Reglan & Tardive Dyskinesia Lawyer Blog

Expert Witness For Pliva Discusses Reglan Warning Label

In this report, an expert witness retained by Pliva expresses the opinion that Pliva's metoclopramide warning label was adequate.

9. However, because of how the FDCA was structured, companies that wanted to
market generic versions of drug products approved under NDAs after 1962, such as
Reglan brand of metoclopramide, would have had to duplicate the expensive animal
and clinical studies the innovator did, even though the patent protection had
ended. This situation had the consequence of providing a virtual monopoly for
drugs first approved after 1962, because generic drug manufacturers did not have
the financial resources to perform extensive clinical and animal studies and to
prepare and submit NDAs to the FDA. The Congress remedied this situation in 1984,
when the Hatch-Waxman amendments to the FDCA extended a simplified administrative
process the FDA used for generic versions of older drugs, called an Abbreviated
NDA (ANDA) to generic versions of drugs first approved after 1962. The public
policy arguments for the Hatch-Waxman amendments included the following:

Reglan Attorney For Wyeth Asks Court to Exclude Evidence Of Reglan Side Effects

This motion was filed in the Louisiana Reglan lawsuit of Tarver v. Wyeth.  The motion asks the court not to allow Dr. Daniel Sewell to testify about the association between Reglan and movement disorders like tardive dyskinesia.

On behalf of Wyeth, Mr. Reilly contacted Dr. Sewell in early 1999 to ask him about
his paper on Tardive Dyskinesia and to investigate his willingness to consult with
Wyeth on the Woodworth matter. Dr. Sewell informed Mr. Reilly that he was not
working with plaintiff's counsel in Woodworth and that he did not have any
conflicts that would prohibit him from working for Wyeth. Mr. Reilly eventually
scheduled an in-person meeting with Dr. Sewell. At their meeting, which took place
on or about April 27, 1999, Mr. Reilly and other counsel for Wyeth met with Dr.
Sewell for three-and-a-half hours. Dr. Sewell spent another hour-and-a-half
reviewing medical records and a videotape related to the plaintiff in Woodworth.

During this lengthy meeting, counsel for Wyeth shared confidential information
regarding the Woodworth case, including their thoughts on the merits of
plaintiff's claims and the adequacy of the Reglan(R) label. In the course of that
meeting, Dr. Sewell provided his assessment of plaintiff's condition; his thoughts
about the use of Reglan(R) for gastrointestinal disorders; his opinions about the
adequacy of the Reglan(R) label, especially in light of his paper on the use of
Reglan(R) in the VA center; and general defense strategies. It is important to
emphasize that the plaintiff in Woodworth was represented by the same attorney in
this case -- Mr. Ralph Pittle. Indeed, plaintiffs theories of liability in the
instant case are similar if not identical to those pursued in Woodworth by Mr.
Pittle.

From this point forward, Mr. Reilly and Wyeth reasonably believed that Wyeth had
established a confidential relationship with their new consultant, Dr. Sewell. In
fact, following this meeting, Dr. Sewell sent Mr. Reilly "an invoice for my
consultation with you and Stuart Gordon in San Diego." This invoice clearly
demonstrated that, from Dr. Sewell's perspective, a consultation had occurred. See
Affidavit of James R. Reilly in Support of Wyeth's Motion to Exclude Plaintiffs'
Expert Daniel Sewell at "Exhibit A." This confidential relationship was further
confirmed by Mr. Reilly's payment to Dr. Sewell for his services.

Dr. Joseph Lyon prepared the following report for Wyeth in the case of Mcneil v. Wyeth.  He concludes that there is not enough reliable information to determine how likely an individual is to develop tardive dyskinesia or another movement disorder after using Reglan (or Metoclopramide) for a long period of time.

4. To determine what a person's risk of developing a disease such as tardive
dyskinesia after exposure metoclopramide you must have an incidence rate. Any
other measure of the association is of limited worth in determining if exposure to
MCP causes TD. A prevalence rate is determined by multiple factors, all of which
are subject to bias, and unless each of these biases are quantified, the
prevalence rates are of little or no use in determining if there is a causal
connection between the exposure and subsequent development of the disease in
question.

5. The only article I could find in the medical literature that reported an
incidence rate of TD among users of metoclopramide was published by B-E. Wiholm et
al., entitled "Tardive dyskinesia associated with metoclopramide" British Medical
Journal 1984; 288:545-547. This study measured new cases of TD among users of MCP
in Sweden. The cases were reported to an adverse drug reporting system, and the
use of MCP was obtained from prescription data for Sweden. Depending on the
definition of a long term prescription use the authors estimated the incidence of
TD among users of MCP to range from 0.037 cases to 0.050 cases per 100
person-years

6. Using these incidence rates the occurrence of new cases of TD among 100
individuals with long-term use of MCP who were followed up for one year can be
estimated. There would be no new cases of TD (expectation would be of 0.037 to
0.050 case) during a single year. If the group were followed for 10 years its
unlikely any cases would have occurred (expectation of 0.36 to 0.50 cases). It
would require following 100 individual between 20 to 30 years before the first
case would occur.

7. The Wiholm study has been criticized because it Is based on the reporting of
adverse events to diagnose TD, and it possible that an adverse drug reporting
system would underestimate the true incidence of TD. But the estimates can still
be used to approximate the occurrence of new cases of TD among users of MCP. If
the Wiholm study underestimated the incidence of TD associated with MCP use by 10
fold it would still require following 100 people who were taking MCP for 2 to 3
years before the first case of TD occurred.

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.