A wrongful death lawsuit filed in Pinellas County accuses a pharmaceutical manufacturing company of causing the death of a 45-year-old Largo woman who left behind a young daughter.
Lydia C. Fernandez died in May 2008 of an accidental overdose on morphine, according to a report by the Pinellas-Pasco Medical Examiner's Office.
The suit was filed in late April against St. Louis-based KV Pharmaceutical Co., and its subsidiaries Ethex Corp. and Ther-Rx Corp.
According to the suit filed bythe daughter's legal guardian, Fernandez was found dead by her daughter.
Fernandez' sister, Nydia Feldner of Warwick, N.Y., is the child's guardian and the representative of Fernandez' estate.
She declined to comment on the litigation but said her niece was 11 years old when her mother died.
On the morning of May 7, 2008, the daughter went into her mother's bedroom to say goodbye before she left for school and found her mom unresponsive, according to a medical examiner report. The girl called 911, and Fernandez was pronounced dead by paramedics.
Fernandez' doctor told a medical examiner investigator that his patient suffered from chronic back pain.
She filled a prescription for 150 30 mg tablets of morphine in March 2008, the suit says. A Largo police detective who investigated the death said a pill count at the scene revealed Fernandez had taken fewer pills than the prescribed number.
The suit is seeking damages for the daughter's loss of "support and services," loss of parental companionship, funeral expenses and lost earnings.
Calls to KV Pharmaceutical Co. were not returned.
According to news releases by the U.S. Food and Drug Administration, Ethex Corp. recalled some lots of 30 mg morphine tablets in June and November 2008, and others in January 2009.
The batches were recalled because they possibly contained "oversized" pills that "could result in patients receiving as much as about twice the expected dosage of these drugs," according to one FDA release.
In March, the United States Attorney's Office Eastern District of Missouri announced that Ethex Corp. had pleaded guilty to two federal felony charges of failing to tell the FDA about a manufacturing problem similar to the one believed to have caused the oversized morphine pills.
That error, which resulted in oversized medications of two other prescription drugs, was caused by machines that "lacked some of the safety and automation features that more modern tablet press machines typically had," the FDA said.
The company was fined $23.4 million in that case and ordered to pay an additional $2.3 million in restitution to Medicare and Medicaid.
Stockholders filed suit against KV Pharmaceutical Co. in December 2008, alleging the company made false statements about its FDA compliance and failed to report the manufacturing issues.
According to court records from the U.S. District Court for the Eastern District of Missouri, that case was dismissed in February, but is being appealed.
A national search of news articles shows Ethex Corp. and its parent company have been sued by several people who claim they or their loved ones overdosed on morphine pills that contained the higher dosages.
Rita Farlow can be reached at email@example.com or (727) 445-4157.