Reglan & Tardive Dyskinesia Lawyer Blog

Expert Witness Discusses Reglan Risks in Texas Reglan Lawsuit

This is the partial deposition of Hal Morgenstern, Ph.D.  In it, he discusses the relative risks of developing tardive dyskinesia after using Reglan or Metoclopramide.

Q. Would you calculate that for me on this piece of paper?

A. I remember that I had to solve for something in this, let's see, okay. There
were 51 metoclopramide and 51 others. Okay. I took -- multiply that times that
divided by that times that.

Q. Would you write that down for me? So your odds ratio is the product of 15 times
42 divided by the product of 36 times 9?

A. As I recall.

Q. And you say o-r with a --

A. Little hat above it.

Q. Thank you. I thought there was a technical term for it.

A. There probably is. Most people just say hat. It means estimate. I'm just used
to doing it.

Q. And why do you say this is an odds ratio estimate?

A. Because I estimated it from the data.

Q. And what I'm getting at is, do you ever calculate odds ratios that are not
estimates?

A. Not from data.

Q. And this gave you 1.94, correct?

A. Uh-huh.

Q. And the confidence interval was .76 to 4.97?

A. Yes, if you're reading from my -- yes.

Q. And that confidence interval includes one, correct?

A. Yes.

Q. And what is the significance of the fact that the confidence interval includes
one?

A. Just means that the 95 percent confidence interval includes the null value.

Q. You chose a 95 percent confidence interval; why?

A. Just standard, I could have chosen anything, most common, some people use 99,
some people use 90.

Q. But 95 percent is the most standard confidence interval used in epidemiology?

MR. PITTLE: Object to the form.

A. I think so.

Q. Now look at the paper on page 1472. Under tardive dyskinesia, it says 29
percent (n=15) of --

A. I'm sorry, where are you?

Q. 29 percent (n=15) of metoclopramide users met the case definition of tardive
dyskinesia compared with 17.6 percent (n=9) of non-users, correct?

Expert Witness Report Filed In Lawsuit Regarding Adverse Reactions to Reglan

The following expert report was prepared for Wyeth by Lawrence Schiller, M.D.  in the case of Mcneil v. Wyeth.  The doctor expresses his opinion that certain symptoms were not caused by Reglan.

11. No scientific evidence or literature has ever linked chest pain, cardiac
enlargement, an abnormal E.C.G., a deep cough, mucous build-up on tongue,
excessive perspiration, difficulty in breathing, chronic bronchitis, spitting up
of blood, loss of appetite or weight, or coughing or choking when consuming
liquids to the use of Reglan. The foregoing symptoms complained of by plaintiff
were not caused by her Reglan use.

12. Although there are potential adverse effects associated with the use of
Reglan, the benefits of the medication outweigh those risks associated with its
use. In addition, no safer alternative design for the medication exists. Reglan is
frequently the only medication that can relieve the debilitating symptoms of
gastrointestinal motility conditions, including GERD, diabetic gastroparesis, and
chronic intestinal pseudo-obstruction. Therefore, it is imperative that Reglan be
available for physicians to prescribe, especially since not all patients are
receptive to all treatments.

Tardive Dyskinesia Lawyer Alleges Reglan Black Box Warning Should Have Come Sooner

In the Arkansas Reglan lawsuit of Fields v. Wyeth, the tardive dyskinesia lawyer representing Bettye Fields alleges that the black box warning Reglan has should have come sooner:

I.

INTRODUCTION

Plaintiff sued these defendants for their negligent acts, which proximately caused Plaintiff's injuries. This is a failure to warn case. Wyeth and Schwarz Pharma, Inc. claim that they cannot be liable for the warning they crafted, no matter how negligently, because they are neither the manufacturers nor suppliers of the drug Plaintiff ingested. Though they appear not to have manufactured the drug at issue here, Wyeth and Schwarz Pharma, Inc. should remain liable under claims of negligence, fraud and misrepresentation as they relate to failure-to-warn claims. Wyeth and Schwarz Pharma, Inc. are the manufacturers of name-brand Reglan(R), generically known as MCP. Ms. Fields took the generic form. MCP/Reglan(R), typically prescribed for gastroesophageal reflux disease, carries a significant risk of tardive dyskinesia, a severe drug side effect characterized by grotesque involuntary movements of the mouth, tongue, lips, and extremities, involuntary chewing movements, and a general sense of agitation, especially with extended use. Tardive dyskinesia is a terribly debilitating condition. Plaintiff contends that the various defendants failed to adequately warn of the risks of tardive dyskinesia associated with extended use of MCP/Reglan(R), that the drug, by whomever manufactured, ought to carry a black box warning of the risk of tardive dyskinesia with extended use. It was in fact the warning created and sponsored by Wyeth and Schwarz Pharma, Inc., the warning that the FDA approved, that, by law, the MCP consumed by Bettye Fields carried. In fact, as of February, 2009, MCP/Reglan(R) now carries, as mandated by the FDA, just such a “Black Box” warning.[FN1] As a result, Ms. Fields has suffered permanent, disabling and disfiguring injuries.

FN1. The newly required warning says that “Chronic treatment with [MCP] can cause tardive dyskinesia.... [MCP] therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia .... Prolonged treatment (greater than 12 weeks) ... should be avoided in all but rare cases....” See Exhibit A.

A designer who is not also the manufacturer should share the same duty in design and warning.

II.

Reglan Attorney Alleges that Reglan Manufacturers Knowingly Sell a Defective Product

In this document, which was filed in Mensing v. Wyeth, the Reglan lawyer representing the plaintiff alleges that manufacturers of Reglan or its generic form, Metoclopramide, are knowingly selling a defective product with an inadequate warning label:

The position created by the melding of the Defendants' arguments here creates a “Catch-22” for any plaintiff who is permanently injured by the misrepresented adverse effects of the drug MCP. The name brand manufacturer, Schwarz contends that it owes no duty regarding its misrepresentations in the label of its name brand drug that misstates the actual risk of developing EPS, because Plaintiff did not consume its pills, and only direct product liability claims should be recognized against it. Then, to complete the ironic situation, generic manufacturers argue that the drugs they made that were consumed by Plaintiff - - even if defective for their own misstatements - - are not susceptible to suit either, because their “hands were tied”[FN21] by having to follow the false statements of the name brand manufacturer.

FN21. Unfortunately, the generic manufacturers choose to continue to keep manufacturing and selling generic MCP in light of their knowledge that the label is false.

If the Defendants' arguments, taken as a whole, are correct, Plaintiff would have no remedy for developing tardive dyskinesia, a life-altering, permanent injury that could have been avoided with a simple, accurate statement about the dangers associated with MCP, rather than misstatements. As a result, if the Defendants are correct, the tort system will not only have failed Plaintiff, but it will fail every doctor who prescribes MCP in the future or their patient who will needlessly develop EPS because none of the Defendants will have been found to have a legal duty to accurately state the risks associated with MCP. However, this result should not be the case in light of the duties continued in the Restatement and Minnesota law. In turn, Schwarz's motion should be denied.