O'Malley
Five separate groups of plaintiffs have filed suits against the companies that they claim failed to warn them of neurological movement disorders associated with the gastrointestinal medications they were taking.
The plaintiffs 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 complaints filed Feb. 25 in St. Clair County Circuit Court. Copies of the lawsuits were not available in the Circuit Clerk's office until this month.
A group of 86 plaintiffs filed one suit while a group of 84 plaintiffs filed a second; a group of 85 plaintiffs filed a third; a group of 83 plaintiffs filed a fourth; and a group of 75 plaintiffs filed the fifth.
These are not the first lawsuits to be filed against the manufacturers of the drug. A nearly identical lawsuit was also filed Feb. 25 and involved 70 plaintiffs.
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.
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 complaints say.
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 complaints.
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 suits state. The drug should only be used for 12 weeks; however, its manufacturers say the medication is safe for extended use, the complaints say.
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 complaints.
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 complaints.
The defendants also allegedly 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 complaints, the plaintiffs allege negligence against Walgreens and strict liability and failure to warn against the makers of the medication.
Brand name defendants include:
Wyeth
Pfizer
Schwarz Pharma
UCB GmbH
Alaven Pharmaceutical
Baxter Healthcare 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 numbers: 11-L-113, 11-L-114, 11-L-115, 11-L-117, 11-L-118.