Ranes v. Adams Laboratories, Inc.

Decision Date05 February 2010
Docket NumberNo. 06-1428.,06-1428.
Citation778 N.W.2d 677
PartiesBryan RANES, Appellant, v. ADAMS LABORATORIES, INC.; Adams Respiratory Therapeutics; Owl Pharmacy; Frank Reznicek; Amanda Mathews; Hy-Vee, Inc.; McKesson Corporation; and Michael Rinaldi, Appellees.
CourtIowa Supreme Court

Curt N. Daniels, Chariton, for appellant.

Stephen R. Eckley of Belin Lamson McCormick Zumbach Flynn, P.C., Des Moines, for appellee Adams Laboratories, Inc.

Thomas H. Walton and Kristina M. Stanger of Nyemaster, Goode, West, Hansell & O'Brien, P.C., Des Moines, for appellees Owl Pharmacy, Frank Reznicek, and Amanda Mathews.

Kermit B. Anderson and Stacie M. Codr of Finley, Alt, Smith, Scharnberg, Craig, Hilmes & Gaffney, P.C., Des Moines, for appellee Hy-Vee, Inc.

Patrick H. O'Neill, Jr. of O'Neill & Murphy, LLC, St. Paul, Minnesota, and William J. Bush of Bush, Motto, Creen, Koury & Halligan, P.L.C., Davenport, for appellee McKesson Corporation.

Michael H. Figenshaw of Bradshaw, Fowler, Proctor & Fairgrave, P.C., Des Moines, for appellee Michael Rinaldi.

CADY, Justice.

In this appeal from various summary judgment rulings by the district court in a toxic-tort case involving a claim that the ingestion of prescription medication allegedly containing phenylpropanolamine caused brain injury, we primarily consider the admissibility of testimony from an expert witness that the injuries allegedly suffered by the plaintiff were caused by the ingestion of phenylpropanolamine. The district court determined the causation opinion by the expert witness would be inadmissible at trial and granted summary judgment to the defendants. On appeal, we affirm the decision of the district court.

I. Background Facts and Proceedings.

Phenylpropanolamine (PPA) is a drug that was used over the course of three decades as an ingredient in many cough and cold products, as well as in appetite-suppressant products. It was approved by the Food and Drug Administration (FDA) in the 1970s as safe and effective and eventually became one of the most commonly used drug ingredients in the United States. It was widely used in both prescription and over-the-counter drugs, with billions of doses sold each year.

In November 2000, the FDA notified manufacturers and distributors of drug products containing PPA that a recent epidemiological study, conducted by the Yale University School of Medicine in collaboration with the FDA and manufacturers of PPA, had found a low risk of hemorrhagic stroke among women who used weight-loss products containing PPA. The FDA did not initiate a drug recall in response to the study, but recommended drug companies discontinue marketing products containing PPA. The study found no increased risk of hemorrhagic stroke among men who used products with PPA. It also found no increased risk among women who used cold and cough products containing PPA, but suggested such products presented a possible risk for hemorrhagic stroke in women based on the increased risk found with weight-loss products. See Walter N. Kernan, et al., Phenylpropanolamine and the Risk of Hemorrhagic Stroke, 343 New Eng. J. Med. 1826, 1826-32 (2000) [hereinafter Kernan].

The FDA recommendation was widely reported to the public by the news media. Most manufacturers of the drug products containing PPA promptly responded to the announcement by discontinuing the distribution of their products containing PPA, including Adams Laboratories, Inc. and Adams Respiratory Therapeutics, the manufacturers of a prescription cough and cold medicine containing PPA called "Aquatab C." Adams also notified distributors and customers to return the product. Adams then reformulated Aquatab C by substituting PPA with pseudophedrine and made the new product available in March 2001. Aquatab C was distributed for Adams by McKesson Corporation.

On February 4, 2002, Bryan Ranes ingested Aquatab C. He had gone to Mercy Medical Center in Centerville with complaints of a sore throat, congestion, and a stuffy nose. He was seen by Dr. Michael Rinaldi, who prescribed three medications, including Aquatab C. Ranes' mother went to Owl Pharmacy in Centerville to fill the Aquatab C prescription. The pharmacist who filled the prescription was Amanda Mathews. The supervising pharmacist at Owl Pharmacy was Frank Reznicek. Owl Pharmacy did not have Aquatab C in stock at the time, but obtained it for Ranes from a nearby Hy-Vee Pharmacy.

Within thirty-five minutes of ingesting a tablet of Aquatab C, Ranes claimed he began to experience intense and excruciating pain on the left side of his head and numbness in his left arm and left side of his head. These symptoms, and many others, allegedly reoccurred after Ranes ingested additional tablets of Aquatab C.

In the months and years that followed, Ranes was seen by a number of physicians at a number of medical facilities both in and outside Iowa for a growing number of symptoms and complaints. The complaints and symptoms Ranes reported included convulsions, urinary incontinence, unsteady walk, vision and hearing problems, back and chest pain, diarrhea, altered taste and smell, muscle spasms, arm pain and weakness, tremors, numbness, and even the sight of worms crawling out of his hands. Some of the symptoms predated the ingestion of PPA. Prior to Ranes' visit with Dr. Rinaldi, on November 14, 2001, Ranes was examined at the Centerville Medical Clinic by Dr. Donald Fraser for multiple complaints of pain in every body part. The results of the examination were normal, and Dr. Fraser believed the complaints may have been attributable to general psychiatric problems such as hypochondriasis and chronic anxiety.

Following Ranes' visit with Dr. Rinaldi on February 4, 2002, Ranes was examined by a variety of physicians. An examination at Mercy Hospital in Des Moines on February 8, 2002, four days after Ranes was prescribed Aquatab C, included an MRI of the brain. The MRI was unremarkable, and the neurological examination by Dr. Paul Babikian was normal. Dr. Babikian testified he did not believe Ranes suffered from vasculitis of the cerebral vascular system. Subsequently, on March 6, 2002, Ranes was seen by Dr. Hala Shamsuddin, an infectious disease specialist at the University of Iowa Hospitals and Clinics. The accompanying neurological examination was normal, although Dr. Shamsuddin's records indicate Ranes may have been suffering from somatization disorder (a multisymptomatic disorder characterized by multiple physical complaints with no known medical explanation) and delusions of parasitosis. A CT scan at Mercy Medical Center in Des Moines on March 13, 2002, was normal, with no indication of intracranial hemorrhage. Ranes was subjected to a multispecialty team evaluation conducted at Mayo Clinic in Rochester, Minnesota, from March 25, 2002, to April 26, 2002. A CT scan of the brain was normal, and no neurological disorder was observed by neurologist Dr. Jeffrey Britton. Doctors could find no indication of a stroke, intracranial hemorrhage, or seizure. An MRI, MRA, CT scan, and spinal tap conducted at St. Anthony's Regional Medical Hospital in Rockford, Illinois, on April 30, 2002, showed no abnormalities. St. Anthony's neurosurgeon Dr. Charles Wright could not diagnose Ranes with a neurological disorder, but his summary reported possible significant depression. Still unsatisfied with the results, Ranes went to the University of Nebraska Medical Center on August 8, 2002. An MRI of the brain and an MRA of the heart conducted at the University of Nebraska Medical Center were normal. A neurological exam conducted at Creighton Medical Center on September 10, 2002, was normal. Finally, on November 11, 2003, an examination performed at Washington University School of Medicine by Dr. Jin-Moo Lee, a stroke neurologist and assistant professor of neurology, concluded the symptoms displayed by Ranes from February of 2002 to date were not consistent with a stroke. Dr. Lee considered PPA in his analysis and ruled it out due to the absence of stroke in Ranes' case.

On March 5, 2004, Ranes filed a lawsuit against multiple individuals and corporations based on multiple legal claims, including negligence, strict liability, fraudulent nondisclosure, breach of fiduciary duty, battery, and infliction of emotional distress. Underlying each legal claim was an allegation that the ingestion of Aquatab C supplied by the defendants was the cause of a brain stroke or other neurological event that resulted in his myriad ailments.

Ranes continued to seek out medical evaluations after he filed his lawsuit. In April of 2004, Ranes was examined at the McFarland Clinic in Ames by Dr. Michael Kitchell, a neurologist. Dr. Kitchell found some indication of neurological problems, but no evidence of a stroke. Dr. Kitchell believed, to a reasonable degree of medical certainty, that Ranes' symptoms were not associated with PPA. In April and May of 2005, Dr. Terry Rolan and Dr. Dale Vaslow at the University of Missouri School of Medicine similarly found Ranes suffered from neurologically related symptoms, but his problems were not associated with a cerebral hemorrhage. They too did not believe Ranes' case was associated with PPA, but rather most likely a "parainfectious autoimmune event leading to a brain stem encephalitis." Dr. Rolan also believed Ranes likely had a psychological aspect to his problems.

During the course of the legal proceedings, Ranes identified Dr. Mark Thoman as an expert witness who would testify at trial in support of his claim that his ailments resulted from a brain stroke or otherwise permanent, progressively degenerative neurological sequelae caused by the ingestion of Aquatab C containing PPA. Dr. Thoman is a specialist in toxicology and has primarily practiced medicine as a pediatrician. He is not a neurologist and has not authored any reports or articles on the effects of PPA. He is not one of Ranes' treating physicians and has never examined him. Dr....

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