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Avoiding Mass Torts: Pre-Litigation Counseling

By James M. Beck and Mark Herrmann

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?

Ha!

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.

Full post as published by Drug and Device Law on December 08, 2008 (boomark / email).