The Iowa Supreme Court recently ruled that a patient injured by a generic drug could successfully sue the drug maker, Pliva Pharmaceuticals, under state law. This is a landmark decision that may have ripple effects across the country. Dangerous drug lawyers at Pintas & Mullins tackle this issue below.
Generic vs. Brand Name Drugs
First, a little background on generic versus brand name drugs in the United States. When Big Pharma develops a new drug, it enjoys 20 years of patent protection before any generics can be made. Once the patent expires, the FDA requires that all generic drugs contain the same active ingredients as the brand name drugs, be identical in strength, dosage form, and route of administration, meet quality standards, and be manufactured under the same regulations as brand names.
There is an elaborate and comprehensive system in place to ensure the efficacy, safety, quality and purity of most generic drugs, particularly of those used in life-or-death situations, such as amoxicillin. The issue of generic drugs may never cross the minds of some people; yet in the U.S., this issue is an ideological, legal, business, economic, and regulatory battle.
Big Pharma has spent decades of time, money and resources trying to convince physicians and the public that generics are not as safe as branded drugs. This is a common phenomenon in our mass-marketed society – Kleenex vs. tissue paper, Jiffy vs. store-brand peanut butter, etc. – but it is quite different in pharmaceuticals, which must be approved and regulated.
The exorbitant costs of pharmaceuticals in the U.S. has been argued over since the 1960s, when the large price differences between branded and generic drugs prompted public outcry. Costs have only amplified over time – cancer drugs especially – and we tolerate it. We depend on drugs more over lifestyle changes to cure our ailments, which are by and large caused by our affluent lifestyle. The more we depend on drugs, the more Big Pharma can charge us for them.
How they Differ
Generic drugs are not exactly, 100% identical to brand name drugs; there is a specific matrix the FDA uses to prove they are bioequivalent in all the ways that matter (more on this can be found here, on the FDA’s Generic Drugs Q&A). Generics can be different in seemingly insignificant ways: the colors, size, price, shape, manufacturing plant, chemical binders, coatings, dyes, and filling agents.
The sciences of similarity and difference are not proven or defined as fact, however. Definitions change all the time and new forms of potential difference keep coming out. When there is so much we admittedly do not know about pharmaceuticals and how they interact in our bodies, why are we taking the risk?
Again, this comes down to drug pricing. Many, many people would not be able to afford the drugs they need to survive if they were not made by generic companies. But almost anything can cause adverse or catastrophic reactions when it comes to medications, even things that aren’t active ingredients. There are much more to those tiny little pills than what meets the eye, and decades of medical research proves that the inactive ingredients can be just as important, or just as dangerous, as the active ingredients.
The highest courts in our country are grappling with this issue as well, to varying results. The most important decision came in 2011, in the U.S. Supreme Court’s (SCOTUS) Pliva v Mensing ruling. SCOTUS found that, since the FDA requires labeling on generic drugs to be identical to brand name counterparts, those injured by generic drugs cannot sue the manufacturers for failure to warn.
This decision awarded generic manufacturers immunity from liability based on failure to warn claims. Two years later, in Mutual Pharmaceuticals v Bartlett, SCOTUS again granted generic makers immunity, this time from claims based on design defects. This was a huge blow to patients and public safety. More than 80% of all drugs prescribed are generic. Since these decisions, anyone injured by these drugs have little to no legal recourse against the companies that made them.
Recently, the Iowa Supreme Court offered a bit of hope for injured patients. This landmark decision, Pliva v Theresa Huck, came from a lawsuit filed by Theresa Huck, who was injured by Pliva’s drug metoclopramide (the generic of Reglan). Huck developed a serious neurological disorder, tardive dyskinesia, from the drug and sued both Pliva and Reglan’s branded manufacturer, Wyeth Pharmaceuticals.
The Iowa Supreme Court found that Wyeth was not liable for Huck’s injuries since she took the generic form of Reglan; it also found that SCOTUS’s Mensing decision could not apply to her case, opening Pliva up to liability.
The court found that Huck’s claim was based on Iowa’s laws of insufficient warnings because Pliva did not issue stronger warnings on metoclopramide that the federal government approved in 2004. Thus, the state law had to apply rather than the federal law. Mensing applies only to federal labelling laws.
Huck claimed that Pliva failed to update its warning labels in 2004 when the FDA approved new, stronger warnings for Reglan. The Iowa Supreme Court agreed, ruling that Pliva could and should have independently updated its labels to match the new warnings, that it had a federal duty to do so, and that Huck’s claims survived the 2011 SCOTUS preemption.
The updated warnings listed the risk of tardive dyskinesia as a possible side effect and that patients should not take the drug for longer than 12 weeks. Neither Huck nor her doctor saw these new warnings, because Pliva’s metoclopramide did not include it. She consequently developed the neurological disorder, which causes uncontrollable body movement and has no cure or treatments, and continued to take the drug for two years.
Pliva attempted to have the decision appealed to SCOTUS, however the court denied its petition without elaboration. In 2009, the FDA took further action, requiring all forms of metoclopramide to include a Black Box Warning – the FDA’s most severe alert – about the risk of tardive dyskinesia and long-term use.
The lesson here is that patients injured by generic drugs need to carve out creative legal avenues in order to sue generic drug makers. Huck and her legal team succeeded because they filed a claim based on breach of state law duty to warn, rather than federal law duty to warn (known as the Hatch-Waxman Act, more on this below).
Another story on a successful tardive dyskinesia plaintiff can be found here. The plaintiff in that case took metoclopramide and developed the disorder, suing Wyeth and winning in Alabama Supreme Court.
New FDA Rule Proposal Fuels Battle
In 2013, the FDA proposed a rule that would allow generic drug makers to update their own labels without first gaining federal approval. In a public hearing on this proposal, several consumer and advocacy groups came together to voice their support.
This proposal makes sense at the most basic level: as long as a drug stays on the market, we are constantly learning new information about its risks. Currently, when new safety studies come out on a drug, brand name companies can independently update the drug’s labels to reflect this new information, while generic drug companies cannot.
This was evidenced in Huck’s lawsuit, when in 2004 Wyeth updated the labels to include the risk of tardive dyskinesia, and Pliva did not. Generic companies like Pliva are not allowed to make changes to labels unless the FDA approves them or the branded name updates labels first. Generic companies have little to no incentive to update their labels or to monitor side effects, since they are protected by the 2011 SCOTUS ruling.
As stated, generics make up about 84% of the American drug market. That means the vast majorities of people taking medications do not know the true risks of these drugs, and have no legal recourse if they suffer a severe side effect.
Advocates argue that this FDA proposal would immediately solve this problem. Generic companies counter-argue that the proposal would have disastrous ripple-effects and that it contradicts the federal Hatch-Waxman Act. This Act, enacted in the mid-1980s, requires all generics to have the same labels as generic equivalents. It is also what the majority of SCOTUS judges based their 2011 decision upon. Drug industry insiders view this proposal as a direct conflict to the Act’s guiding principle.
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