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.
United States District Court, N.D. Texas,
Dallas Division.
Dallas County
Sue C. MCNEIL, Plaintiff,
v.
WYETH f/k/a/ American Home Products Corporation d/b/a A.H. Robins Company,
Defendant.
No. 3:02-CV-2072-L.
June 5, 2003.
BEFORE ME, the undersigned authority, on this day personally appeared Lawrence R.
Schiller, M.D., F.A.C.P., F.A.C.G., known to me, or proved to me through
identification or other document, to be the person whose signature appears below,
and after being fully duly sworn according to law, upon his oath, deposed and
said:
1. My name is Lawrence R. Schiller, M.D. I am over 18 years of age, of sound mind,
have never been convicted of a felony or crime of moral turpitude, and am fully
competent to make this Affidavit. I have personal knowledge of each fact set forth
in this Affidavit. And each such fact is true and correct.
2. I am a board certified gastroenterologist with a medical practice in Dallas,
Texas. I am an attending physician in the Department of Internal Medicine at
Baylor University Medical Center in Dallas and a Clinical Professor in the
Department of Internal Medicine of the University of Texas Southwestern Medical
Center at Dallas. I also serve as the Program Director of Gastroenterology
Fellowship and am the Chairman of the Institutional Review Board of Human Subject
Protection at Baylor University Medical Center.
3. I received my Bachelor of Science degree from Pennsylvania State University in
1970, and my medical degree from Jefferson Medical College of Philadelphia of
Thomas Jefferson University in 1972. I completed my residency in Internal Medicine
at the Department of Internal Medicine of Temple University Hospital in
Philadelphia in 1975, and completed my chief residence there in 1976. I also
completed my Gastroenterology Research Fellowship at the University of Texas
Health Science Center at Dallas in 1980.
4. I am a Diplomate of the National Board of Medical Examiners and of the American
Board of Internal Medicine and a Diplomate in the subspecialty of Gastroenterology
of the American Board of Internal Medicine. I also became a Fellow in the American
College of Physicians in 1983 and a Fellow in the American College of
Gastroenterology in 1989. A further elaboration of my credentials is provided in
my curriculum vitae, which is attached as Tabl.
5. During the course of my 20 years in practice as a gastroenterologist, I have
frequently prescribed a prescription medication called Reglan(R), which is
indicated for the treatment of various gastrointestinal disorders.
6. "Gastrointestinal motility" is a term that refers to the normal contractions of
the gastrointestinal tract that propel food and waste products from food through
the tract. Disorders of gastrointestinal motility can result from many causes.
Sometimes there are nerve or muscular problems within the intestine which can lead
to a variety of symptoms including nausea, vomiting, heartburn, regurgitation,
abdominal distension, pain, constipation, diarrhea, and fecal incontinence.
Motility problems can also cause nausea, vomiting, and heartburn which can be
symptoms of slow gastric emptying or lack of contractions in the upper intestine
which leads to gastric stasis.
7. Gastroesophageal reflux disease, commonly known as "GERD," is a medical
condition of impaired gastrointestinal motility. Specifically, it is defined as
chronic symptoms or mucosal damage produced by the abnormal reflux of gastric
contents into the esophagus. Heartburn is the most common symptom of GERD. In
addition, other extraesophageal or atypical symptoms, including chronic cough,
laryngitis, and other otolaryngologic conditions, asthma, and unexplained chest
pain, can be associated with GERD. In fact, GERD is one of the most common causes
of chronic cough. Reglan does not cause coughing or pulmonary problems. In severe
refractory cases of GERD more serious symptoms include erosions, stricturing, and
scarring of the esophagus and respiratory problems resulting from aspiration of
regurgitated gastric contents.
8. Patients suffering from GERD and other gastrointestinal disorders frequently
benefit from treatment with a "prokinetic" drug, which is a drug that enhances
movement or contractions of the esophagus, stomach, and the upper intestine.
Reglan(R) is currently the only approved prokinetic drug in the United States
indicated for the treatment of GERD that is readily available for physicians to
prescribe. Propulsid (cisapride), the other prokinetic drug most frequently
prescribed in the United States over the last decade, can now be prescribed only
under extremely restricted circumstances.
9. All prescription drugs have potential side effects, and many frequently used
drugs can have severe side effects. Reglan is no exception. During the course of
my practice, several of my hundreds of patients on Reglan have developed movement
disorders, including one case of tardive dyskinesia. Movement disorders including
tardive dyskinesia are a rare but well- recognized potential adverse effect of
Reglan. Symptoms associated with movement disorders include involuntary movements
of the mouth and jaw (including biting one's tongue), pain in the jaw area,
uncoordination, involuntary movements of the extremities, tremors, involuntary
rocking, nervousness and speech problems.
10. Movement disorders, and specifically tardive dyskinesia, are thoroughly
discussed in the Clinical Pharmacology, Warnings, and Adverse Reactions sections
of the attached physician package insert (Tab 2) accompanying Reglan (which is
reproduced annually in the Physicians Desk Reference), in the medical literature,
and in gastroenterology textbooks since the late 1980s. The descriptions of these
adverse effects in the package inserts are consistent with my experience as a
gastroenterologist prescribing this drug to a large number of patients over the
last two decades. The information and warnings in the Reglan package insert are
more than adequate to inform physicians of the potential benefits and risks
involved in treatment with this drug.
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.
Further sayeth not.
Lawrence R. Schiller, M.D., F.A.C.P., F.A.C.G.
SWORN TO AND SUBSCRIBED before me on the 5th day of June 2003, to certify which
witness my hand and official seal.
Notary Public in ad for the state of Texas
My Commission Expires: July 26, 2006
Sue C. MCNEIL, Plaintiff, v. WYETH f/k/a/ American Home Products Corporation d/b/a
A.H. Robins Company, Defendant.
