Alan Morrison

Squeeze Play

Consider the following all too common situation: a patient sees a doctor for an ailment, the doctor makes a diagnosis, the doctor checks the Physicians Desk Reference (“PDR”) and prescribes a drug, the pharmacist substitutes an identical generic drug (as required by state law unless the doctor insists on the brand name product), and the patient develops some new disease as a result of taking the drug. The patient learns that the new disease was actually not a surprise and that there is substantial evidence that patients can contract that disease from that drug so that either another drug (or alternative treatment) could have been used or other precautionary measures taken. Suit is then brought against the doctor, the maker of the brand name product (because it prepared and paid for the PDR entry on which the doctor relied), and the maker of the generic that the patient took. (Disclosure: I am co-counsel in one such case and advising in others.)

The claims against all the defendants are related but different. They are related in the sense that the patient is claiming that, if everyone had done his part in conveying the information about the risks from this drug, the harm to the patient would not have occurred. The specific claim against the generic maker is failure to warn of whatever dangers it was aware regarding the new disease. In the case of the brand name company, since its product was not the one ingested, it had no affirmative duty to warn, and so it is being sued for its intentional or negligent misrepresentation in what it actually said in the PDR. Since it is continuing to sell its brand name product, the inclusion of the information about it is not gratuitous and is indeed part of its obligation to provide accurate labeling for its products. Finally, the doctor is being sued for failure to consider the available information before prescribing the drug. The applicable law is that of comparative fault so that each defendant can be held liable only if some fault can be ascribed to it and then only in proportion to the fault of the others. Now for the squeeze play.

The brand name company argues that, since the patient did not take its drug, it cannot be held liable. This is true, say the brand name companies, even if its PDR entry is the only public information on which doctors (and patients) can rely, even if it had additional information about the dangers of the drug that it intentionally withheld in order to increase its profits by selling its version of the drug, and even if it alone had such information. The generic responds by saying that, even if it had some additional information, its hands are tied because it must follow the labeling used by the brand name company (including the PDR), and it cannot change that labeling since that was the basis on which its right to market its identical generic product. The doctor contends that it had no such information and thus cannot be held liable for relying on the PDR, a position often taken by the generic. If any of the participants can be shown not to have additional adverse information, the law would not exonerate them from liability, but the brand name and the generic both claim that, even if they did know of additional risks, they still cannot be held liable, which means that no drug maker can be held liable and the doctor will almost certainly be let off also. Hence the squeeze play.

How do defendants justify this result? For the brand name companies, their defense is simple, which may be why the courts have bought it so far: this is a products liability case, it is not my product, and so I can’t be held liable for what’s wrong with my competitor’s product. Generics say, our hands are tied on changing the labels or even creating a new PDR entry because the FDA won’t let us change the label (that claim has not been fully tested), but they also say that they don’t know anything more than doctors or the general public about these adverse reactions to the drug, and so they are not at fault. The bottom line, according to the drug companies, is that none of them (and almost certainly no doctor) can be held liable, even if someone intentionally withheld significant information about the adverse effects caused by a drug and that drug harmed the patient.

Those claims are being tested in court now, and perhaps the courts in some states will come to their senses and conclude that, under comparative fault, if someone(s) had information about dangers from a drug and failed to warn or failed to correct prior erroneous warnings, that person(s) should be held liable for the resulting harm. It surely should not be the law that no one is responsible, but if the squeeze play is successful, that will be the result.

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Posted at 9:52 AM, Jan 26, 2007 in
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Lawyer Questions.

If the error rate of any enterprise is a high 10%, what are the odds so many defendants could have committed an error, resulting in the injury to the plaintiff? If each defendant errs 10% of the time, what are the odds that four defendants would join their errors to injure the plaintiff, let's say 0.1 X 0.1 X 0.1 X 0.1 = 0.0001 (1 in 10,000 chance)? Naturally, add the element of time, and the chance of committing errors requiring an 1 in 10,000 chance becomes infinitesmally small.

If the burden of proof in a case is a 51% certainty that the evidence favors one side or the other, what must the chance of the event be to have a 51% chance of being accurately detected?

For example, if the cumulative chance of an event is a lottery like 1 in a million chance, what is the chance of accurately detecting such foreseeability as 1 in a million by a jury applying a 51% chance of accuracy of verdict?

It's 1 in 2 million, quite far from 1 in 2 required. If you have more than 1 or 2 defendants, the claim is frivolous per se, by the standards of the rules of evidence, and the procedural due process rights of the civil defendant. Not just frivolous, but impossible per se.

Posted by: Supremacy Claus | January 26, 2007 9:57 PM

Doesn't this illustrate the entire problem mindset with trial lawyers? "It surely should not be the law that no one is responsible..."

Why not? Sometimes bad things happen. That doesn't mean someone must be "responsible" for those things.

All drugs have side effects. The only way to avoid side effects is not to take them. Some people are perfectly happy to accept the benefits of a drug if it works well, but think someone else should pay for the risks.

Posted by: David M. Nieporent | January 27, 2007 2:27 AM

"none of them (and almost certainly no doctor) can be held liable, even if someone intentionally withheld significant information about the adverse effects caused by a drug and that drug harmed the patient"

That is because it is a special case ,with a panoply of fctors , which cant be sorted so easily. but it may not be necessary that even if there was an unintended consequence ,someone has to be liable for it . Why not sue FDA which won't change the package insert even if generics supposedly have found some thing else.I am no fan of corporations ,but here it seems you are a little desperate for your pocketbook

Posted by: Anirban | January 28, 2007 8:47 AM