FDA To McKesson – You Failed In Opioid Diversion Reporting: “FDA Cites Proof Of Failure To Report In-House Diversion”

McKesson Corp. Failed In Opioid Diversion Reporting: “By Failing To Report In-House Diversion”

(MASS TORT NEXUS MEDIA) In a very clear and direct statement, the FDA has issued a formal warning letter to McKesson Corp. where “failure to monitor and report” diversion of prescription opiates including when the diversion took place within McKesson’s in-house control. Examples of opiate deliveries to Rite-Aid pharmacies containing naproxen instead of opiates were delivered in broken-seal containers. Even after Rite-Aid reported the diversions on more than one occasion, there was a failure by McKesson to report the diversion to authorities as required by law, as well as failing to conduct a proper internal investigation.

A December 2018 congressional report on prescription pill dumping squarely placed the blame on U.S. prescription drug distributors and the Drug Enforcement Administration for not doing enough to help mitigate the nation’s opioid addiction and overdose crisis.

The report released by the House Energy and Commerce Committee followed an 18-month investigation and focused on the three largest U.S. wholesale drug companies, McKesson Corp., Cardinal Health and AmerisourceBergen, and regional distributors outlines a pattern of total avoidance at the highest levels where opioid prescription reporting was required by law.

The report cited examples of massive pill shipments to West Virginia, which has a population of 1.8 million and has by far the nation’s highest death rate from prescription drugs. McKesson shipped an average of 9,650 hydrocodone pills per day in 2007 to a now-closed pharmacy in Kermit, which has a population of about 400. The shipments were 36 times above a monthly dosage shipment threshold the company had established that year. Why there was no reporting on the catastrophic numbers remains a matter to be resolved in litigation, because McKesson offers no realistic explanation for their bad conduct in failure to report as required by law.

The report cited  prior federal records that showed drug wholesalers shipped 780 million hydrocodone and oxycodone pills to West Virginia from 2007 to 2012, a period when 1,728 people fatally overdosed on the painkillers. For instance, drug companies collectively poured 20.8 million hydrocodone and oxycodone pills into the small city of Williamson, West Virginia, between 2006 and 2016, according to a set of letters the committee released Tuesday. Williamson’s population was just 3,191 in 2010, according to US Census data.  These numbers are outrageous, and we will get to the bottom of how this destruction was able to be unleashed across West Virginia,” committee Chairman Greg Walden (R-Ore.) and ranking member Frank Pallone Jr. (D-N.J.) said in a joint statement to the Charleston Gazette-Mail.

The nation is currently grappling with an epidemic of opioid addiction and overdose deaths. The Centers for Disease Control and Prevention estimate that, on average, 115 Americans die each day from opioid overdoses. West Virginia currently has the highest rate of drug overdose deaths in the country. Hardest hit have been the regions of West Virginia, Ohio and Kentucy where for some reason the opioid industry chose to focus their efforts, the how and why of their focus is being addressed in the federal and state courts across the country, with the primary cases being filed in the “Opiate Prescription Multidistrict Litigation MDL 2804” , being heard in the US District Court-Northern District of Ohio, in front of Judge Dan Polster, see Opiate Prescription MDL 2804 Briefcase.

It would now seem that McKesson will have to defend their failed diversion reporting conduct not only in the thousands of lawsuits they are facing, but in the renewed scrutiny that comes along with being outed as on eof the primary causes of the existing opioid crisis in America.

THE FULL FDA WARNING LETTER TO MCKESSON CORPORATION DATED FEBRUARY 7, 2019 IS BELOW

 

 

 

 

 

 

 

Via SIGNATURE CONFIRMED DELIVERY
February 7, 2019

John H. Hammergren

Chief Executive Officer

McKesson Corporation

One Post Street

San Francisco, California 94104

 

Dear Mr. Hammergren:

From June 25 to July 3, 2018, U.S. Food and Drug Administration (FDA) investigators conducted an inspection at your corporate headquarters located at One Post Street, San Francisco, California.  FDA investigators also inspected your distribution center facility at 9700 SW Commerce Circle, Wilsonville, Oregon, from June 26 to 29, 2018.

This warning letter summarizes significant violations of the verification requirements found in section 582(c)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(c)(4)). These verification requirements are intended to help preserve the security of the supply chain for prescription drug products, thereby protecting patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.  The verification requirements at issue include those that apply to wholesale distributors when they determine or are notified that a product is suspect or illegitimate.[1]

FDA issued a Form FDA 483 to McKesson Corporation at its San Francisco corporate headquarters on July 3, 2018.  FDA reviewed your firm’s responses, dated July 25, 2018, September 25, 2018, and November 4, 2018.

During FDA’s inspection, FDA investigators observed that your firm failed to have systems in place to enable compliance with the verification requirements of section 582(c)(4) of the FD&C Act. Specific violations include, but may not be limited to, the following:

  1. Your firm failed to respond to illegitimate product notifications as required, which includes identifying all illegitimate product subject to such notifications in your possession or control and quarantining such product (section 582(c)(4)(B)(iii)).

      2. Your firm failed to quarantine and investigate suspect product (section 582(c)(4)(A)(i)).

      3. Your firm failed to keep, for not less than 6 years, records of the investigation of suspect product and the disposition of        illegitimate product (sections 582(c)(4)(A)(iii) and 582(c)(4)(B)(v)).

Failure to comply with any of the requirements under section 582 of the FD&C Act is a prohibited act under section 301(t) of the FD&C Act (21 U.S.C. 331(t)).

Example 1: In September and October 2016, McKesson was notified by your pharmacy trading partner, Rite Aid, that three separate Rite Aid pharmacies received illegitimate product, which they reported had been distributed by McKesson. Initially, McKesson was notified by Rite Aid on September 1, 2016, that their pharmacy located in Milford, Michigan, received a bottle labeled as containing 100 tablets of oxycodone hydrochloride (NDC 0406-8530) manufactured by Mallinckrodt. The seal of the bottle was broken, and the bottle contained no oxycodone hydrochloride.  The bottle contained only 15 tablets, which were later determined to be naproxen.  Rite Aid reported to McKesson that it had received this product through a transaction with McKesson.  Mallinckrodt submitted an illegitimate product notification (via Form 3911) to FDA about this oxycodone hydrochloride, noting that “the tablets that were in the bottle were foreign tablets.”

Rite Aid’s pharmacy located in Waterford, Michigan, also received illegitimate product, which they reported had been distributed by McKesson.  The pharmacy received one bottle, also labeled as containing 100 tablets of oxycodone hydrochloride, which had a broken seal and did not contain oxycodone hydrochloride.  The bottle’s contents were also replaced with 15 tablets of naproxen.  Rite Aid reported to McKesson that it had received this product through a transaction with McKesson. On September 15, 2016, Rite Aid alerted McKesson by email about this discovery of product with missing tablets.  Mallinckrodt submitted an illegitimate product notification to FDA (via Form 3911) about the oxycodone hydrochloride, noting that the Rite Aid pharmacy in Waterford “reported that upon opening a bottle of Mallinckrodt Oxycodone 30mg the seal was broken and 100 tablets of Oxycodone 30mg were missing.  Fifteen tablets of generic Aleve ([n]aproxen sodium 220mg tablets) manufactured by Amneal Pharmaceuticals were inside the bottle.”

On October 6, 2016, Rite Aid’s pharmacy located in Warren, Michigan, also received illegitimate product, which they reported had been distributed by McKesson.  The pharmacy had ordered five bottles of oxycodone hydrochloride.  In three of the bottles they received, all the oxycodone hydrochloride had been removed.  These three bottles contained various combinations of naproxen and ciprofloxacin hydrochloride.  Mallinckrodt submitted an illegitimate product notification (via Form 3911) to FDA about these products, noting that “three bottles were missing all 100 tablets of [o]xycodone [h]ydrochloride 30mg tabs and contained foreign tablets.”

Your firm’s investigation of these three incidents of illegitimate product determined that, because of the lack of evidence of tampering with these packages and the proximity of these three Rite Aid pharmacies, it was likely that the oxycodone hydrochloride was replaced with other product while the packages were in the possession or control of McKesson.

These instances illustrate your firm’s failure to have systems in place to enable compliance with the requirements of section 582(c)(4) of the FD&C Act. After receiving illegitimate product notifications from Rite Aid, your firm was required to respond by identifying all illegitimate product subject to such notification that was in its possession or control, including any product that was subsequently received (section 582(c)(4)(B)(iii)). McKesson was then required to quarantine such product within its possession or control from product intended for distribution until such product was dispositioned (section 582(c)(4)(B)(i)(I)), dispose of any illegitimate product within its possession or control (section 582(c)(4)(B)(i)(II)), take reasonable and appropriate steps to assist trading partners to dispose of illegitimate product not in the possession of McKesson (section 582(c)(4)(B)(i)(III)), and notify within 24 hours FDA and all immediate trading partners that may have received such illegitimate product (section 582(c)(4)(B)(ii)). Your firm was also required to keep, for not less than 6 years, records of the disposition of illegitimate product (sections 582(c)(4)(B)(v)).

Although your firm conducted an investigation related to these bottles of oxycodone hydrochloride, your firm was unable to demonstrate that you met key obligations under section 582(c)(4). For example, you did not demonstrate that you identified all illegitimate product subject to the notification, such as by searching for product with the same lot number or NDC, or that you quarantined any such product. Similarly, your firm failed to demonstrate that you notified your immediate trading partners who may have received product with the same lot number or NDC. This is particularly troubling because your firm’s investigation noted that the oxycodone hydrochloride was likely replaced with different product at a McKesson distribution center. Also troubling is that during the FDA inspection of your firm’s San Francisco headquarters, a McKesson representative stated that incidents involving stolen or diverted controlled substances are not treated as Drug Supply Chain Security Act (DSCSA) verification events within the firm. In fact, DSCSA explicitly defines illegitimate product to include “a product for which credible evidence shows that the product is counterfeit, diverted, or stolen.”[2] Finally, your firm provided no records to demonstrate the disposition of these illegitimate products.

Corrective Actions

FDA has reviewed your firm’s responses to the Form FDA 483 and subsequent correspondence.

  1. Your firm’s response to the Form FDA 483 states that while you investigated “incidents related to potential diversion and theft issues … the incidents were not necessarily related to suspect or illegitimate products.”  This response parallels your representative’s statement to FDA investigators at your San Francisco headquarters that incidents involving stolen or diverted controlled substances are not treated as DSCSA verification events within the firm.  These statements demonstrate a lack of understanding of the definitions of suspect and illegitimate products, and of your firm’s responsibilities when notified of an illegitimate product by a trading partner.  All prescription drug products in finished dosage form for administration to a patient[4]– including those containing controlled substances – are subject to DSCSA verification requirements in section 582(c)(4). Moreover, the statute defines illegitimate product to include “a product for which credible evidence shows that the product is counterfeit, diverted, or stolen.”[5] Under the law, your firm must treat incidents involving suspect and illegitimate products as subject to DSCSA requirements, including products that are controlled substances.
  2. Your firm’s response to the Form FDA 483 cannot be evaluated because it lacks sufficient supporting documentation.  Your response states that McKesson plans to make procedural updates to its standard operating procedures, without describing what these updates are or providing new standard operating procedure documents for review.  FDA does not have enough information to conclude that future investigations of suspect or illegitimate product by McKesson will be conducted in a manner compliant with DSCSA.  Your firm’s response dated November 4, 2018, contains similar information as your previous response; namely regarding updates you have made to various policy documents.  Again, however, your firm provided no supporting documentation for review.
  3. Although your November 4, 2018, response to FDA states that you intend to form a “Product Safety Committee that will be responsible for coordination of all actions related to suspect or illegitimate product,” your firm provided no information about the composition of this committee or the procedures under which the committee will function.  As a result, your response does not demonstrate how the proposed change will improve McKesson’s compliance with DSCSA verification requirements.

 Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facilities. You are responsible for investigating and determining the causes of the violations identified above, and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law.

Failure to promptly correct these violations may result in legal action without further notice, including injunction. Unresolved violations in this warning letter may also prevent other federal agencies from awarding contracts.

Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the specific steps that you have taken to (1) correct the violations identified in this warning letter, and (2) identify and conduct appropriate investigations and follow-up related to other reports of suspect or illegitimate product that you have identified or received. Please include an explanation of each step being taken to prevent the recurrence of violations and include copies of related documentation. In addition, provide the steps your firm has taken to prevent incidents of theft and diversion. If you disagree with the characterization of the violations of the FD&C Act in this warning letter, include your reasoning and any supporting infom,ation for our consideration. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the corrections.
Please send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Rd.
Irvine, California 92612-2506
Sincerely,

Alonza Cruse

Director

Office of Pharmaceutical Quality Operations

Office of Regulatory Affairs

 

 

 

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Plaintiff Scores Win in Cook IVC Filter MDL Bellwether Trial

Indiana Jury Awards Tonya Brand $3 million In Damages

By Mark A. York (February 6, 2019)

 

(MASS TORT NEXUS MEDIA) A federal jury awarded plaintiff Tonya Brand $3 million in the most recent Cook MDL 2570 IVC Filter bellwether trial on February 1, 2019 in Indianapolis. See Tonya Brand v. Cook IVC Filter Jury Verdict Form Feb 1, 2019 , where the jury determined that the design of the Cook Celect IVC Filter was defective and returned a verdict of $3 million dollars.

The jury declined to award punitive damages against Cook Medical, Inc. with Ms. Brand’s trial counsel, Misty Farris offering “we are happy with the jury verdict and are encouraged that the Celect IVC Filter was recognized as being defectively designed, as far as punitive damages not being awarded—we respect the jury decision to not award punitives and look forward to the next trial.” See Tonya Brand v Cook Punitive Jury Instructions Feb 5, 2019.

Ms. Farris further added, “We believe this was the right verdict and perhaps the defense may consider this when determining whether or not to begin settlement discussions,” as there are no other bellwether trials scheduled in the Cook MDL 2570 following the Tonya Brand trial. Will this verdict move Cook Medical and its legal team toward the start of settlement negotiations?

The Brand trial is just one of the more than 5,000 cases filed against Cook Medical, Inc. and its affiliates, where plaintiffs are alleging its blood clot filters were defectively designed. Ms. Brand’s attorneys offered to the jury that she pulled a part of her Cook IVC filter out of her thigh in 2011 after it broke up and deteriorated, while pieces of the device remain lodged in in other areas of her body and are unable to be removed. For additional information on the Cook IVC Filter MDL 2750 docket see Cook-Medical IVC-Filter-MDL-2570-Docket Briefcase, by Mass Tort Nexus.

In addition to Misty Farris, of Dallas-based Fears Nachawati, the trial team consisted of Ben Martin of  the Law Offices of Ben C. Martin; Denman Heard, of the Heard Law Firm; Laura Baughman, with Baron & Budd and Joseph Williams of Indiana-based Riley Williams & Piatt, with a sincere congratulations to the entire team on their trial victory!

The Brand jury verdict came in the third bellwether trial in the Cook IVC MDL 2750, after two previous cases selected for trial resulted in wins for Cook.

Cook promoted its Celect IVC filter which was implanted into Ms. Brand as retrievable, but the filters often tilt and pierce the inferior vena cava, or pieces break off and may travel to the duodenum and aorta as well as other parts of the body, resulting in metal fragments pressing against the spine and other critical areas and organs, making it impossible to remove without major surgery. Many times the filter migration requires multiple attempts at surgical removals which fail due to the location of where the metal IVC filter fragments have migrated to.

What is an IVC Filter?

An inferior vena cava (IVC) filter is a small device surgically inserted into the inferior vena cava, the largest vein in the body. These devices, resembling a cage with spindly legs, are designed to trap blood clots from traveling to the lungs and causing a pulmonary embolism. A pulmonary embolism is a potentially fatal blockage of an artery that carries blood from the heart to the lungs. The idea is that the clots will dissolve naturally once trapped in the filter. Some filters are permanent, but otherwise the U.S. Food and Drug Administration (FDA) recommends removing the filter between the 29th and 54th day after the filter is implanted, unless the threat of pulmonary embolism hasn’t subsided. The FDA concluded this specific time span based on a mathematical model they developed using available medical data. When the agency discovered this, they did issue a safety notice in 2010 and again in 2014 outlining the risks of leaving the devices in for too long.

Plaintiff claims include that Cook knew its Celect IVC filter had perforation problems before it was cleared by the FDA, yet pushed it to the market anyway. There are independent studies that found Celect had a perforation rate of greater than 79 percent, while the Cook-sponsored study the company presented to the FDA prior to Celect’s 510(k) clearance in 2008 showed a zero percent perforation rate.

Over 9000 IVC Filter Claims Filed

Since 1979 when IVC filters were first introduced, hundreds of thousands of IVC filters have been implanted in patients. In August 2010, the FDA issued a safety communication stating IVC filters “are not always removed,” and known long term IVC filter risks include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation. There are now over 9,000 IVC filter lawsuits pending against Cook Medical, Johnson & Johnson, C.R. Bard, Cordis Corporation, B. Braun, Rex Medical, and other manufacturers in state and federal courts.

What are the risks of an inferior vena cava filter placement?

  • Infection
  • Excess bleeding
  • Allergic reaction
  • Damage to the blood vessel at the insertion site
  • Blockage of blood flow through the vena cava, which can cause leg swelling
  • A filter that travels to the heart or lungs, causing injury or death
  • A filter that pierces through the inferior vena cava, causing pain or damage to other organs
  • Problem with placement of the filter
  • Continued risk of a blood clot that travels to the lungs

Clinical Research Shows IVC Filter Dangers Were Known

 “Caval Penetration by Inferior Vena Cava Filters”

https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.115.016468

Zhongzhi JiaAlex WuMathew TamJames SpainJ. Mark McKinneyWeiping Wang    Originally published13 Jul 2015

https://doi.org/10.1161/CIRCULATIONAHA.115.016468 Circulation. 2015;132:944–952

Blood clot filters are implanted in an estimated 250,000 people in the U.S. each year, most without incident. In the last decade, millions of filters have been implanted in Americans and Cook Medical, Inc. is justone of 11 manufacturers that make these devices and are involved in litigation pending in both federal and state court dockets across the country.

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  1. For the most up-to-date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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(Disclaimer: Excerpts in this document and media content may have originated in other media publications)

 

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