What do Tysabri, Lipitor, and Gardasil have in common (besides the obvious, they're all FDA-approved pharmaceuticals)? All these beneficial drugs are under assault, in various ways, by non-scientific and just plain frivolous, greed-inspired litigation. Yet, only one has been named in a recent lawsuit. Can you guess which?
Tysabri is a powerful weapon against a certain form of progressive Multiple Sclerosis (MS). Around the time of Tysabri's release, studies were published showing the remarkable degree to which it reduced the devastating toll of MS when used in combination with another MS drug. In fact, patients were lining up to get it before their disease left them dependent. Shortly thereafter, however, three patients were found to have developed a rare infection, progressive multifocal leukoencephalopathy (PML), and two of these died. Thus, only four months after its release the drug's maker, Biogen-Idec, without waiting for comments from the FDA, pulled Tysabri off the market. Follow-up studies confirmed the rarity of the infectious complication, and that the only times PML occurred was when the drug was used in combination. Only this month the company announced the re-release of Tysabri--at a substantial price hike. (In non-economic terms, MS patients were deprived of this breakthrough drug for almost a year and a half, thanks to fears of litigation over a rare complication).
Gardasil is the newly-released vaccine from Merck, which has been shown to be highly protective when administered to pre-teen girls against the human papillomavirus (HPV) known to cause cervical cancer. There is no real medical issue involved with the use of this vaccine--it has been shown to be safe--but some groups and some parents oppose its inclusion among the children's and teens' mandatory vaccines. The other issue: the price tag. Merck is charging in the range of $360--$500 for the series of three shots required for maximum efficacy. This would make Gardasil the most expensive vaccine ever made.
Lipitor is the best-selling drug in the world. This cholesterol-lowering statin is both extremely safe (side-effects, usually mild, are uncommon; serious reactions occur with about a one in one-hundred-thousand frequency) and highly effective in lowering the level of artery-clogging LDL-cholesterol. It has likely been responsible to some degree for reducing the number of heart attacks and cardiac-related deaths since its introduction almost ten years ago. This Pfizer product was recently named in a lawsuit by two plaintiffs alleging various ailments as a result of their use of this drug. Pfizer, noting the long history of safe use of lipitor, and the fact that the package insert (label) points out the types of reactions known to occur, denies any responsibility for the plaintiffs' complaints (not even mentioning the obvious fact that these patients had their own doctors who are directly responsible for deciding on treatments such as lipid-lowering drugs).
All these drugs--and those of us who hope to benefit from them-- are the victims of our system of litigation. The lipitor lawsuit was lodged in one of our notorious judicial hellholes (or, more diplomatically, "magnet courts"), Madison county, Illinois, where trial lawyers love to file their suits, no matter how tenuous the link to that region. Judges and juries there are prone to awarding windfall judgments to "injured" citizens based on lawyers' courtroom theatrics and little more. The price of Lipitor takes concerns about such suits into account.
But more directly related to our fertile tort soil are the prices of Gardasil and Tysabri. Merck still teeters on the brink of insolvency due to the feeding frenzy about Vioxx, its withdrawn painkiller tied to increased risk of heart disease--even though studies have shown similar effects from several of the older arthritis drugs, known as NSAIDs. How can we expect Merck not to charge all the traffic will bear, in hopes of recouping some of its damages, real and expected, much of which will flow directly into the pockets of tort lawyers now circling them?
And when Biogen-Idec pulled Tysabri, do you think they might have been anticipating a similar assault against their drug from patients and family members alleging all sorts of problems stemming from its use? The Vioxx scenario demonstrated, however, that pulling a drug from the market not only won't insulate the company from lawsuits--it will likely do the opposite (note that Pfizer's similar drug, Celebrex, has not suffered anything near the attacks that Merck has since it pulled Vioxx in September 2004). Now that the demand for Tysabri has, if anything, increased, they would be foolish not to charge whatever they can to salt away in case lawyers discover new forms of injury they can try to tie to it.
"Googling" almost any drug on the market results in more links to trial lawyers trolling for "injured" clients than to any actual useful drug information--even for drugs with such high benefit-risk profiles as Lipitor and other statins. The new FDA approach to simplify the drug label and make drug companies less susceptible to lawsuits in state courts via federal preemption may lead to lower demands on drug companies' budgets, and to lower drug prices for us all. Tort reform would also be a big help in this area. Almost any reform would be far better than the current situation, where a hefty piece of a drug's price winds up in the pockets of trial lawyers, to our detriment and that of America's health.
