About 15 years ago several people died after taking one brand of an over-the-counter headache remedy. A poisonous substance had been introduced to the remedies after they left the factory.

The Tylenol-type tragedy, precipitated by intentional, criminal product tampering, has since generated many lawsuits and questions. Modifications to or tampering with mechanical or electrical products can raise similar problems. The specter of criminal intervention has cast a shadow over even the largest companies. How then can the courts protect your company and yourself from the unreasonable imposition of liability for damages intentionally caused by a maniac? There is no simple answer.

Guidelines. In a product-tampering suit, the manufacturer will assert that it used due care in manufacturing the product and should not be held liable for the later product alteration. The plaintiff's (victim's) attorney will have anticipated this argument and will assert that the manufacturer should have known that its product's packaging could be tampered with and easily altered. If the company has experienced past problems or even threats of this nature (evidence of foreseeability), then the plaintiff will contend that the product was not adequately packaged, or that it was not designed either to make tampering difficult or to make such tampering easy to detect.

The argument may be effective because it deflates the company's claim that it didn't cause the damage, and it also tends to shift the focus from the intervening tamperer back to the company. This works quite nicely if the plaintiff can maintain the despicable flavor of the deed while transferring the guilt to the manufacturer.

Traditionally, the courts have viewed intentional adulteration as an independent intervening act that breaks the chain of proximate cause, but a more pragmatic sociolegal trend is gaining ground.

Questions to ask. Look at the company's own records for answers. Do they disclose information, studies, or prior notice of similar claims? Was the tampering reasonably foreseeable? If so, were feasible alternative packaging methods considered?

The company should study the availability, cost, and efficiency of alternative packaging and its own testing documentation. Government and industry regulations, standards, if any, and competitor's approaches should also be considered. Obviously, no matter how tamper-proof the product or packaging, the safeguards usually can be circumvented. The legal test is the reasonableness of the company's efforts.

In a case I defended, the manufacturer of a carnival ride had designed and built a quality, safe ride. However, after acquiring the ride, the purchaser tampered with it to enhance the ride's "thrill" characteristics. When the ride went out of control due to excessive air pressure, one person died and 20 people were injured.

Resulting litigation involved the manufacturer, who, ultimately, contributed to a settlement to end the lawsuit. Had the manufacturer built-in additional safeguards against over-pressurization, its exposure might have been reduced.

More emphatic warnings against modifications also would have improved the legal position.

Q: What should we do if tampering occurs or is suspected?

It is imperative to act decisively and quickly. Not only must you protect potential consumers, but your corporate image and product integrity is also crucial. Johnson & Johnson's response to the Tylenol crisis is a textbook study in prompt decisive actions and appropriate public relations.

Q: Is my company automatically responsible if someone adulterates or modifies our product?

No. If your company has taken the appropriate actions to prevent foreseeable tampering or modification, you will generally not be held responsible. However some tampering, such as intentionally introducing bacteria into food during processing, may create a breach of warranty which is harder to defeat.

Q: How frequently do product alterations occur?

Such incidents are rare. Purchasers are more likely to modify products in unauthorized ways, which lead to most injury claims. Preventive design measures, such as safety guards that workers can't remove, are important design features.

Q: What if one of our products is deliberately sabotaged?

Immediately after considering the consumer's safety, you should consider the public relations aspects of the problem. If the public perceives there is a problem, nothing less than prompt decisive action, such as a recall, will leave the company in a positive light. Complicated engineering explanations are likely to harm the company's image and leave consumers at risk.