In product liability litigation, it is the manufacturer’s behavior in relation to the design and development of a “product”, and all its components that may go on trial. The “product” includes the physical product, catalog data, service manual, advertising, labels, shipping package, maintenance, field assembly, installation, service, warranty, owners manual and sales brochure. A defect in the design, development and manufacture of any of these elements can be the proximate cause of a mishap and personal injury, whether the product is a medical device, pharmaceutical, automobile or refrigerator.
Product designers need to understand the full definition of a product so that their insurance loss prevention activities include controls for all product components. Since ISO 9001, ISO 13485 and FDA’s QSR include design and development protocols as a component of their QMS, each of the preceding aspects of “product” must receive attention during the design phase of development.
It is useful to remember that a plaintiff’s attorney, who otherwise may have no case against a manufacturer, will look for records that show a pattern of irresponsible behavior in order to question the safety of a product. The federal Rules of Civil Procedure 401 and 402 state that, ”all ‘relevant’ evidence is admissible, and evidence is ‘relevant’ if it has ‘any tendency to make the existence of a fact that is of consequence to the determination of the action more or less probable than it would be without the evidence’.” Consequently, plaintiff’s request for production of documents will cast a wide net in an effort to obtain every conceivable record and document that could suggest that a product is unsafe. This will extend beyond documents relevant to ISO 9001, but it will include ISO 9001 QMS documents as well.
Once Legal Action has been initiated, the Destruction of Documents is a Criminal Offense
To say that shredding documents after the initiation of legal action is stupid, is a gross understatement. Criminal indictments for obstruction of injustice will be brought against those individuals doing the shredding, who in turn often negotiate with prosecutors and provide evidence in exchange for reduced sentences. External observers (both lawyers and journalists) have noted that document shredding has allowed the government to move much faster in its pursuit of the facts of a case. While documents no longer needed by companies are routinely destroyed in formal Records Managements Programs, such programs must be suspended whenever a lawsuit is filed. Document destruction constitutes a criminal obstruction of justice and destruction of evidence.
Attorney-client Privilege cannot be used to withhold documents from Plaintiff’s Request for Production of Documents
In an earlier blog, I reviewed Case IH Fire Products Liability Litigation where Defendant Case Company requested that Plaintiffs' request for corrective action review minutes and management review minutes did not have to be turned over because there was an attorney present during the corrective action review. Their request was denied by the US District Court Judge and appealed to the United States Circuit Court of Appeals for the Eighth Circuit. That court denied the appeal and upheld the District Court’s ruling. Case Company then filed a Writ of Certiorari with the United States Supreme Court to overturn the ruling of the US Circuit Court of Appeals. On June 5, 2000 the US Supreme Court denied the Writ thereby upholding the District Court Judge’s decision that Case Company turnover its management review minutes and corrective action minutes to Plaintiffs’ attorneys. (Attorney-client privilege is restricted to instances where the attorney is representing a client who is involved in a lawsuit, not an attorney who happens to be present in a meeting unrelated to active litigation.)
While the legal implications of document control extend far beyond what an ISO 9001 QMS defines as document control, it includes all ISO 9001 documents, records and minutes. There is no special exemption from legal rules governing documents just because they are part of a quality management system. In sum, can a ISO 9001 QMS be used to respond to legal questions and liability exposure? The answer is yes. An ISO 9001 QMS provides an excellent platform for systematically using preventive law to address legal issues and liability exposure, but it requires competent professional attention and legal expertise for that to happen. Just as risk management without preventive law is not risk management, ISO 9001 without preventive law, becomes unmanaged risk.