author: SPIEGEL, District Judge:

text:
    Ermina D'ANTONIO, Plaintiff, v. UNITED STATES of America, Defendant.
    No. C-1-80-578.
    United States District Court, S.D. Ohio, W.D.
    Feb. 4, 1983.
    Joseph M. Corabi, Steubenville, Ohio, Mark P. Friedlander, Jr., Arlington, Va., for plaintiff.
    Joseph E. Kane, Donetta D. Wiethe, Asst. U.S. Attys., Cincinnati, Ohio, for defendant.
   FINDINGS OF FACT AND CONCLUSIONS OF LAW

SPIEGEL, District Judge:

This action is brought pursuant to the Federal Tort Claims Act (FTCA), 28 U.S.C. §§ 1346, 2671 et seq. and the National Swine Flu Immunization Program Act, 42 U.S.C. § 247b. This suit was filed on April 11, 1980. It was subsequently transferred to the United States District Court for the District of Columbia pursuant to a transfer order from the Judicial Panel on Multidistrict Litigation (MDL). After consolidated pretrial proceedings, the case was remanded to this Court for further proceedings and trial. This case was tried as a bifurcated trial in Stuebenville, Ohio on January 3 and 4, 1983 and in Cincinnati, Ohio on January 5, 6 and 7, 1983.

The plaintiff Ermina D’Antonio alleges she contracted Guillain-Barre syndrome (GBS) as a direct result of a swine flu inoculation which she received on or about October 30, 1976. Plaintiff seeks damages for temporary and permanent injuries resulting from the GBS.

In August of 1976 Congress enacted the Swine Flu Act, substituting the United States as the only party liable for damages resulting from an inoculation of swine flu vaccine. It further established the FTCA as the vehicle for asserting any claims against the government. A comprehensive history of the Swine Flu Act is reported in several cases and will not be repeated here. For a thorough analysis see Hunt v. United States, 636 F.2d 580 (D.C.Cir.1980). For the reasons set forth below we find that Ermina D’Antonio has proven by a preponderance of the evidence that her GBS was caused by the swine flu vaccine.

The following constitutes our findings and conclusions on the issue of causation.

FINDINGS OF FACT

BACKGROUND

The plaintiff, Ermina D’Antonio was born on February 11, 1912 in Mingo Junction, Ohio. She lived in Mingo Junction all of her life until she contracted GBS at which time she had to move to Stuebenville, Ohio. Plaintiff was in general good health, working as a bookkeeping and office manager for a beer distributor in Min-go Junction at the time she received a swine flu shot on October 30, 1976. She had worked there for thirty-four years. Plaintiff was able to easily walk up and down the steep hillsides of her Mingo Junction home, remain on her feet at work when required, and pursue a vigorous life. She did see her family physician, Dr. Paul W. Ruksha whenever she had a physical problem. Plaintiff was known to have a nervous condition for which Dr. Ruksha had prescribed tranquilizers for a number of years. Dr. Ruksha also treated plaintiff for fatigue over a number of years for which he administered shots of B-12.

Plaintiff received the swine flu shot on October 30, 1976. She experienced no immediate reaction to the vaccine. By late December of 1976 plaintiff began to experience pervasive symptoms of fatiguing and tiring easily. This caused a significant change in her living pattern and instead of watching television or visiting relatives and friends as she usually did, she went to bed early and went to sleep. Although she continued to go to work on a daily basis she found it necessary to “push” herself to accomplish the same tasks. At this point, plaintiff believed that something serious was happening to her but she did not know what it was. She did not seek any medical attention from Dr. Ruksha or any other physician until January 24, 1977.

By mid-January, 1977 plaintiff began to feel like she had some sort of virus. She was nauseous and her abdomen ached. On January 24, 1977 she went to see Dr. Ruksha and told him that she had been sick for a few days. She complained of fatigue, diarrhea, dry tongue, and pain in her entire abdomen area. She had a temperature of ninety-nine degrees. Dr. Ruksha gave her lomatil, sumycin (antibiotic) and a shot of B-12.

Plaintiff took the medicine that Dr. Ruksha had prescribed but continued to feel worse. It is unclear whether she went back to work after seeing Dr. Ruksha on January 24 but by January 26, 1977 plaintiff was very ill. She was lying down about 7:00 in the evening and felt an intense pain on her right side in addition to the nausea and aching described above. Plaintiff called Dr. Ruksha’s nurse who told her to put ice on her side. At 9:30 plaintiff felt much worse. She called the nurse back and the nurse told her to go to the emergency room. Plaintiff took a cab to Ohio Valley Hospital in Stuebenville, Ohio about 10:00 p.m. She first saw Dr. Meyers in the emergency room and then Dr. Ruksha arrived at the hospital and examined her. Dr. Ruksha asked that plaintiff be examined by Dr. Licata, a general surgeon.

Dr. Ruksha and Dr. Licata initially believed that plaintiff had appendicitis. The hospital examination indicated plaintiff had a slight fever, rebound tenderness, guarding and white blood cell count of twenty-two thousand with shift to the left. A neurological exam also was performed. Plaintiff was taken to the operating room where Dr. Licata performed an emergency appendectomy. After making the incision and removing the appendix, Dr. Licata found it to be healthy, but removed it anyway. Thereupon he made an examination of the lower abdominal area and found it free of infection. He also found that the blood vessels that ordinarily supply blood to the stomach area were not gorged and swollen or inflamed as he would have expected to find if she had been suffering from some infectious process.

Dr. Licata noted in the record the “possibility of gastroenteritis”, but testified that he made that entry only because he did not know what else could be wrong with the plaintiff. Later, as her symptoms progressed into the acute paralytic stage, he concluded that she had not had gastroenteritis at the time she was admitted to the hospital but rather that the symptoms were a part of the developing neurological disease.

Plaintiff did not improve following surgery. She found that she could not get out of bed without assistance and complained to Dr. Licata of her symptomology. Dr. Licata testified that plaintiff did make complaints immediately following surgery but that he ignored them because they were not consistent with symptoms he believed a patient would experience following surgery. By January 30, 1977 the plaintiff reported tingling and a paralysis significant enough so that she could not walk without assistance. Dr. Ruksha became concerned at this time that she was suffering from GBS and called in Dr. Amrick Chattha, a neurologist, on February 2, 1977. Dr. Chattha performed a neurological examination of plaintiff which disclosed motor weakness of all four extremities and an absence of reflexes. A spinal tap also was performed which indicated an elevated protein count in the spinal fluid. Dr. Chattha diagnosed plaintiff as suffering from GBS and recommended that she be transferred to the intensive care unit.

By February 3, 1977 the GBS had progressed to a degree of paralysis that required intubation to assist the plaintiff in breathing. On February 5, 1977 a tracheotomy was performed by Dr. Joseph Agresta, an otolaryngologist. Dr. Agresta observed at the time that plaintiff was essentially totally paralyzed and required life support systems to stay alive.

Plaintiffs GBS continued to progress and by February 21, 1977 a gastrostomy was performed to assist her with her eating. Shortly thereafter, plaintiffs GBS began to plateau and she began to recover in late February of 1977. She continued to improve for several months and was discharged from the Ohio Valley Hospital on April 6, 1977. After a period in a rehabilitation center, plaintiff returned home. In June of 1978 plaintiff moved to Stuebenville, Ohio because she could not climb the hill leading to her house in Mingo Junction.

GBS has been associated with numerous antecedent events, and in this case the question was which, if any, of three relevant events caused plaintiffs GBS: the vaccination, occurring on October 30, 1976; the alleged gastroenteritis or gastrointestinal infection, occuring on January 22, 1977; or the operation, occuring on January 26, 1977. Plaintiff asserted that she never had a gastrointestinal illnéss or infection and that the nausea and abdominal pain she experienced in late January of 1977 were symptoms of her GBS already in progress. Plaintiff asserted further that she had experienced sub-clinical symptoms of GBS as early as mid-December of 1976, evidenced by severe fatigue and weakness and that her GBS was caused by the swine flu shot. It was the government’s position that the onset of the GBS began on January 30, 1977 that being the first hospital record made of the neurological symptoms of tingling and inability to walk. It was further defendant’s position that the events closer in time to the onset of the GBS were the most likely causes and, finally, that a case of GBS that did not begin until the thirteenth week after the vaccination was, because of epidemiological studies, not provable as causally connected. The expert witnesses called by the respective parties dealt with these issues.

MEDICAL TESTIMONY

Dr. Amerik Chattha, plaintiff’s treating neurologist, testified that he first saw the plaintiff on February 2, 1977. At that time plaintiff was not able to move her extremities and her respiratory muscles were paralyzed. Dr. Chattha testified further that plaintiff reached the nadir of her disease one day later when she was completely paralyzed and unable to breath. It was his opinion, based on a reasonable degree of medical certainty, that the operation that plaintiff had undergone on January 26 was not the cause of her GBS. He stated that most cases of GBS that appear to be caused by surgery, follow the surgery by one week to ten days. Because plaintiff had visible symptoms of GBS three days after surgery, it was Dr. Chattha’s conclusion that there was no causal relationship.

Dr. Chattha testified further that there was no way of determining exactly when plaintiffs GBS began. He stated that even though the hospital record showed that a neurological exam was performed upon plaintiffs admission to the hospital, she was not seen by a neurologist and only a neurologist would be able to detect subtle signs of neurological problems. He further opined that it was not possible to set an absolute limit on the time between an antecedent event and a resulting illness. With regard to the study performed by the Center for Disease Control (CDC) he agreed that the incidence of GBS after the shot gradually decreased over time, but believed it was not possible to conclude •from this that there was no relationship between the swine flu shot and GBS after ten weeks.

Dr. Chattha testified further that he did not believe that any gastrointestinal illness plaintiff might have suffered would have caused her GBS. In his experience a gastrointestinal illness generally occurs two to three weeks prior to the onset of severe symptoms and he believed that in this case the nadir of plaintiffs GBS was too close in time to plaintiffs alleged gastrointestinal illness for the illness to have caused the GBS. He did state, however, that it was possible that GBS could follow a gastrointestinal illness by a week and that he was not, therefore, one hundred percent sure that the swine flu shot caused plaintiffs GBS.

Dr. Antonio Licata, a surgeon and a treating physician, testified that in his opinion, based on a reasonable degree of medical certainty, that the plaintiff did not suffer gastroenteritis. Dr. Licata testified that he first saw plaintiff on January 26, 1977 at which time she was exhibiting symptoms of appendicitis. She had abdominal pain and a condition known as “rebound tenderness” which indicates internal abdominal problems. She also had a high white blood count. When he operated, however, he found a normal appendix which he removed anyway per normal procedure. In his post-surgery notes he indicated that plaintiff had gastroenteritis but soon changed his mind when she developed symptoms of GBS so quickly after the operation. He testified that she did make some general non-specific complaints to him following surgery but because they appeared to be unrelated to the surgery and because she is known to be an emotional woman, he basically ignored her complaints. Dr. Licata testified that rebound tenderness is usually not a symptom of gastroenteritis or a gastrointestinal infection. His opinion was further based on the fact that patients generally recover quickly from gastroenteritis and, in this case, plaintiff continued to get worse. Moreover, Dr. Licata noted that he thoroughly examined plaintiffs abdomen during surgery and that it looked normal and exhibited no sign of infection or inflammation. He stated that the only reason he wrote in his hospital notes that plaintiff had gastroenteritis was that he felt he had to write something down and he was unable to determine what was wrong with her.

Dr. Charles M. Poser, a prominent neurologist, also testified on behalf of the plaintiff. It was his opinion, to a reasonable degree of medical certainty, that the plaintiff’s GBS was causally connected with the swine flu vaccination she received on October 30, 1976.

Although the exact cause of GBS is not known it is generally recognized as an auto-immune disease wherein stimulated antibodies become misdirected and attack the patient’s peripheral nervous system instead of, or in addition to, the foreign substance. This attack causes lesions in the myelin sheath, the substance providing protection or covering to the nerve axons. It is Dr. Poser’s opinion that once this process is begun, the disease may lie dormant for a number of weeks or months exhibiting sub-clinical symptoms only. This occurs according to Dr. Poser because nerves have certain protection factors and each person responds differently depending on the nerve involved. In fact, the nerves have so many protection factors that a nerve can lose some of its sheath without affecting an individual’s behavior or performance. This has been shown in persons who have recovered from GBS and have no more symptoms but have remaining damage to the nerve sheath.

It was Dr. Poser’s opinion that the onset of plaintiff’s GBS began with the first mild sub-clinical symptoms which appeared in late December of 1976, seven to nine weeks after the injection of the vaccine. Dr. Poser testified that the fatigue suffered by plaintiff in December was a “bridging symptom” between the swine flu shot and the onset of neurological symptoms. Dr. Poser agreed that fatigue was not necessarily a symptom of GBS but stated that in certain circumstances it could be. He believed in this case that plaintiff’s fatigue in December and January was a manifestation of GBS because it was so extreme that it caused a significant change in plaintiff’s daily habits and because it eventually led to neurological involvement. He believed the fatigue to be suggestive of muscle weakness. Dr. Poser credited plaintiff’s testimony that she felt that something very serious was wrong with her and concluded that she was exhibiting a sub-clinical manifestation of her GBS.

It was further Dr. Poser’s opinion that the symptoms that thereafter appeared and taken at the time by the doctors as flu, gastroenteritis or appendicitis, were simply the clinical manifestations of the demyelinating attack on the peripheral nervous system, which system includes the autonomic nervous system. Dr. Poser testified that in his experience GBS patients often have autonomic nervous system involvement. He stated that while the autonomic response ordinarily would be one of repression of the autonomic nervous system rather than over-activity of the autonomic nervous system, it. is not unusual to see over activity of the type exhibited by plaintiff and which caused plaintiff’s nausea, vomiting, and diarrhea.

Dr. Poser was of the opinion that plaintiff’s symptoms on January 26, 1977 were symptoms of an autonomic nervous system involvement rather than symptoms of gastroenteritis for a number of reasons. The high white blood count noted in the hospital record indicated an elevation of a particular type of white cell known as a poly. Gastroenteritis is most often a viral illness which does not create an increase in polys, rather, the polys would decrease with gastroenteritis. Dr. Poser admitted that if plaintiff had suffered from a bacterial gastroenteritis there could be an increase in the number of polys but concluded from the hospital record that she did not suffer from a bacterial illness. He stated that a bacterial illness was very serious and that the record did not indicate that she had been as sick as he would expect her to be if she had a bacterial infection. Moreover, he stated if she had been so sick the doctors never would have performed an operation. Additionally, plaintiff exhibited signs of rebound tenderness and guarding. This is caused by muscles tensing to protect the abdomen. Dr. Poser stated that this is not an uncommon response to an acute condition such as GBS but that it would not be expected to occur with gastroenteritis. Further, if plaintiff had had gastroenteritis there would have been an infection or inflammation of the abdomen that would have revealed itself during surgery. He stated that the hospital record indicated that Dr. Licata had performed a thorough examination of the abdomen and found that it was normal. Finally, he stated that even though diarrhea was noted, the record also indicated she was constipated and that this was inconsistent with a finding of gastroenteritis.

Dr. Poser concluded that plaintiffs GBS had occurred within seven to nine weeks of the shot after being informed of the substance of plaintiff’s testimony in this case. Prior to trial he had concluded that plaintiff’s GBS arose within twelve to thirteen weeks after the shot, relying on the date when plaintiff’s numbness and paralysis began to manifest itself. It is his theory that a person who has received a vaccine remains at risk as long ás the body retains antibodies to that vaccine. Because persons have been shown to retain a high antibody to swine flu vaccine six months after the vaccination, he believes that there could be a causal connection of up to six months between the vaccination and onset of the disease. It is his opinion that medical thinking in this area has been too restrictive and that physicians are now beginning to recognize that they had to look further in a patient’s past to identify a causative factor. This is based on his observation that people respond differently to an antigen depending on that individual’s particular immune system. He stated that it is unrealistic to presume that the disease process will manifest itself in the same time and manner in every person. Dr. Poser has published two articles in support of this theory which as yet have not been challenged. (Exs. 8, 10).

Therefore, even if plaintiff’s symptoms in December and January were not symptoms of GBS, Dr. Poser still concluded, to a reasonable degree of medical certainty, that the swine flu shot received by plaintiff in October of 1976 caused her GBS. He stated that in his opinion the study performed by Dr. Schonberger for the CDC was being improperly used. He stated the study was important to indicate that there could be a causal relationship between a vaccine and an onset of disease for a longer period of time than previously thought, but that it should not be concluded from this study that there can be no causal relationship after eight weeks. He agreed that in most cases the symptoms would arise within eight weeks but stated this ignores the person whose symptoms take longer to develop. Dr. Poser also examined a chart prepared by Dr. Schonberger and noted it indicated an increase in the incidence of GBS twelve weeks after the shot. Even though Dr. Schonberger stated that he did not believe that this increase was statistically significant, Dr. Poser disagreed. Dr. Poser noted further that CDC set forth no reporting criteria when the study was conducted and that there is no way to tell whether there was overreporting or underreporting of incidents of GBS after the shot.

Dr. Poser testified further that in his opinion plaintiff’s GBS could not have been caused by her surgery on January 26,1977. He stated that he did not agree that surgery was a causative factor in the development of GBS, but even if it was, it was too close in time to the onset of severe symptoms to have caused the disease.

Dr. Terrence M. Phillips, director of the Immuno-Chemistry Laboratory and Associate Professor of Medicine at the George Washington University Medical Center in Washington, also testified on behalf of the plaintiff. Dr. Phillips received a sample of blood drawn from the plaintiff and a vial of the particular lot of Parke-Davis vaccine which had been injected into the plaintiff’s arm. With this material, he performed certain standard immunological tests; they are indirect Immunofluorescence, Counter-Current Immunoelectrophoresis, and Enzyme-Linked Immunoassay. From the final tests, he produced lines of identity which he identified as demonstrating, to a greater than scientific certainty, to-wit, with an eighty (80%) percent accuracy, that there were antibodies in plaintiff’s blood which reacted against human peripheral nerve tissue and against components of the swine flu vaccine. Dr. Phillips also had removed the lymphocytes from plaintiff’s blood and through his testing, was able to conclude that a component of the vaccine was causally connected to the peripheral neuropathy suffered by the plaintiff. The 'peripheral neuropathy in this case was stipulated to be GBS.

Dr. Phillips acknowledged that he had carried his work beyond the standard tests for cross-reaction in an effort to identify the specific protein within the vaccine that contained the offending antigen. Previously he had identified that antigen to be P2 Protein. He acknowledged that he was not now pressing this scientific point in this case because it had become the subject of controversy, not only in the courts but also in the scientific community. He expressed the opinion that until he and Dr. Brostoff exchanged materials or Dr. Eylar and Dr. Brostoff exchanged materials and had them tested, he would withhold judgment on whether he, as he believed, had isolated the specific agent. His tests, however, as to the causal relationship between the vaccine and the plaintiff’s disorder were not dependent upon the isolation of P2 Protein.

Dr. Steven Brostoff, Professor of Neurology and Basic and Clinic Immunology and Microbiology at the Medical University of South Carolina testified on behalf of the government. Dr. Brostoff is recognized as an authority on P2 and experimental allergic neuritis (EAN), the animal model for GBS in humans. Dr. Brostoff works with experimental animals in his immunological studies of demyelinating diseases. Dr. Brostoff testified that scientists have been able to produce an experimental demyelinating disease in animals with the use of P2 Protein and a booster injected into the animal. It is thought by Dr. Brostoff that the same result would occur if P2 Protein were injected into humans but he stated that the risk of such experiment is too extreme and, therefore, it has not been done.

Dr. Brostoff testified that in his experience neurological symptoms generally develop within four to five weeks after injection of P2 and that he has never seen development of neurological disease after thirteen weeks.

Dr. Brostoff also testified that he tested a number of samples of swine flu vaccine and that he was unable to find any P2 Protein in any of the samples. Dr. Bros-toff stated that he uses a radio-immuno-assay (RIA) which he believes is the most sensitive test. Dr. Brostoff tested the vaccine given to plaintiff in this case and did not find any P2.

With regard to lines of identity identified by Dr. Phillips, Dr. Brostoff stated that even though the lines of identity appear to connect, the bands are wide and somewhat diffuse. He stated this could indicate several bands running together and overlapping rather than the single line of identity testified to by Dr. Phillips. Moreover, Dr. Brostoff stated that even assuming Dr. Phillips did find lines of identity, these lines do not prove that the swine flu vaccine caused a peripheral neuropathy. All they prove is that there is an antibody that recognizes both the peripheral nerve extract and the vaccine. He stated it would not be surprising to find antibodies to peripheral nerve in a person who suffered from GBS. A person also would have antibodies against any vaccine they were injected with.

The final expert witness was Dr. James Parker, a neurologist from Columbus, Ohio. Dr. Parker testified that it was his opinion, to a reasonable degree of medical certainty that the swine flu shot which plaintiff received on October 30, 1976 did not cause her GBS. It was his opinion that plaintiff suffered from gastroenteritis and that this was the cause of her GBS.

Dr. Parker testified that abdominal pain, vomiting, high white blood count and fatigue were not diagnostic of GBS but were consistent with the diagnosis of gastroenteritis. He testified that he had never seen a patient present autonomic symptoms or fatigue in the first stages of GBS. He stated it was his experience that the illness generally progresses to a state of paralysis within a few days after onset. He testified that plaintiff’s complaints of fatigue in December were non-specific and had nothing to do with her subsequent GBS. Further, Dr. Parker noted that none of these complaints were found in any of the medical reports. He also stated that with GBS there more likely would be a repression of the autonomic nervous system rather than overactivity indicated by nausea and vomiting. He also stated that there can be an increase number of polys with a viral infection even though this is rare.

Dr. Parker relied primarily on the CDC study to conclude there was no causal relationship between the swine flu shot received by the plaintiff on October 30 and the GBS which Dr. Parker concluded occurred thirteen weeks later. He stated that there was no evidence to support Dr. Poser’s theory that equates the protective effect of a vaccine with a continuing risk of developing GBS. He agrees that each person develops GBS in a different manner and that there is no set time in which the auto-immune disease may be activated. It was his belief, however, that no relationship between the swine flu shot and the onset of GBS beyond an eight week period had ever been demonstrated.

Dr. Parker testified further that in his opinion the increase in the incidence of GBS in the twelfth week following vaccination was not statistically significant to show a causal relationship between vaccination and the onset of GBS at twelve weeks. Dr. Parker stated that this conclusion was supported by other epidemiological studies that were performed subsequent to the swine flu vaccination program which indicated a causal relationship of up to four to six weeks only.

Dr. Parker agreed with Drs. Poser and Chattha that the surgery likely was too close in time to have caused plaintiff’s GBS.

Dr. Parker also stated that, assuming plaintiff’s symptoms of GBS occurred in mid-December, he would conclude to a reasonable degree of medical certainty that the swine flu shot caused GBS. It was his opinion, however, that the symptoms of fatigue experienced by plaintiff in December were too vague and too far removed from the eventual onset of the paralysis in late January and early February to have a causal relationship.

DISCUSSION

This case presented to the Court complicated factual issues not encountered in any of the swine flu cases we have previously considered. Both sides offered testimony from prominent and knowledgeable neurologists who disagreed on most issues. It is the Court’s responsibility to listen to the evidence presented in this trial and make a determination on the question of whether the swine flu shot caused this plaintiff’s GBS. After carefully considering all of the evidence the Court finds that plaintiff has carried her burden of proving by a preponderance of the evidence that the swine flu vaccination she received on October 30, 1976 was the proximate cause of her GBS.

GBS is an inflammatory disease of the myelin sheath of the peripheral nerve. The peripheral nerves are those which originate at the spinal cord and traverse the body, serving muscles and organs throughout the body. The peripheral nervous system includes the autonomic nervous system.

GBS is a disease which can only be diagnosed symptomalogically. Because there is no dispositive test which can be administered to determine whether a person has GBS, a physician can only look at the symptoms a patient is experiencing and exhibiting and decide whether those symptoms are consistent with a diagnosis of GBS. In June of 1978 the National Institute of Neurological and Communicable Disorders and Strokes (NINCDS) published a list of criteria for the diagnosis of GBS. These criteria have assisted physicians in recognizing GBS, but the criteria listed are not exhaustive. Because GBS is a syndrome it can manifest itself in many ways.

The cause of GBS is unknown. GBS has been associated with over one hundred antecedent events, including surgery and gastroenteritis and now the swine flu shot. No one knows what the connection is between such antecedent events and GBS; it is only known that, based on the temporal relationship between the two — i.e. the fact that there is a short and relatively predictable time interval between the event and the onset of GBS, there is some association between them.

An epidemiological study was conducted by the CDC from October 1, 1976 through January, 1977. Information was collected from doctors and hospitals all over the country but some states were excluded. Participation in the study was voluntary and there is no way to determine how many cases of GBS were not reported. Moreover, there was no reporting criteria established and there is no way of knowing how many cases were reported as GBS that were not in fact GBS.

Dr. Lawrence Schonberger, an epidemiologist, headed the CDC study. He concluded from the results of the study that there was an increased risk of GBS associated with the swine flu vaccine up to ten weeks after vaccination. Dr. Schonberger con-eluded that after ten weeks the incidence of GBS returned to the “baseline rate”, that is the rate at which GBS would be expected to occur naturally in the population absent the shot. The baseline rate was determined to be approximately .22 cases per million of population per week. This figure reflected the number of persons who were not vaccinated with the swine flu vaccine and who nevertheless contracted GBS, and whose cases were reported to the CDC.

The Schonberger study is proof, therefore, that there is a causal relationship between the swine flu vaccine and the occurrence of GBS in certain individuals at least within a period of ten weeks. Even though no one knows how or why, the medical experts all agree that the swine flu shot did in fact cause GBS.

We conclude from the evidence presented that plaintiff experienced symptoms of GBS within seven to nine weeks after receipt of the swine flu vaccine. More likely than not, the fatigue testified to by plaintiff was the result of muscle weakness which is a classic early symptom of GBS. After hearing plaintiff testify and observing her demeanor while on the witness stand, we find the plaintiff to be extremely credible in this regard. Even though she is an older woman and had suffered some fatigue in the past, the fatigue and weakness she suffered in December of 1976 and January of 1977 was clearly different than anything she had experienced before. It significantly altered her lifestyle and even though she continued to work she had to “push herself” and was not able to do anything else but sleep in the evenings. She felt weak and was afraid that something terrible was going to happen to her. We are not troubled by the fact that she did not report these symptoms to Dr. Ruksha or any other doctor at the time as they are significant only in retrospect. We do not think it unusual that a woman of her age, even considering the frequency with which she saw her doctor, would not go to her doctor with these types of complaints; the evidence does not support a conclusion that plaintiff ran to her doctor whenever she felt tired or ill.

Further, the fact that she did not advise the doctors upon admission to the hospital of her fatigue in December and January also does not convince us that she did not experience these symptoms. By the time she got to the hospital she was in extreme distress and not able to communicate well. Moreover, there is no evidence that anyone specifically asked her about how she had felt a month prior. Plaintiff is not a person who would be expected to know that this information would be relevant and cannot be, therefore, held accountable for her failure to relate it to the doctors. We believe that plaintiff was telling the truth and observe that if she had been trying to manufacture symptoms of GBS, she likely would have come up with something more precise than what she offered.

We rely primarily on the testimony of Dr. Poser for our conclusion that the fatigue and weakness that plaintiff experienced in December and January were symptoms of her GBS. Dr. Poser was of the opinion, to a reasonable degree of medical certainty, that the fatigue testified to by plaintiff was a “bridging symptom” of her GBS. Dr. Poser testified that he had observed similar responses in a number of his patients. This type of mild, sub-clinical beginning of GBS is well described in Dr. Poser’s article entitled “Late-Onset of Guillain-Barre Syndrome”. In that article Dr. Poser observes that a number of doctors have found abnormalities in the peripheral nerves of patients with GBS after complete functional recovery. It is Dr. Poser’s opinion that the opposite also is true: pathological changes in the nerves can exist without symptoms prior to the development of acute GBS. Hence, the appearance of mild sub-clinical symptoms prior to the manifestation of severe symptoms.

Dr. Poser’s opinion finds support in the work of Dr. Barry G.W. Arnason who has concluded that GBS may begin with mild distal weakness and progress at a slow tempo to quadriparesis. (See Arnason, “Inflammatory Polyradiculoneuropathies”, Ex. J at 1135). Dr. Arnason found in the alternative that the GBS may progress for a time, become arrested or actually improve for a time and then resume its progressive course. Finally, the NINCDS criteria relied on by the government lists as a variant: “Progression beyond four weeks. Occasionally, a patient’s disease will continue to progress for many weeks longer than four or the patient will have minor relapse.”

We find that plaintiff’s surgery was not the cause of her GBS. Not only do we conclude that her GBS arose prior to surgery, but even if it had not, all of the doctors agreed that the surgery occurred too close in time to the manifestation of severe neurological disorders to have caused plaintiff’s GBS.

We find further that plaintiff did not suffer from a gastrointestinal infection in late January of 1977 but was experiencing an autonomic nervous system dysfunction related to her GBS. We were convinced by the testimony of Dr. Licata and Dr. Poser that the results of tests and examinations performed at the time of the operation were inconsistent with a diagnosis of gastroenteritis. We are especially impressed with the fact that no inflammation or infection was observed by Dr. Licata during his internal examination of plaintiff’s abdomen. Further, the increase in the number of white blood cells with a shift to the left (polys) did not indicate a viral infection, and we are convinced by Dr. Poser’s testimony that plaintiff was not sick enough to have had a bacterial infection. Further, the testimony of Drs. Licata and Poser was that rebound tenderness and guarding also are inconsistent with gastroenteritis. Dr. Parker’s opinion that plaintiff did have gastroenteritis was based upon a review of the same medical records relied upon by Drs. Licata and Poser but we find that such opinion is not supported by the evidence in the record. The fact that Dr. Licata originally indicated in the hospital report that plaintiff had gastroenteritis does not significantly detract from his opinion rendered at trial that she did not have gastroenteritis at the time of surgery. It is not unusual in cases of GBS that early symptoms will be mistaken for something else and that only when the syndrome fully manifests itself can the doctors understand what was occurring in the early stages.

We find from the evidence, therefore, that the onset of plaintiff’s GBS occurred seven to nine weeks after she received the swine flu vaccination. We conclude further that such vaccination was the proximate cause of plaintiff’s GBS. This conclusion is supported by the CDC study which recognized a causal relationship up to ten weeks. It is further supported by the opinions of plaintiff’s expert witnesses and the medical literature they relied upon. In addition, defendant’s own expert witness, Dr. Parker, agreed that if plaintiff had symptoms of GBS in mid-December or early January, then the cause of her GBS likely would be the swine flu shot. Because we have found that she did in fact have symptoms of GBS in December and January, we conclude from this that the shot caused her GBS.

Moreover, even assuming that the fatigue experienced by plaintiff in December and January was not a symptom of her GBS, we would still conclude from the facts presented in this case, that the swine flu shot plaintiff received on October 30, 1976 was the proximate cause of her GBS.

We have already concluded that plaintiff did not have gastroenteritis in January of 1977, but was experiencing an autonomic nervous system dysfunction related to her GBS. Assuming therefore that the onset of plaintiff’s GBS occurred in late January of 1977, the onset date would be within eleven to twelve weeks after receipt of the swine flu shot. The report prepared by Dr. Schonberger indicates there was an increased incidence of GBS following a swine flu shot at twelve weeks. Dr. Schonberger does not believe that the increased incidence shown at twelve weeks is statistically significant and the government therefore argues that it does not constitute proof of a causal a relationship. We disagree for a number of reasons. Statistics is an inexact science and there always is some error. There were known problems with reporting and it is more likely than not that the background rate figure arrived at by Dr. Schonberger was not exact or that some cases of GBS went unreported. See Sulesky v. United States, 545 F.Supp. 426 (S.D.W.Va.1982) (Dr. Schonberger found different background rate of GBS in unrelated study). To conclude, therefore, that the few cases of GBS that occurred twelve weeks after receipt of the shot are not sufficient in number to create a statistical significance ignores the fact that, statistics aside, there appears to be a relationship in those few cases. As stated by Dr. Poser, everyone responds to an event differently, depending on their personal makeup, and there always will be people who fall outside the norm. We recognize that in most cases symptoms of GBS arose, if at all, within six weeks after receipt of the vaccine, but that figure represents only the majority of cases. We find that because some increase in the incidence of GBS was shown at twelve weeks, no matter how small, that increase is significant in this case where there is no other identifiable cause of plaintiffs GBS. See, Hockett v. United States of America, Civil No. 79-4311 (S.D.Fla.1982).

This conclusion is further supported by the testimony of Dr. Chattha who stated that in his experience, it is not possible to set an absolute limit on the amount of time that may elapse between a causative event and a result. Rather, he believes that the cause and effect relationship gradually decreased over time and the fact that a person develops GBS after ten weeks does not necessarily rule out a causal relationship.

We, therefore, conclude that a causal relationship between plaintiffs GBS and the swine flu shot she received on October 30, 1976 has been demonstrated by the close temporal relationship between the shot and onset of GBS. A causal relationship also is demonstrated by the. test results of Dr. Phillips. If we had nothing but Dr. Phillips’ test results and none of these other factors we have identified as being indicative of causation, we might come to a different conclusion. We find, however, that Dr. Phillips’ testimony and test results support all of the plaintiff’s evidence of causation and indicate that more likely than not, the swine flu shot received by the plaintiff caused her GBS.

CONCLUSIONS OF LAW

This Court has jurisdiction over this action pursuant to the National Swine Flu Immunization Act of 1976, 42 U.S.C. § 247b, and the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b), 2671 et seq.

The case is tried by the Court sitting without a jury, pursuant to 28 U.S.C. § 2402.

Plaintiff has the burden by a preponderance of the evidence that the swine flu shot she received on October 30, 1976 was the cause or a substantial cause of her GBS.

Ohio law provides that proof of proximate cause consists of proof that the original act produces a result which would not have otherwise taken place and does so in a natural and continuous sequence. Strother v. Hutchinson, 67 Ohio St.2d 282, 286-87, 423 N.E.2d 467 (1981).

The Court concludes that plaintiff Ermina D’Antonio met her burden of proving that the swine flu vaccine caused or substantially contributed to her GBS.

The final pretrial order of the United States District Court for the District of Columbia provides that where a person has developed GBS as a proximate result of the swine flu vaccination no theory of liability need be established in order to recover damages. Accordingly the only issue remaining before this Court is the question of damages.

A preliminary pretrial conference is scheduled for February 11, 1983 at 3:00 p.m. The conference will be by telephone and the attorneys need not be present in Cincinnati. Matters we will discuss include: setting of a discovery cut-off date; filing of proposed findings of fact and conclusions of law; possibility of settlement discussions with the transferor judge; and, if the case cannot be settled, the setting of a trial date.

Defendant’s motion to substitute trial exhibit (doc. 47) is hereby granted.

SO ORDERED.


source: Caselaw Access Project

author: SHERMAN G. FINESILVER, Chief Judge.

license: Public Domain

text:
    Jeanette SMITH, Plaintiff, v. C.R.C. BUILDERS CO., INC., and Glover Brick, Inc., Defendants.
    Civ. A. No. 82-F-2120.
    United States District Court, D. Colorado.
    March 3, 1983.
    Francis Jean Pottick, Boulder, Colo., for plaintiff.
    Daniel M. Fowler, Denver, Colo., for defendant C.R.C. Builders Co., Inc.
    Harry G. Titcombe, Jr., Denver, Colo., for defendant Glover Brick, Inc.
   ORDER GRANTING MOTION TO QUASH AND GRANTING MOTION TO REMAND

SHERMAN G. FINESILVER, Chief Judge.

THIS MATTER is before the Court on a Motion to Quash filed on behalf of federal petitioner Manuel Ypsilantes. Mr. Ypsilantes is the Safety Supervisor for the Denver area Office of the Occupational Safety and Health Administration (“OSHA”), United States Department of Labor (“DOL”). This action was initially brought in the District Court in and for the County of Arapahoe, State of Colorado, to recover damages for the death of Plaintiffs husband. See Smith v. C.R.C. Builders Co., Inc., et al, Case No. 82-CV-770. In preparation of the State action, Plaintiff sought to discover from the federal petitioner the contents of an investigative file compiled by OSHA in its investigation into the circumstances of Mr. Smith’s death at a work site. Mr. Ypsilantes is currently in possession of the subject investigation file.

Certain portions of the file were made available to Plaintiff upon her request. The remainder of the file was not released, however, on the grounds of an informer’s privilege and investigative privilege asserted by OSHA. Mr. Ypsilantes failed to comply with a subpoena duces tecum served on him by Plaintiff for the production of the file. This refusal was at the direction of the Deputy Solicitor of Regional Operations, DOL, Ronald G. Whiting. Arapahoe County District Judge Thomas C. Levi ordered Mr. Ypsilantes to answer the subpoena duces tecum in full by September 28, 1982. When he failed to comply with this Court order, Mr. Ypsilantes was issued a contempt citation by Judge Levi on November 12, 1982.

Pursuant to 28 U.S.C. §§ 1441 and 1442(a)(1), Mr. Ypsilantes removed the contempt citation to this Court. Section 1441 is the general removal section, while section 1442(a)(1) allows for the removal to federal court any civil or criminal action commenced against an officer of the United States. The removal of contempt proceedings is supported by the case law. See, e.g., State v. Schaffer, 565 F.2d 961 (7th Cir.1977); State v. Carr, 386 F.2d 129 (4th Cir.1967). We find this Court’s jurisdiction to be properly invoked in this ease to consider the limited question of Mr. Ypsilantes’ Motion to Quash the subpoena duces tecum served on him by Plaintiff.

Mr. Ypsilantes’ Motion to Quash is based on the requirements of 29 C.F.R. § 2.22 (1983), promulgated by the DOL. Section 2.22 provides:

In terms of instructing an employee or former employee of the manner in which to respond to a demand, the Associate Solicitor, Regional Solicitor, or Associate Regional Solicitor, whichever is applicable, shall follow the instructions of the appropriate Deputy Solicitor of Labor. No employee or former employee of the Department of Labor shall, in response to a demand of a court or other authority, produce any material contained in the files of the Department, or disclose any information relating to material contained in the files of the Department, or disclose any information or produce any material acquired as part of the performance of his official duties or because of his official status without approval of the appropriate Deputy Solicitor of Labor.

29 C.F.R. § 2.22 (1983) (emphasis supplied). This regulation was promulgated in its present form by the DOL in 1981 in order to establish a uniform policy within the Department for responding to the growing numbers of subpoenas being served on DOL employees. See 46 FED.REG. 49542 (October 6, 1981). It mimics in many respects other office “housekeeping” regulations promulgated under the authority of 5 U.S.C. § 301 (1980), by various other governmental agencies or Departments.

The Supreme Court has in the past given effect to similar regulations promulgated by the Secretary of the Treasury, Boske v. Comingore, 177 U.S. 459, 20 S.Ct. 701, 44 L.Ed. 846 (1900), and the United States Attorney General, United States ex rel. Touhy v. Ragen, 340 U.S. 462, 71 S.Ct. 416, 95 L.Ed. 417 (1951). In Touhy, the Supreme Court considered whether a subordinate official of the Department of Justice could refuse to obey a subpoena duces tecum ordering production of papers of the Department in his possession. The official’s refusal was grounded on a regulation issued by the Attorney General very similar to the one involved in this case. The authority for the regulation in Touhy was 5 U.S.C. § 22, the predecessor section to 5 U.S.C. § 301. The Supreme Court in Touhy held that the Attorney General could validly withdraw from his subordinates the power to release department papers and that the official could properly refuse to produce those papers pursuant to a subpoena duces tecum. Touhy, 340 U.S. at 467-68, 71 S.Ct. at 418-19.

Plaintiff argues that Touhy is outdated and no longer the law in light of a post-Touhy amendment to 5 U.S.C. § 22. In 1958, Congress amended § 22 (now § 301) to add the following sentence: “This section does not authorize withholding information from the public or limiting the availability of records to the public.” [72 Stat. 547]. The purpose of the amendment was to correct an evolving situation whereby the statute had “... been twisted from its original purpose as a ‘housekeeping’ statute into a claim of authority to keep information from the public and, even, from the Congress.” 2 U.S.Code Cong. & Admin.News 3352 (1958). Plaintiff contends that the only substantive provision which might allow nondisclosure of this OSHA investigation file is the exemption provided under the Freedom of Information Act, 5 U.S.C. § 552(b) (1980). Plaintiff further contends that neither Mr. Ypsilantes nor the DOL has met its burden to state explicitly which exemptions under the Freedom of Information Act they are asserting as grounds for not complying with the subpoena duces tecum.

Plaintiff has misinterpreted the significance of this 1958 amendment to section 301 as it relates to the issue before the Court on Mr. Ypsilantes’ Motion to Quash. It is true that this amendment made it clear that “housekeeping” regulations promulgated under section 301 did not, of themselves, create a privilege against disclosure of information under the Freedom of Information Act. See Marcoux v. Mid-States Livestock, 66 F.R.D. 573, 576 (W.D.Mo. 1975). What the amendment did not do, however, is alter the long-established rule that a superior government official could withdraw from his subordinates the power to release government documents. In this respect, the Supreme Court’s holdings in Boske and Touhy remain the controlling law.

The United States Court of Appeals for the Tenth Circuit has recognized the continuing vitality of Boske and Touhy in several post-1958 cases. In United States Steel Corporation v. Mattingly, 663 F.2d 68 (10th Cir.1980), the Tenth Circuit reversed a District Court order compelling enforcement of a subpoena against an employee of the United States Bureau of Standards. The Court based its reversal on Touhy. United States Steel Corporation, 663 F.2d at 68. In Saunders v. Great Western Sugar Company, 396 F.2d 794 (10th Cir.1968), the Tenth Circuit reviewed a “housekeeping” regulation promulgated by the Small Business Administration similar in impact to the regulation before this Court. While noting that a requirement that the litigants proceed against the proper SBA official in the District of Columbia might prove a hardship, the Court in Saunders nevertheless held that it was “bound by Touhy and Boske.” Saunders, 396 F.2d at 795. Other courts have relied on Touhy to uphold similar regulations. See, e.g., United States v. Bizzard, 674 F.2d 1382,1387 (11th Cir.1982). cert. denied, 459 U.S. 973, 103 S.Ct. 305, 74 L.Ed.2d 286 (1982); United States v. Allen, 554 F.2d 398, 406 (10th Cir.1977), cert. denied, 434 U.S. 836, 98 S.Ct. 124, 54 L.Ed.2d 97 (1977); Cates v. LTV Aerospace Corp., 480 F.2d 620, 623 (5th Cir.1973); Committee for Nuclear Responsibility, Inc. v. Seaborg, 463 F.2d 788, 793 (D.C.Cir.1971).

The only question before this Court is whether Mr. Ypsilantes has the power to release the records sought by Plaintiff’s subpoena duces tecum. Under the specific circumstances of this case, Mr. Ypsilantes does not have such power in the absence of the approval of a Deputy Solicitor of the DOL. Section 2.22 of the DOL regulations has the force and effect of law. Mr. Ypsilantes can neither be compelled to disobey a direct order from his superior, Ronald G. Whiting, nor punished for his adherence to the mandate of section 2.22 of the DOL regulations. See Marcoux, 66 F.R.D. at 579.

Section 2.22 does not create an exemption from discovery under the Freedom of Information Act. Nor does it “preempt” the provisions of Rule 45 of the Colorado Rules of Civil Procedure. Section 2.22 simply regulates the manner in which discovery requests made on DOL employees are handled to ensure more consistent treatment. Litigants, whether they are in state or federal court, are bound to follow the procedure contemplated by section 2.22 in seeking DOL documents. They may not subpoena DOL employees without the approval of the employees’ superiors. Since Mr. Ypsilantes has been denied authority to release the file in question here, the only recourse available to Plaintiff is to procure service of the subpoena duces tecum upon the appropriate DOL official, most likely Mr. Whiting.

The DOL may still wish to withhold its approval for Mr. Ypsilantes to release the entire investigative file. The propriety of any privilege asserted by the DOL is not presently before this Court. That question must be resolved by a court with jurisdiction over the DOL official asserting the privilege.

ORDER

For the reasons stated above, Mr. Ypsilantes’ Motion to Quash is GRANTED. Finding our jurisdiction limited to the resolution of this Motion, and finding further no additional bases for our assertion of jurisdiction over this matter, this action is hereby REMANDED to the District Court in and for the County of Arapahoe, State of Colorado, for further proceedings.


author: STUART, District Judge.

text:
    STATE OF IOWA, ex rel. Thomas J. MILLER, Attorney General of Iowa, Plaintiff, v. John R. BLOCK, Secretary of United States Department of Agriculture; the United States Department of Agriculture, an agency of the United States Government, Defendants.
    Civ. No. 84-356-A.
    United States District Court, S.D. Iowa, C.D.
    Aug. 22, 1984.

      Thomas J. Miller, Atty. Gen., Timothy D. Benton, Asst. Atty. Gen., for plaintiffs.
    G.F. Hoffman III, Leon, for plaintiff-intervenors.
    Richard K. Willard, Acting Asst. Atty. Gen., Dennis G. Linder, Atty., Arthur Goldberg, Atty., Dept. of Justice, Washington, D.C. and Richard C. Turner, U.S. Atty., Des Moines, Iowa, for defendants.
   RULING AND ORDER ON MOTION TO DISMISS

STUART, District Judge.

Plaintiffs’ motion for preliminary injunction and defendants’ motion to dismiss came on for hearing August 10, 1984. Appearances are noted in the Clerk’s minutes for that date. Although defendants requested a ruling on their motion to dismiss before hearing on the motion for preliminary injunction, the Court determined that it was in the interest of justice and judicial efficiency to submit the motions together. Evidence on the motion for preliminary injunction was received on August 10, 1984, and statements of counsel on both motions were heard on August 13, 1984.

After having heard the statements of counsel and the testimony, reading the affidavits, and reviewing the written briefs and the remainder of the file, the Court concludes that the defendants’ motion to dismiss must be granted.

This action was initially brought by the State of Iowa under the Federal Administrative Procedure Act’s judicial review provisions, 5 U.S.C. sections 701-706 [hereinafter “APA”], in an effort to compel John R. Block, Secretary of the United States Department of Agriculture, to implement five federal agricultural disaster relief programs in Iowa. Several Iowa farmers intervened as plaintiffs in the action after defendants filed their motion to dismiss. Plaintiffs contend that defendants’ failure to implement the five programs wrongfully contravened the intent of Congress stated in the statutory provisions providing for the programs. According to plaintiffs, Mr. Block’s failure to implement the five programs to relieve the drought-stricken conditions of farmers in several Iowa counties, was arbitrary, capricious, an abuse of discretion, and a violation of the separation of powers doctrine. Plaintiffs ask the Court to hold Mr. Block’s failure to act unlawful under 5 U.S.C. section 706, and to issue a preliminary and permanent injunction compelling defendants to exercise their discretion to implement the five programs.

Defendants moved to dismiss the State of Iowa for lack of standing, and to dismiss the entire action for lack of subject matter jurisdiction. The Court will consider each of defendants’ contentions separately.

I. State of Iowa’s Standing.

The State of Iowa has brought this action as parens patriae on behalf of its citizens and on its own behalf because the economic well-being of the State will be injured if substantial numbers of Iowa farmers are forced out of business due to defendants’ failure to implement the five agricultural disaster relief programs.

A. Parens Patriae Standing.

In Massachusetts v. Mellon, 262 U.S. 447, 43 S.Ct. 597, 67 L.Ed. 1078 (1923), the State of Massachusetts sought to represent its citizens against the United States Secretary of the Treasury in a challenge to the constitutionality of a certain federal statute. The Court held:

It cannot be conceded that a State, as parens patriae, may institute judicial proceedings to protect citizens of the United States from the operation of the statutes thereof. While the State, under some circumstances, may sue in that capacity for the protection of its citizens (Missouri v. Illinois, 180 U.S. 208, 241 [21 S.Ct. 331, 343, 45 L.Ed. 497]), it is no part of its duty or power to enforce their rights in respect to their relations with the Federal Government. In that field it is the United States, and not the State which represents them as parens patriae____

Massachusetts v. Mellon, 262 U.S. at 485-86, 43 S.Ct. at 600. Several courts read Mellon as prohibiting states from suing as parens patriae the federal government. E.g., Pennsylvania v. Porter, 659 F.2d 306, 317 (3d Cir.1981) (interpreting prior caselaw), cert. denied, 458 U.S. 1121, 102 S.Ct. 3509, 73 L.Ed.2d 1383, (1982); Graham v. Schweiker, 545 F.Supp. 625, 627 (S.D.Fla.1982). In Pennsylvania v. Kleppe, 533 F.2d 668 (D.C.Cir.), cert. denied, 429 U.S. 977, 97 S.Ct. 485, 50 L.Ed.2d 584 (1976), the Court of Appeals for the District of Columbia Circuit addressed the issue before this Court. The Kleppe Court held that, absent a showing that a state’s action as parens patriae would not substantially intrude into the discretionary administrative workings of the federal agency, the federal government is the only proper party to act as parens patriae for citizens seeking benefits flowing directly from the federal government. Id. at 679-80. The State does not contend that this action would not constitute a substantial intrusion into the discretionary administration of the United States Department of Agriculture. Thus, under the pre-July 1982 precedent, the State of Iowa would not have standing to sue as parens patriae.

In July 1982, the United States Supreme Court handed down Alfred L. Snapp & Son, Inc. v. Puerto Rico, 458 U.S. 592, 102 S.Ct. 3260, 73 L.Ed.2d 995 (1982), holding that Puerto Rico could represent its citizens as parens patriae in an action against private persons for violating a federal statute. The Court carefully pointed out, however, that the action could not have been maintained against the federal government. Four members of the Court stated a proposition that the concurring justices did not dispute: “A State does not have standing as parens patriae to bring an action against the Federal Government.” Id. at 610 n. 16, 102 S.Ct. at 3270 n. 16.

Thus, it appears that the Supreme Court has recognized the continuing viability of the holding in Mellon. Applying that rule, the Court concludes that the State does not have standing to bring this action as par-ens patriae.

B. Proprietary Interest Standing.

The State of Iowa alleges that defendants’ failure to implement the agricultural disaster relief programs will harm the State by causing increased unemployment, decreased tax revenues, injury to the State’s interest in insuring equal treatment in the federal system, injury caused by increased fiscal outlays resulting from social dislocation, and general injury to the economic well-being of Iowa citizens. The State admits that neither it nor any of its agencies would receive any relief under any of the five programs, and that it takes no part in administering any of the programs.

1. Are the State’s alleged interests “proprietary?”

In Alfred L. Snapp & Son, Inc. v. Puerto Rico, 458 U.S. 591, 102 S.Ct. 3503, 73 L.Ed.2d 994 (1982), the United States Supreme Court distinguished between proprietary interests — which can serve as the basis of the State’s action — and quasi-sovereign interests, which can form the basis only for an action as parens patriae. The Court stated that a proprietary interest is one a state acquires by owning property or participating in a business-type venture, id. 458 U.S. at 601-02, 102 S.Ct. at 3265-66, while a quasi-sovereign interest is typified by a state’s concern for the health and well-being of the state’s residents in general or a desire not to be discriminatorily denied its rightful status within the federal system. Id. at 607-08, 102 S.Ct. at 3268-69. It is apparent that the State’s alleged injuries of increased unemployment, disparate treatment, and general injury to the economic well-being of the state are quasi-sovereign in character. Thus, such injuries, although appropriate for forming the basis of standing as parens patriae, are not sufficient to form the basis of standing on proprietary interests. Pennsylvania v. Kleppe, 533 F.2d 668, 671 (D.C.Cir.), cert. denied, 429 U.S. 977, 97 S.Ct. 485, 50 L.Ed.2d 584 (1976).

2. Has the State shown that it has suffered injury in fact and that the State’s injuries are not merely generalized grievances?

In order to state a cognizable Article III case and controversy, the State must show that its own alleged injuries are actual or imminent, that the injuries can be fairly traced to the challenged inaction of the Secretary, and that the injury can be redressed by specific judicial relief. Valley Forge Christian College v. Americans United for Separation of Church and State, Inc., 454 U.S. 464, 472-74, 102 S.Ct. 752, 758-59, 70 L.Ed.2d 700 (1982); Cason v. Pierce, 719 F.2d 931, 933 (8th Cir.1983). In addition, in order to show that it is a proper party-plaintiff, the State must show that its injuries are to itself, and not generalized grievances shared in substantially equal measure by the citizens of Iowa. Warth v. Seldin, 422 U.S. 490, 499-500, 95 S.Ct. 2197, 2205, 45 L.Ed.2d 343 (1975). Several of the State’s alleged injuries, while sufficient to support standing as par-ens patriae against a private defendant, fail to constitute distinct, palpable injuries to the State as a state. The State’s alleged injuries of increased unemployment, increased social outlays due to social dislocation, and general injury to economic well-being are so speculative and causally removed from the alleged wrong, that they do not constitute injury in fact. The alleged injuries to the State in the forms of increased unemployment, decreased tax revenues, and disparate treatment are generalized grievances, shared by each citizen of Iowa. See Pennsylvania v. Kleppe, 533 F.2d 668, 672 (D.C.Cir.), cert. denied, 429 U.S. 977, 97 S.Ct. 485, 50 L.Ed.2d 584 (1976) . In summary, the Court concludes that the State has failed to allege an injury to itself that would constitute a sound basis for standing in federal court.

3. Is the State arguably within the zone of interests protected by the agricultural disaster relief programs?

In order to maintain standing to sue, the State must also show that its alleged interests in this suit are arguably within the zone of interests protected by any one of the five agricultural disaster relief programs. Association of Data Processing Servs. v. Camp, 397 U.S. 150, 154-56, 90 S.Ct. 827, 830-31, 25 L.Ed.2d 184 (1970); Taylor v. Jones, 653 F.2d 1193, 1207-08 (8th Cir.1981). The language of the statutes establishing the programs indicate that Congress intended to relieve farmers stricken by agricultural disasters. The State of Iowa is not an intended beneficiary of any of the programs and has no part in administering them. Under these circumstances, the Court concludes that the State also lacks standing because it is not even arguably within the zone of interests created by the programs. Pennsylvania v. Kleppe, 533 F.2d 668, 671-72 (D.C.Cir.), cert. denied, 429 U.S. 977, 97 S.Ct. 485, 50 L.Ed.2d 584 (1976); see Granville House, Inc. v. Department of Health & Human Servs., 715 F.2d 1292, 1299 (8th Cir.1983); Kozera v. Spirito, 723 F.2d 1003, 1007 (1st Cir.1983); Comment, State Standing to Challenge Federal Administrative Action: A Re-examination of the Parens Patriae Doctrine, 125 U.Pa.L.Rev. 1069, 1095-98 (1977) .

In summary, the Court concludes for the reasons stated above that the State lacks standing to bring this action on the basis of its asserted proprietary interests.

II. Subject Matter Jurisdiction.

The parties agree that the implementation of the agricultural disaster relief programs is committed to the discretion of the Secretary of the United States Department of Agriculture. Plaintiffs contend that the Secretary abused that discretion by failing to implement the programs in several Iowa counties after the drought of 1983 ravaged southeast Iowa, and that his exercise of discretion is reviewable under the APA, 5 U.S.C. section 706(2)(A). Defendant contends that the discretion to implement the programs is vested solely in the Secretary, and that such discretion is not subject to judicial review, pursuant to the APA, 5 U.S.C. Section 701(a)(2).

The exception to judicial review established by Section 706(2)(A) “is a very narrow exception____ The administrative history of the Administrative Procedure Act indicates that is applicable in those rare instances where ‘statutes are drawn in such broad terms that in a given case there is no law to apply.’ ” Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 410, 91 S.Ct. 814, 821, 28 L.Ed.2d 136 (1971). There is a presumption that agency action is reviewable, which is rebutted only when the review court has no law to apply. Tuepker v. Farmers Home Administration, 708 F.2d 1329, 1331-32 (8th Cir.1983).

In determining whether there is law to apply, federal courts have analyzed pragmatic considerations as to whether an agency determination is the proper subject of judicial review. These pragmatic considerations include whether the challenged agency action is of a type Congress intended to be left to a reasonable exercise of agency expertise, and whether the problem that formed the basis of the challenged agency action is one suitable for judicial determination. Id. at 1332; Chaney v. Heckler, 718 F.2d 1174, 1195 (D.C.Cir. 1983) ; see Cooperative Power Association v. Federal Energy Regulatory Commission, 733 F.2d 577, 581 (8th Cir.1984) (per curiam); United States v. l426.5 Acres of Land, 732 F.2d 1375, 1379-81 (8th Cir. 1984) ; United States v. Wiley’s Cove Ranch, 295 F.2d 436, 440-43 (8th Cir.1961).

The language used by Congress in the statutes establishing the five agricultural disaster relief programs indicates that Congress intended to make a broad delegation of power to the Secretary. None of the language mandates that the Secretary implement the programs under certain conditions. Instead, Congress used permissive language, allowing the Secretary to set the terms of implementation he determined to be in the national interest. This broad delegation of authority by Congress leaves the Court with little, if any, standard for reviewing the Secretary’s failure to implement the programs.

Pragmatic considerations also incline the Court to find that the Secretary’s failure to implement the five programs in southeast Iowa is not a proper subject for judicial review. Throughout the years Congress has authorized a broad range of discretionary assistance programs to deal with agricultural disasters. Recognizing that the Secretary possesses expertise in agricultural affairs and the means of evaluating the everchanging national agricultural conditions, Congress often vested discretion in the Secretary to determine whether to implement such programs. In deciding which programs to implement and the areas or individuals that are entitled to assistance, the Secretary must consider the level of relief required, the national and international ramifications of implementation, the level of relief afforded by programs already implemented, and various other economic and managerial issues. For the Court to fairly and fully review the discretionary decision of the Secretary, all of the factors that entered into the decision would have to be brought before the Court, if that would be possible. In addition, the Court does not believe that it could properly review the Secretary’s determinations— which were certainly based on data gathered from national and international sources — and then limits its decision whether the Secretary acted arbitrarily to the situation presented in several southeast Iowa counties.

Were it to review the Secretary’s decision, the Court would have no difficulty in finding that the emergency assistance programs actually implemented by the Secretary did not provide sufficient relief to the livestock farmers in southeast Iowa who find themselves in precarious financial situations due, at least in part, to the adverse weather conditions of the past three years. But it is not for the Court to substitute its judgment for that of the Secretary under the circumstances presented here.

As indicated above, the Secretary must look far beyond the particular local situation in exercising his discretion. The national and international concerns, the empirical data, the ramifications of particular actions including the effect of the national budget and other factors that may be involved in a particular decision are so far-reaching and complex that this discretionary determination is not a proper subject of judicial review. Accordingly, the Court shall grant the motion to dismiss for lack of subject matter jurisdiction.

IT IS THEREFORE ORDERED that defendant’s motion to dismiss plaintiff State of Iowa for lack of standing shall be and hereby is granted.

IT IS FURTHER ORDERED that defendants’ motion to dismiss this action for lack of subject matter jurisdiction shall be and hereby is granted.

      . The five programs are (1) the Emergency Feed Program, 7 U.S.C. Section 2267; (2) the Livestock Feed Program, 7 U.S.C. Section 1427; (3) the Disaster Reserve Program, 7 U.S.C. Section 1427a; (4) a prevented-planting and reduced-yield program, 7 U.S.C. Section 1444d; and (5) a program for the orderly disposal of stockpiled grain, 7 U.S.C. Section 1851.

      . This holding is closely tied to the Court’s determination of the State's failure to show sufficient injury in fact on these grounds, infra.

      . Section 706(2)(a) provides:
      To the extent necessary to decision and when presented, the reviewing court shall decide all relevant questions of law, interpret constitutional and statutory provisions, and determine the meaning or applicability of the terms of an agency action. The reviewing court shall—
      (2) hold unlawful and set aside agency action, findings, and conclusions found to be—
      (A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law;

      . Section 701(a)(2) provides:
      (a) This chapter applies, according to the provisions thereof, except to the extent that—
      (2) agency action is committed to agency discretion by law.
      Section 706 of the APA provides the standards for reviewing agency action after it has been determined that judicial review exists. Review-ability is determined by section 701. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 413, 91 S.Ct. 814, 822, 28 L.Ed.2d 136 (1971).

      . The Court recognizes that the Secretary’s regulation, 7 C.F.R. Section 1475.53, presents the judicial review issue in a distinct procedural context. However, the Court accepts the defendants’ statement that the Livestock Feed Program, 7 U.S.C. Section 2267, could be re-implemented by the Secretary at any time by merely rescinding Section 1475.53.