Porter v. Whitehall Laboratories, Inc.

• Citation: 791 F. Supp. 1335
• Decision Date: 30 March 1992
• Docket Number: No. IP 88-1192-C.,IP 88-1192-C.
• Parties: Manual PORTER and Phyllis Porter, Plaintiffs, v. WHITEHALL LABORATORIES, INC., American Home Products Corporation and the Upjohn Company, Defendants.
• Court: U.S. District Court — Southern District of Indiana

791 F. Supp. 1335

Manual PORTER and Phyllis Porter, Plaintiffs, v. WHITEHALL LABORATORIES, INC., American Home Products Corporation and the Upjohn Company, Defendants.

No. IP 88-1192-C.

United States District Court, S.D. Indiana, Indianapolis Division.

March 30, 1992.

COPYRIGHT MATERIAL OMITTED

Vernon J. Petri, Indianapolis, Ind., for plaintiffs.

Ralph A. Cohen, Ice Miller Donadio & Ryan, William P. Wooden, Katherine L. Shelby, Wooden McLaughlin & Sterner, Indianapolis, Ind., for defendants.

MEMORANDUM ENTRY DISCUSSING SUMMARY JUDGMENT ENTERED IN FAVOR OF DEFENDANTS WHITEHALL LABORATORIES, INC., AMERICAN HOME PRODUCTS CORPORATION AND THE UPJOHN COMPANY

TINDER, District Judge.

An essential element of each of Plaintiffs' claims against the three Defendants is that the Defendants' products (ibuprofen tablets) were in fact a cause of Plaintiff Manual Porter's injury, an acute renal failure. In their Motions for Summary Judgment, the Defendants asserted that Plaintiffs' evidence completely fails on the issue of causation. Plaintiffs are unable to overcome the challenge provided by Defendants' Motions. Based on the discussion of relevant legal principles, findings of fact and conclusions of law presented below, Defendants' Motions for Summary Judgment will be granted.

BACKGROUND

Plaintiff Manual Porter ("Mr. Porter" or "Manual"¹) fractured his left great toe on October 3, 1986; he sought treatment from his physician, Dr. Diana Wells. Dr. Wells sent Mr. Porter to Bloomington Hospital, in Bloomington, Indiana. At the hospital, Mr. Porter was treated by a Dr. Jones, who gave Mr. Porter Tylenol # 3 for his pain and requested that he return on October 10 for surgery to set the toe. Mr. Porter had continuing pain in spite of the Tylenol and returned to Dr. Wells' office on October 4. Dr. Wells knew of no contraindications to Mr. Porter receiving Motrin or Vicodin; her nurse practitioner gave Mr. Porter samples of each pain reliever. Mr. Porter took fourteen Motrin tablets between October 13, 1986 and November 7, 1986. Between November 7 and November 18, Mr. Porter took approximately fifteen Advil tablets from a bottle of twenty-four tablets his wife had purchased for him. Mr. Porter never took more than one Advil tablet at a time or more than two tablets in any single day.

Other than his injured toe, Mr. Porter had no significant health problems prior to November 19, 1986. On that day he returned to Dr. Wells' office complaining of headache, vomiting and blurred vision. Based upon Mr. Porter's symptoms, Dr. Wells sent him to Bloomington Hospital for treatment by Dr. Richard Combs, a nephrologist. Tests run by Dr. Combs indicated that Mr. Porter was experiencing an end-stage renal failure from which he would not recover.

Mr. Porter was readmitted to Bloomington Hospital in January, 1987 for a renal biopsy. That biopsy revealed an anti-glomerular basement membrane glomerulonephritis ("anti-GBM") and a membranoproliferative glomerulonephritis ("MPGN"). These are types of rapidly progressive glomerulonephritis ("RPGN"). The glomerulus is the filtering unit of the kidney. Glomerulonephritis is an inflammation and disease of the glomerulus that causes decreased renal function; RPGN is a description of glomerulonephritis that refers to how rapidly the renal function decreases. There are different types of glomerulonephritis, each having its own cause, some of which are known and some unknown. Anti-GBM is an auto-immune reaction involving the glomerular basement membrane; MPGN is another kind of glomerulonephritis caused by an immune reaction. Anti-GBM RPGN is sometimes also known as crescentic anti-GBM RPGN. RPGN is a rare and serious disease, which leads to end-stage renal failure in a significant number of cases without any ibuprofen or other drug use.

There is a separate disease process in the kidney known as interstitial nephritis, which is an inflammation of part of the kidney known as the interstitium. Interstitial nephritis often occurs as a secondary result of glomerulonephritis; the glomerulonephritis is the cause of the secondary interstitial nephritis. Samples taken from Mr. Porter indicated that he experienced interstitial nephritis also.

Mr. Porter's medical records and biopsy have been examined by the following relevant persons: Dr. Combs, the nephrologist from Bloomington Hospital; Dr. William Dick, a nephrologist at Indiana University Hospital, Indianapolis; Dr. Fred Z. Ferris, a nephrologist at Jewish Hospital in Louisville, Kentucky; Dr. Francesco Del Greco, a nephrologist; David M. Benjamin, Ph.D., a clinical pharmacologist; Dr. Richard Muther, a nephrologist; Dr. Robert McClusky, a renal pathologist; and, Dr. John Niles, a nephrologist. Statements and opinions from these medical professionals, submitted in the form of affidavits and deposition testimony, form the basis for Plaintiffs' and Defendants' claims regarding whether ibuprofen caused Mr. Porter's acute renal failure.

Defendant Whitehall Laboratories, Inc. is a subsidiary corporation of Defendant American Home Products Corporation (collectively called "Whitehall Defendants"); they make an over-the-counter pain relieving drug known as Advil, which contains 200 milligrams of ibuprofen. Defendant The Upjohn Company ("Upjohn") makes a prescription strength drug known as Motrin, which contains between 400 and 800 milligrams of ibuprofen. Ibuprofen is a type of non-steroidal anti-inflammatory drug ("NSAID"), and has been available in the form of Motrin at least since 1975.

Manual Porter's treating nephrologists testified in their depositions that Mr. Porter' kidney failure was caused by RPGN and that the disease process responsible for his RPGN was anti-glomerular basement membrane disease. (Combs Dep. at 8, 12, 22-25; Ferris Dep. at 5-6; Dick Dep. at 12.) Every other nephrologist or other expert who examined Mr. Porter's medical data and physical evidence testified that Mr. Porter's acute renal failure was caused by RPGN. (Del Greco Dep. at 69; Benjamin Dep. at 134, 222; Muther Aff. ¶ 10; McCluskey Dep. at 127; Niles Dep. at 151, 188-89.)

Ibuprofen is in the class of drugs known to cause tubular and interstitial nephritis. (Jacobs Dep. Ex. 1; Muther Dep. at 63.) The renal effects of ibuprofen have been studied for years and have been the subject of numerous studies and peer review articles in the scientific literature. There is no evidence in the record that any scientific or epidemiological tests or studies concluded that ibuprofen causes anti-GBM or MPGN or any other kind of RPGN. (Muther Aff. ¶ 11; Combs Dep. at 27-28, 91; Dick Dep. at 15-16; Ferris Dep. at 28, 44; Jacobs Aff. ¶ 8; Benjamin Dep. at 166; Del Greco Dep. at 133-34, 43.) There have been no reported cases connecting glomerulonephritis and NSAIDs. (Dick Dep. at 89; Del Greco Dep. at 153-54.) There is no known literature, study or scientific evidence that interstitial nephritis can progress to or cause any kind of RPGN. (Benjamin Dep. at 169; Del Greco Dep. at 143.) Both Dr. Ferris and Dr. Del Greco stated that a temporal relationship alone does not provide scientific proof of an iatrogenic reaction. (Ferris Dep. at 54; Del Greco Dep. at 152.)

Given the complete absence of epidemiological studies, most experts stated that there can be no reasonable degree of medical certainty that ibuprofen caused Mr. Porter's acute renal failure. Pointing to the absence of medical literature, Dr. Dick stated that he could not provide the opinion that it was more likely than not that ibuprofen was a cause of Mr. Porter's renal failure. (Dick Dep. at 52-53, 57, 89.) After initially connecting Mr. Porter's disease to ibuprofen because of their temporal relationship,² Dr. Combs reevaluated his position after a literature search disclosed no reports of an association between ibuprofen and RPGN. (Combs Dep. at 91.) Dr. Ferris stated consistently that he did not know what caused Mr. Porter's crescentic glomerulonephritis. (Ferris Dep. at 85.)

Three other experts agreed that no studies show any causal relationship between ibuprofen and the type of acute renal failure experienced by Mr. Porter; notwithstanding, these experts postulated theories describing such a relationship. Dr. Ferris stated that was a "theoretical possibility" that ibuprofen "aggravated a kidney problem that might have independently or separately developed while Manual was taking some of these medications." (Ferris Dep. at 70-71, 89-90.)³ Given that his alternative "aggravation theory" was merely a hypothesis — based solely on the temporal relationship (Id. at 73) — Dr. Ferris could not state to a reasonable degree of scientific probability that Mr. Porter would not have had a total renal failure in the absence of ibuprofen even if ibuprofen did aggravate an existing condition. (Id. at 92.) Dr. Benjamin stated his opinion that ibuprofen caused an unspecified kidney condition which progressed to RPGN in an unexplained manner, although he stated further that he knew of no study or data providing such a relationship and also demonstrated a general lack of knowledge of the diseases from which Mr. Porter suffered. (Benjamin Dep. at 168-170.)

While stating that medical studies and his own research on ibuprofen have provided no scientific support (Del Greco Dep. at 107-09, 114), Dr. Del Greco stated his personal hypothesis that ibuprofen caused Mr. Porter's interstitial nephritis which then progressed to glomerulonephritis. (Id. at 75-80, 133-35, 43.) Dr. Del Greco agreed that there was no scientific proof for this theory, and that it was "a hypothesis, the proof of which remains to be made." (Id. at 146.) As with every other expert, Dr. Del Greco testified that Mr. Porter could have had the same condition whether or not he ever took ibuprofen. (Id. at 114.) Dr. Del Greco agreed that if Mr. Porter's RPGN was caused by ibuprofen, then it would be the first such case known to medical science. (Id. at 153-54.)

Plaintiffs' Amended...