filled with generic drugs.  When there is a generic equivalent to a brand name, more than 90% of the time, a generic is prescribed.  All who take generic drugs are at risk; if they are injured from the drug, they will not be able to recover.  See Erwin Chemerinsky, The Case Against the Supreme Court (2014).

Timothy S. Tomasik was a member of the American Bar Association’s Task Force on Federal Agency Preemption of State Tort Laws.