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Purdue can be questioned on research on OxyContin exposure in utero – Boston, Massachusetts

Boston, Massachusetts 2021-04-07 14:24:02 –

A A federal judge is working to provide lawyers representing children with birth defects due to exposure to opioids in utero with documents on addictive painkillers and links to birth defects. Approved to ask Purdue Pharma.

This decision is modest, but it is a potentially significant victory in the long-running battle to link OxyContin with neonatal withdrawal syndrome (NAS). NAS is a series of symptoms that occur when a baby withdraws from a particular drug while exposed to the womb. NAS is most often caused by opioid use during pregnancy.

According to the National Institute on Drug Abuse, an estimated 32,000 babies were born in the United States using NAS in 2014. This is more than five times the increase in 2004. In other words, every 15 minutes a baby was born suffering from opioid withdrawal. Some birth defects include long-term problems with bones, muscles, and movement, as well as behavioral and developmental problems.

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Investigating the potential link between OxyContin and NAS is one of many skirmishes taking place in New York’s bankruptcy court, while Purdue Pharma recommends a huge number of prescriptions to many doctors. And that is the painkiller.

Concerns about NAS have been going on for many years. A Review Congenital deficiencies such as congenital heart disease, spina bifida, and cleft palate may be associated with the use or misuse of prescription opioids during pregnancy, according to a 2017 medical literature survey published in pediatrics. .. And Survey Published in the American Journal of Obstetrics & Gynecology in 2010, it found an association between opioid analgesic treatment of mothers in early pregnancy and certain birth defects.

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However, lawyers representing 3,000 NAS children, 13% of whom report birth defects, are seeking a more direct link between OxyContin and NAS from Purdue. In particular, they are seeking research in animal toxicology.

“Animal toxicity is at the heart of proving certain common causal relationships,” Kevin Thompson, one of the so-called NAS Commission lawyers, told us. “The importance of toxicology is that it affects biological receptors.”

So far, lawyers have been searching the database for over a year in a 160-million-page disclosure repository collected in federal court in Cleveland, and many proceedings have been filed against opioid makers. It states that it is. The lawyer added that Purdue and its representatives maintain that all relevant documents have been provided, including toxicological studies submitted to the Food and Drug Administration in connection with the marketing application.

However, the lawyer received information from Other company Partnerships with Purdue Universities such as Mundipharma suggest that more research may exist. This led them to file a proceeding in the bankruptcy court and pursue further documents in anticipation of the findings. The bankruptcy judge instructed the lawyers to continue the search, but once their search is complete, Purdue must provide someone to answer questions about the existence of appropriate documents.

A Purdue spokesperson said the company “has provided thousands of documents to the (lawyer’s) committee, including related OxyContin studies. The judge denied the NAS committee’s request and we have already provided it. They instructed us to review the vast amount of information they did, and they could then deposit a record manager to make sure that what was said in our paper was provided. I will. “

However, NAS Commission lawyers argued that Purdue “boldly misunderstood” the decision and that the request was granted.

Scott Bigford, one of the NAS lawyers, said: Committee. “And we need all the toxicology reports, including those that weren’t submitted to the FDA … I believe this is the evidence everyone needs.”

“I would like to add that Purdue is not illegal or wrong even if it does not disclose all science to the FDA as part of Oyx Contin’s application. This is typical pharmaceutical industry practice here. The difference is that Purdue has been convicted twice of misleading behavior in the medical community, which makes this finding even more important. “

In October, Purdue pleaded guilty as part of three felony criminal charges. $ 8.3 billion settlement With the US Department of Justice, which has also settled a civil lawsuit against the company. And in 2007, the holding company and three executives pleaded guilty to the federal criminal accusation and paid $ 634 million as a settlement.

Last month, Purdue University called on members of the Suckler family, which owns a pharmaceutical company, to relinquish control and pay states, cities and tribes about $ 4.3 billion to repay costs associated with the long-term opioid crisis. I submitted a revised bankruptcy plan. The United States The plan aims to end about 3,000 proceedings accusing Purdue University of sparking the opioid crisis, but a group of about 20 state attorneys’ presidents oppose the plan.



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