Thursday, April 09, 2009

Non-Prescribed Plaintiffs, In Pari Delicto, And Duty

As far as pharmaceutical mass torts go, the fen-phen litigation has been around for as long as any. But just because it’s mature litigation doesn’t mean that the old dog can't do new tricks. Last month a fen-phen case produced the first post-Levine decision recognizing implied preemption, as we discussed here. This month we’ve got Crowe v. Wyeth (a/k/a “In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability Litigation” – it's obvious why we prefer to call it “Crowe”), 2009 WL 902351 (E.D. Pa. April 2, 2009), raising the in pari delicto defense.

The what?

Gotta love that legal Latin. In pari delicto is lawyer jargon for the rule that public policy won’t permit a tort plaintiff to recover if the plaintiff’s illegal activity was the reason the plaintiff got hurt in the first place. We discussed this concept once before, here, in the context of plaintiffs who were drug addicts and were injured through illegal abuse of prescription drugs. The Restatement puts it this way:


[I]f the injured person has violated a statute designed to prevent a certain type of risk, he is barred from recovery for harm caused by violation of the statute if, but only if, the harm resulted from a risk of the type against which the statute was intended to give protection.
Restatement (Second) of Torts §889, comment b (1979). If you’re interested in more about in pari delicto generally, see the discussion in our prior post. Today. we're only discussing the doctrine's application to a specific set of facts.

What happened (or supposedly happened) in Crowe was that the person allegedly injured by fen-phen was never prescribed the drug - ever. Instead, the spouse had a prescription, but didn’t use it. Instead, the injured person had taken the spouse’s left over pills. Years later, there was a diagnosis of primary pulmonary hypertension, which was eventually fatal. 2009 WL 902351, at *1. A wrongful death action was filed by the surviving spouse – ironically the very person who had originally allowed the decedent to take fen-phen illegally without a prescription.

Or so the plaintiff claimed. There’s a pointed footnote in the opinion pointing out that all the contemporaneous medical records affirmatively stated that the decedent “did not have exposure to appetite suppressants.” Id. at *1 n.3. So this could well be a claim that, like so much of the fen-phen litigation, is simply fraudulent.

These peculiar facts lead, first, to the interesting point of how to apply the learned intermediary rule to somebody who never had a prescribing physician to begin with. Predictably, the plaintiff argued that the learned intermediary rule shouldn’t apply at all. Id. at *2. Talk about trying to profit from criminal conduct. Thankfully, the court didn’t let the plaintiff get away with that and applied the rule (under Missouri law) to “bar[] those claims whose gravamen is failure to warn.” Id.

Having dispatched the warning claims, the defendant also went after the remaining, design-based claims. The dispute became whether the in pari delicto doctrine, in it’s Missouri iteration, was contingent on a balance of the parties’ relative culpability. Ultimately the court held that it did and found the issue to be one for the jury:


The doctrine of in pari delicto prohibits a plaintiff from maintaining an action when, in order to establish his cause of action, he must rely, in whole or in part, on an illegal or immoral act or transaction to which he is a party. Missouri courts have weighed the relative culpability of the parties when applying its equitable counterpart, the doctrine of unclean hands.

[Defendant] argues that it is inappropriate to balance the relative culpability of the parties in legal actions where damages are sought. . . . However, none of [its] cases states that it is inappropriate to balance the relative culpability of the parties. . . . Here, we cannot say that, as a matter of law, plaintiffs are barred from relief. This is a question for the jury to decide. The Latin phrase “in pari delicto” literally means “in equal fault.” We simply cannot conclude at this stage of the case that [the decedent], who took his wife's prescription drugs, was in pari delicto or in
equal fault with [defendant].
Id. at *3-4 (citations, quotation marks and other stuff omitted). The court did not follow either non-drug cases from Missouri, which had held that the doctrine barred recovery as a matter of law, id. at *3, or drug cases from other jurisdictions that had applied the doctrine without balancing the defendant’s fault with the plaintiff’s criminal acts. Id. at *4 n.7 (all these drug-related cases are discussed in our prior post).

Oddly the Crowe opinion does not address the most relevant of the out of state cases, Perotti v. Johnson & Johnson Vision Products, Inc., 2004 WL 3016092 (Ohio App. Dec. 30, 2004), although the court cited it for a much more minor point. See Crowe, 2009 WL 902351, at *2 (citing Perotti as a “cf.” for the proposition that the learned intermediary rule applies). In fact, Perotti held a lot more than that. It affirmed dismissal as a matter of law of another claim brought by a plaintiff injured while using a product prescribed for someone else.

In Perotti the plaintiff was injured while wearing contact lenses that were never prescribed for him, but rather for his spouse. Id. at *1 (“plaintiff borrowed and wore his wife’s prescribed. . .contact lenses to bed”). Perotti held that the manufacturer owed no duty to anybody who is not prescribed its product:

[T]he threshold question is whether plaintiff is a foreseeable user of defendants’ product. In other words, does plaintiff come within the circle of those persons to whom injury should have been reasonably anticipated by defendants. Do defendants owe plaintiff a duty of care. . .?

The uncontested evidence establishes that the [contact] lenses plaintiff wore. . .were prescribed not for him, but only for his wife. During deposition, plaintiff admitted that he has been wearing contact lenses since 1995. He acknowledged that his own contact lenses were specifically prescribed for him. Plaintiff admits that prescribed contact lenses are fitted for each person's eyes and that they are prescribed according to particular sizes and strengths. . . . On this record, we find no evidence to establish that plaintiff falls within the circle of persons defendants should have anticipated would use their prescription. . .contact lenses. To the contrary, the undisputed evidence establishes that defendants did not owe plaintiff a duty because they could not have foreseen him as a potential user of his wife’s prescription [contact] lenses.


Id. at *2-3 (various affidavits and other factual stuff omitted). Why the plaintiff was wearing contact lenses – let alone somebody else’s – just to go to bed is not is not addressed.

Finally, if as in Crowe the applicability of in pari delicto is going to hinge on a balancing of the relative fault of the manufacturer and the criminal conduct of the plaintiff, then why not bring into the mix the fault of the remaining culpable party – the person who was originally prescribed the product, but who illegally gave it to the plaintiff to use? In other words join as co-defendants the spouses in Crowe or Perotti? Let the jury determine their fault as well. Such a claim was approved in Gipson v. Kasey:


Several [state] statutes prohibit the distribution of prescription drugs to persons lacking a valid prescription. . . . [Unlike social host situations] no recognized social benefit flows from the illegal distribution of prescription drugs. . . . [Defendant] additionally argues that because his act of providing pills to [persons for whom they were not prescribed] was not sufficient by itself to cause harm to [plaintiff], no duty was owed. We reject the suggestion that no duty can exist if the plaintiff’s conduct contributed to his injury. Whether the plaintiff’s conduct constituted an intervening (or even a superseding) cause of the harm suffered is a question of fact and does not determine whether a duty exists. . . . [Plaintiff’s] own actions may reduce recovery under comparative fault principles or preclude recovery if deemed a superseding cause of the harm, but those are determinations to be made by the factfinder.
150 P.3d 228, 233-34 (Ariz. 2007) (various citations and other stuff omitted).

After all, if a court is going to stretch the concept of duty to find that the manufacturer of a prescription drug or medical device can be liable to someone who illegally used the product without a prescription, then a fortiori (there’s more legal Latin for you) there should be a duty owed by the not-so-learned intermediary – the person having the prescription who illegally gave the drug/device to injured person. In this situation, of the three: the plaintiff, the person prescribed the product, and the manufacturer, the only person who did not act criminally was the manufacturer.

1 comment:

Shaune said...

Interesting case. It is common to get asked why we need to do a separate service for contact lenses. Some people even wonder why it would be necessary if they are simply wearing color contact lenses. It is common to see Hollywood stars wearing cosmetic lenses to change their eye color or to make their eyes look crazy in one way or another. Other people have been wearing the same lens, or same prescription, for years. In these cases it would seem natural to ask why it is neccessary to have a doctor be the gatekeeper.



A few years ago, contact lenses were designated a medical device by the FDA. Injury, infection and abuse prompted this classification. Contact lenses increase the risk of certain complications. For instance, a lens that does not move well on the eye can 'suction' to the eye and cause inflammation that can be quite painful. While wearing contact lenses there is an increase for infection. Proper care is vital to prevent infection and there is need to be in contact with a and optometric physician incase an infection does occur. Allergy and hypoxia (lack of oxygen to the eye) are two other common complications to contact lens wear.



A thorough exam by an optometrist can identify potential problems before they occur. Careful selection of appropriate lens material and design followed by evaluation of the movement can help to prevent many of these problems. Yearly examination can then identify issues before they become serious. I had one patient recently who came into the office. He went to college in Cedar City. His mother spoke to me and indicated that he had a history of contact lens abuse. When I spoke to him it was stressed that he needed to order contact lenses because wearing lenses too long can cause complications and that new contacts cost less than fixing an eye infection. Three months later he called our office with a ragin red eye.



Contact lens wear can be a great modality. Recent studies indicate that children may have a better self image if they wear contact lenses instead of glasses. People with large prescriptions can avoid fishbowl glasses by wearing contacts. The important part is that they are managed and cared for well. That is where facilities such as Clear View Eye Care can help; they can service most contact lens fittings and issues to help maintain healthy vision.