Product liability and food safety reforms move along

Although Congress is deeply embroiled in resolving budget and related issues, "behind the scenes" progress continues to be made in the areas of product liability and food safety reform. There is an apparent stalemate on a third area of reform - the treatment of federal regulatory issues - and it is likely this subject will not be completed until next year.

With respect to product liability reform, both the House and the Senate have passed product liability bills that include many similar provisions. In general, the provisions would establish expedited product liability settlements; alternative dispute resolution procedures; uniform standards of product seller liability; uniform standards for the award of punitive damages; a 2-year statute of limitations; a 25-year statute of repose; and an offset of damages by the amount of workers compensation benefits received by the claimant.

Special rules would apply to limit product liability actions that could be taken against suppliers of both raw materials and components used in permanently implantable medical devices. These provisions of the legislation are an effort by law-makers to preserve the supply of these raw materials, as well as the medical implants manufactured from them, by protecting biomaterials suppliers from the high cost of defending themselves when there is no evidence of negligence or production of defective products.

Reconciling Differences

With respect to other issues, the House and Senate tort reforms differ: The House bill is significantly more expansive than the Senate version. For example, the House bill sets limits on judgments for all civil lawsuits, while the Senate version is limited to product liability matters. The House bill also includes medical malpractice reform, while the Senate bill does not. Finally, the two bills differ in the amount of punitive damages that may be awarded.

As a result of the differences in the bills, they must go to a conference committee for reconciliation. The conference committee has not yet been appointed. However, the word now is that the Senate judiciary staff and the Senate and House Commerce Committees' staffs have been meeting regularly to iron out differences. This means that once a conference committee is appointed, its report can be issued and acted upon by the full Congress on an expedited basis.

Reasonable Deadlines

As to food safety reform, earlier this year the House Subcommittee on Human Resources and Intergovernmental Relations of the Committee on Government Reform and Oversight requested that the Food and Drug Administration (FDA) submit within one month's time a legislative proposal that would assure the agency's compliance with reasonable deadlines for acting on food additive petitions. The request was made by the subcommittee chairman, Christopher Shays (R-CT).

Apparently, the FDA is still fashioning a response to Congressman Shays' request. We understand that the form of response is currently under review in the Dept. of Health and Human Services. Supposedly, this response will not be in the form of a legislative proposal but will be more like an "issues" paper that sets forth solutions to problems of FDA's backlog of food additive petitions.

On the Senate side, Senator Nancy Kassebaum (R-KS), chair of the Senate Labor and Human Resources Committee, has turned her FDA reform "concept" paper into a draft bill. The bill is expected to be the basis for FDA reform action in the Senate. With respect to indirect food additives, the draft bill requires manufacturers to notify FDA at least 90 days before introducing a new additive onto the market.

Moreover, FDA must respond within 90 days of receiving the notification, and, if it fails to do so, the additive would be deemed approved.

The third major area of reform-broad-based regulatory reform - appears to be languishing. S.343, the comprehensive regulatory reform legislation that would require agencies to perform costs/benefit analyses and risk assessments before issuing major federal rules, has failed a third cloture vote. Senator Robert Dole (R-KS) stated that he would not call the legislation for another vote unless a compromise agreement could be worked out ahead of time. Apparently no further efforts to obtain passage of S.343 will be made this year, since the cloture votes needed to proceed have not been obtained.


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