- Email: [email protected]
Legal Blotter
LEGAL BLOTTER
by Robert F. Steeves, director of APhA's legal division
basis of drug recalls Drug recalls have become a common phenomenon for pharmacists and athers in the health care field, yet few realize there is no direct legal foundatian for recalls. There is no section or subsection of the federal Foad, Drug and Cosmetic Act which describes or even alludes to this procedure. It has been one fashianed by administrative experience. The basic enforcement procedures against deficient praducts under the act are seizures and injunctions. Where a seizure actian is initiated, custady af a quantity of the products invalved are taken under court arder with subsequent legal praceedings to. candemn and dispase af the articles. Injunctians are issued against persons or ·firms possessing the praducts to prevent further distribution. If a drug is adulterated or misbranded and is being held far introductian into. the channels af cammerce, either procedure wauld be useful to. prevent the praduct from being released into thase channels. Hawever, it is unlikely that an injunctian or seizure actian would be required at this paint in the usual case and FDA regularly reports the valuntary destruc-
drug auction ruling New YDrk state nDW restricts the purchase 'Of drugs in open cantainers to registered pharmacists 'Only. The new ruling by the State BDard 'Of Regents at the request 'Of the BDard 'Of Pharmacy was approved in an amendment tD the bDard ruling cDncerning dispositiDn of drugs at auctiDn. The restrictiDn tD prevent lass af drug efficacy and tD prDtect the health 'Of the public places added responsibility upDn the pharmacist, the BDard 'Of Pharmacy explains. A pharmacist purchasing such drugs will be respDnsible fDr their quality and 'Of necessity must make certain they meet all standards befDre dispensing them in his pharmacy.
578
tion of deficient foad, drugs and casmetics at this stage. Where the distribution process has already started before defects or abjections abaut the product or given lat of a praduct is known, the chief legal toal available to. stop further distributian wauld be a seizure action. Sectian 304 af the act governs seizures and provides that the praduct can be seized by' the government by appropriate legal pracedures. There is a guarantee against multiple seizures with twa exceptions1. where the misbranding has been the basis of a prior legal judgment in favor of the gDvernment 2. when FDA has fa,c ts to suggest that the product is dangerous to health Dr the labeling is fraudulent
In most recall situations, FDA cauld prabably shaw danger to. health and hence not be limited to a single seizure action. Hawever, seizure of a substantial part af a lot af a praduct wauld be a laborious task and wauld invalve a multitude of court processes. Not to. be overloaked ar minimized is Section 705 (b) of the act which pravides that the commissioner may disseminate infarmation regarding drugs where, in his opinion, the situatian invalves "imminent danger to health 'o r grass deception of the consumer." It is probably this pravision, caupled with FDA's autharity to institute seizure actions, which supplies the necessary mativatian to invoke cooperatian from all but the most recalcitrant where drug recall is deemed necessary. In the legal sense, all drug recalls for alleged ar supposed vialatians of the act are valuntary caaperative effarts of FDA and industry. Likewise, the recall procedure emplayed in any given case is a negotiated plan between FDA and the firm ar person respansible far the recall. T-he patential af product liability suits far bath pharmacists and distributors and the passibility af malpractice suits for pharmacists are also imp or-
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
tant factors in assessing the effectiveness and usefulness of drug recalls. For this purpose, it matters little what approach FDA takes. Where FDA natifies the manufacturer that it considers a given product ar lot significantly deficient, all that would be needed to canstruct a probably successful lawsuit would be demonstratian that injury to a patient was caused by the deficiency. Under these circumstances, it obviously is in the interest of the manufacturer to rem ave as much of the praduct fram the market as is possible and to. give adequate warning quickly against its further use. This illustratian can be carried one step further to the level of practicing pharmacists. A pharmacist who dispenses further amounts of the praduct after warnings have been issued and recall pracedure initiated is inviting legal difficulty. FDA's list of drug recalls is being published widely in the professional and trade press so that it would he difficult for any pharmacist to. attempt to. defend himself on the basis that the information was not available to him. Apart fram the respansibilities pharmacists carry as custodians of the nation's drug supply, failure to remove and safeguard further distribution af a drug subject to. recall poses seriaus product liability and malpractice issues. It cauld be alleged-and indeed be the case-that any injury to a patient under these circumstances was caused by the pharmacist's failure to heed a timely and appropriate warning -regardless of the source af the warning. The liability questian undoubtedly plays a significant role in the efforts and expense put into. recall procedures. To date, the liability of a pharmacist far failure to heed ar act appropriately to. a drug recall natice is theoretical. However, the pharmacist is the last man in the usual line of distributian of drugs to. patients. As such, he bears a heavy prafessianal and legal respansibility in drug recalls.
by Robert F. Steeves, director of APhA's legal division
basis of drug recalls Drug recalls have become a common phenomenon for pharmacists and athers in the health care field, yet few realize there is no direct legal foundatian for recalls. There is no section or subsection of the federal Foad, Drug and Cosmetic Act which describes or even alludes to this procedure. It has been one fashianed by administrative experience. The basic enforcement procedures against deficient praducts under the act are seizures and injunctions. Where a seizure actian is initiated, custady af a quantity of the products invalved are taken under court arder with subsequent legal praceedings to. candemn and dispase af the articles. Injunctians are issued against persons or ·firms possessing the praducts to prevent further distribution. If a drug is adulterated or misbranded and is being held far introductian into. the channels af cammerce, either procedure wauld be useful to. prevent the praduct from being released into thase channels. Hawever, it is unlikely that an injunctian or seizure actian would be required at this paint in the usual case and FDA regularly reports the valuntary destruc-
drug auction ruling New YDrk state nDW restricts the purchase 'Of drugs in open cantainers to registered pharmacists 'Only. The new ruling by the State BDard 'Of Regents at the request 'Of the BDard 'Of Pharmacy was approved in an amendment tD the bDard ruling cDncerning dispositiDn of drugs at auctiDn. The restrictiDn tD prevent lass af drug efficacy and tD prDtect the health 'Of the public places added responsibility upDn the pharmacist, the BDard 'Of Pharmacy explains. A pharmacist purchasing such drugs will be respDnsible fDr their quality and 'Of necessity must make certain they meet all standards befDre dispensing them in his pharmacy.
578
tion of deficient foad, drugs and casmetics at this stage. Where the distribution process has already started before defects or abjections abaut the product or given lat of a praduct is known, the chief legal toal available to. stop further distributian wauld be a seizure action. Sectian 304 af the act governs seizures and provides that the praduct can be seized by' the government by appropriate legal pracedures. There is a guarantee against multiple seizures with twa exceptions1. where the misbranding has been the basis of a prior legal judgment in favor of the gDvernment 2. when FDA has fa,c ts to suggest that the product is dangerous to health Dr the labeling is fraudulent
In most recall situations, FDA cauld prabably shaw danger to. health and hence not be limited to a single seizure action. Hawever, seizure of a substantial part af a lot af a praduct wauld be a laborious task and wauld invalve a multitude of court processes. Not to. be overloaked ar minimized is Section 705 (b) of the act which pravides that the commissioner may disseminate infarmation regarding drugs where, in his opinion, the situatian invalves "imminent danger to health 'o r grass deception of the consumer." It is probably this pravision, caupled with FDA's autharity to institute seizure actions, which supplies the necessary mativatian to invoke cooperatian from all but the most recalcitrant where drug recall is deemed necessary. In the legal sense, all drug recalls for alleged ar supposed vialatians of the act are valuntary caaperative effarts of FDA and industry. Likewise, the recall procedure emplayed in any given case is a negotiated plan between FDA and the firm ar person respansible far the recall. T-he patential af product liability suits far bath pharmacists and distributors and the passibility af malpractice suits for pharmacists are also imp or-
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
tant factors in assessing the effectiveness and usefulness of drug recalls. For this purpose, it matters little what approach FDA takes. Where FDA natifies the manufacturer that it considers a given product ar lot significantly deficient, all that would be needed to canstruct a probably successful lawsuit would be demonstratian that injury to a patient was caused by the deficiency. Under these circumstances, it obviously is in the interest of the manufacturer to rem ave as much of the praduct fram the market as is possible and to. give adequate warning quickly against its further use. This illustratian can be carried one step further to the level of practicing pharmacists. A pharmacist who dispenses further amounts of the praduct after warnings have been issued and recall pracedure initiated is inviting legal difficulty. FDA's list of drug recalls is being published widely in the professional and trade press so that it would he difficult for any pharmacist to. attempt to. defend himself on the basis that the information was not available to him. Apart fram the respansibilities pharmacists carry as custodians of the nation's drug supply, failure to remove and safeguard further distribution af a drug subject to. recall poses seriaus product liability and malpractice issues. It cauld be alleged-and indeed be the case-that any injury to a patient under these circumstances was caused by the pharmacist's failure to heed a timely and appropriate warning -regardless of the source af the warning. The liability questian undoubtedly plays a significant role in the efforts and expense put into. recall procedures. To date, the liability of a pharmacist far failure to heed ar act appropriately to. a drug recall natice is theoretical. However, the pharmacist is the last man in the usual line of distributian of drugs to. patients. As such, he bears a heavy prafessianal and legal respansibility in drug recalls.