Drug Safety

Drug Safety

Washington Supreme Court rules medical device maker has duty to warn hospitals about defects.

The AP (2/9) reports the Washington Supreme Court held that Intuitive Surgical Inc. has a duty to warn hospitals, as well as physicians, about defects in their products. The 6-3 decision emphasized that warnings to physicians “didn’t excuse the company’s duty to warn the hospital” involved in the case. The ruling “overturned a Kitsap County jury and ordered a new trial” against Intuitive Surgical Inc.

Abbott Laboratories halts use of HeartMate PHP blood pump after death, malfunctions.

The Minneapolis Star Tribune (2/9, 1.27M) reports Abbott Laboratories announced it is halting the use of the HeartMate PHP catheter, a “commercially promising blood pump,” in the US and Europe in response to a patient death and several malfunctions. Abbott said in a Feb. 6 recall notice, published Thursday in the Federal Institute for Drugs and Medical Devices in Germany, that “it has received eight reports of pumps stopping during high-risk procedures to unlock blood vessels.” The company said the “eight problems affected 1.9 percent of the devices shipped, implying about 420 units in the market are affected by the Feb. 7 recall notice,” according to the Star Tribune. Clinicaltrials.gov, which is maintained by the National Institutes of Health, “says the study’s 64 sites around the United States include the University of Minnesota Medical Center Fairview in Minneapolis and the Mayo Clinic in Rochester.”

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