Engineering Ethics

1994: Bjork-Shiley Heart Valve Defect 107

In prescribing such regulations, the Secretary shall have due regard for

the professional ethics of the medical profession and the interests of

patients. The prohibitions of paragraph (7) of this subsection continue to

apply to records, reports, and information concerning any individual who has

been a patient, irrespective of whether or when he ceases to be a patient.

The Secretary shall by regulation require distributors to keep records and

make such records available to the Secretary upon request. Paragraphs (4)

and (8) apply to distributors to the same extent and in the same manner as

such paragraphs apply to manufacturers and importers. (USC, 2005)

AN ENGINEERING PERSPECTIVE

In 1980, Bjork became aware that valve-strut failures were occurring and

demanded corrective action. Although known as a surgeon, Bjork was in

essence also a biomedical engineer who co-designed the Bjork-Shiley valve.

Bjork threatened to publish cases of valve-strut failures. A panicked Shiley

executive telexed: “ATTN PROF BJORK. WE WOULD PREFER THAT

YOU DID NOT PUBLISH THE DATA RELATIVE TO STRUT FRAC-

TURE.” The executive’s reason for holding off public exposure of the failure

was “WE EXPECT A FEW MORE.” Bjork kept silent (Palast, 1998) until

he began publishing his corrective action investigations in 1985 (Bjork, 1985).

REFERENCES

Bjork, V. O., The development of the Bjork-Shiley artificial heart valve. Clin Cardiol, Jan,

1984, 7, 3–5.

Bjork, V. O., Metallurgic and design development in response to mechanical dysfunction of

Bjork-Shiley heart valves. Scand J Thorac Cardiovasc Surg, Jan, 1985, 19, 1–12.

de Mol, B. A., Kallewaard, M., McLellan, R. B., van Herwerden, L. A., Defauw, J. J., and van

der Graaf, Y., Single-leg strut fractures in explanted Bjork-Shiley valves. Lancet, Jan 1,

1994, 343, 9–12.

Food and Drug Administration (FDA), Support Statement for Medical Devices: Current Good

Manufacturing Practice (CGMP), Quality System (Q/S) Regulation. 21 CFR Part 820,

OMG No. 0910–0073. 2004. http://www.fda.gov/ohrms/dockets/98fr/04n-0034-ss00001.pdf.

Lindblom, D., Bjork,V. O., and Semb, B. K. H., Mechanical failure of the Bjork-Shiley valve.

J Thorac Cardiovasc Surg, May, 1986, 92, 894–907.

Lindblom, D., Rodriguez, L., and Bjork, V. O., Mechanical failure of the Bjork-Shiley valve.

J Thorac Cardiovasc Surg, Jan, 1989, 97, 95–97.

Meier, B., Pfizer unit to settle charges of lying about heart valve; Pfizer unit to settle U.S. charges.

NY Times, A33, July 2, 1994.

Michaud, A., Shiley Inc. settles false-claims suit courts: Irvine-based firm and its parent to

pay $10.75 million to U.S. in case involving flawed artificial heart valves. LA Times, A1,

July 1, 1994.

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