Topics and Cases - Reglan
Reglan (metoclopramide) is a prescription drug used to treat a number of gastrointestinal conditions including slow gastric emptying in people with diabetes and heartburn caused by gastroesophageal reflux. For these conditions, Reglan works to increase muscle contractions aiding in faster digestion. Reglan is manufactured by Baxter Healthcare Corporation.
While Reglan is FDA approved for short-term treatment (not to exceed 3 months), evidence shows that for the one-third of patients using Reglan chronically, they have a high risk of developing serious, debilitating neurological disorders.
Facts about Reglan:
- Reglan was approved as a brand-name drug by the FDA in 1999. The FDA approved short-term (4-12 weeks) usage of metoclopramide in 1985.
- Tardive Dyskinesia is a neurological disorder that develops because of the use of neuroleptic drugs. It causes involuntary muscle movements.
- The only cause of Tardive Dyskinesia is taking these drugs which are prescribed to treat psychiatric and gastrointestinal conditions such as Reglan.
- There is no known cure for Tardive Dyskensia.
- Additional side effects of chronic use of Reglan include secondary Parkinsons, blepharospasm, ocular deviation and akathisia are characterized by abnormal movements that can become permanent in some patients.
- In February 2009, the FDA issued a warning label for Reglan. This was a black box warning, the most serious type the FDA issues.
- The FDA specifically warned that chronic use of Reglan has been linked to tardive duskiness even after the drugs are no longer taken.
Litigation News:
- Incredibly, lawsuits over the use of metoclopramide and its effects have been going on since 1989, when a court first ruled that a metoclopramide user should have been informed of the potential side effects.
- Another attempt to consolidate the cases was rejected by the US Judicial Panel on Multidistrict Litigation earlier this year.
- Reglan litigation in New Jersey, however, has been consolidated. More than 1,000 cases have been consolidated in a class action lawsuit where Judge Carol E. Higbee has been assigned to oversee the consolidation.
- The first New Jersey case is expected to go on trial later in 2011.
- In 2011, the Supreme Court ruled, in a case known as Mensing, that generic manufacturers were immune from liability in the case of a woman who suffered from tardive dyskinesia following use of generic metaclopromide.
- Most recently, throughout September, October and November 2011, lawsuits were filed in California Superior Court, including a mass tort cases with six current plaintiffs in San Francisco.