Morphine tablets were too large, says suit against KV, Ethex

Three individuals have filed suit against a drug manufacturer over allegations their prescriptions contained a potentially lethal amount of morphine because the tablets were too large.

Plaintiff Lester Skinner says his wife, Carolyn Skinner, died after an accidental overdose from an extended-release morphine sulfate tablet prescription.

The two other plaintiffs, Stephanie Fox and Walter Mueller, allege they ingested the physician-prescribed morphine sulfate in October and November, respectively. It caused them to experience severe abdominal pain, nausea, vomiting, severe headaches and other side effects, according to the complaint.

Josh J. Driscoll of Driscoll and Cueto in St. Louis, Christopher Cueto of Driscoll and Cueto in Belleville and Robert L. Salim of Natchitoches, La., will be representing them.

Continuing to this day, Fox and Mueller say they receive medical care and treatment for the side effects they experienced while taking the prescribed medication.

According to the complaint filed May 29 in St. Clair County Circuit Court against KV Pharmaceuticals and its subsidiary Ethex Corp., the plaintiffs took the drug before it was recalled in November. The recall occurred because authorities believed the pills to be oversized and to contain twice the amount of active ingredients.

KV Pharmaceuticals and Ethex knew the drugs were potentially harmful, even before the recall, the complaint says.

"Despite such knowledge, however, Defendants, and each of them, for the purpose of enhancing their profits, knowingly and deliberately failed to warn the public, including Plaintiffs, of the extreme risk of physical injury occasioned by said defect and intentionally proceed with dissemination of the drugs with knowledge that consumers, like Plaintiffs and Plaintiffs' Decedent, would be exposed to serious danger when they ingested the defective drug," the suit states.

Even the FDA sent at least eight warnings to KV Pharmaceuticals about violations of good manufacturing processes. The violations would result in discrepancies in the production line of the drugs on which the plaintiffs accidentally overdosed, the plaintiffs allege.

Still, it was not until November that the morphine sulfate tablets were recalled.

"Defendants placed Plaintiffs, Plaintiff's Decedent and the public at large at risk of serious injury and/or death and caused Plaintiffs and Plaintff's Decedent to suffer personal injuries and harm, including medical expenses, anxiety and fear induced from ingesting the defective and misbranded drug, and in some instances death," the suit states.

Even now, the plaintiffs claim KV Pharmaceuticals and Ethex have not answered all their questions. For example, they are unsure how many Ethex recalled pharmaceutical products contained the amount of excessive ingredients, how long the drugs were sold, how many reports of illness and injury the defending companies received relating to the excessive dosage and the nature and extent of the report of illness that were received.

Fox, Mueller and Carolyn Skinner, prior to her death, suffered physical injury, pain, nausea, vomiting of blood, extreme fatigue, loss of income, loss of opportunity, loss of family and social relationships and medical expenses, according to the complaint.

They also have been prevented from pursuing their normal activities and employment, have suffered severe mental anguish and have been deprived of their ordinary pursuits and enjoyments of life, the suit states.

Because of Carolyn Skinner's death, Lester Skinner suffered economic loss, loss of comfort and society, loss of support and emotional suffering, he claims.

Causes of action include strict products liability, negligent design, negligent failure to warn, common law fraud, negligent misrepresentation, breach of express warranty and breach of implied warranties.

KV Pharmaceutical and Ethex Corporation failed to provide adequate warnings of the drug's dangers and failed to act properly on adverse event reports it received, Fox, Mueller and Skinner allege.

Even though the companies did not conduct adequate tests in clinical trials, they misrepresented to the medical community, the FDA, AIDAC and U.S. consumers the drugs were found to be safe, according to the complaint.

Through their fraudulent acts, omissions, concealments and suppression of the dangers associated with morphine sulfate tablets, KV Pharmaceutical and Ethex Corporation prevented Fox, Mueller or Skinner 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.

Fox, Mueller and Skinner are seeking damages in excess $800,000, plus pre- and post-judgment interest, costs, unspecified punitive damages and other relief to which they may be entitled.

They are also asking the court to award punitive damages to punish the defending companies and to deter them and others in a similar situation from like conduct.

St. Clair County Circuit Court case number: 09-L-286.