It can cost upwards of a billion dollars, start to finish, to put a new drug on the market.
First, there's all the research and testing, tweaking the chemistry until it is demonstrably able to treat one or more health problems. Once that's done, the finished product has to go through clinical trials. It then has to be approved by the FDA, and also patented so others can't bogart its success for a few years. Once all that red tape is cleared, the company still has to launch a comprehensive marketing campaign to convince the public they made the right drug for the job.
All of this helps to explain why the costs for name-brand drugs can be so high. Fortunately the pharmaceutical industry helps alleviate this issue with generic drugs, which are chemically almost identical and are marketed after the patent on the name-brand medication expires. The FDA requires generics to be "bioequivalent" to the name-brand drugs, meaning that they are required to be the same strength and dosage form, with minimal variance.
Since the medications have the same active ingredients and purpose, they also share similar side effects. Unlike with name-brand drugs, though, people who suffer harmful issues from using the generic drugs are left with few legal options to be compensated for their damages.
This can be traced back to the outcome of Pliva, Inc. v Mensing in 2011.
Pliva, Inc. v Mensing: Background
In the early 2000's, Minnesota woman Gladys Mensing was prescribed metoclopramide, a generic form of the acid-reflux medication Reglan, to combat her diabetic gastroparesis. She used the medication according to the prescription's instructions for four years, and during that time developed a motion disorder called tardive dyskinesia, which causes uncontrollable movements of the limbs and/or face. This is a serious neurological issue, and severely affects one's quality of life. Moreover, it can't necessarily be stopped just by discontinuing the causal medication--the damage can be permanent.
Determining that her prescription was the source of the malady, Mensing sought damages against Pliva, Inc., the manufacturer of the generic drug. Her claim was a Failure to Warn product liability claim, in which a manufacturer is negligent of their public duty by not suitably warning consumers of possible risks related to using a product.
Mensing's claim was denied in Minnesota District Court, which claimed that state tort laws were preempted by the federal Food, Drug, and Cosmetics Act (FDCA). This law, codified in 1938, asserts the Food and Drug Administration (FDA)'s control in approving and overseeing new drugs on the market. It also sets guidelines for how much regulation generic medications undergo before they are approved, and how they must be labeled.
Mensing's written brief states that "Where state and federal laws directly conflict, state law must give way." That's a good summary of preemption, which is established by an article of the Constitution commonly called the "Supremacy Clause."
Here's a broad example to see this idea in action outside of the Mensing context:
Widgets are a controversial new device. A state passes a law that says "no citizen may sell Widgets anywhere in this state". In the interest of promoting commerce, however, the federal government has established the "Widget Sales Protection Act", prohibiting actions that limit or outlaw Widget sales. A vendor in the state that outlawed Widget sales is found to be selling them anyway, and is charged with violating the state law. He may challenge the state law on the basis that it is preempted by federal law, and therefore violates the Supremacy Clause of the U.S. Constitution.
In instances where a citizen can't obey both state and federal laws because the two are in conflict, the Supremacy Clause lends greater weight to the federal stance.
Gladys Mensing appealed the decision to the Eighth Circuit Court of Appeals, which reversed the initial findings and ruled in her favor. The logic applied by the Circuit judge was that while Pliva, Inc. was unable to unilaterally fulfill their obligations as outlined by state tort law, they still had available options within the boundaries of federal law that could have made a difference. The FDCA prohibited the company from making changes to its labels, but still permits manufacturers to make suggestions about label changes in the event that risks are discovered. Generic manufacturers are also permitted to write and send "Dear Doctor" letters, which inform physicians of potential risks that have not yet made their way to official labeling.
These latter methods, while useful, are not mandatory in the same way that label changes are. Essentially, Pliva viewed their obligation as all-or-nothing, and since "all" was a federally preempted non-factor, they opted for nothing, taking no intermediate steps for prevention or remedy. This was viewed by the Circuit judge as unsatisfactory performance of their duty not to harm their consumers.
Pliva, Inc. naturally appealed the new ruling. It was in the highest appellate court in the land, the United States Supreme Court, that the final word was handed down.
Mensing's claim was incorporated with that of Julie Demahy, another patient who was prescribed generic metoclopramide and developed tardive dyskinesia. Demahy had pursued damages in a Louisiana venue against Actavis, Inc., another maker of the generic drug.
In June of 2011, several years after the initial actions were filed, SCOTUS ruled that the manufacturers of generic medications cannot be held liable for the same "failure to warn" side effects that their name-brand counterparts can, because of stipulations in the FDCA. Mensing's and Demahy's cases were struck down.
Examining the Reasoning Behind the SCOTUS Ruling
When the case was brought before the justices, they examined the policies of the FDCA and the modifications that had been made to it in 1984, called the Hatch-Waxman Amendments.
Hatch-Waxman partially adapted the Changes-Being-Effected (CBE) policies outlined in the FDCA. These relate to the system drug manufacturers have to follow when making changes to their product labels. While the bulk of the Amendments was designed to help "fast track" a generic drug through the FDA vetting processes, one of its side effects was the idea that the information on the generic drug's label must exactly match that of the innovator.
Based on the stipulations of the adapted CBE process, the justices determined that the manufacturers of generic medications are actually not allowed to make changes to their labels unless their name-brand counterparts have already done so. It was determined that Pliva, Inc. would not have been able to add information about tardive dyskinesia to its metoclopramide label unless Reglan's manufacturer, Baxter Pharmaceutical, had made those specific changes first.
While individual states, Minnesota included, do have consumer-protection laws about failure to warn, the FDCA is currently written in such a way that Pliva, Inc. could not have complied with those state regulations unless it violated FDA guidelines, which are rooted in federal law. Under these circumstances, federal preemption was acknowledged by the court's justices.
In delivering the decision, Justice Clarence Thomas said:
"When the 'ordinary meaning' of federal law blocks a private party from independently accomplishing what state law requires, that party has established pre-emption."
Pliva, Inc. was absolved of liability by this statement. While "doing everything in their power to help" as suggested by the Circuit judge is a noble ideal, remedy was actually taken out of the company's hands by the stipulations of the FDCA. From a legal standpoint, following the guidelines of the preemptive federal law was enough to protect Pliva from liability.
The decision was not unanimous; in a dissenting opinion, Justice Sotomayor voiced misgivings about the results of the ruling:
"As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug...this outcome makes little sense."
Why This Ruling is So Important
Mensing laid some very unfortunate groundwork in the field of consumer protection. Thanks to the ruling, the majority of generic drug manufacturers are immune to litigation in the event their products cause harm to their users, as long as they don't deviate from the labels of the name-brand drug.
In essence, had Gladys Mensing been prescribed Reglan instead of metoclopramide--keeping in mind that the drugs are chemically similar, but legally distinct--she may have had a claim against Baxter Pharmaceutical. Because her prescription was filled with the generic, however, the SCOTUS decision rendered her without recourse to seek damages against Pliva, Inc., as well as setting legal precedent that prevents future action on behalf of people injured by generic drugs.
Justice Thomas noted when delivering the decision that they regretted the "unfortunate hand" dealt to Mensing and Demahy (as well as the multitudes of other generic-drug users). Instead of trying to re-interpret the CBE rules, though, they upheld them as written, and left the onus of changing them on the FDA and Congress.
At last count, generics were used to fill roughly 80% of prescriptions in America. That's 8 out of every 10 folks who are basically out of luck if those drugs take a bad turn.
There's all kinds of reasons a patient's prescription might be filled with the generic drug at the pharmacy. Many insurance plans are only willing to foot the bill for generic drugs if they're available. In many states, it's left to a pharmacy's discretion to fill a prescription with generics even if the prescription is written for the name-brand drug. Medicinally they're indistinguishable, and it saves the patient money at the time, but if anything goes haywire, Mensing laid precedent that keeps the patient from seeking damages against the drug's maker.
Naturally, this ruling has come under attack by a number of consumer advocacy groups, but so far they have had little traction. They will likely persist as long as it takes, given that Mensing constitutes an enormous blow to consumer rights.
Reglan itself saw several label revisions as more information came to light about tardive dyskinesia, and per the CBE regulations, that opened the door for generic manufacturers to update their warnings too. For many, though, all that is too little, too late.
It's Not Impossible to Seek Damages.
You'll note that I keep saying things like "majority," not "all," and citing percentages that aren't one hundred.
That's because it's not categorically impossible to pursue a claim when a generic drug hurts you; regrettably most of them are off-limits, but there are times when the parent company that makes the name-brand drug owns the subsidiary firm that makes the generic drug.
A couple of good ideas if you're considering pursuing a claim:
- Talk to your pharmacy and find out whether your prescription for Drug X was filled with actual Drug X or a generic equivalent. Even if it's scribbled on a pad by your doctor as Drug X, many pharmacies are legally allowed to fill the bottle with generics, so it's a good start to check on that.
- Have them print you a record; you are entitled to the information they have on file about your prescription history.
- Armed with this information, check with an attorney. Consultations are usually free.
While I doubt anyone considers the legal ramifications of buying a generic versus name-brand prescription, it's a non-decision that can have terrible ramifications in certain instances.