Monday, December 08, 2008

Avoiding Mass Torts: Pre-Litigation Counseling

Last month, a regular reader of this blog suggested that we publish a post giving drug and device companies some pre-litigation counseling. What, our reader asked, should companies do to minimize the risk that they become embroiled in a mass tort?


There's an old political cartoon, maybe from The New Yorker, where a man is strolling down a city street. The caption reads: "Exercises regularly. Eats right. Doesn't smoke. Doesn't drink. Has regular check-ups." In the cartoon itself, you see that a safe has fallen out of a window and is about do this poor fellow in.

We realize that we're not providing much help to drug or device companies, but that cartoon illustrates some of our feelings when we're asked for preventive steps that companies can take to avoid mass tort litigation.

What can we say?

Do everything right.

Obey the law. Report adverse events on time and honestly. Shoot straight with the FDA on labeling issues. Steer far clear of promoting products for off-label uses.

Comply with industry standards. Ensure that your standard operating procedures satisfy good clinical practice standards. Don't fall significantly behind your industry peers in areas that could affect product safety or safety reporting.

Write smart. Make sure employees aren't doing things like calling your own products "defective," because if they do, somebody else will, too. Have a corporate communications policy that instructs employees to communicate only facts -- not unsupported opinions or snide comments -- in e-mails. Be sure that employees understand that a "joke" in an e-mail today will not look funny to a future jury sitting in the presence of a widow or an amputee.

Avoid recalls. This is an odd topic. On the one hand, recalls attract attention, and they often attract massive litigation. So do everything possible to avoid them. On the other hand, if a recall is necessary, then do it promptly, and do it right. If it becomes apparent that the public health demands that you recall a product, then don't let fear of litigation slow you down. Execute the recall, and then address the consequences.

Draft a document retention policy, and then enforce it. Preserve what you need, and eliminate what's unnecessary.

Have a lawyer who knows about product liability go over your sales contracts and contracts with suppliers. It probably won't help much with personal injury plaintiffs, but it can head off some subsidiary litigation and help keep the folks you buy from and sell to on your side in a mass tort.

Do all that -- exercise regularly, eat right, don't smoke -- and then a safe may drop on your head anyway.

Because the events that trigger mass torts are often unrelated to a company's righteousness or preparedness. A television show may prompt a mass tort, as "20/20" did for Bone Screws and Connie Chung did for Breast Implants. Or your company may obey the law and industry standards religiously, may learn from post-marketing adverse events that a product must be recalled, may recall the product promptly and execute the recall perfectly -- and may find itself embroiled in a mass tort because of the very fact of the recall itself.

Or a new study may appear in the medical literature and prompt a wave of litigation. Or a label change may draw unwarranted (and unwanted) attention. Or some FDA regulatory action may do the same.

Mass torts are not always -- and perhaps not even typically -- caused by the company's own conduct, but rather are often prompted by external events. Companies that have done intelligent pre-litigation planning may very slightly reduce the impact of the ensuing litigation, but the litigation will nonetheless be long and expensive.

We wish that weren't the truth. We wish there were some advice we could give that would let companies avoid mass torts. In fact, if any of our readers have better ideas than the ones we've suggested, please let us know, and we'll be delighted to publish a follow-up post offering more advice.

But for the time being, a big chunk of our advice is this: Watch for falling safes.


hg said...

This is a genuine and serious question. I hope you will respond in that way.

Among the criteria you provide:

"Do everything right.

Obey the law. Report adverse events on time and honestly. Shoot straight with the FDA on labeling issues. Steer far clear of promoting products for off-label uses."

Can you name instances (ideally at least five, more is better) in which a company did all the above in the drug arena, and yet was still subject to defending mass torts? Even more relevant, mass torts which they lost and/or settled?

If you do, and I agree they are listed in good faith (which I will if they are), I will guarantee you here that I will discuss them in a large course I teach on FDA, pharma, and policy, and attribute the list to DDL.

Students want and need to hear this perspective, and so do I.

Go for it.

Thank you,


hg said...

p.s. The question itself will be on the required reading list, so I hope I will have your answer to include as well. Again thanks.

Max Kennerly said...

I'm not so hot on the document and communication policies.

Unless those policies manage to eliminate 'smoking gun' documents -- which I doubt, given how a 'gun' is normally made 'smoking' by a party failing to "do everything right" -- then they won't reduce the frequency of litigation or size of liability, they'll just create gaps in the documentary record. That's a problem for defendants for two reasons:

First, it may enable plaintiff's lawyers like me to fill those gaps with whatever I think was there. Sometimes that happens by way of circumstantial evidence. Sometimes -- and this situation can be much worse for defendants -- the absence of documentary evidence leaves the defendant's deposition and trial testimony ungrounded, allowing me to set and spring traps for deceptive witnesses, walking them where they don't want to go and making them look like liars when they do it.

Second, I'll get a copy of those communications and document retention policies in discovery, and I will use them to show that the company actually established a policy to discourage employees from recording their own opinions. Add that to the point above and, well, you might have yourself a recipe for disaster. Fact is, whenever there are gaps in the documentary record, it increases the importance of witness credibility. If, by design, your company didn't keep a thorough record and I reveal one of your employees to have been less than candid, then you're toast.

(The above is adapted from a post on my blog, linked via my name here)

Beck/Herrmann said...

This is a response to HG. Please understand that we can't evaluate a number of mass torts due to our involvement in them. Thus we can't discuss SSRIs or Baycol, which may well fit into the category we're talking about.

The classic example of the safe (or piano) falling on head situation is the bystander mass tort - where there has been misconduct, but the bad actor is judgment-proof for one reason or another. The DuPont/proplast litigation (where the manufacturer was bankrupt and plaintiffs went after a component supplier) is a classic example. The Human Tissue litigation is another in this category. Emergent litigation over Heparin (and lots of non-drug products as well) deliberately contaminated by Chinese suppliers also falls into this category.

Then there are the bystander mass torts - one drug/device in a related class runs into trouble and every manufacturer in the zone of danger gets sued. Statins after Baycol, Cox IIs after Vioxx, atypical anti-psychotics after Zyprexa, ICDs after Prizm, IUDs after the Dalkon Shield, are all concrete examples. Bone screws might have fit into that category, too, if not for the off-label use issues. There's a huge amount of "you too" pile-ons (our opponents would call it leveraging their experience) in mass torts.

There are mass torts that arise due to the emergence of novel medical conditions that blindside everyone. DES (cancer in offspring) and Blood Products (the advent of AIDS) are two examples.

The mere fact that there's a blockbuster drug making its manufacturer a lot of money can lead to a mass tort. The Viagra MDL litigation would be the current poster-child for the "if your big enough, you'll attract attention" theory of mass torts. Ritalin and Claritin are past examples we can think of.

And then there are the perinatal/neonatal injury situations (birth defects, birth trauma, early-onset conditions). You have would-be plaintiffs with serious injuries in search of possible deep-pocketed culprits. That's why drugs and devices involved with procreative functions are frequently called "litigens." (1) Bendectin is probably the paradigm of a drug attracting enough birth defect litigation to drive it from the market not because it was ever shown to cause anything, but simply because it was taken during pregnancy. (2) Thimerosal is in the same boat, only on the other side of the birth event. (3) And speaking of Thimerosal, virtually every childhood vaccine has been targeted at one time or another, most notoriously DTP, simply because vaccinations happen at the same time as the emergence of neonatal (mostly mental) conditions. (4) Nor is it coincidence that almost every new form of contraception - the pill, IUDs, Norplant, and most recently, OrthoEvra and Nuvaring - ends up the subject of a mass tort. That's why we view tort reform as a women's rights issue. (5) And there's the strange case of Accutane. It's a well-known teratogen; it carries every warning on it known to man, and then some; and the manufacturer still gets sued over and over again for birth defects.

We could go on, but we think that you've probably got other subjects you have to cover in your class. Good luck with it.

Ron Miller said...

The "don't recall" problem basically says let the product die a slow death by stopping production but don't pull off what is out there. These are the best cases for plaintiffs because they could have done something by that point but clearly did not. A last oppotunity to right the wrong. Does these smaller number of large cases outweigh the rush to litigation after a recall from the company's econcomic perspective? Maybe, but that would be a cynical calculus.

Not that you are necessarily suggesting this but that's how it may come off to some.