Grubbs v. United States

Decision Date29 February 1984
Docket NumberNo. S 80-323.,S 80-323.
Citation581 F. Supp. 536
PartiesCatherine GRUBBS, Plaintiff, v. UNITED STATES of America, Defendant.
CourtU.S. District Court — Northern District of Indiana

Lee Dabagia, Michigan City, Ind., Mark P. Friedlander, Jr., Arlington, Va., for plaintiff.

R. Lawrence Steele, U.S. Atty., Hammond, Ind. by Donald P. Moroz, Asst. U.S. Atty., South Bend, Ind., for defendant.

MEMORANDUM AND ORDER

ALLEN SHARP, Chief Judge.

I.

This case was tried before the court by very able counsel and the court uses this means of entering its findings of fact and conclusions of law.1

The stipulations of fact not in issue in the Final Pretrial Order applicable to all cases, show that the first knowledge of problems appeared in the second and third week of November 1976. (See Stipulations 217-226, MDL Docket 330, Exhibit 4, pg. 18, contained in the Final Pretrial Order In Re Swine Flu Immunization Products Liability Litigation.)2 The moratorium on the Swine Flu Program was called on December 16, 1976, which arose out of the finding that the Guillain-Barre Syndrome was associated with the Swine Flu vaccination. (Stipulation of Facts 227 and 228.) The plaintiff, in this case, had received her vaccination only thirteen days before, on December 3, 1976.

Three weeks after the receipt of her Swine Flu shot, she began to show evidence of the first prodromal symptoms of the onset of this disease. When the disease process had progressed to the point of pain in the back, the plaintiff, although reluctant to go to a doctor, did, upon the urgings of her family and friends, go to a doctor who was unable to make a diagnosis, but began treating the plaintiff with Cortisone and muscle relaxants. The pain and the treatment continued over a number of months, with the Cortisone giving relief for a period of a week or so after each shot. It was reasonable for the plaintiff, having placed herself in the care of a physician, to follow his instructions and advice and believe that the medications being given would lead to a cure.

When the disease process worsened and the severity of the back pains intensified in April of 1977, she sought other medical advice and was placed in a hospital on May 9, 1977, for certain tests which led the doctor, Doctor Smith, to believe that the difficulties she was suffering would be relieved by a D & C operative procedure which was performed. This, too, did not lead to a resolution of the medical problem, and the plaintiff was referred to Doctor Keenan, a neurologist, who immediately was able to make the diagnosis of the Guillain-Barre Syndrome. There was no doubt in this diagnosis as all of the diagnoses that followed and all of the hospitalizations that followed over the next two year period, every doctor made the diagnosis of the Guillain-Barre Syndrome.

If the plaintiff's disorder was the Guillain-Barre Syndrome, then the plaintiff need prove no theory of liability in order to recover from the Government, pursuant to the Stipulation found in the Final Pretrial Order in the Multi-district Litigation. That Stipulation, which is directly applicable in this case, provides that if the court finds that the plaintiff has developed the Guillain-Barre Syndrome and that the Guillain-Barre Syndrome was caused by the Swine Flu vaccination, no theory of liability need be established by the plaintiff in order to recover damages. (See Stipulation and Final Pretrial Order, Paragraph IX.) Thus, in this case, the plaintiff must first establish that she suffered Guillain-Barre Syndrome caused by a Swine Flu vaccination, then the United States will stipulate that no theory of liability need be proven. The issue in this case is whether the plaintiff contracted the Guillain-Barre Syndrome and whether the Guillain-Barre Syndrome was caused by the vaccination.

This court specifically finds that the testimony of Catherine Grubbs concerning the onset of her disability and the history thereof to be highly credible. This court takes strong exception to counsel for the Government labeling it as "her inconsistent and incomplete evidence". Such may be within the limits of proper advocacy but it is absolutely contrary to this court's impression of the plaintiff as a witness.

To a large extent the United States of America and its chief witness are at war with issues that have already been decided in the Multi-district proceedings.

All of the doctors, both for the plaintiff and for the defendant, agree that the disease suffered by the plaintiff was chronic Guillain-Barre Syndrome. It is the position of the Government, however, that chronic Guillain-Barre Syndrome does, in fact, not really exist, but, rather, the disorder is known as chronic idiopathic polyradiculoneuropathy or CIP, and that CIP, essentially, is not the Guillain-Barre Syndrome. These are words, however, of form and not of substance. This is most clearly illustrated in Government's Exhibit Number 4, "Mayo Clinic Proceedings", dated November of 1975. The article entitled "Chronic Inflammatory Polyradiculoneuropathy", authored by, among others, Doctor Peter Dyck, discusses the diagnostic criteria for this neurological disorder. On page 634 of that exhibit and that article, Doctor Dyck wrote under "Discussions":

Since similar pathogenic mechanisms may be common to the acute and chronic varieties, the separation may be arbitrary, but it is clinically useful because the natural history is different and, indeed, the distinction is arbitrary.

Plaintiff's Exhibit Number 8, being MDL Document Number 103, is Chapter 56 from the textbook, Peripheral Neuropathy, edited by Doctor Peter Dyck. This particular chapter is authored by Doctor Barry G.W. Arnason and is entitled "Inflammatory Polyradiculoneuropathies". In this article, he points out on page 1135 that the illness may begin with a mild distal weakness and progress at a slow tempo to quadriparesis. Alternately, it may progress for a time, become arrested or improved for an interval, and then resume its progressive course. There, he is discussing chronic inflammatory polyradiculoneuropathy.

In the testimony he gave in Multi-District Litigation on June 25, 1979, in plaintiff's Exhibit Number 1, Doctor Arnason testified, at page 75, that it was his view that there is a chronic form of inflammatory neuropathy which, in his opinion, is a variant of the Guillain-Barre Syndrome.

Doctors Hinman and McGee, in the article, "Guillain-Barre Syndrome with Slow Progressive Onset and Persistent Elevantion of Spinal Fluid Protein", plaintiff's Exhibit Number 2, clearly stated that the "classification of Guillain-Barre Syndrome has been the subject of much discussion and review and they include those cases that could be considered chronic as opposed to acute." These type of cases were included in the article entitled "Recurrent and Chronic Relapsing Guillain-Barre Polyneuritis" by Doctor Thomas et al., being plaintiff's Exhibit Number 14.

Controlling in this matter, are the NINCDS notes, Multi-District Litigation Document Number 589, plaintiff's Exhibit Number 13, which is referred to in the Final Pretrial Order Stipulation which provides that:

In cases in which the United States contests that the illness alleged is, in fact, the Guillain-Barre Syndrome, it intends to rely upon the National Institute of Neurological and Communicative Diseases and Strokes Guidelines as working criteria.

Doctor Kincaid, who testified for the Government, acknowledged that the plaintiff met those diagnostic features which are required for a diagnosis of the Guillain-Barre Syndrome and that variants three and four, found at page 4 of that Exhibit, describe what Doctor Kincaid referred to as CIP and, therefore, if these standards were applied to Catherine Grubbs, she suffered Guillain-Barre Syndrome within the definition used in the Pretrial Stipulation. That being the case, there is no question that she suffered Guillain-Barre Syndrome, contemplated or recognized by the Government as being the disease for which they are liable if there is a causal relationship.

If the symptoms for the Guillain-Barre Syndrome began in late December of 1976, then the onset was within three weeks of the vaccination and would far more likely than not have been caused by the vaccine. Plaintiff's Exhibit Number 10, Multi-District Litigation Document Number 121, is the epidemiologic study, "Guillain-Barre Syndrome Following Vaccination in the National Influenza Immunization Program, United States, 1976-77", by Dr. Lawrence Schoenberger, epidemiologist from the Center for Disease Control, and has often been referred to in the litigation as the "Schoenberger Study". The tables or charts shown on page 9 of the MDL Document and page 113 of the report show that the greatest period of relative risk was in the third week after the vaccination. As Doctor Shoenberger wrote on page 8 of the Multi-District Litigation Document"

"Based on the attack rated by week after vaccination in Figure 6, the relative risk of GBS (the ratio of attack rates in the vaccinated and unvaccinated populations) were determined (Figure 7). The peak relative risk, which exceeded 12, occurred in weeks two and three after vaccination, and prior to the tenth week after vaccination, all relative risks were significantly greater than one."

The statistical likelihood that the vaccine caused GBS in the Plaintiff here was 93.5 percent, accepting that the symptoms occurred in the third week following vaccination.

Doctor Langmuir testified (Multi-District Litigation on July 20, 1979, Plaintiff's Exhibit Number 3, p. 23):

"Q As of January, 1977, when you did this data and analyzed it, what opinion did you hold as to the relationship between the appearance of Guillain-Barre Syndrome in Swine Flu vaccinees, and the fact that they had been given the Swine Flu vaccine?
A I was quite persuaded by that time that this was a causal relationship.
Q Dr. Langmuir, using a term that lawyers sometimes use, `Reasonable
...

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