Posts Tagged ‘ Preemption ’

How Generic Drugs Discriminate Against the Poorest Patients

April 10th, 2012. By AbiK

No one wants to come right out and say it, but that’s basically what’s going on with generic drugs. Poor patients are effectively discriminated against simply by having no choice other than to buy the cheapest version of whatever pill they’ve been prescribed. Cheaper meds are fine—until you factor in that the more expensive brand name equivalents come with a bit of an extra ‘insurance policy’—no, not the type of insurance you’re thinking of—it’s insurance in the sense of legal recourse should something go wrong as a result of taking the drug.

Let’s face it, outside of those who claim to buy the cheaper equivalent on ‘principle’, for the most part the folks who are buying generics are those who either simply cannot afford the brand-name drug or those who’ll lose prescription coverage benefits unless they opt for the generic shown on the approved formulary from their insurance company. We’re not talking the 1% here, folks.

Sure, it’s great that cheaper generic versions of big-name blockbuster drugs are available—we’d all be broke otherwise. But generics have a hidden cost, too…

Legally speaking, that cost can be tremendous. How so? Well, what if something goes wrong—horribly wrong—upon taking the drug? What if there’s a serious reaction to the drug, like a ruptured tendon from a fluoroquinolone? Or tardive dyskinesia from a ‘good as Reglan’ generic? Sure, the generic drug should in most instances perform like its pricier twin—but there’s a catch: unlike with brand name drugs, if something goes wrong, there’s not much legally at present that can be done (from a strict product liability standpoint—not talking malpractice here).

The issue with generic drugs has to do with liability—being liable when harmful side effects occur. And simply put, generic manufacturers are not held liable.

Currently, it’s the brand name drug manufacturers who are responsible for ensuring their drug has gone through a rigorous FDA-approval process and they’re also responsible for making any label changes should new warnings be applied to a drug they’ve produced.

Generic manufacturers, however, don’t have quite the same responsibility. The Hatch-Waxman Act—officially, the Drug Price Competition and Patent Term Restoration Act of 1984—made it easier for generics to find their way to market. Generic drugs do not have to go through a lengthy FDA approval process if they’re able to prove that the generic drug is equivalent to the brand name version. And, as such, the generic drug simply picks up the labelling information and package insert information from the brand name drug. When any changes are necessary (e.g., adding a black box warning), the generic is required to duplicate what’s happened with the brand name drug.

The most significant benefit of the Hatch-Waxman Act for blockbuster brand name drug manufacturers is that it allows the big pharma companies a period of exclusivity in the marketplace before the generic drug enters the market.

Now, the difference between a drug liability lawsuit for a generic vs a brand name is most glaring when you look at lawsuit outcomes. One of the most publicized examples showing the difference between a brand name drug lawsuit and a lawsuit with the same, but generic, drug involves phenergan.

In both cases the plaintiffs—both women who were administered the anti-nausea drug in a hospital and then subsequently lost an arm due to gangrene—sued the drug manufacturers. In the brand-name case, it was v. Wyeth; in the other, the generic, it was v. Baxter Healthcare. The upshot was that the plaintiff who had the ‘good fortune’ to have been given the brand name version received a multi-million dollar settlement. The generic patient? Her lawsuit against Baxter was dismissed. She had also filed a malpractice lawsuit, the final terms of which were undisclosed. 

Both women had life-altering injuries; only one received settlement money from the drug manufacturer.

While the phenergan lawsuits began in a hospital setting where the choice of brand name or generic may not have been the patients’ to make, the outcomes of their lawsuits show the stark difference in terms of liability claims. And, for patients who simply cannot afford to choose a brand-name drug, choosing the generic becomes a more or less de facto decision to give up the right to sue the drug company. And in that sense, generic drugs do discriminate against the poorest patients.

Tags: Big Pharma, Discrimination, Drug Formulary, Drug Lawsuit, Generic Drugs, Preemption, Prescription drugs, Product Liability
Posted in Discrimination, Drugs/Medical, Emerging Issues | No Comments »

Understanding Preemption in Plain English

March 5th, 2010. By Kristine B

Over the last year or so, there’s been some discussion in the media about “preemption.” So, I thought I’d take this opportunity to explain preemption and why it’s important (specifically, why and how it affects you). 

In legal-speak, preemption is based on the Supremacy Clause of the US Constitution. That clause states that some matters are of national importance rather than local importance. In those matters, national (federal) law must take precedence over state laws. Furthermore, states cannot pass laws that are inconsistent with the federal law. Preemption extends downwards as well, so that state law takes precedence over community law. 

Ok—let’s give a completely unrealistic and ridiculous example to simplify things here. Let’s say our friends in Washington DC decide that Wednesdays should be “Wear Red” day—kind of a “have heart” or weekly AIDS Awareness thing. Now let’s also suppose that some state actually bans wearing red on Wednesdays. Whoops—would seem to be a problem here, right? Ahh, but with preemption, federal law could “preempt” state law and you could look forward to viewing a sea of red every Wednesday. 

Now, this happens where the matter is of national importance. Not every law is subject to preemption. Also, there are situations in which state and federal laws are similar and do not entirely contradict each other, leaving questions about which laws should be followed. 

For example, not all states have the same employment laws. There’s a federal law, called the Fair Labor Standards Act (FLSA) that sets out employee wages and hours worked. However, many states have laws that overlap with the FLSA and also set out wage and hour regulations. In those situations, it is not Read the rest of this entry »

Tags: Pleading Ignorance, Preemption
Posted in Drugs/Medical, Pleading Ignorance | 3 Comments »