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.
Charlotte A. Jones
Theodore Morrow Jr.
Patricia Rice as parent and guardian of Ethan Rice
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:
Baxter Haelthcare Corporation
Morton Grove Pharmaceuticals
Generic defendants include:
Teva Pharmaceuticals USA
Teva Pharmaceuticals Industries
The Harvard Drug Group
United Research Laboratories
Mutual Pharmaceutical Company
ANIP Acquisition Company
Smith and Nephew
Paco Pharmaceutical Services
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.