Supreme Court Decision Verifies Liabilities Associated With Cross-Referencing Errors
Manufacturers would be well-advised to resist GPO pressure to abandon their existing HIBC product codes because cross-referencing to others increases the risk of errors and therefore to liability for potential damages.
In what is described as a major decision, the Supreme Court ruled this week “that the manufacturer bears responsibility for the content of its label at all times,” the majority concluded in Wyeth v. Levine, No. 06-1249. The decision means that even if a label is within FDA guidelines, the manufacturer remains liable for label content.
Thus even if HIBCC and other standards are deemed acceptable and within FDA labeling guidelines, errors made when arbitrarily migrating between them can lead to liability. Recent requirements, such as those currently being supported by the Premier Strategic Advisory Committee, will require significant cross-referencing which will expose manufacturers to liabilities for damages in the event that there are any errors.
HIBCC has long taken the position that cross-referencing of product codes is an ill-advised and unsafe practice. The Supreme Court’s decision is consistent with the HIBCC Advisory.
Read more on the Supreme Court's ruling below:
The Wall Street Journal: High Court Eases Way to Liability Lawsuits
The New York Times: Drug Approval Is Not a Shield From Lawsuits, Justices Rules |
