{"id":17603,"date":"2019-08-17T20:15:42","date_gmt":"2019-08-17T20:15:42","guid":{"rendered":"https:\/\/www.lifeandnews.com\/articles\/?p=17603"},"modified":"2019-08-18T04:16:56","modified_gmt":"2019-08-18T04:16:56","slug":"shouldnt-there-be-a-law-against-reckless-opioid-sales-turns-out-there-is","status":"publish","type":"post","link":"https:\/\/www.lifeandnews.com\/articles\/shouldnt-there-be-a-law-against-reckless-opioid-sales-turns-out-there-is\/","title":{"rendered":"Shouldn\u2019t there be a law against reckless opioid sales? Turns out, there is"},"content":{"rendered":"<p><a href=\"https:\/\/theconversation.com\/profiles\/nicolas-paul-terry-703734\">Nicolas Paul Terry<\/a>, <em><a href=\"http:\/\/theconversation.com\/institutions\/iupui-2368\">IUPUI<\/a><\/em><\/p>\n<p>The massive scale of prescription opioid shipments as the ongoing overdose epidemic unfolded has started to come into focus.<\/p>\n<p>Drug companies shipped <a href=\"https:\/\/www.washingtonpost.com\/investigations\/76-billion-opioid-pills-newly-released-federal-data-unmasks-the-epidemic\/2019\/07\/16\/5f29fd62-a73e-11e9-86dd-d7f0e60391e9_story.html\">76 billion opioid pain pills<\/a> to U.S. health care professionals, hospitals and pharmacies between 2006 and 2012, according to data <a href=\"https:\/\/www.washingtonpost.com\/investigations\/76-billion-opioid-pills-newly-released-federal-data-unmasks-the-epidemic\/2019\/07\/16\/5f29fd62-a73e-11e9-86dd-d7f0e60391e9_story.html\">The Washington Post<\/a> and the <a href=\"https:\/\/www.wvgazettemail.com\/newly-released-federal-data-unmasks-epidemic-that-led-to-billion\/article_4c672920-756f-5cd1-8c4e-6d17951cafa1.html\">Charleston Gazette-Mail\u2019s owner<\/a> acquired by <a href=\"https:\/\/assets.documentcloud.org\/documents\/6163333\/19a0133p-06.pdf\">suing the government<\/a>.<\/p>\n<p>Hundreds of pills per person were delivered to rural areas like <a href=\"https:\/\/www.washingtonpost.com\/national\/a-remote-virginia-valley-has-been-flooded-by-prescription-opioids\/2019\/07\/18\/387bb074-a8ca-11e9-9214-246e594de5d5_story.html\">Wise County, Kentucky<\/a>, and the town of <a href=\"https:\/\/www.pharmacist.com\/article\/remote-virginia-valley-has-been-flooded-prescription-opioids\">Norton, Virginia<\/a>. Meanwhile, the number of <a href=\"https:\/\/overdosemappingtool.norc.org\/\">fatal overdoses<\/a> involving all kinds of prescription opioids soared across all of <a href=\"https:\/\/www.medpagetoday.com\/neurology\/opioids\/78170\">Appalachia and other hotspots<\/a> as the national death toll climbed from 3,442 in 1999 to <a href=\"https:\/\/www.drugabuse.gov\/related-topics\/trends-statistics\/overdose-death-rates\">17,029 in 2017<\/a>.<\/p>\n<p>In addition, a federal court in Cleveland has released scores of <a href=\"https:\/\/www.reuters.com\/investigates\/special-report\/usa-courts-secrecy-judges\/\">previously sealed documents<\/a>. The <a href=\"https:\/\/www.washingtonpost.com\/graphics\/2019\/investigations\/opioid-drug-company-documents\/\">corporate memos and legal depositions<\/a> suggest that drug company executives, pharmacists and others involved at every level of the prescription opioid trade failed to heed troubling signs that the industry was facilitating drug abuse.<\/p>\n<p>As a health law professor who studies the <a href=\"https:\/\/ssrn.com\/abstract=3237663\">relationship between the U.S. health care system and opioid overdoses<\/a>, I have <a href=\"https:\/\/ssrn.com\/abstract=3308838\">researched<\/a> the epidemic\u2019s causes. In particular, I have researched the likely <a href=\"https:\/\/twihl.podbean.com\/e\/158-opioid-litigation-update-guest-jennifer-oliva\/\">liability of drugmakers and pharmaceutical distributors<\/a> in the multiple pending and resolved <a href=\"https:\/\/www.baltimoresun.com\/health\/bs-hs-more-lawsuits-filed-over-opioid-crisis-20190722-rskg6ulgb5hujmz7ms4o4vvcvm-story.html\">federal<\/a> and <a href=\"https:\/\/www.npr.org\/sections\/health-shots\/2019\/07\/16\/741960008\/pain-meds-as-public-nuisance-oklahoma-tests-a-legal-strategy-for-opioid-addictio\">state<\/a> lawsuits filed against all of the industry\u2019s key players.<\/p>\n<p>One thing that I\u2019ve often wondered about is why no law on the books could slow what now appears to have been the reckless oversupply of opioids by companies in the health care business.<\/p>\n<p><iframe loading=\"lazy\" id=\"n19t1\" class=\"tc-infographic-datawrapper\" style=\"border: none;\" src=\"https:\/\/datawrapper.dwcdn.net\/n19t1\/1\/\" width=\"100%\" height=\"400px\" frameborder=\"0\"><\/iframe><\/p>\n<h2>A duty to report<\/h2>\n<p>Well, there is, as it turns out.<\/p>\n<p>The <a href=\"https:\/\/www.law.cornell.edu\/uscode\/text\/21\/chapter-13\/subchapter-I\">Controlled Substances Act<\/a> creates what experts call a \u201c<a href=\"https:\/\/www.deadiversion.usdoj.gov\/pubs\/manuals\/pract\/section1.htm\">closed system<\/a>.\u201d That is, the federal government has designed a way to <a href=\"https:\/\/www.everycrsreport.com\/reports\/R45164.html\">track every controlled substance<\/a> \u2013 medications with the potential for abuse or dependence, including opioids \u2013 from factory to pharmacy counter and hospital bed. Manufacturers, distribution companies, health care professionals, pharmacies, hospitals and others who buy, sell and dispense these drugs must be registered with the Drug Enforcement Agency.<\/p>\n<p>The roughly <a href=\"https:\/\/www.dea.gov\/press-releases\/2018\/02\/14\/dea-creates-new-resource-help-distributors-avoid-oversupplying-opioids\">1.73 million people and companies<\/a> registered with the DEA must maintain precise records and report their interactions with all controlled substances.<\/p>\n<p>The Controlled Substances Act categorizes drugs into different \u201c<a href=\"https:\/\/www.deadiversion.usdoj.gov\/21cfr\/21usc\/811.htm\">schedules<\/a>\u201d that determine the degree of regulatory oversight and the responsibilities required of anyone handling them. The government has designated opioids such as Oxycodone and hydrocodone as \u201c<a href=\"https:\/\/www.dea.gov\/drug-scheduling\">Schedule II<\/a>\u201d drugs, the most dangerous category that can be prescribed.<\/p>\n<p>Manufacturers and distributors of Schedule II drugs must file reports about the opioids that pass though their hands using the government\u2019s <a href=\"https:\/\/www.deadiversion.usdoj.gov\/arcos\/index.html\">Automated Reports and Consolidated Orders System<\/a>, or ARCOS. These reports generate data that track the numbers of drugs shipped or sold and their destinations, at county and pharmacy levels.<\/p>\n<p>A <a href=\"https:\/\/www.deadiversion.usdoj.gov\/21cfr\/cfr\/1301\/1301_74.htm\">DEA rule<\/a> issued back in 1971 also requires all registrants to design systems for reporting \u201csuspicious orders\u201d \u2013 meaning, among other things, purchases and deliveries that are unusually big or frequent.<\/p>\n<figure class=\"align-center zoomable\"><a href=\"https:\/\/images.theconversation.com\/files\/287753\/original\/file-20190812-71917-lygxgv.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip\"><img src=\"https:\/\/images.theconversation.com\/files\/287753\/original\/file-20190812-71917-lygxgv.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip\" sizes=\"(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px\" srcset=\"https:\/\/images.theconversation.com\/files\/287753\/original\/file-20190812-71917-lygxgv.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=376&amp;fit=crop&amp;dpr=1 600w, https:\/\/images.theconversation.com\/files\/287753\/original\/file-20190812-71917-lygxgv.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=376&amp;fit=crop&amp;dpr=2 1200w, https:\/\/images.theconversation.com\/files\/287753\/original\/file-20190812-71917-lygxgv.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=376&amp;fit=crop&amp;dpr=3 1800w, https:\/\/images.theconversation.com\/files\/287753\/original\/file-20190812-71917-lygxgv.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=473&amp;fit=crop&amp;dpr=1 754w, https:\/\/images.theconversation.com\/files\/287753\/original\/file-20190812-71917-lygxgv.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=473&amp;fit=crop&amp;dpr=2 1508w, https:\/\/images.theconversation.com\/files\/287753\/original\/file-20190812-71917-lygxgv.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=473&amp;fit=crop&amp;dpr=3 2262w\" alt=\"\" \/><\/a><figcaption><span class=\"caption\">Several high-ranking executives from prescription drug distributors and wholesalers testified about their roles in the opioid addiction epidemic before Congress in 2018.<\/span><br \/>\n<span class=\"attribution\"><a class=\"source\" href=\"http:\/\/www.apimages.com\/metadata\/Index\/Congress-Opioids\/673d1ee4fce8438ca2b1f2568aa553d9\/7\/0\">AP Photo\/Alex Brandon<\/a><\/span><\/figcaption><\/figure>\n<h2>Inadequate oversight<\/h2>\n<p>The federal government gave <a href=\"https:\/\/www.nytimes.com\/2018\/03\/05\/health\/opioid-crisis-judge-lawsuits.html\">the court in Cleveland<\/a> reams of ARCOS data in February 2018. However, U.S. District Judge Dan A. Polster, who is presiding over the landmark opioid litigation that pools some 2,000 separate lawsuits, <a href=\"https:\/\/www.ohnd.uscourts.gov\/sites\/ohnd\/files\/MDL2804-167.pdf\">refused to let the press and the public<\/a> see that information until <a href=\"https:\/\/assets.documentcloud.org\/documents\/6163333\/19a0133p-06.pdf\">an appeals court<\/a> ordered its release.<\/p>\n<figure class=\"align-right zoomable\"><a href=\"https:\/\/images.theconversation.com\/files\/287750\/original\/file-20190812-71897-1uiua8l.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip\"><img src=\"https:\/\/images.theconversation.com\/files\/287750\/original\/file-20190812-71897-1uiua8l.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip\" sizes=\"(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px\" srcset=\"https:\/\/images.theconversation.com\/files\/287750\/original\/file-20190812-71897-1uiua8l.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=422&amp;fit=crop&amp;dpr=1 600w, https:\/\/images.theconversation.com\/files\/287750\/original\/file-20190812-71897-1uiua8l.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=422&amp;fit=crop&amp;dpr=2 1200w, https:\/\/images.theconversation.com\/files\/287750\/original\/file-20190812-71897-1uiua8l.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=422&amp;fit=crop&amp;dpr=3 1800w, https:\/\/images.theconversation.com\/files\/287750\/original\/file-20190812-71897-1uiua8l.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=531&amp;fit=crop&amp;dpr=1 754w, https:\/\/images.theconversation.com\/files\/287750\/original\/file-20190812-71897-1uiua8l.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=531&amp;fit=crop&amp;dpr=2 1508w, https:\/\/images.theconversation.com\/files\/287750\/original\/file-20190812-71897-1uiua8l.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=531&amp;fit=crop&amp;dpr=3 2262w\" alt=\"\" \/><\/a><figcaption><span class=\"caption\">U.S. District Judge Dan A. Polster is overseeing landmark opioid litigation in Cleveland.<\/span><br \/>\n<span class=\"attribution\"><a class=\"source\" href=\"http:\/\/www.apimages.com\/metadata\/Index\/Opioid-Crisis-Lawsuits\/95258a7da15f4f2780766f19f027b553\/1\/0\">AP Photo\/Tony Dejak<\/a><\/span><\/figcaption><\/figure>\n<p>The unsealed documents and data reveal the DEA possessed massive amounts of information about the oversupply of prescription opioids while the overdose epidemic was mushrooming. The newly released court exhibits also suggest that some opioid manufacturers and distributors repeatedly failed to report suspicious orders as required by law.<\/p>\n<p>Congress had already suspected that corporate oversight was lacking.<\/p>\n<p>The <a href=\"https:\/\/republicans-energycommerce.house.gov\/wp-content\/uploads\/2018\/12\/Opioid-Distribution-Report-FinalREV.pdf\">House Energy and Commerce Committee<\/a>, for example, issued a report in 2018 that was highly critical of the DEA\u2019s oversight of opioid distribution in West Virginia. The DEA, according to the report, was aware of wide-scale diversion and suspicious shipments as early as 2005 and even began an initiative to educate distributors about their obligations regarding suspicious orders.<\/p>\n<p>In 2011, <a href=\"https:\/\/www.dea.gov\/sites\/default\/files\/pr\/speeches-testimony\/2012-2009\/110524_testimony.pdf\">then-DEA administrator Michele Leonhart<\/a> testified before a Senate judiciary subcommittee that the agency was increasing its investigations of doctors and pharmacists who illegally diverted controlled substances. What I believe the DEA missed was that the manufacturers and distributors of opioids had gone rogue.<\/p>\n<p>In a recent filing in the consolidated Cleveland case, <a href=\"http:\/\/www.opioidsnegotiationclass.info\/Home\/FAQ#faq2\">local governments<\/a> like Coos County, New Hampshire, and the city of Chicago allege that the corporate defendants\u2019 \u201c<a href=\"https:\/\/www.washingtonpost.com\/investigations\/newly-unsealed-exhibits-in-opioid-case-reveal-inner-workings-of-the-drug-industry\/2019\/07\/23\/acf3bf64-abe5-11e9-8e77-03b30bc29f64_story.html?\">failure to identify suspicious orders was their business model<\/a>.\u201d<\/p>\n<p>The <a href=\"https:\/\/www.washingtonpost.com\/investigations\/newly-unsealed-exhibits-in-opioid-case-reveal-inner-workings-of-the-drug-industry\/2019\/07\/23\/acf3bf64-abe5-11e9-8e77-03b30bc29f64_story.html\">unsealed documents<\/a> suggest a pattern. Manufacturers and distributors either had deficient systems for monitoring of suspicious orders, simply ignored them or went out of their way to call them something else. For example, rather than acknowledging that enormous or extraordinarily frequent orders were \u201csuspicious,\u201d employees and executives would describe these transactions as \u201cpeculiar\u201d or \u201cunusual.\u201d<\/p>\n<p>The newly available documents indicate that when DEA investigators did find evidence that distributors were not reporting suspicious shipments, the authorities reached settlements instead of moving forward with prosecutions. As a result, distributors paid civil penalties rather than facing more serious criminal charges. Therefore, with <a href=\"https:\/\/www.deachronicles.com\/2017\/07\/dea-prevails-over-masters-pharmaceutical-inc\/#more-1886\">few exceptions<\/a>, distributors who had failed to report suspicious shipments were able to stay in business.<\/p>\n<p>And although the number of shipments continued to rise beyond 2012 \u2013 the end of the period covered by the newly available data and documents \u2013 the <a href=\"https:\/\/www.washingtonpost.com\/investigations\/the-dea-slowed-enforcement-while-the-opioid-epidemic-grew-out-of-control\/2016\/10\/22\/aea2bf8e-7f71-11e6-8d13-d7c704ef9fd9_story.html\">number of enforcement actions actually fell<\/a> in 2013.<\/p>\n<p>It wasn\u2019t until 2017 that the DEA seemed to pay serious attention to the role of manufacturers and distributors in the opioid overdose epidemic. That year, it reached a <a href=\"https:\/\/www.dea.gov\/press-releases\/2017\/07\/11\/mallinckrodt-agrees-pay-35-million-settlement\">US$35 million settlement with Mallinckrodt<\/a>, one of the largest oxycodone manufacturers, for failing to detect and report suspicious orders. The settlement also obliged Mallinckrodt to monitor downstream distribution, as the DEA said for the first time that the obligation to \u201cknow your customer\u201d includes knowing \u201cyour customer\u2019s customer.\u201d<\/p>\n<h2>Stepping up enforcement<\/h2>\n<p>I see a new <a href=\"https:\/\/www.congress.gov\/bill\/115th-congress\/house-bill\/6\/text#H8909942BDF304C42AA654FCEAD3C0AA8\">federal law<\/a> President Donald Trump signed in 2018 as a step in the right direction. It tightens up the definition of \u201csuspicious activity,\u201d clarifies reporting obligations and requires the DEA to establish a centralized database for all reports of suspicious prescription drug orders.<\/p>\n<p>The federal government also seems to be taking a more aggressive stance against opioid distributors. For instance, it filed felony charges against the distributor <a href=\"https:\/\/www.justice.gov\/usao-sdny\/pr\/manhattan-us-attorney-and-dea-announce-charges-against-rochester-drug-co-operative-and\">Rochester Drug Co-Operative<\/a> and two of its former executives in April 2019. The government alleges that the company intentionally failed to report suspicious orders and looked the other way amid signs that opioids were being shipped for illicit purposes.<\/p>\n<p>In July 2019, the government announced charges against <a href=\"https:\/\/www.justice.gov\/usao-sdoh\/pr\/pharmaceutical-distributor-executives-pharmacists-charged-unlawfully-distributing\">Miami-Luken<\/a>, another distributor, and two of its former executives for allegedly failing to report suspicious orders and conspiring with two pharmacists to illegally distribute millions of prescription opioid painkillers.<\/p>\n<p>It does look like lawmakers have strengthened the Controlled Substances Act and that the government is making strides on enforcement. However, it remains unclear why it took them so long to use the powers they already had to stop reckless shipments.<\/p>\n<p>[ <em><a href=\"https:\/\/theconversation.com\/us\/newsletters?utm_source=TCUS&amp;utm_medium=inline-link&amp;utm_campaign=newsletter-text&amp;utm_content=thanksforreading\">Thanks for reading! We can send you The Conversation\u2019s stories every day in an informative email. Sign up today.<\/a><\/em> ]<!-- Below is The Conversation's page counter tag. Please DO NOT REMOVE. --><img loading=\"lazy\" style=\"border: none !important; box-shadow: none !important; margin: 0 !important; max-height: 1px !important; max-width: 1px !important; min-height: 1px !important; min-width: 1px !important; opacity: 0 !important; outline: none !important; padding: 0 !important; text-shadow: none !important;\" src=\"https:\/\/counter.theconversation.com\/content\/121021\/count.gif?distributor=republish-lightbox-basic\" alt=\"The Conversation\" width=\"1\" height=\"1\" \/><!-- End of code. If you don't see any code above, please get new code from the Advanced tab after you click the republish button. The page counter does not collect any personal data. More info: http:\/\/theconversation.com\/republishing-guidelines --><\/p>\n<p><a href=\"https:\/\/theconversation.com\/profiles\/nicolas-paul-terry-703734\">Nicolas Paul Terry<\/a>, Professor of Law, <em><a href=\"http:\/\/theconversation.com\/institutions\/iupui-2368\">IUPUI<\/a><\/em><\/p>\n<p>This article is republished from <a href=\"http:\/\/theconversation.com\">The Conversation<\/a> under a Creative Commons license. Read the <a href=\"https:\/\/theconversation.com\/shouldnt-there-be-a-law-against-reckless-opioid-sales-turns-out-there-is-121021\">original article<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nicolas Paul Terry, IUPUI The massive scale of prescription opioid shipments as the ongoing overdose epidemic unfolded has started to come into focus. Drug companies shipped 76 billion opioid pain pills to U.S. health care professionals, hospitals and pharmacies between 2006 and 2012, according to data The Washington Post and the Charleston Gazette-Mail\u2019s owner acquired [&hellip;]<\/p>\n","protected":false},"author":44,"featured_media":17598,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[4],"tags":[1546,1781,6812,3925,4903,3039,516,5991,3996,1026],"_links":{"self":[{"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/posts\/17603"}],"collection":[{"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/users\/44"}],"replies":[{"embeddable":true,"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/comments?post=17603"}],"version-history":[{"count":2,"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/posts\/17603\/revisions"}],"predecessor-version":[{"id":17607,"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/posts\/17603\/revisions\/17607"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/media\/17598"}],"wp:attachment":[{"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/media?parent=17603"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/categories?post=17603"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.lifeandnews.com\/articles\/wp-json\/wp\/v2\/tags?post=17603"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}