The Supreme Court recently heard arguments in a case likely to have profound effects on how vaccines are marketed, distributed and developed. The court’s verdict could affirm the existing regulatory framework for testing and labeling vaccines. That would be good news, as vaccines are among the most effective medical advancements in history.
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A ruling in the other direction, though, would enable a torrent of frivolous lawsuits, threatening future vaccine development and cutting off patient access to medicines.
The case, Wyeth v. Levine, involves a Vermont woman who claims the manufacturer of the anti-nausea drug Phenergan failed to sufficiently warn her doctor of the dangers posed by one delivery method of the drug.
The drug’s label was approved by the federal Food and Drug Administration. But a lower court ruled that the label wasn’t amply informative and that the plaintiff was owed damages.
The question facing the court, then, is whether federal law trumps state law in the area of drug-labeling requirements. If it does, the FDA would have the final word on what needs to be included in a label.
If it doesn’t, then a private citizen could sue for labeling liability even if the firm in question complied with federal law. An anti-pre-emption decision would cause an uptick in litigation against drug makers, particularly vaccine manufacturers.
Vaccines have proven susceptible to unfounded medical scare stories. Witness the high-profile campaign linking the measles-mumps-rubella vaccine with autism, led by ex-Playboy playmateJenny McCarthy. McCarthy’s gripes are unfounded. More than 20 scientific studies have found that the vaccine doesn’t raise a child’s risk for autism. But her efforts have scared countless parents from getting their kids inoculated.
According to the Centers for Disease Control and Prevention, there were 131 reported cases of measles during the first seven months of 2008. That’s the highest total in more than a decade. Ninety-five of those cases were in children who were eligible for vaccination but didn’t receive a shot.
Determining what health risks are sufficiently probable to warrant a warning is a technical process, best conducted by experts. That’s why the FDA, which has some of the world’s best-trained scientists, is so well-suited for the task.
The average American isn’t so suited. Without pre-emption, that’s who would be given the responsibility — jurors and judges.
Trial lawyers know this. They’ll start fishing for plaintiffs in hopes of winning big-money judgments. The threat of frivolous litigation will lead many vaccine manufacturers to halt production. As a study by Vanderbilt economist Kip Viscusi in the Stanford Law Review found, "liability hazards led many firms to exit the vaccine market.”
Federal pre-emption would ensure uniformity in warning labels and guarantee that all Americans have equal access to vaccine information. For the sake of patients, physicians, and public health, the Supreme Court should affirm pre-emption.
Pipes is president and CEO of the Pacific Research Institute ( www.pacificresearch.org).
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There is already a special court set up for vaccination claims. The claims are limited to lost wages and medical expenses, and $250,000.00. That may sound like a lot of money, but I will tell you that three years ago, a flu shot caused me to have what my neurologist called an “adverse immune reaction,” which caused neuropathy in my neck. This causes intense muscle spasms in my neck.
I cannot see a movie in a theater – the pain is just too great. Sitting through a church service is quite painful. My ability to exercise is limited, and has cost me opportunities to be involved in Boy Scout activities with my son. My doctor keeps telling me that I need to get a colonoscopy, but I cannot go even one day without ibuprofen (600 mg 2 to 6 times a day), much less the requisite 2 weeks. The ibuprofen combined with a muscle relaxant tear my stomach up so badly without food that I gained 45 lbs. I have lost 20 of it, but really struggle to avoid further weight gain.
It appears I will have to deal with this pain for the rest of my life. I would gladly trade any recovery I receive, and much more, just to live without the pain in the future.
My reaction is very rare. It is hardly worth mentioning, unless it happens to you. Then you wonder why no one ever warned you about such problems. I don’t want to but vaccine companies out of business, and the federal claims process was set up to prevent that, but unfortunately, money is the only way we have of compensating people for injuries.
My original post had little to do with liability issues and more to do with the misrepresentation of the CDC's data by Pipes. The fact is that less than 60% of the people who developed measles were not vaccinated. Not 90% as he claims...which is annoying. I despise misrepresentation of facts to add a scare factor.
http://www.hrsa.gov/vaccinecompensation/statistics_report.htm shows that more than $916 MILLION dollars have been paid to people injured by vaccines, not just those claiming autism, because every single case there has been dismissed.
The fact is, the federal government already paid out nearly a billion dollars of tax money in payments to people who have been vaccine injured. This pre-emption is just a continuation of the lobbying attempted in the PATRIOT act to completely remove any liability that drug companies have for their product. You see how far that got China with their melamine problems...why do Americans want to set up the US for the same issues? Without liability, there is little economic reason to slow down and consider all the implications of a new class of drugs. Or even the introduction of new drugs with previously prescribed ones.
Sort of like suing the tobacco companies and the attempted suits on the liquor industry. The users say they don't understand the warnings or clearly printed labels on products including those for medicinal use. That comes in handy when looking to get a buck or two. Oh yes, the little old lady who did not understand that coffee is hot.
If there were suit happy people out there more Americans might have medical insurance but because someone tells you that a certain drug caused your problem you believe it and want to suit everybody. It's time for greedy lawyers and a society that wants to get rich off of lawsuits to be done away with period if you have a legitimate claim then so be it but most don't.
The St. Petersburg (FL) Times (11/12) editorializes that while the Supreme Court case of Wyeth vs. Levine "involves a personal and tragic story, the case has the potential for much wider sweep that could handicap the ability of consumers and patients to sue when injured by federally regulated products." In its appeal to the Supreme Court, Wyeth "claims that because the Food and Drug Administration (FDA) approved the drug's warning label, state courts are pre-empted by federal law and have no authority to impose additional liability." But "47 states, including Florida, as well as consumer advocates and medical groups submitted briefs on behalf of Levine. They say that allowing suits in state courts for damages when injuries arise is one of the key methods of ensuring drug safety." The Federal Government has "generally taken the position that FDA regulations and review and state tort liability compose a complementary system of protection for patients. But the Bush administration has shifted this stance, now siding with pharmaceutical companies over injured patients."
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I cannot see a movie in a theater – the pain is just too great. Sitting through a church service is quite painful. My ability to exercise is limited, and has cost me opportunities to be involved in Boy Scout activities with my son. My doctor keeps telling me that I need to get a colonoscopy, but I cannot go even one day without ibuprofen (600 mg 2 to 6 times a day), much less the requisite 2 weeks. The ibuprofen combined with a muscle relaxant tear my stomach up so badly without food that I gained 45 lbs. I have lost 20 of it, but really struggle to avoid further weight gain.
It appears I will have to deal with this pain for the rest of my life. I would gladly trade any recovery I receive, and much more, just to live without the pain in the future.
My reaction is very rare. It is hardly worth mentioning, unless it happens to you. Then you wonder why no one ever warned you about such problems. I don’t want to but vaccine companies out of business, and the federal claims process was set up to prevent that, but unfortunately, money is the only way we have of compensating people for injuries.
http://www.hrsa.gov/vaccinecompensation/statistics_report.htm shows that more than $916 MILLION dollars have been paid to people injured by vaccines, not just those claiming autism, because every single case there has been dismissed.
The fact is, the federal government already paid out nearly a billion dollars of tax money in payments to people who have been vaccine injured. This pre-emption is just a continuation of the lobbying attempted in the PATRIOT act to completely remove any liability that drug companies have for their product. You see how far that got China with their melamine problems...why do Americans want to set up the US for the same issues? Without liability, there is little economic reason to slow down and consider all the implications of a new class of drugs. Or even the introduction of new drugs with previously prescribed ones.
Fifteen of the patients (11%) were hospitalized, including four children aged
Fifteen of the patients (11%) were hospitalized, including four children aged