The
Montgomery
Law Firm, LLC

Bayer AG removed Trasylol (aprotinin) from the market worldwide after studies revealed that the drug can cause kidney damage and cardivascular side effects. Trasylol is used to control bleeding during heart bypass surgery and other serious surgical procedures. Because the drug is administered intravenously and after anesthesia, most patients do not know if Trasylol was used during their surgery. The complications associated with Trasylol has led to an increased risk of death in patients receiving Trasylol versus older, less expensive medications. One researcher estimated that at many as 22,000 could have suffered fatal side effects as a result of Trasylol.

Trasylol, also known as aprotinin, is a blood-clotting drug used during heart surger to prevent bleeding, and was pulled from the market in November 2007 because of serious adverse side effects including renal failure and death. On February 17, 2008 CBS News' 60 Minutes reported how manufacturer Bayer conducted a Trasylol study lead by a prominent Harvard physician and deceptively kep the negative research findings from the FDA and the unsuspecting public, delaying the recall in an effort to boost sales and dominate the cardiac surgery market. Bayer know of Trasylol's serious advers health effects long before the recall, and reported nothing for more than two years, durning which time it's estimated that the drug contributed to the loss of one thousand lives a month.

In 2006, Dr. Dennis Mangano, an eminent medical researcher, completed a study that followed more than 5,000 patients, the largest Trasylol study every conducted. The study showed an important association between the drug and kidney failure requiring dialysis. In early 2006, Mangano presented his study to the FDA's advisory committee, but it was not embraced wholeheartedly because the study looked at hospital records of real-world patients, and was not a clinically controlled experiment testing Trasylol against a placebo.

At the same time, Bayer was holding the results of it's own study, led by Alexander Walker of Harvard, with much of it concurring what Dr. Mangano's study had already shown. Bayer representatives stood before the advisory committee and did not reveal that their study and negative findings even existed. A member of the FDA advisory committee, Dr. William Hiatt told 60 Minutes that had he known about Bayer's study at that first meeting, he would have voted to take Trasylol off the market.

In 2007, the Canadian government conducted it's own large clinical trial of Trasylol, but the study had to be stopped because patients in the study group were dying as a result of taking Trasylol. When the study was halted, Germany banned Trasylol, and both Canada and the FDA persuaded Bayer on November 5th, 2007 to pull worldwid sales of Trasylol.

There were concertns about Trasylol even before it go FDA approval in 1993. In the early 1980's, Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, the hometown of Bayer no less, found severe kidney damage in animals given Trasylol. He reported his findings to Bayer, but felt the manufacturer wasn't interested in examining these side effects. Soon after, the same side effects were being seen in patients in America.

In 1992, a small sudy was conducted, not funded by Bayer, in which Trasylol was given to 20 patients. Thirteen of these patients had problems with kidney failure after the procedure, a definite red flag. Safety concerns are often hard to assess until thousands of patients have been given the drug. But since Bayer never paid for any studies to determine whether there was a kidney failure problem, and their research did show that Trasylol controlled bleeding, the FDA approved it in 1993.

Bayer has marketed the drug aggressivly, getting the FDA in 1998 to expand its approval to cover all heart bypass patients. It is estimated that by 2005, nearly 1/3 of all cardiac surger patients were being given Trasylol, totaling nearly $300 million in sales annually.

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Date of Birth: mm 01 02 03 04 05 06 07 08 09 10 11 12 dd 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 yyyy 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954 1953 1952 1951 1950 1949 1948 1947 1946 1945 1944 1943 1942 1941 1940 1939 1938 1937 1936 1935 1934 1933 1932 1931 1930 1929 1928 1927 1926 1925 1924 1923 1922 1921 1920 1919 1918 1917 1916 1915 1914 1913 1912 1911 1910 1909 1908 1907 1906 1905 1904 1903 1902 1901 1900 Whom are you inquiring on behalf of? Minor Other Self If you are NOT inquiring on your own behalf, what is your relationship? Is the person deceased? Yes No If deceased, the cause of death as stated on the death certificate:  Date of Death: mm 01 02 03 04 05 06 07 08 09 10 11 12 dd 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 yyyy 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954 1953 1952 1951 1950 1949 1948 1947 1946 1945 1944 1943 1942 1941 1940 1939 1938 1937 1936 1935 1934 1933 1932 1931 1930 1929 1928 1927 1926 1925 1924 1923 1922 1921 1920 1919 1918 1917 1916 1915 1914 1913 1912 1911 1910 1909 1908 1907 1906 1905 1904 1903 1902 1901 1900 Was there an autopsy performed? Yes  No  n/a Is the person diabetic Yes  No Did the person have any preexisting kidney dysfunction? Yes  No If YES, what conditions? Did the person have any other conditions being treated with long-term medications? Yes  No If YES, what condition(s)/medication(s)? Has the person had Heart Surgery? Yes  No If YES, date of Heart Surgery: mm 01 02 03 04 05 06 07 08 09 10 11 12 dd 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 yyyy 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954 1953 1952 1951 1950 1949 1948 1947 1946 1945 1944 1943 1942 1941 1940 1939 1938 1937 1936 1935 1934 1933 1932 1931 1930 1929 1928 1927 1926 1925 1924 1923 1922 1921 1920 1919 1918 1917 1916 1915 1914 1913 1912 1911 1910 1909 1908 1907 1906 1905 1904 1903 1902 1901 1900 Hospital where Heart Surgery was performed: Hospital Address: Operating Physician's Name: Operating Physician's Address Did the person suffer Kidney Damage after the Heart Surgery was performed? Yes  No If YES, how long after the surgery was the Kidney Damage? Did the person receive Dialysis? Yes  No If YES, how long after the surgery was the Dialysis? Did the person suffer a Heart Attack or Stroke after the Heart surgery? Yes  No If YES, how long after the surgery? Did any doctor tell you that the drug Trasylol was used during your Heart Surgery? Yes  No If YES, doctor's name and address: Did any doctor give you an explanation of why this happened to you? Yes  No If YES, doctor's name and address: What did the doctor say?

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