Opioids

  • Opioid Medical Record Review & Outsourcing Services

Opioids are a class of drugs that act on the nerve cells in the body and brain to relieve pain. There are different types of opioids like Buprenorphine, Butorphanol, Codeine, Fentanyl, Oxycodone. Hydrocodone, Hydromorphone, and Hydromorphone are opioids that are not commonly used.

Popular Opioids

  • Buprenorphine - Subutex - FDA Approved in Oct 2002. Manufacturers: Actavis Elizabeth LLC, Hi-Tech Pharmacal Co., Inc, Mylan Pharmaceuticals Inc., Rhodes Pharmaceuticals L.P., Sun Pharmaceutical Industries, Inc, Teva Pharmaceuticals USA, West-Ward Pharmaceuticals

  • Butorphanol - Stadol. Manufacturers: Generic formulations manufactured by Novex, Mylan, Apotex and Ben Venue Laboratories

  • Codeine - Used in cough syrups, or in a combination with paracetamol (acetaminophen) or a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen. Tylenol/Elixir are brand names.

  • Fentanyl - Actiq, Duragesic, Fentora - FDA approved 1959. Manufacturer: Janssen Pharmaceuticals

  • Oxycodone - OxyFast, OxyIR, OxyNorm, Roxicodone - FDA Approved in 1995. Manufacturers: Actavis, Apotex, Endo Pharmaceuticals, Mylan and many more

  • Methadone - Dolophine - FDA approved in 1947. Manufacturers: Eli Lilly, Mallinckrodt Pharmaceuticals

Opioids are on the market for ages and have been used basically for pain relief for post-surgical pain, cancer-related pain, chronic or persistent pain. Opioids when used in proper dosage and along with a combination of other pain treatments, work in relieving pain successfully, until unless there is a misuse or abuse of the drug.

Misuse/Abuse of Opioids

Companies manufacturing Opioids convinced the medical community that these medications were not addictive and were purely beneficial. This belief raised the number prescriptions and sales unwarrantedly, resulting in a mass misuse of these drugs, to the extent that this was identified by the U.S. Food and Drug Administration (FDA) as a public issue and named it an 'Opioid crisis'.

 

Serious Alleged Injuries may include:

  • Tolerance with continued use
  • Dependence with continued use
  • Neonatal Opioid Withdrawal Syndrome (NOWS)
  • Addiction
  • Overdose
  • Death

FDA SAFETY WARNINGS:

  • In the early 2000s, reports of abuse of Opioids started surfacing which are aggravating to date. Since then, the FDA has taken prompt actions to control the misuse in the form of issuing of warning letters, class-wide label changes, arranging workshops, designing awareness programs, and joint meetings.

  • The FDA also took an initiative to produce opioids, which are abuse deterrent. As defined by the FDA, Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance.

  • OxyContin, Targiniq ER, Embeda, Hysingla ER, MorphaBond ER, Xtampza ER, Troxyca ER, Arymo ER, Vantrela ER, RoxyBond are approved by the FDA with a labeling describing abuse-deterrent properties. This is as per the FDA's Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling.

Legal Updates:

Defendants:

Purdue Pharma LP, Johnson & Johnson, Teva Pharmaceutical Industries Ltd, Actavis, Inc., and Endo International Plc and drug distributors AmerisourceBergen Corp, Cardinal Health Inc, and McKesson Corp.

Defense Law Firm:

  • Endo International Plc - Baker Donelson Bearman Caldwell & Berkowitz

  • Purdue Pharma L.P - Frazer Greene Upchurch & Baker LLC

  • Teva Pharmaceuticals USA, Inc., - Morgan Lewis & Bockius, LLP

  • Actavis, Inc. - Morgan, Lewis & Bockius

  • AmerisourceBergen Corp - Watkins & Eager, PLLC

National Prescription Opiate Litigation (MDL 2804)

Manufacturer Defendants' Liaison Counsel

  • Mark S. Cheffo - Dechert, LLP

  • Carole S. Rendon - Baker & Hostetler - Cleveland

Distributor Defendants' Liaison Counsel

  • Enu Mainigi - Williams & Connolly

  • Shannon E. McClure - Reed Smith, Philadelphia

  • Geoffrey E. Hobart - Covington & Burling LLP

Allegations: Allegations are made against manufacturers that they violated the rules by not informing the Federal authorities about the unusual size, suspicious purchases, or the frequency of bulk purchases. There is an allegation that huge benefits were reaped by manufacturers, and they intentionally failed to inform the medical providers about the addictive nature and consequences of Opioids.

Till date, large amounts of settlements have already been agreed upon by many manufacturers for the opioid crisis: McKesson, Mallinckrodt, Costco Wholesale, and Cardinal Health are to name a few among them, and the fight still continues.

In October 2017, President Donald Trump declared the U.S. opioid crisis to be a Public Health Emergency under the federal law as 72,000 Americans died from drug overdose in 2017 which according to the Centers for Disease Control and Prevention is a new record.

Plaintiffs' Co-Lead Counsel:

The following individuals are appointed to serve as co-lead counsel for the plaintiffs in MDL 2804:

  • Paul J. Hanly, Jr.- Simmons Hanly Conroy  LLC

  • Joseph F. Rice - Motley Rice LLC

  • Paul T. Farrell Jr. - Greene Ketchum, Farrell, Bailey & Tweel, LLP


Plaintiff Executive Committee

The following individuals are appointed to serve as PEC in for MDL No. 2804:

  • Don Barrett - Barrett Law Group, P.A.

  • Elizabeth Cabraser - Lieff, Cabraser, Heimann & Bernstein, LLP  

  • James E. Cecchi - Carella, Byrne, Cecchi, Olstein, Brody & Agnello, P.C.

  • Erin Dickinson- Crueger Dicksonson LLC  

  • James R. Dugan, II - The Dugan Law Firm, APLC

  • Paul J. Geller  - Robbins Geller Rudman & Dowd LLP  

  • Michael J. Fuller - McHugh Fuller Law Group

  • R. Eric Kennedy - Weisman, Kennedy & Berris CO., LPA

  • Mark Lanier - Lanier Law Firm

  • Peter J. Mougey- Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor P.A.

  • Ellen Relkin - Weitz & Luxenberg, P.C.

  • Lynn Sarko - Keller Rohrback  

  • Hunter J. Shkolnik - Napoli Shkolnik PLLC

  • Christopher A. Seeger - Seeger Weiss LLP

  • Roland Tellis - Baron & Budd, P.C.

  • James D. Young - Morgan & Morgan

Lawsuit Status:

National Prescription Opiate Litigation MDL No. 2804 (In Re: National Prescription Opiate Litigation) was formed in October 2017. Defendant names include wholesalers of opioid drugs, AmerisourceBergen Corporation, Cardinal Health, Inc., McKesson Corporation; the list also includes primary drug makers Purdue Pharma, Teva, Cephalon, Janssen, Endo, Actavis, and Mallinckrodt in certain litigations.

Infants suffering from neonatal abstinence syndrome due to their mother's opioid addiction were denied a separate MDL by Judge Polster in June 2018 and also the U.S JPML denied the formation of a separate MDL in December 2018, stating this might lead to a "substantial overlap" with the existing opioid MDL.

In July 2018, NY Judge Garguilo announced none of the claims against opioid manufacturers would be dismissed, indicating that each claim was adequate.

The first bellwether trial to take place in September 2019.

Timeline :

Verdicts & Settlement: No settlement verdict has been announced yet in the opioid litigation.

Litigation Progress:

  • September 2018: In September 2018, Endo International Plc sought to resolve about 1,000 opioid lawsuits filed by state attorneys general and private lawyers representing cities and counties over its Opana painkiller in a confidential deal which would keep them out of legal exposure.

  • In September 2018, Merrimack County Superior Court Judge John Kissinger rejected Purdue Pharma's motion to dismiss claims filed against it over opioids’ deceptive marketing in New Hampshire.

  • November 2018: Two largest drugstore chains Walgreens and CVS were sued by Florida in November 2018 over their inactive conduct to the increasing demand, supply, and abuse of opioid drugs in Florida.

  • In late November 2018, a Tennessee judge dismissed a lawsuit that labeled Big Pharma opioid manufacturers as drug dealers of opioids. This is the result of lawsuits filed by 14 prosecutors of 47 Middle and East Tennessee counties against several opiate manufacturers and distributors in 2017.

  • May 2019: Cleveland County District Judge Thad Balkman has fixed May 28, 2019, as the trial start date for opioid litigation against Opioid Big Pharma industry and its affiliates in Oklahoma.

Evidence:

  • Indication of Usage in Medical and Pharmacy Records
  • Duration of Usage
  • Complications and their treatment after intake

Medical Record Review and claim validation of Opioids case should take approximately 4 hours in most instances; however, this approximation may vary in cases based on the volume of records.

Accreditations

HIPAA

Neural IT has successfully implemented HIPAA for securing Health records....

ISO 27001 Certification

Neural IT has successfully passed the ISMS re-certification audit and is now ISO 27001:2013 certi...

NSIC - CRISIL

NSIC-CRISIL has assigned a "SE 2A" rating to Neural IT, indicating a company with High Performanc...

Associations

CAALA

CAALA - "Neural IT is proud to be associated with CAALA (Consumer Attorneys Association of Los An...

CAOC

CAOC - "Neural IT is proud to be associated with CAOC (Consumer Attorneys of California) as a Ven...

NYSTLA

NYSTLA - "Neural IT is proud to be associated with NYSTLA (New York State Trial Lawyers Associati...

News & Events

Valentine's Day Celebration @ Neural IT, 2019!
Neural IT celebrates Valentine's Day each year to convey heartfelt thanks and appreciation to all
Neural IT celebrated its Quarterly Program 'Rewards & Recognition: 2019'
Neural IT celebrated its Quarterly Program 'Rewards & Recognition: 2019,'  a motivational pra
Neural IT New Year Bash 2019
As we welcome year 2019, we also welcome 12 new chapters, 365 new chances.

Latest Tweets