FDA encourages voluntary reporting on medical products
AAOS members may submit a voluntary adverse event form to the Food and Drug Administration (FDA) through the agency’s MedWatch program for product problems with drugs, devices and biologics. Reports are used to improve the product safety profile, increase patient safety, and may be used to support a modification to the use or the design of the product. FDA will not disclose the reporter’s identity in response to a Freedom of Information request, but may share it with the manufacturer unless requested otherwise. Visit MedWatch Web site.
S.C. Supreme Court bans POPTS
The South Carolina Association of Medical Professionals and the South Carolina Orthopaedic Association (SCAMP/SCOA) filed a complaint, challenging the action of the Board. The trial court ruled for SCAPTA by deferring to the AG advisory opinion, and SCAMP/SCOA appealed the ruling to the state appellate court. Upon request, the AAOS filed an amicus curiae brief.
The state Supreme Court took the case from the appellate court due, in part, to the policy issues raised by the AAOS amicus brief, which argued that the trial court (and AG opinion) failed to conduct any analysis of the benefits of POPTS; that POPTS is nearly universally accepted in the United States; and that there is no evidence that anyone in South Carolina has been harmed by POPTS.
Three members of the Supreme Court agreed with the trial court that the Act prohibits POPTS, adopting the AG’s conclusion that POPTS should be banned because two other states (Missouri and Delaware) have prohibited POPTS. Interestingly, the opinion ignored two facts: nearly all other states allow some version of POPTS and federal law specifically endorses POPTS.
The majority also failed to conduct any analysis of the benefits of POPTS or cite any circumstance in South Carolina (or any other state) in which a patient was harmed by POPTS. While the opinion acknowledged that it may be inconsistent with federal law allowing POPTS, it rationalized this discrepancy by stating that federal law is irrelevant for interpreting the Act.
The dissent (including the Chief Justice) stated that the Act was ambiguous and should be interpreted consistent with federal law to allow POPTS: “the majority inappropriately dismisses the importance of the other existing statutes enacted to prevent abuse and misuse of health care services and government-sponsored health care plans in its analysis.”
The dissent also took issue with the Board’s abrupt ban on POPTS after six years and consequently would “reverse the lower court and find the Board’s actions constitute an invalid regulation that is null and void for failure to comply with the rule-making provisions” of state law requiring public participation whenever the law is changed.
Finally, the dissent stated that banning POPTS improperly treats physical therapists differently from other health care workers because “there is no reasonable relationship between the legislative purpose [of the Act] and the separate classification of physical therapists apart from other health providers.” The dissent concluded that POPTS is proper and the trial court’s decision banning POPTS should be reversed.
The decision can be found on online.
Peer counselors available for medical liability defendants