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Estate of Lamontagne v. Bristol-Myers Squibb4/4/2005
Concurring: Ronald Cox, William Baker
PUBLISHED OPINION - Motion to Publish Granted May 10, 2005
Juliann Dollmeyer, the personal representative of the Estate of Sandra LaMontagne (the Estate) appeals the trial court's decision on summary judgment to dismiss the Estate's prescription drug product liability claims against Bristol-Myers Squibb Company (BMS). The Estate contends there are material issues of fact about whether the "contraindication" section of the package insert for the prescription drug Glucophager adequately warned doctors of the risks of lactic acidosis for Type II diabetic patients who also have kidney dysfunction. The Estate also contends there are material issues of fact about whether the negligence of BMS was the proximate cause of Sandra LaMontagne's death and whether the Estate's lawsuit is barred by the statute of limitations. We conclude the warnings contained in the Glucophager package insert repeatedly and unmistakably warn doctors of the risk of lactic acidosis and the risks of using Glucophager for patients with kidney dysfunction. We affirm.
FACTS
Sandra LaMontagne, a 58-year-old woman, suffered from a number of long standing health problems including Type II diabetes, kidney dysfunction, liver impairment, obesity, and congestive heart failure.
In 1995-96, LaMontagne experienced several serious episodes of dangerous blood sugar level fluctuations. Despite using insulin for her diabetes, LaMontagne's blood sugar levels were abnormal and she experienced increased edema (swelling). Her primary physician, Dr. Adrian Call, testified that he was having difficulty successfully treating and controlling LaMontagne's diabetes.
On January 9, 1997, LaMontagne was admitted to Northwest Hospital for anemia and hyperkalemia (elevated potassium levels) and was given blood transfusions. LaMontagne was also continuing to suffer from edema that resulted in a weight gain in one month of 30-40 pounds. According to laboratory tests taken on January 17, LaMontagne an elevated creatinine level of 2.0 mg/dL. For females, a creatinine level above 1.4 mg/dL is abnormal and indicates kidney dysfunction. The laboratory tests also indicated liver impairment with a GGT level of 740. A GGT level for a healthy person is 0-40.
On January 20, Dr. Call prescribed Glucophager to control LaMontagne's diabetes. In 1997, Glucophager was a relatively new drug used to treat insulin-resistant diabetic patients. Dr. Call learned about Glucophager from reading articles and lectures and had previously used Glucophager to treat 10-20 other diabetic patients.
BMS manufactures the drug metformin under the brand name of Glucophager. After receiving Federal Drug Administration (FDA) approval, BMS began marketing Glucophager in the United States in 1995. When metformin accumulates in the blood, it can cause lactic acidosis, a serious and sometimes fatal condition. Metformin is primarily removed from the body by the kidneys. The risk of lactic acidosis significantly increases when a patient has kidney dysfunction. Other risk factors include liver impairment and heart problems including congestive heart failure.
LaMontagne took Glucophager from January until June 1997. The testimony of LaMontagne's doctors and the medical records establish that they prescribed Glucophager even though she had kidney dysfunction, the primary risk factor identified for lactic acidosis. During the entire time LaMontagne took Glucophager, her creatinine level never dropped below 2.0 mg/dL.
Dr. Call testified that he knew when he prescribed Glucophager that LaMontagne had known risk factors including
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