The family of a Jefferson County woman has filed suit against drug manufacturer over allegations the woman's prescription contained a lethal amount of morphine because the tablets were too large.
Frank Morris Goodman and Misty Sonnier allege Judy Goodman died after an accidental overdose from an extended-release morphine sulfate tablet prescription filled at a Walgreen pharmacy in Nederland.
According to the complaint filed Jan. 13 in Jefferson County District Court against KV Pharmaceuticals and its subsidiary Ethex Corp., Judy Goodman took the medicine from June 2007 until she died on April 10 from drug toxicity. Walgreens was not named as a defendant in the suit.
In June 2008, Frank Goodman received an "Urgent Drug Recall" notice informing the family that "her tablets may be over-sized and to contact her physician."
"If over-sized, the ER tablets would have included more than the acceptable dosage for Mrs. Goodman," the suit states. "Unfortunately, Defendants' recall of Defendants' defective Morphine Sulfate ER tablets was too late."
The Goodmans provided the drug maker with Judy's medical records and death certificate which stated the cause of death as "drug toxicity." The plaintiffs claim a doctor for the defendants did contact them about Mrs. Goodman's death to "help prepare a report of this death to the government."
"Unfortunately, despite written request, Defendants did not allow (plaintiffs) to participate in that report, nor did Defendants make any effort to further communicate or share information," the complaint states. "Notably, the Defendants provided the Plaintiffs no information whatsoever, while the Plaintiffs voluntarily provided Defendants records and information pertinent to the overdose."
Before her death, Judy Goodman experienced physical pain and mental anguish, a loss of consortium and a loss of society damages, the suit states.
Because of Judy Goodman's death, Frank Morris Goodman and Sonnier suffered lost wages, conscious pain and mental anguish, they claim.
They also experienced physical impairment, physical disfigurement, lost services and income and lost business opportunities and incurred medical and funeral expenses, according to the complaint.
Causes of action include products liability, negligence and gross negligence, defective design, breach of express and implied warranty, fraudulent/negligent misrepresentation, deceptive trade practices, negligent recall, negligence per se and non-compliance with government standards.
KV Pharmaceutical and Ethex Corporation represented the drug was safe for its intended use, but it was not and there were no warnings of its dangers, Frank Morris Goodman and Sonnier allege.
Through their fraudulent acts, omissions, concealments and suppression of the dangers associated with morphine sulfate tablets, KV Pharmaceutical and Ethex Corporation prevented the Goodmans from discovering the over-sized dose of morphine in the tablets, the plaintiffs claim.
Both companies also failed to adequately conduct testing and research on the tablets prior to selling them and failed to adequately conduct post-marketing surveillance and testing of the drug after its arrival on the market, according to the complaint.
"Defendants, Ethex Corporation and KV Pharmaceutical, under-reported, underestimated, and downplayed the serious and dangerous side effects of Morphine Sulfate ER Tablets," the suit states. "The Morphine Sulfate ER Tablets manufactured and/or supplied by Defendants were defective due to inadequate warnings or instructions because the manufacturer knew or should have known that the product created a high risk of death."
The suit alleges the companies manufactured, produced and sold the tablets without conducting adequate testing, failed to adequately warn the public and the medical profession of the dangers of the tablets and by failed to provide adequate instructions regarding safety precautions to be observed by users who came into contact with the tablets.
In addition, Ethex Corporation and KV Pharmaceutical negligently advertised and recommended the use of morphine sulfate tablets without sufficient knowledge of its dangers, represented the drug was safe for use for its intended purpose when it was not, improperly obtained the approval of the FDA to market the drug after misrepresenting risks of the drug to the FDA, failed to perform appropriate post-market testing and surveillance of the tablets and failed to timely recall the tablets, the plaintiffs allege.
Frank Morris Goodman and Sonnier are seeking unspecified damages in excess of the minimum jurisdictional limits of the Jefferson County District Court, pre- and post-judgment interest, costs, unspecified punitive damages and other relief to which they may be entitled.
Mark Sparks of Provost and Umphrey Law Firm in Beaumont will be representing them.
The case has been assigned to Judge Gary Sanderson of the 60th District Court.
Case No. B183-015