{"id":318,"date":"2015-05-03T13:10:53","date_gmt":"2015-05-03T17:10:53","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/healthlaw\/?p=318"},"modified":"2015-05-03T13:11:14","modified_gmt":"2015-05-03T17:11:14","slug":"texas-compounding-pharmacies-health-care-providers-under-texas-medical-liability-act","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/healthlaw\/2015\/05\/03\/texas-compounding-pharmacies-health-care-providers-under-texas-medical-liability-act\/","title":{"rendered":"Texas Supreme Court Holds That Compounding Pharmacies Are Health Care Providers Under Texas Medical Liability Act"},"content":{"rendered":"<p>On April 24, 2015, <a href=\"http:\/\/www.txcourts.gov\/media\/944000\/131014.pdf\" target=\"_blank\">the Texas Supreme Court dismissed claims<\/a> against a compounding pharmacy and its individual pharmacists\u00a0which alleged negligence in compounding a lipoic acid medication, finding that the defendants\u00a0were\u00a0health care providers entitled to the protections in the Texas Medical Liability Act (&#8220;<i>TMLA&#8221;<\/i>).<\/p>\n<p><!--more--><\/p>\n<p>In\u00a0the case <i>Randol Mill Pharmacy et al. v. Miller et al<\/i>., Case No. 13-1014 (Tex. Sup. Ct.), the plaintiff&#8217;s physician prescribed\u00a0and administered weekly intravenous injections of 200 mg\/ml lipoic acid,\u00a0an antioxidant supplement. \u00a0The plaintiff alleged that she\u00a0underwent nine weeks of treatment\u00a0without incident, but in the tenth treatment she suffered a severe adverse reaction and as a result was hospitalized for several weeks,\u00a0received multiple blood transfusions, and went permanently blind in both eyes. \u00a0Randol Mill Pharmacy compounded the lipoic acid that allegedly caused the adverse reaction.<\/p>\n<p>In her complaint against the compounding pharmacy and its individual\u00a0pharmacists, the plaintiff alleged that these defendants gave\u00a0inadequate and inappropriate warnings and instructions for using\u00a0the compounded lipoid acid; that the compounded lipoid acid was defective, ineffective and unreasonably dangerous; and that the compounding pharmacy and pharmacists generally breached implied warranties with respect to the\u00a0design,\u00a0manufacture, inspection, marketing, and\/or distribution of the compounded lipoid acid.<\/p>\n<p>The compounding pharmacy and individual pharmacists moved to dismiss the complaint, arguing that the plaintiff asserted health care liability claims governed by the TMLA and was therefore required to serve an expert report\u00a0within 120 days\u00a0of filing suit or have her case dismissed. \u00a0The trial court denied the motion, and a divided court of appeals\u00a0affirmed. \u00a0On appeal, the Texas Supreme Court reversed, finding that the compounding pharmacy and individual pharmacists met the definition of \u201chealth care providers\u201d under the TMLA\u00a0because (1) the compounded lipoic acid was a \u201cprescription medicine\u201d under the TMLA\u00a0and (2) in compounding the medication for the plaintiff&#8217;s physician&#8217;s office use, the defendants engaged in \u201cactivities limited\u00a0to the dispensing of prescription medicines.\u201d<\/p>\n<p>The Texas Supreme Court also rejected the argument that the defendants were not protected by the TMLA because plaintiff\u2019s claims were so-called product-liability claims.\u00a0 In so holding, the court found that the plaintiff&#8217;s claims were &#8220;health care liability claims&#8221; subject to the TMLA because\u00a0(1) the plaintiff&#8217;s claims alleged that the\u00a0compounding pharmacy and individual pharmacists departed from accepted standards of care, and (2) the plaintiff\u2019s claims were not based on the manufacturing of a defective product.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On April 24, 2015, the Texas Supreme Court dismissed claims against a compounding pharmacy and its individual pharmacists\u00a0which alleged negligence in compounding a lipoic acid medication, finding that the defendants\u00a0were\u00a0health care providers entitled to the protections in the Texas Medical Liability Act (&#8220;TMLA&#8221;).<\/p>\n","protected":false},"author":158,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[537,440,203,406,60,530],"ppma_author":[917],"class_list":["post-318","post","type-post","status-publish","format-standard","hentry","category-health-law","tag-compounding","tag-elinor-h-murarova","tag-liability","tag-litigation","tag-pharmacy","tag-tort-reform"],"authors":[{"term_id":917,"user_id":158,"is_guest":0,"slug":"ehart","display_name":"Elinor H. Murarova","avatar_url":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-content\/uploads\/sites\/8\/2015\/01\/hartelinor-125x150.jpg","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-json\/wp\/v2\/posts\/318","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-json\/wp\/v2\/users\/158"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-json\/wp\/v2\/comments?post=318"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-json\/wp\/v2\/posts\/318\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-json\/wp\/v2\/media?parent=318"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-json\/wp\/v2\/categories?post=318"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-json\/wp\/v2\/tags?post=318"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/healthlaw\/wp-json\/wp\/v2\/ppma_author?post=318"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}