Sunday, October 16, 2005

THE CUTTER INCIDENT AND PARANOIA

DISCLAIMER: The following post includes commentary on legal matters, including suits filed several years ago in the State of California. Although the author is licensed to practice law in the State of Louisiana, this commentary is by no means exhaustive or definitive. First, the author is not terribly well-versed in California law, and second, the author has career and family responsibilities that simply won’t allow time for the type of research this subject probably merits. Under no circumstances, should the following be considered as legal advice.

I really do not want this blog to become a continuous rant against Paul Offit. So hopefully this will be the last post devoted to him for quite a while.

Over the course of the last few posts, I have looked at some of the opinions Dr. Offit puts forth; I have discussed why I think he is wrong; and, most intriguingly, I have speculated on the reasons why Dr. Offit would continue to engage in questionable thinking and actions even though he should know better (thanks for that turn of the phrase, Kristina).

Much of what people on my side of the fence write about Dr. Offit is devoted to the issue of his conflicts of interest: perhaps too much. I must admit that I find it hard to believe that Dr. Offit’s passion stems solely from self-interest. It may well be that Dr. Offit’s motivation has more to do with a desire to protect a vaccine program that he looks upon with a certain degree of pride.

The two cries we hear so often from vaccine apologists are: (1) that the claims of a link between vaccines and autism discourage parents from having their children vaccinated, and (2) that we are all just tools of greedy plaintiff lawyers who don’t care if they wrongfully destroy a vital component of our national health-care policy. The first argument obviously has no teeth. Just this past July, the CDC announced that vaccination rates were at an all-time high, with about 81 percent of the nation’s 19-to-35-month-old children receiving all the vaccinations in the recommended series. So the real issue is whether vaccine manufacturers should be worried about baseless litigation.

Paul Offit gave an interview recently to U.S. News and World Report, and it certainly provides some illumination as to how seriously he takes the litigation threat. The word “thimerosal” was never mentioned in the interview; the occasion was an opportunity for Dr. Offit to hawk his new book, The Cutter Incident. For those who are not familiar with the story, Cutter Laboratories was one of the manufacturers of the original Salk polio vaccine. The Salk vaccine relied on killed polio virus to create the immunity, but somehow Cutter mixed in live polio virus into some of the doses. As a result, thousands of children were infected with polio, including 10 who died.


Despite the acknowledged mistake of putting a live virus into some of the doses, Dr. Offit blames the incident on a reliance on animal studies. (Of course, we know the low esteem in which Dr. Offit holds animal studies.) Dr. Offit blames the Cutter incident for what he sees as the sorry state of affairs in the vaccine industry today.

Does that mean that vaccines now can be just as dangerous?

No. Because of Cutter, vaccines go through thousands of tests to make sure they contain exactly what they are supposed to contain. They are tested in thousands of people before they are licensed, and they’re watched carefully afterwards to make sure they don't cause any rare side effects.

So things are good with vaccines?

Also no. Cutter spawned a lawsuit that eventually brought the vaccine industry to its knees, which is where it is today.

By “to its knees,” Dr. Offit is specifically referring to the dramatic reduction in the number of vaccine manufacturers that produce a greater number of required vaccines. Of course, Dr. Offit doesn’t attribute any other factors that just might have contributed to that reduction, such as the increased cost of testing that rightfully must be part of the development of a vaccine, or even the merger of pharmaceutical companies. But could a single lawsuit bring an industry “to its knees?” Possibly, but it certainly wasn’t the suit Dr. Offit describes in his interview.

Shouldn’t people who were harmed by Cutter have sued? And won? They got polio, after all.

I'm not saying they shouldn’t sue. But the jury found that Cutter was liable even though they were not negligent. That meant vaccine makers could be sued for any harm. And juries who don’t understand science, and who don't understand the difference between causality and coincidence, award giant sums of money. That scares companies away from making vaccines. Group B strep infections -- the leading bacterial killer of newborns -- could be prevented with a vaccine for pregnant women. We have the technology to do it. But nobody is willing to risk lawsuits from women with babies born with unrelated birth defects.

Once again, we’re confronted with Dr. Offit’s attitude that lay people are simply too stupid to understand the intricacies of medicine and science. But was he right about the Cutter suit and its impact on the law? No.

The suit to which Dr. Offit apparently refers resulted in a reported decision that reviewed the jury’s verdict. Gottsdanker v. Cutter Laboratories, 6 Cal.Rptr. 320 (Cal. App. 1 Dist. 1960) actually involved only two of the infected patients, with a total jury award of $147,300 (including medical expenses). Now in fairness to Dr. Offit, there were undoubtedly many other suits that resulted from this incident, and this suit acted as somewhat as a precedent for those suits (at least for suits filed in California), but it hardly seems that $73,650 per child qualifies as a “giant sum of money,” even in the 1950’s economy. Some children probably were awarded more, but some probably got less.

Dr. Offit’s description of the suit is almost accurate, but only “almost.” It is true that the jury inexplicably determined that Cutter was not negligent. Perhaps the judge charged the jury that actual knowledge of a defect was required; I really don’t know. The point is the verdict against Cutter was not without a legal basis existing outside of the negligence theory. What the jury found, with eventually the court of appeal agreeing, was that Cutter breached an implied warranty of fitness. In other words, Cutter’s express disclosure that “local and other untoward reactions have been very minimal” was not sufficient to counteract the implied warranty that the vaccine would not cause the very disease it was supposed to prevent. The court of appeal addressed the same sorts of policy issues that Dr. Offit claims have been lost through the imposition of liability in cases like this:

Defendant strongly argues that public policy will best be served by denying recovery in warranty for “new” drugs. The argument is that development of medicines will be retarded if manufacturers are held to strict liability for their defects. While this argument might have merit if the warranty involved had to do with the mere failure of a medicine to cure or of a vaccine to prevent, it seems to be of but little weight where, as here, the warranty is limited to an assurance that the product will not actively cause the very disease it was designed to prevent.
6 Cal.Rptr. 326.

The real question becomes the extent to which Gottsdanker had an impact on the development of liability claims against vaccine manufacturers. The answer to that question is “not very much.”

When the Sabin oral polio vaccine was introduced, it used a live virus to create the desired immunity, and predictably, some doses contained viruses that were not properly attenuated, and patients wound up contracting polio as a result of receiving the vaccine. One reported California decision reviewing jury verdicts against a manufacturer (for the “giant sums” of $60,000 and $80,000) discussed the Gottsdanker holding. The court in Grinnell v. Charles Pfizer & Co., Inc., 79 Cal.Rptr. 369 (Cal. App. 1 Dist. 1969) noted that the appropriate theory for suits against vaccine makers was really the more traditional tort theory of strict liability rather than a theory of implied warranty. (In most jurisdictions, strict liability denotes a species of liability in which the plaintiff must show a defect, but because of the superior position of the defendant to be on notice of the defect, the plaintiff is not required to show that the defendant had actual or constructive knowledge of the defect. The recent trend in most states is to eliminate theories of strict liability, particularly in products liability claims.)

The continuing trend in California continued to be that courts became increasingly protective of vaccine manufacturers. In Sheffield v. Eli Lilly & Co., 192 Cal.Rotr. 870 (Cal. App. 1 Dist. 1983), the court refused to apply strict liability on an industry-wide basis for defects in certain doses of the Salk vaccine, nor did it allow the plaintiffs to rely on the doctrine of res ipsa loquitur. That doctrine (literally, “the thing speaks for itself”) would have shifted the burden of proof to the defendants to show themselves free from fault. The court’s ruling kept the burden of proof on the plaintiffs to prove all elements of liability.

Finally. the decision in Kearl v. Lederle Laboratories, 218 Cal.Rptr. 453 (Cal. App. 1 Dist. 1985), signaled the death of the type of decision that Dr. Offit claims to be such a threat to the vaccine program. Therein, the court of appeal reversed a finding of liability against a manufacturer of the oral polio vaccine, and limited the causes of action available to plaintiffs:

We hold that although in standard products liability litigation a plaintiff may utilize a strict liability design defect theory, such a strict liability cause of action must be prohibited for public policy reasons if the court determines, after taking evidence, that the product complained of is “unavoidably dangerous”; in such special cases, a plaintiff may proceed on a design defect theory only on the basis of negligence.
218 Cal.Rptr. 454.

That holding specifically addresses the concerns of Dr. Offit, as stated in his interview, that we “learn things the hard way in medicine, when things do go wrong.” In essence, the court held that vaccine manufacturers could not be held to a standard of perfection.

I have not conducted in-depth research into the current state of affairs in California products-liability law. And while I am not an expert in products-liability law on a nationwide basis, I do have a more-than-passing familiarity with the national scene, and my knowledge of Louisiana law on that subject is pretty good. If any state allows the completely baseless manufacturers’ liability that Dr. Offit claims is out there, I certainly am not aware of it. Even the Gottsdanker case, while on the liberal side, had a rational basis under the law.

All industries are subject to being sued, and sometimes those suits turn out to be factually unwarranted. The medical field, including pharmaceutical companies, are no exception. Even when defendants prevail, just being sued can be an expensive proposition. Unfortunately, that is part of the cost of doing business in this day and age. By and large, however, the courts and legislative bodies do a pretty good job of providing a favored status for medical providers and pharmaceutical companies. For example, claims cannot be brought directly against a vaccine manufacturer unless they first go through what has become known as the “vaccine court.”

The vaccine court is an arm of the United States Court of Claims. Instead of suing vaccine manufacturers directly, plaint5iffs file suit against the United States, and awards come from a fund built up from a tax on vaccines. Not one penny of vaccine profits go to funding the awards. After going through the vaccine court process, plaintiffs who are dissatisfied with the outcome may opt out and refile their claim in an ordinary court, but, of course, that can delay the ultimate resolution of their claims by years. The system is designed to handle vaccine claims without threatening the economic viability of vaccine manufacturers.

Also, courts are now required to adhere to what has become known as the Daubert test for determining whether expert opinions are allowed to go before a jury. Not only must the party demonstrate that the witness is qualified as an expert, but a valid basis for the opinion must be established. That is, it must be shown that the expert’s opinion was formed through the scientific method, or the jury never hears from the expert.

As I have mentioned before, I represent corporations and insurers. My practice includes the defense of products-liability claims. I am all for putting an end to lawsuit abuse. If Congress decides to provide more protection to an already protected industry, that option is always available. The American people would prefer that we see no more last-minute riders to unrelated bills, but we would all have to live with any further provisions that are subject to a national debate. In my humble opinion, though, the vaccine industry already has all the protection it needs.

The perceived threat of litigation is simply not sufficient to provide a rational basis for the paranoia that fuels the deception we get from vaccine apologists. What worries Paul Offit and those like him is not the threat of frivolous litigation. It is the growing reality that parents of autistic children just may have a legitimate claim.

1 Comments:

Blogger JP said...

Wade,

You might be shocked to know that I actually agree that the Cutter Incident's role in the "state of vaccine business" today is overstated.

Several factors have led to the dearth of vaccine manufacturers today, the biggest being President Clinton's Vaccines For Children Act in the mid-90's that mandated vaccines for low-income families. This put tremendous price pressure on vaccines and greatly eroded their profitability. Add in the testing and production costs inherent in vaccines (not to mention potential liability concerns) and it's no wonder only one or two entities are making each vaccine today.

Cutter did have the effect of increasing the number of vaccine lawsuits. That's true. That's why the drug companies (supported, ironically, by Barbra Loe Fisher and the NVIC) pushed for the Vaccine Injury Compensation Program in the late-80's. It was meant to be a win-win - children with legitimate injury due to vaccines would get paid, manufacturers would be shielded from potential liability. Whether's it's met that objective is obviously a subject for debate.

I think Offit soft sells the real reason (price pressure put forth by universal vaccine mandates) that profits have declined. Since Offit has long been an advocate of public health measures, I'm not surprised by that. The VFC is a terrific idea from a public health measure (make sure kids get vaccinated) but it has the side effect of making vaccines manufacture unprofitable for the most part.

This isn't to say that vaccine-related liability isn't a big concern for the drug companies, because it is. Because a lot of the thimerosal cases were moved out of the VICP into regular court, all bets are off now.

But even if the thimerosal lawsuits weren't looming on the horizon, vaccines wouldn't be a cash cow. The total revenue generated by vaccines is dwarfed by sales of certain individual allergy or heart drugs.

10/17/05, 11:13 AM  

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