Estate of LaMontagne v. BMS

111 P.3d 857
CourtCourt of Appeals of Washington
DecidedMay 23, 2005
Docket53489-1-I
StatusPublished

This text of 111 P.3d 857 (Estate of LaMontagne v. BMS) is published on Counsel Stack Legal Research, covering Court of Appeals of Washington primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Estate of LaMontagne v. BMS, 111 P.3d 857 (Wash. Ct. App. 2005).

Opinion

111 P.3d 857 (2005)

ESTATE OF Sandra LaMONTAGNE, Donald LaMontagne, as Personal Representative of the Estate, Donald LaMontagne, Individually and as Heir of the Estate; Lynn Dollmeyer, Individually and as Heir of the Estate; Juliann Dollmeyer, Individually and as Heir of the Estate, Merrilee Buckley, Individually and as Heir of the Estate, Marlee Riggin, Individually and as Heir of the Estate, June Meehan, Individually and as Heir of the Estate, December LaMontagne, Individually and as Heir of the Estate, Scott LaMontagne, Individually and as Heir of the Estate, Appellants,
v.
BRISTOL-MYERS SQUIBB, a Corporation with its principal place of business in the State of Connecticut; Joseph Eschbach, MD and Jane Doe Eschbach, his wife and their marital community; Adrian Call, MD and Jane Doe Call, his wife and their marital community; John Doe No. 1, and Jane Doe No. 1, his wife and their marital community; John Doe No. 2 and Jane Doe No. 2, his wife and their marital community; John Doe No. 3, a manufacturer of generic metformin, Respondents.

No. 53489-1-I.

Court of Appeals of Washington, Division 1.

April 4, 2005.
Publication Ordered May 4, 2005.
As Corrected May 23, 2005.

*858 Ralph D. Pittle, Bellevue, WA, for Appellants.

Michael R. Scott, Seattle, WA, for Respondents.

SCHINDLER, J.

¶ 1 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 Glucophage® 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 Glucophage® package insert repeatedly and unmistakably warn doctors of the risk of lactic acidosis and the risks of using Glucophage® for patients with kidney dysfunction. We affirm.

FACTS[1]

¶ 2 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.

¶ 3 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.

*859 ¶ 4 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.[2] The laboratory tests also indicated liver impairment with a GGT level of 740. A GGT level for a healthy person is 0-40.

¶ 5 On January 20, Dr. Call prescribed Glucophage® to control LaMontagne's diabetes. In 1997, Glucophage® was a relatively new drug used to treat insulin-resistant diabetic patients. Dr. Call learned about Glucophage® from reading articles and lectures and had previously used Glucophage® to treat 10-20 other diabetic patients.

¶ 6 BMS manufactures the drug metformin under the brand name of Glucophage®. After receiving Federal Drug Administration (FDA) approval, BMS began marketing Glucophage® 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.

¶ 7 LaMontagne took Glucophage® from January until June 1997. The testimony of LaMontagne's doctors and the medical records establish that they prescribed Glucophage® even though she had kidney dysfunction, the primary risk factor identified for lactic acidosis. During the entire time LaMontagne took Glucophage®, her creatinine level never dropped below 2.0 mg/dL.

¶ 8 Dr. Call testified that he knew when he prescribed Glucophage® that LaMontagne had known risk factors including kidney dysfunction, liver impairment and congestive heart disease and he knew her creatinine levels were elevated.

Q: Now, first of all, did you have any concern at that time that she had any evidence of renal impairment?
A: I did have concern about her renal function. She had had some blood work done in January of '97, January 9th of "97, where her creatnine was 2.5. And she had one subsequent to that visit on January 28, '97 where her creatinine value was 2.3.[3]
....
Q: When you started her on Glucophage she had a known risk factor for lactic acidosis, that being renal impairment, evidenced by elevated creatinine levels, correct?
A: Yes.[4]
....
Q: Another risk factor for lactic acidosis in patients receiving Glucophage is congestive heart failure, is that correct?
A: Yes.
Q: Did Sandra LaMontagne have congestive heart failure during the time that she was receiving Glucophage under your prescription?
A: Yes, I believe that she did have congestive heart failure.[5]

But in Dr. Call's clinical judgment, Glucophage® was the only option left to try and manage LaMontagne's diabetes. At the time there were only three drugs available to control her diabetes and the first two had failed.

¶ 9 Shortly after prescribing Glucophage®, Dr. Call referred LaMontagne to Dr. Joseph Eschbach, a nephrologist, for an evaluation of her kidney dysfunction and edema. Dr. Eschbach knew LaMontagne's creatinine level had elevated to 2.3 mg/dL, and also understood the risks in using Glucophage®. Dr. *860 Eschbach also testified that Glucophage® was the only viable option to manage her diabetes and its benefits out weighed the risks:

Q: Did you understand in January of 1997 that metformin was expressly contraindicated in patients with creatinine levels as high as 2.3?
....
A: I understood the risk involved.
Q: Did you have any concern that the risks exceeded the benefits of metformin as a choice of managing Ms. LaMontagne's diabetes?
A: This had to be put in perspective. It was the only the drug that was managing her diabetes. There were only three drugs available at that time to manage diabetes. The first two failed to do so, and that is why she was placed on metformin. And her husband made it very clear that this drug was the only drug that was controlling her diabetes.[6]

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Bluebook (online)
111 P.3d 857, Counsel Stack Legal Research, https://law.counselstack.com/opinion/estate-of-lamontagne-v-bms-washctapp-2005.