November 2010 Georgia Reglan News

The U.S. Solicitor General has asked the U.S. Supreme Court to reject an appeal by pharmaceutical companies in a generic Reglan lawsuit, in a case known as the Mensing decison.

The manufacturers of the generic Reglan, metoclopramide, are seeking a reversal of an appellate court decision that holds them liable for failing to warn patients about the risk of tardive dyskinesia, a rare movement disorder linked to the drug. The Supreme Court asked the U.S. Solicitor General for an opinion on the accountability of generic Reglan manufacturers.

The Solicitor General supported the appellate court ruling in an amicus brief that had been filed a week ago.  “The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted,” the brief said. “A generic manufacturer can (and indeed, must) inform the FDA of new information about the risks that may require a change in the labeling of its drug.”

GERD in Infants

It is common for infants to spit up after a meal, but frequent vomiting among infants may be caused by GERD (gastroesophageal reflux disease).

Definition:
It refers to immaturity of lower esophageal sphincter function, manifested by frequent transient lower esophageal relaxations that results in retrograde flow of gastric contents into the esophagus.
Gastroesophageal reflux is classified as follows:

Physiological reflux: These patients have no underlying predisposing factors or conditions. Growth and development are normal, and pharmacologic treatment is typically not necessary.
Pathological reflux or gastroesophageal reflux disease (GERD): Patients frequently experience complications , requiring careful evaluation and treatment.

Secondary gastroesophageal reflux: This refers to a case in which an underlying condition may predispose to gastroesophageal reflux. Examples include asthma (a condition which may also be, in part, caused by or exacerbated by reflux and gastric outlet obstruction.


More here.

5th Circuit Case Says No Preemption in Generic Reglan Lawsuit

On January 8, 2010, the United States Court of Appeals for the Fifth Circuit held that state law failure to warn claims against generic drug manufacturers are not preempted by federal regulation. Demahy v. Actavis, Inc., 2010 WL 46513 (C.A. 5 (La.).

This decision is consistent with that of the Eighth Circuit in Mensing v. Wyeth, 588 F.3d 603 (8th Cir. 2009) and was guided by the Supreme Court's decision in Wyeth v. Levine, 129 S. Ct. 1187 (2009), holding that such a claim is not preempted against name brand drug manufacturers.

In Demahy, the drug was the generic form of Reglan (metoclopramide) manufactured by Actavis. Demahy claimed that her long-term ingestion of the drug caused her to develop a neurological movement disorder called tardive dyskinesia. She asserted personal injury claims under the Louisiana Products Liability Act for, among other things, failure to warn of the risks of the drug's long-term use.

The Fifth Circuit rejected the argument that compliance with state duties to warn would burden generic manufacturers with duplicative drug trials, noting that clinical studies are not prerequisites to labeling changes and reports of adverse drug reactions can substantiate the need for a heightened warning. The Fifth Circuit's decision was grounded in the belief that a central premise of federal drug regulation is that the manufacturer bears responsibility for the content of its label at all times.

Here's the opinion: Here.

Reglan: No MDL For Litigation

The JPML heard argument last week regarding a request by Plaintiffs' lawyers to consolidate proceedings involving Reglan. Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.

The Petition was opposed by several drug maker of metoclopramide including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

What's next? Likely a mess of results or rulings in multiple courts, both State and Federal.

Reno Article: Reglan (Georgia, Alabama)

"It's wonderful when prescription medications cure ailments, but what happens when they cause adverse medical side effects?" The article goes on to note:


"I'm angry because I appear to be suffering from permanent central nervous system damage associated with the prescribed drug Reglan (brand name for "metoclopramide"), prescribed over a year ago for a digestive disorder.

I received a letter dated April 30 from my GI's office noting the FDA has placed a "Black Box Warning" on Reglan, explaining, it's possibly linked "with the development of a condition known as "tardive dyskinesia," a permanent CNS condition that's untreatable.

TD is a disorder of the tongue, mouth and jaw, causing them to move uncontrollably in abnormal ways.

The drug can also cause face jerking or involuntary body movements, including:

"Repetitive movements of the extremities

"Lip smacking, pursing, puckering

"Grimacing

"Tongue protrusion

"Rapid eye movements

"Impaired movement of fingers

"The movements are pretty much constant, except during sleep," reported Dr. Jeff Bronstein in a Los Angeles Times article. He's with the UCLA David Gaffen School of Medicine.

If you have taken Reglan, or are taking it now, the FDA says it's time to call your physician, whether you are experiencing side effects or not."

Read the rest here.

Late 2008 - Adverse Drug Event Reports Reach Record Numbers

In 2008, one site reports that there were a record number of reports submitted to the US Food and Drug Administration (FDA) about serious injuries, disabilities, and deaths associated with drug therapy.

Almost 23,000 cases of serious ADEs—including 1,397 cases attributed to error—were reported to the FDA in April-June 2008, nearly 40% higher than the average of reported cases during the four quarters in 2007. The increase came about equally in reports originating from health professionals and consumers. Among the 23,000 ADEs were 2,968 deaths and 585 cases of disability or birth defects. The 2,968 reported deaths in this quarter declined from a record 4,824 deaths in the first quarter of 2008, but deaths remained substantially higher in 2008 than in 2007.

Source here.

Reglan News: Lawyers seeking to Consolidate in Nevada

What we are hearing: Lawyers have filed a Motion with the JPML, asking that all of the filed Reglan cases be consolidated and moved to a US District Court in Nevada.

Reglan (metoclopramide) is a drug which is only approved for short-term use to treat gastrointestinal disorders like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, because those conditions are usually chronic problems, it is often prescribed for longer periods of time. Illnesses include essential tremors, Tardive Dyskinesia, and other movement disorders.

We're investigating this drug and how it may have harmed Georgia consumers. Go here for more information.