The Bush Administration has switched the government’s position on an important product liability question in a case that could have profound effects for all Americans. At issue in Riegel v. Medtronic Inc., No. 06-179, is whether citizens are preempted or barred from suing a company for a product that was approved for sale by the Food and Drug Administration.
The case before the Supreme Court involves a balloon catheter that burst during an angioplasty being performed on Charles R. Riegel. The manufacturer, Medtronic had received FDA approval for the device and successfully argued that this approval preempted any tort lawsuits. Two lower courts agreed with the company.
The Court held in 1996 that such approvals did not preempt tort liability — a position supported by the federal government. However, things have changed. The Bush Administration has changed the government’s position to support the industry and the Court has changed — particularly with the addition of Sam Alito and John Roberts, who are both viewed as highly sympathetic to such industry arguments.
In tort law, there has long been a concept of negligence per se where the violation of a statutory or regulatory standard of conduct is treated as a clear act of unreasonableness (one still have to prove causation and other elements of the tort). However, there is not a concept of reasonableness per se where compliance with such a statute means that you must be created as clearly reasonable.
The common law had it right. The prior rule protected consumers by allowing juries to respond to a defective product despite the failure to act by the government. There are a variety of reasons why, after approval, an agency may not act to deal with a defect. First, the government simply moves slowly in such matters due to limited resources or information. Second, there is danger of agency capture — a close affinity that can develop between a regulator and regulated party. Third, an Administration like the Bush Administration can show routinely favor industry protection over consumer protection.
If successful, the Administration would prevent citizens from litigating risks that it has ignored in products. For an administration like this one, it reduces the likelihood that your protection of an industry will not be challenged in a substantive way in court.If one looks back historically, however, litigation has been one of the main driving forces of uncovering risks — long before the government has acted.
Ironically, this case was heard the day that consumer advocates found that 35% of toys on the shelves for the holidays contain lead. For the story, click here
This is a decision that would cost lives and, if the industry prevails, it is something that Congress should move to correct. It is a case that has not gotten much attention, but holds enormous implications for citizens and product safety.
For a copy of the excellent public citizen brief, click here