A wife and 32-year-old mother of two died July 31, 2012, after taking the
prescription painkiller fentanyl for five days, per
Hawaii News Now. Her husband, a Marine now stationed on the mainland, has filed a
wrongful death lawsuit against his wife’s doctor and pharmacist.

According to
Mayo Clinic, fentanyl is a narcotic analgesic that is prescribed “to relieve
moderate to severe chronic pain when around-the-clock pain relief is needed
for a long period of time.” As
CBS News reported September 8, 2011, fentanyl is 80 times stronger than the opiate morphine.

“For patients who are not opioid-tolerant, the amount of fentanyl
in one fentanyl patch of the lowest strength is large enough to cause
dangerous side effects, such as respiratory depression (severe trouble
breathing or very slow or shallow breathing) and death,” the FDA
has stated.

Other overdose symptoms include clammy skin, extreme sleepiness, seizures,
and cardiovascular problems such as low blood pressure and bradycardia,
or slowed heart rate, per
ProjectKnow.

December 21, 2007, the FDA issued a public health advisory stating, “The
fentanyl patch should only be used by patients who are opioid-tolerant,”
but, according to the Marine’s wrongful death attorney, that warning
was covered up by the prescription label.

The pharmacist is also being sued for failing to check for potential drug
interactions even though Andrea Wells had filled prescriptions at that
store before, and the pharmacy has appeared on national TV touting its
drug interaction tracker.

According to the lawsuit, Wells was prescribed three times the normal dose
of fentanyl; however, that doctor’s lawyer has stated that “he
has prescribed [the drug] for literally hundreds of patients over the
years with no adverse results.”

Fentanyl Patch Recalls

Fentanyl patches have been recalled several times throughout the years
since the FDA approved the drug in 1990. For instance:

  • WebMD announced a duragesic and generic fentanyl pain patch recall on February 13, 2008;
  • CBS News reported Watson Pharmaceuticals’ recall on August 10, 2009; and
  • the FDA posted Actavis, Inc.’s recall on October 21, 2010.

One CBS News source stated, “For some reason, fentanyl patches get
recalled once or twice a year. If they come up with an airplane called
Fentanyl patch, don’t get on it.”

FDA Warnings

While inspecting Noven Pharmaceuticals, Inc., from January 30, 2011, to
February 14, 2011, the FDA found that the fentanyl manufacturer did not
have procedures in place to guarantee a consistent “strength, quality,
and/or purity.” It also discovered unidentified brown particles
in a sample of adhesive solution, which it mentioned in an August 2011
warning letter citing various Food, Drug, and Cosmetic Act violations.

April 18, 2012, the FDA reminded the public that fentanyl patches are deadly.

“Recently, FDA evaluated a series of 26 cases of pediatric accidental
exposures to fentanyl patches reported over the past 15 years,”
the agency stated. “Of these 26 cases, ten resulted in death and
12 in hospitalization. Sixteen of the 26 cases occurred in children two
years old or younger.

“The FDA previously alerted the public to the appropriate use and
disposal of fentanyl patches in 2005 and 2006, following the receipt of
reports of death and life-threatening adverse events related to fentanyl
overdose,” it continued. “The adverse events occurred when
the fentanyl patch was used to treat pain in patients who were not tolerant
to opioids and when opioid-tolerant patients applied more patches than
prescribed, changed the patch too frequently or exposed the patch to a
heat source.”

Fentanyl-Related Wrongful Death Lawsuits

November 17, 2008, Bloomberg reported that a jury had ordered Johnson &
Johnson to pay a family $16.6 million in the death of a 38-year-old woman.

“This is the third trial loss for the company on Duragesic,”
CBS News stated December 7, 2008. “A … jury last month awarded $13.3
million to the family of Susan Hodgemire, 34, who died after undergoing
back surgery and using the Duragesic patch. In June 2007 a federal jury
awarded $5.5 million to the father of a 28-year-old man who died in 2003
while wearing the patch.”

If you have questions about filing a wrongful death lawsuit over use of
the fentanyl patch, attorney
Chris Mellino welcomes you to
contact our Cleveland office for a free consultation.