{"id":1019,"date":"2015-07-31T18:55:06","date_gmt":"2015-07-31T18:55:06","guid":{"rendered":"https:\/\/gilhoylaw.com\/blog\/?p=1019"},"modified":"2015-07-31T18:55:06","modified_gmt":"2015-07-31T18:55:06","slug":"boston-scientific-loses-preemption-argument-in-manufacturing-defect-case","status":"publish","type":"post","link":"https:\/\/gilhoylaw.com\/blog\/boston-scientific-loses-preemption-argument-in-manufacturing-defect-case\/","title":{"rendered":"Boston Scientific Loses Preemption Argument in Manufacturing Defect Case."},"content":{"rendered":"<p><span style=\"color: #000000;\">Generally, under the law of products liability, a manufacturing defect is an unintended defect in an otherwise safe product that occurs when the product departs from its intended design and is thus more dangerous than it should be. <\/span><strong><span style=\"font-family: Times New Roman;\">In Massachusetts, manufacturers are required to uphold a near-equivalent of strict liability called the implied warranty of merchantability. <\/span><\/strong><\/p>\n<p><iframe loading=\"lazy\" width=\"400\" height=\"280\" src=\"https:\/\/www.youtube.com\/embed\/vzResghV3g0\" frameborder=\"0\" allowfullscreen><\/iframe><\/p>\n<p><span style=\"color: #000000;\">In <span style=\"text-decoration: underline;\"><span style=\"font-family: Times New Roman;\">Dweyer v. Boston Scientific Corp.<\/span><\/span>, <\/span><strong><span style=\"font-family: Times New Roman;\">a man implanted with a cardiac resynchronization therapy defibrillator died from head trauma sustained after he lost consciousness and fell when the device malfunctioned<\/span><\/strong><span style=\"color: #000000;\">.<\/span><\/p>\n<p><span style=\"color: #000000;\">Subsequently, the device was explanted from his body and returned to the manufacturer, Boston Scientific Corporation, for testing. <\/span><strong><span style=\"font-family: Times New Roman;\">The results confirmed that the wiring in the device transformer had failed<\/span><\/strong><span style=\"color: #000000;\">. The decedent\u2019s wife sued the manufacturer for negligence and breach of the implied warranty of merchantability. According to a Foley Hoag article, <\/span><strong><span style=\"font-family: Times New Roman;\">she alleged that the <em><a href=\"https:\/\/gilhoylaw.com\/boston-massachusetts-wrongful-death.php\"><span style=\"color: #0563c1;\">wrongful death<\/span><\/a><\/em> had been caused by a defect resulting from the defendant\u2019s violation of various federal Current Good Manufacturing Practices regulations<\/span><\/strong><span style=\"color: #000000;\"> applicable to all medical devices.<\/span><\/p>\n<p><span style=\"color: #000000;\">Boston Scientific moved to dismiss the case on the grounds that the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act expressly preempted the wife\u2019s claims because federal law occupied the field and thus supplanted state law.<\/span><\/p>\n<p><span style=\"color: #000000;\">The court noted the absence of Massachusetts authority on the specific issue, and thus deferred to the reasoning of the United States Court of Appeals for the Seventh Circuit. <\/span><strong><span style=\"font-family: Times New Roman;\">The court held that Current Good Manufacturing Practices regulations adopted by the Food and Drug Administration are legally binding requirements for the manufacturers of Class III medical devices.<\/span><\/strong><\/p>\n<p><span style=\"color: #000000;\">Moreover, the court held that even in the absence of Current Good Manufacturing Practices regulations, <\/span><strong><span style=\"font-family: Times New Roman;\">the wife\u2019s allegations would give rise to a right to recover under Massachusetts law<\/span><\/strong><span style=\"color: #000000;\">, which imposes a duty of reasonable care on manufacturers and recognizes a breach of warranty where a manufacturing defect makes a product unreasonably dangerous. The wife\u2019s state law claims paralleled federal requirements and thus were not preempted according to the court.<\/span><\/p>\n<p><span style=\"color: #000000;\">If you or a loved one has suffered an injury related to a defective product, <\/span><span style=\"font-family: Times New Roman;\">please email us at <\/span><a href=\"https:\/\/gilhoylaw.com\/boston-massachusetts-contact-gilbert-hoy-lawyers-attorneys.php\"><strong><em>info@gilhoylaw.com<\/em><\/strong><\/a> or call 617-787-3700 now to speak with one of our Boston <strong><em><a href=\"https:\/\/gilhoylaw.com\/boston-massachusetts-defective-product-injury-lawyers-attorneys.php\"><span style=\"color: #0563c1; font-family: Times New Roman;\">product liability lawyer experts<\/span><\/a><\/em><\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Generally, under the law of products liability, a manufacturing defect is an unintended defect in an otherwise safe product that occurs when the product departs from its intended design and is thus more dangerous than it should be. In Massachusetts, &hellip; <a href=\"https:\/\/gilhoylaw.com\/blog\/boston-scientific-loses-preemption-argument-in-manufacturing-defect-case\/\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[29,4,9],"tags":[],"_links":{"self":[{"href":"https:\/\/gilhoylaw.com\/blog\/wp-json\/wp\/v2\/posts\/1019"}],"collection":[{"href":"https:\/\/gilhoylaw.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/gilhoylaw.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/gilhoylaw.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/gilhoylaw.com\/blog\/wp-json\/wp\/v2\/comments?post=1019"}],"version-history":[{"count":1,"href":"https:\/\/gilhoylaw.com\/blog\/wp-json\/wp\/v2\/posts\/1019\/revisions"}],"predecessor-version":[{"id":1020,"href":"https:\/\/gilhoylaw.com\/blog\/wp-json\/wp\/v2\/posts\/1019\/revisions\/1020"}],"wp:attachment":[{"href":"https:\/\/gilhoylaw.com\/blog\/wp-json\/wp\/v2\/media?parent=1019"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/gilhoylaw.com\/blog\/wp-json\/wp\/v2\/categories?post=1019"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gilhoylaw.com\/blog\/wp-json\/wp\/v2\/tags?post=1019"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}