O'Malley
A group of 70 plaintiffs have filed suit against the companies that they claim failed to warn them of neurological movement disorders associated with the gastrointestinal medications they were taking.
Lead plaintiff Kathleen Agresta and 69 others claim they took the medication Reglan or its generic counterpart, metoclopramide. The drugs are classified as gastrointestinal stimulants, antiemetics and dopamine antagonists, according to the complaint filed Feb. 25 in St. Clair County Circuit Court. A copy of the lawsuit was not available in the Circuit Clerk's office until this month.
Attorneys Jeffrey J. Lowe, former St. Clair County Circuit Judge Michael J. O'Malley and Jacob A. Flint of Carey, Danis and Lowe in St. Louis will be representing them.
Plaintiffs include:
Kathleen Agresta
Irma Allen
Amy Angelo
Minnie Austin
Patsy Birkett
Cindy Branch
Opel Broughton
Rhonda Brown
Audry Buford
Cynthia Castle
Harold Comeaux
Francesca Dalton
Janice Day
Rosetta Dickerson
Andrew Ebert
Michael Edwards
Larry Ellis
Paul Ferguson
Bobby Fullen
Sandra Fuller
Crystal Gammon
Kathy Gandy
Larry George
Rebecca Gorby
Michelle Grambo
Amanda Harbin
Barbara Harow
Wilda Harrison
David Hill
Randy Hill
Betty Hollis
Renee Holton
Mary Hood
Helen Hopkins
Karen Johnson
Antonina Johnson
Charlotte A. Jones
Patricia Manning
Rita Maples
Lola Mills
Theodore Morrow Jr.
Orie Napier
Terri Nau
Betty Newton
Angela Norton
Venda Parks
Jacqueline Perry
Carri Peterson
May Price
Murad Qayyum
Violet Rather
Virginia Reno
Patricia Rice as parent and guardian of Ethan Rice
Ellis Riggins
Kyle Robertson
Barbara Sarver
Linnette Saunders
Pamela Sipps
Ethel Smith
Byron Smith
Tabatha Smith
Robin Talhelm
Martha Todd
Hazel Walker
Mildred Wilcox
Roy Williams
Willa Williams
Roy Williamson
Mary Winters
Daniel Wolfe
According to the suit, the drugs also affect the brain and cause their users to experience involuntary movements.
"The term tardive dyskinesia refers to any abnormal, involuntary movement resulting from exposure to at least one dopamine receptor blocking drug, such as Reglan/metoclopramide, and persisting even after the drug is discontinued," the complaint says.
The dyskinesia can affect many parts of the body, including the head, face, neck, arms and trunk, the plaintiffs claim. There is no cure for the disorders, according to the complaint.
Dozens of studies since 1973 have revealed the dangers of the drug -- both in people who used the drug long term and short term, the suit states. The drug should only be used for 12 weeks; however, its manufacturers say the medication is safe for extended use, the complaint says.
The defending companies had access to the studies, but failed to warn physicians and users of the results of studies, the plaintiffs claim.
The FDA finally required a black box warning to be placed on Reglan and its generic counterparts on Feb. 26, 2009. The warning highlighted the risk of the neurological movement disorders associated with the drug, according to the complaint.
The makers of Reglan and metoclopramide negligently failed to ensure the public had access to accurate warnings and failed to conduct post market safety surveillance, according to the complaint.
In addition, the defendants failed to review all adverse drug event information and report risks of the drug to patients, failed to periodically review all medical literature on the risks of the drug and failed to monitor the sales of the drug -- information that would have shown them the medication is over prescribed.
In addition to the companies that manufactured the drug, the plaintiffs name Walgreens as a defendant, saying it failed to provide notifications to them when their medication regimen exceeded 12 weeks.
In their complaint, the plaintiffs allege negligence against Walgreens and strict liability and failure to warn against the makers of the medication.
Brand name defendants include:
Wyeth
ESI Lederle
Pfizer
Schwarz Pharma
UCB GmbH
Alaven Pharmaceutical
Baxter Haelthcare Corporation
Wockhardt USA
Morton Grove Pharmaceuticals
Generic defendants include:
Teva Pharmaceuticals USA
Teva Pharmaceuticals Industries
PLIVA
Barr Pharmaceuticals
Duramed Pharmaceuticals
Qualitest Pharmaceuticals
The Harvard Drug Group
Pharmaceutical Associates
Beach Products
United Research Laboratories
Mutual Pharmaceutical Company
Silarx Pharmaceuticals
Sandoz
ANIP Acquisition Company
Watson Laboratories
Rugby Pharmaceuticals
Actavis Elizabeth
Actavis Group
APP Pharmaceuticals
Amneal Pharmaceuticals
Bedford Laboratories
Hospira Inc.
Ipca Pharmaceuticals
McKesson Corporation
Northstar RX
Rugby Laboratories
Norbrook
Smith and Nephew
VistaPharm
Roxanne Laboratories
USL Pharma
Par Pharmaceuticals
Halsey Drug
SuperPharm
Paco Pharmaceutical Services
Vintage Pharmaceuticals
Schering Corporation
Ranbaxy Pharmaceuticals
Ivax Pharmaceuticals
The plaintiffs are seeking a judgment of more than $50,000 and actual and punitive damages, plus costs, post-judgment interest and other relief the court deems just.
St. Clair County Circuit Court case number: 11-L-112.