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GOLOD v. LA ROCHE

May 20, 1997

ANN R. GOLOD and ERVIN H. GOLOD, Plaintiffs, against HOFFMANN LA ROCHE d/b/a ROCHE PHARMACEUTICALS, Defendant.


The opinion of the court was delivered by: SWEET

 Sweet, D.J.,

 Defendant Hoffmann La-Roche, Inc. ("Hoffmann") has moved for summary judgment pursuant to Rule 56, Fed. R. Civ. P.

 For the reasons set forth below, Hoffmann's motion will be denied. In addition, certain expert testimony will be excluded at trial.

 Plaintiffs Ann R. Golod ("Golod") and her husband Ervin H. Golod are individuals residing in New York, New York.

 Hoffmann is a foreign drug manufacturing company with its principal place of business in the State of New Jersey.

 Prior Proceedings

 This action was filed on January 29, 1993, seeking damages for Hoffmann's failure to adequately test and warn against the dangers associated with the use of Tegison, a drug manufactured by Hoffmann. Hoffmann's motion for summary judgment was filed on March 16, 1996. On January 28, 1997 this action was transferred to this Court pursuant to Rule 16, Rules for the Division of Business Among Southern District Judges. Oral argument on Hoffmann's motion was heard on February 6, 1997. Further submissions were received through February 28, 1997, at which time the motion was considered fully submitted.

 Facts

 In deciding a motion for summary judgment, "as a general rule, all ambiguities and inferences to be drawn from the underlying facts should be resolved in favor of the party opposing the motion, and all doubts as to the existence of a genuine issue for trial should be resolved against the moving party." Brady v. Town of Colchester, 863 F.2d 205, 210 (2d Cir. 1988) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 330 n.2, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986) (Brennan, J., dissenting); Adickes v. S. H. Kress & Co., 398 U.S. 144, 158-59, 26 L. Ed. 2d 142, 90 S. Ct. 1598 (1970)). The facts as presented here are construed accordingly, and they are limited to this motion.

 I. Tegison

 Tegison is the brand name of a prescription drug manufactured and distributed by Hoffmann. The chemical name of the drug is etretinate. Tegison is a retinoid, closely related to Vitamin A. Because it is a prescription drug, Tegison can only be prescribed by, and used at the direction of, a licensed physician. Tegison was approved for sale in the United States by the United States Food and Drug Administration ("FDA") on September 30, 1986.

 Tegison is "indicated" to treat severe recalcitrant psoriasis. At all times relevant to the complaint, the Physician's Desk Reference ("PDR") and package insert for Tegison, which are approved by the FDA, stated in part:

 
INDICATIONS AND USAGE:
 
Tegison is indicated for the treatment of severe recalcitrant psoriasis... . Because of significant adverse effects associated with its use, Tegison should be prescribed only by physicians knowledgeable in the systemic use of retinoids and reserved for patients with severe recalcitrant psoriasis who are unresponsive to or intolerant of standard therapies... .

 1990 Physician's Desk Reference (44th ed.) at p. 1773. *fn1"

 The 1986 Tegison package insert warns of adverse ocular effects using the following language:

 
WARNINGS:
 
Ophthalmic effects: Corneal erosion, abrasion, irregularity and punctate staining have occurred in patients treated with Tegison, although these effects were absent or improved after therapy was stopped in those patients who had follow-up examinations. Corneal opacities have occurred in patients receiving isotretinoin: they had either completely resolved or were resolving at follow-up six to seven weeks after discontinuation of the drug. Other ophthalmic effects that have occurred in Tegison patients include decreased visual acuity and blurring of vision, night vision decrease, minimal posterior subcapsular cataract, iritis, blot retinal hemorrhage, scotoma and photophobia. Any Tegison patient experiencing visual difficulties should discontinue the drug and have an ophthalmological examination.

 The January 1987 and August 1988 Tegison Patient Leaflet gives the following warning:

 
In the first few weeks -- perhaps before you see any healing -- you may begin to have some side effects ... [including] eye irritations... . If you develop any of these side effects, check with your doctor to determine if any change in the amount of your medication is needed.... A number of patients have experienced decreased night vision.
 
YOU SHOULD BE AWARE THAT TEGISON MAY CAUSE SOME MORE SERIOUS SIDE EFFECTS. BE ALERT FOR ANY OF THE FOLLOWING:
 
BLURRED VISION ... PERSISTENT FEELING OF DRYNESS OF THE EYES ...
 
IF YOU EXPERIENCE ANY OF THESE SYMPTOMS OR ANY OTHER UNUSUAL OR SEVERE PROBLEMS, DISCONTINUE TAKING TEGISON AND CHECK WITH YOUR DOCTOR IMMEDIATELY. THEY MAY BE THE EARLY SIGNS OF MORE SERIOUS SIDE EFFECTS WHICH, IF LEFT UNTREATED, COULD POSSIBLY RESULT IN PERMANENT EFFECTS.

 The June 1988 Tegison Patient Information Brochure contains similar language.

 II. Reports of Adverse Reactions to Tegison & Other Retinoids

 In an Adverse Experience Report *fn2" dated June 15, 1987, a patient on Tegison for five months reportedly suffered from unilateral scotoma (a blind spot) in his right eye. The report states that "no firm relationship to Tegison [was] made," but that the patient was not taking any other medications during those five months.

 In November 1987, the FDA received an Adverse Experience Report from Hoffmann about a 48-year old woman who suffered "some" loss of vision resulting from cataracts after a 5-month course of Tegison. The negative experience did not abate from the time the drug was discontinued until the time of the report.

 Another Adverse Experience Report dated July 14, 1988, describes a patient on Tegison 2-3 months who experienced retinal holes and retinal detachment, as well as non-ocular side effects. Although the other effects subsided when Tegison was discontinued, the retinal problems did not. The retinal detachment was repaired, but the patient continued to have limited vision in the right eye. The report shows that although the patient had a history of psoriasis, it was not until he began his Tegison therapy that he developed numerous side effects, including a prominent cystic change in his right macular which restricted his vision. The report also states that an ophthalmologist felt that the eye problems were not related to Tegison therapy.

 Hoffmann also manufactures Accutane, a pharmaceutical product prescribed for severe acne. Like Tegison, Accutane is also a retinoid, closely related to Vitamin A. The Tegison package insert states that "Nearly all of the adverse events reported to date with Tegison administration resemble those of hypervitaminosis A syndrome [i.e., vitamin A poisoning]." The testimony of Dr. Kenneth R. Barasch ("Dr. Barasch"), one of Golod's experts, also provides some evidence that Vitamin A derivatives, including Tegison and Accutane, have similar side effects. Hoffmann's own witnesses have conceded that there are some similarities in the side effects caused by retinoids. Dr. Robert Armstrong of Hoffmann testified at his deposition that he did not know of any differences in the ophthalmologic side effects of Tegison and Accutane, other than that night blindness is more common with Accutane. Moreover, a report on post-marketing surveillance of side effects submitted to a Swiss medical publication, Schweitzerische Aerztezeitung, by Dr. T. Fisch of Hoffmann La Roche and other physicians, combines Tegison and Accutane and notes that both "have a potential of causing any of the adverse reactions . . . known to be associated with hypervitaminosis A. Many of these signs are only manifested after prolonged treatment." Hoffmann also apparently used information on Accutane in preparing its package insert for Tegison, as the draft package insert for Tegison referred to Accutane. Hoffmann made revisions to the Tegison patient leaflet in order to conform the Tegison leaflet to the then-recently approved Accutane leaflet. In addition, a June 12, 1985 Hoffmann memo documenting Hoffmann's meeting with the FDA concerning Tegison noted that Hoffmann's post-approval program for Tegison included packaging for Tegison that would be similar to that for Accutane.

 FDA Drug Experience Reports show that as early as 1982, patients reported debilitating eye symptoms that developed during or after a course of Accutane therapy. Several patients reported that the symptoms, which ranged from persistent dry eyes to various eye pains and cataracts, did not subside when they ceased taking Accutane.

 Golod has also proffered computer printouts from the FDA's Spontaneous Reporting System, which include summarized reports of adverse experiences associated with (although not necessarily caused by) various drugs. Approximately ninety percent of the reports in this database are submitted directly by the manufacturers of the drugs, who must, under law, report adverse events that are made known to them. These printouts reflect two reports prior to 1990 of blindness in patients using Tegison. The printout for Accutane shows that in 1983, a 17-year old patient reported a total loss of vision in his left eye and a fifty percent loss of vision in his right eye, and, in 1984 and 1985, four patients reported blindness. These summaries do not indicate the duration of the blindness. Other than the 17-year-old, the summaries do not indicate the severity of the blindness. None of the summaries states the clinical course of events leading to blindness.

 III. Golod's Use of Tegison

 Golod has had psoriasis since 1973, when she was 37 years old. Her psoriasis had impaired her ability to perform daily activities such as walking, writing and working. In June 1981, Golod first consulted with Dr. Marc Grossman ("Dr. Grossman"), a board-certified dermatologist in White Plains, for treatment of her psoriasis which had resisted all previous standard forms of treatment.

 In June 1985, *fn3" Dr. Grossman, who was a researcher for Hoffmann, prescribed Tegison for Golod, which she used intermittently in various doses, as her psoriasis improved and worsened, until the end of July 1990, when she discontinued use of the drug. The dosage of Tegison varied over the course of her treatment, ranging from 25mg and as much as 100mg per day during each treatment. The total amount of Tegison which Golod ingested over the five years was 46 grams. Golod was generally overweight during her course of Tegison therapy.

 After initially prescribing Tegison to Golod, Dr. Grossman supervised Golod's intermittent taking of the drug for about six years, until July 1990. From November 1984 to July 1990, Golod underwent nine discrete courses of therapy with Tegison. Dr. Grossman frequently adjusted Golod's dosage of Tegison in light of the severity of her psoriasis. Tegison was effective in ameliorating the physical symptoms of Golod's psoriasis.

 IV. Golod's Medical History Between 1984 and 1990

 Within three weeks of beginning her first course of Tegison in November 1984, Golod began experiencing pain under her rib cage on her right side and tenderness in the area of her liver. In addition to Dr. Grossman, Golod consulted Dr. Marc Berenzweig ("Dr. Berenzweig"), her family physician since 1978, regarding these symptoms. Dr. Berenzweig considered the possibility that Golod might have a "retinoid induced hepatitis." He examined Golod and ordered that she undergo certain tests, including various blood tests and a sonogram. Golod temporarily discontinued the taking of Tegison in December 1984. Dr. Berenzweig ultimately concluded that she had an abdominal pain of unknown etiology.

 Golod resumed Tegison therapy in January 1985. Less than one month later, while she was taking Tegison, Dr. Grossman noted the presence of what he called "eyelid dermatitis" and recommended an ophthalmic ointment to Golod.

 While she was taking Tegison in the 1980's, Golod experienced a variety of other symptoms including: drying of the eyes and mucous membranes; itching and burning of the eyes; peeling of the palms and soles; the curling and partial loss of hair, eyebrows and eyelashes; disintegration of the fingernails; and what she termed "vitamin A poisoning." Golod has described her ocular problems as "prevalent" during the time she was taking the drug. Prior to 1985, the time she began taking Tegison, Golod had not experienced any serious eye problems.

 From 1986 on, Golod was monitored by an ophthalmologist. In April 1986, while on a course of etretinate therapy, Golod complained of itching and tearing in her eyes. Dr. Grossman noted his observation of erythema (redness) and scaling of her upper and lower eyelids. He recommended that she discontinue the drug and consult an ophthalmologist. Mrs. Golod consulted with Dr. Marc A. Horowitz ("Dr. Horowitz"), a board-certified ophthalmologist. Dr. Horowitz determined that Golod had a cataract in her left eye commonly seen with psoriasis. He further determined that Golod was experiencing allergic conjunctivitis.

 In June 1988, Dr. Grossman again recommended that Golod discontinue Tegison in response to her complaint of dry eyes. Golod again consulted with an ophthalmologist, Dr. Alan Greenbaum ("Dr. Greenbaum"). Dr. Greenbaum noted Mrs. Golod's complaints of blurring vision in her left eye and ocular pain. He diagnosed corneal erosion and a map-dot fingerprint corneal dystrophy in her left eye, as well as an epithelial irregularity in her right eye.

 In July 1988, Golod consulted with another ophthalmologist, Dr. Henry Oksman ("Dr. Oksman"). Between July 4, 1988 and July 20, 1990 (when she last ingested etretinate), Golod consulted with Dr. Oksman on more than twenty occasions.

 Dr. Oksman treated Golod for numerous ocular conditions and complaints she had at various times between July 1988 and July 1990 -- both when Golod was on and when she was off etretinate. These complaints and conditions included: (i) keratitis sicca; (ii) loss of epithelium; (iii) corneal ulcer; (iv) double vision; (v) conjunctivitis; (vi) keratitis; (vii) epithelial irregularity and thinning; (viii) epithelial defect and possible diplopia; (ix) keratitis sicca; (x) complaint of redness of the eye and epithelial defect; (xi) corneal ulcer, epithelial defect and keratitis sicca; and (xii) right eye swelling.

 When Golod experienced ocular side effects, her dermatologist typically instructed Golod to stop taking the drug temporarily, and explained that based on his review of the package insert, (which was published in the PDR, a reference containing prescribing information for certain drugs), these side effects were expected, and that her eye problems would resolve shortly after she stopped taking Tegison. Golod had read the Tegison package insert and discussed these side effects with Dr. Grossman, but was not concerned about these adverse ocular effects, because there was no warning that these effects would be of a permanent, or a very serious nature. Golod does not remember reading literature about Tegison other than the package insert which came in the Tegison box. Moreover, ...


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