The Tylenol Mafia (74 page)

31
           
Burke’s Nightmare

James Burke gave the best performance: Kempton, Murray. “Yet another happy ending on Donahue.”
Chicago Sun-Times
: February 25, 1986

 
“You can actually discuss and present”: Associated Press. “Tylenol maker launches PR drive to restore painkiller's good image.”
The Stars and Stripes
, February 20, 1986.

The highlight of Burke’s:
Koepp
, Stephen.
“A Hard Decision to Swallow.”
TIME
, March 03, 1986.

“I’m not sure”:
Norman, Michael. “FBI Finds No Tampering with Packaging of Tylenol.”
The New York Times
: February 19, 1986.

 
“I don’t believe that”: Norman, Michael. “FBI Finds No Tampering with Packaging of Tylenol.”
The New York Times
, February 19, 1986.

Shortly after his
Donahue
appearance, Burke said he:
Cimons
, Marlene; Jackson, Robert L. “Latest Tylenol Poisoning: A Nightmare Comes True.”
LA Times
, February 23, 1986.

On Wednesday, February 12
^th
, Vergari told reporters: Associated Press. “Poison in new Tylenol death differs from '82.”
The Galveston Daily News
, February 13, 1986.

I have it “on good authority”: Norman, Michael. “FBI is assigning Tylenol inquiry ‘highest priority.’”
The New York Times
, February 15, 1986.

 
“We have a small group of scientists”: Associated Press. “Recent Cyanide Poisoning Differs From One In 1982.”
Marysville Journal-Tribune
, February 13, 1986.

A chemical analysis of the potassium cyanide in both containers: Norman, Michael. “FBI is assigning Tylenol inquiry ‘highest priority.’”
The New York Times
, February 15, 1986.

 
“The work we did”: Norman, Michael. “FBI is assigning Tylenol inquiry ‘highest priority.’”
The New York Times
, February 15, 1986.

Young said more sophisticated testing: Norman, Michael. “FBI is assigning Tylenol inquiry ‘highest priority.’”
The New York Times
, February 15, 1986.

“
the
potency of the poison could last almost indefinitely”: McFadden, Robert D. “Two Bottles of Poisoned Tylenol Were Shipped By Same Distributor.”
The New York Times
, February 16, 1986.

On February 12
^th
, three days before the FDA came clean: Associated Press. “Recent Cyanide Poisoning Differs From One In 1982.”
Marysville Journal-Tribune
, February 13, 1986.

Carl Vergari refused to go along: Associated Press.
“Poisoned Tylenol: no time limit.”
Sunday Intelligencer/Montgomery County Record
, February 16, 1986.

“This particular package in Woolworth’s”:
Cimons
, Marlene.
“Tylenol Probe Shifts to Time of Delivery.”
LA Times
, February 17, 1986.

The Bronxville police were more forthcoming: Associated Press. “Ban urged on over-the-counter capsules.”
The Stars and Stripes
, February 18, 1986.

Yesterday
A&P
temporarily: “Great Atlantic and Pacific Tea Company Inc. removes from sales all Tylenol capsules as a precautionary measure, related to a police investigation of a death in Westchester County, N.Y.”
PR Newswire
, February 11, 1986.

Frank Young said the second and third bottles: News Service. “Second bottle of poisoned Tylenol found.”
The Post Standard
, February 14, 1986.

James Burke said the Tylenol in the first and second:
Cimons
, Marlene.
“Tylenol Probe Shifts to Time of Delivery.”
LA Times
, February 17, 1986.

However, that warehouse was not actually owned
: Gary, Macklin. “Grocers concentrate on sales, purchase distribution expertise.”
Refrigerated Transporter
, July 1, 2004.

Since 1981, C&S Wholesale Grocers: “A Difficult Decision.”
C&S Wholesale Grocers website.
Accessed June 1, 2011.
http://www.cswg.com/company/history/difficult-descission.htm

J&J spokesperson Robert Kniffin said:
McFadden, Robert D. “Two bottles of poisoned Tylenol were shipped by same distributor.”
The
New York Times
, February 16, 1986.

McNeil President, Joseph Chiesa, inadvertently
:
Prokesch
, Steven, “Tylenol Capsule Output is
Suspended
by Maker.”
The
New York Times
, February 14, 1986.

J&J and the FDA said Tylenol was a very high turnover product: Kempton, Murray. “Yet another happy ending on Donahue.”
Chicago Sun-Times
, February 25, 1986. -- Norman, Michael. “Officials Say Fatal Tampering of Tylenol was Isolated Case.”
The New York Times
, February 12, 1986.

FDA Spokesperson, William Grigg, said that because Tylenol is a popular item: Norman, Michael. “Officials Say Fatal Tampering of Tylenol was Isolated Case.”
The New York Times
, February 12, 1986.

The contract length must have been six months
: Knight-Ridder. Billion to 1 odds against tampering at separate plants?”
Syracuse Herald-Journal
, February 18, 1986.

In-bound finished goods: Johnson & Johnson “Position Paper on Accounting for Inbound Finished Goods Freight.”

If the customer specifies: Johnson & Johnson.
“J&J Revenue Recognition Policy (WW-210A).”
August 1, 2001.

The first clue to the true source:
 
Inquirer Wire Service (with contribution from Michael B.
Coakley
).
“Cyanide in Tylenol; Woman Dead.”
Inquirer
, February 11, 1986.

Under room temperature: “Tylenol Professional Product Information.” 2010. June 20, 2011.
http://www.tylenolprofessional.com/assets/TYL_PPI.pdf

A drug’s shelf life: CFR Title 21, Sec. 211.166 (Stability testing)

On Saturday, February 15, Vergari: McFadden, Robert D. “Two bottles of poisoned Tylenol were shipped by same distributor.”
The
New York Times
, February 16, 1986.

32
           
The Puerto Rican Diversion

Vergari said Federal investigators: McFadden, Robert D. “Two bottles of poisoned Tylenol were shipped by same distributor.”
The
New York Times
, February 16, 1986.

“The report we’re getting”:
 
“Tests Link Poisons in Two Tylenol Bottles.”
The Post-Standard
, February 15, 1986.

On June 28, 2001: FDA.
“FDA Witnesses Destruction of Drug Products.”
June 28, 2001.
Accessed July 10, 2011.
http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm107058.htm

Johnson & Johnson had a major:
 
GAO Report. “Potential Economic Impacts of Changes in Puerto Rico’s Status Under S. 712.” April 1990.

Robert Kniffin said the Tylenol from Lot AHA090 “was manufactured in Dorado”: McFadden, Robert D. “Two bottles of poisoned Tylenol were shipped by same distributor.”
The New York Times
, February 16, 1986.

Several Johnson & Johnson spokespersons: Norman, Michael, 2D Tainted Bottle of Tylenol Found by Investigators.”
The New York Times
, February 14, 1986. -- McFadden, Robert D. “Two bottles of poisoned Tylenol were shipped by same distributor.”
The New York Times
, February 16, 1986.

The FBI also confirmed that the Tylenol: “FBI is assigning Tylenol inquiry ‘highest priority.’”
The New York Times
, February 15, 1986.

Since 1983, the McNeil Consumer Products Company had been manufacturing Tylenol in Las Piedras:
 
“2010 Resume: E.
Cividanes-Freiría
& Assoc. CIVIDANES & ROSA Architects – Consultants.” E.
Cividanes-Freiría
& Associates website, 2010.
Accessed July 22, 2011.
http://www.civirosa.com/documents/Resume%20ECF-A%202010-Industrial.pdf

Johnson & Johnson did, however, own: “Dorado Site Overview.”
Biovail
website.
Accessed July 1,
2011
 
http://biovail-facility.com/overview.htm
-- DOD Defense Logistics Agency (DLA) Contract with McNeil Pharmaceutical, Dorado, Puerto Rico.
Contract number DLA12085C0390, April 13, 1985.
-- “2010 Resume: E.
Cividanes-Freiría
& Assoc. CIVIDANES & ROSA Architects – Consultants.”
E.
Cividanes-Freiría
& Associates website, 2010.
Accessed July 22, 2011.
http://www.civirosa.com/documents/Resume%20ECF-A%202010-Industrial.pdf

The McNeil Pharmaceutical Company had FDA approval: JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION, VOL. 74,
NO
. 4
,1982
– “Dorado Site Overview.”
Biovail
website.
Accessed July 1,
2011
 
http://biovail-facility.com/overview.htm
  

Robert Kniffin said that the Montgomeryville facility was one of three: McFadden, Robert D. “Two Bottles of Poisoned Tylenol Were Shipped
By
Same Distributor.”
The New York Times
, February 16, 1986.

The McNeil Pharmaceutical Company had its headquarters:
 
McNeil Pharmaceutical.
“McNeil Pharmaceutical Company; SUPROL Brand
Suprofen
; 6505-00D001599.”
DrugBank
website.
December 4, 1986. Accessed July 20, 2011
http://www.drugbank.ca/system/msds/DB00870.pdf?1265922742
. – Reynolds, Brian E. “
McNEil
Pharmaceutical Div. of McNeil Labs Inc. -- HALDOL Brand Haloperidol Tablets; 10 MG; 6505-01-048-8982.” Vermont Safety Information Resources website, November 21, Accessed July 20, 2011.
http://hazard.com/msds/f2/bgh/bghxx.html
. -- Reitz, Allen.
“About the Cover.”
ACS Publications website, March 11, 1991.
Accessed July 22, 2011.
http://pubs.acs.org/doi/pdf/10.1021/bk-1991-0463.pr001
.
-- Allen Reitz Biography on Planet Connect website.
Accessed July 22, 2011.
http://events.planetconnect.com/careerworkshopprogram.html
 

In the 1980s, the McNeil Pharmaceutical plant in Montgomeryville: McNeil Pharmaceutical.
“McNeil Pharmaceutical Company; SUPROL Brand
Suprofen
; 6505-00D001599.”
DrugBank
website.
December 4, 1986. Accessed July 20, 2011
http://www.drugbank.ca/system/msds/DB00870.pdf?1265922742
.
 
– Mintz, Morton. “Drug fiends: even inside Johnson & Johnson, public safety can take a back seat to profits.”
Washington Monthly
, April 19, 1991.
-- “2010 Resume: E.
Cividanes-Freiría
& Assoc. CIVIDANES & ROSA Architects – Consultants.”
E.
Cividanes-Freiría
& Associates website, 2010.
Accessed July 22, 2011.
http://www.civirosa.com/documents/Resume%20ECF-A%202010-Industrial.pdf

The plant also manufactured
Tylox
capsules: “When it
Really
Hurts.”
Tylox
advertisement, on NCBI website 1986.
Accessed July 22, 2011.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1251264/pdf/annsurg00091-0002.pdf
 

The McNeil Pharmaceutical plant in Dorado: JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION, VOL. 74, NO. 4
,1982
– “Dorado Site Overview.”
Biovail
website.
Accessed July 1, 2011.
http://biovail-facility.com/overview.htm