Case Study On Misbranded Medical Device

Acu-dot is a magnetic analgesic patch which is used to relieve pain in the muscles and joints temporarily. They are small, pin sized magnets attached to an adhesive patch. These were sold to the public as sheets and were also given a pamphlet which read the clear instructions about how to use the device. The pamphlet vaguely informed about the information of the outer packaging. However it was written that it is "Not a pill, not a drug and Easy to use. "Facts: Several claims were made by the people who sold the product saying it reduces minor muscle and joint pains by improving blood circulation as the magnet present in each patch attracts the iron in the blood. However some people were against the device saying that the labeling of the device was falsely claimed and misleading people and hence a case was filed against the device.

Issue

Any device that is misbranded is liable to be proceeded against and condemned in any district court of the US within the jurisdiction the article is found. The device shall be deemed to be misbranded if the label is false or misleading unless the labeling bears adequate instructions for use (21 U. S. C. 334). The petitioner claims that the Acu-dots are "misbranded", as that term is used in 21 U. S. C. § 352, in the labeling is "false or misleading" (subsection (a)) and "fails to bear adequate directions for use" (subsection (f) (1)). The device is therefore subject to seizure under 21 U. S. C. § 334. So, the sole issue presented to the Court was whether the Acu-dot devices are ‘misbranded' or not. LEGAL STANDARDUnder the Food, Drug and Cosmetics Act, any drug or device manufacturer must comply with current Good Manufacturing Practice requirements. The medical device –ACU-DOT is "misbranded", as set forth in 21 U. S. C. § 352(a) because it’s labeling is "misleading. " So the device should be properly seized and condemned, as provided for in 21 U. S. C. § 334

Analysis

Both the petitioner and the party presented evidence to the court whether the device was misbranded or not. The petitioner came up with strong evidence focusing on one point that the descriptions of the device was read as "magnetic analgesic patch[es]" and "for temporary relief of occasional minor aches and pains of muscles and joints. The petitioner further submitted few evidence of Results to court which were the studies conducted by three experts- one biophysicist and two medical doctors. The results showed that none of the theories offered by the party were valid explanations for the mechanism by which the devices were to achieve their results. Adding to it the three experts proved that the kind of mechanism mentioned by the party claimed to treat the pain would be possible only with a placebo effect-which is not a valid theory.

On behalf of proving the effectiveness of the medical device the party also presented many evidences explaining several theories for the mechanism of the device. They explained that the magnetic action of the device `drew' blood to the affected area, which action had the therapeutic effect. They also added that that the blood, being composed i iron-based chemicals, produced an electromotive force within the body when passing through the field of the magnet, which is similar to that of the electric generators producing electricity by moving an electric wire through a magnetic field. Hence, the pressure of the device against the skin creates therapeutic effects in a way much similar to acupuncture techniques. However, each of the government witnesses was able to suggest major flaws in the concept explained by the party which had very weak theoretical support for the mechanism of the device.

Conclusion

The petitioner won the case and the Officials of the FDA Agency informed the party (claimant-intervener) by letter of November 8, 1978, that proposed labeling for the Acu-dot was not satisfactory and would be in violation of the Food and Drug Act. The Court further informed the party that it does not encourage any party to market a product that works only by means of a placebo effect on the basis that it nevertheless often achieves a relief of pain as claimed. The medical device of this action is properly seized and condemned, as provided for in 21 U. S. C. § 334.

I totally agree with the decision made by the court as the Acu-dot is not inherently capable of creating an analgesic effect, hence misleading people by misbranding their product. I support the explanation of The "placebo effect" which is a curative effect caused by a biologically inert substance that can be attributed more to the mental relief of the patient than to any effect of the drug or device on the disorder. The most commonly-known placebo is the `sugar pill'. One important attribute of the placebo is that it has its effect only because the patient believes it will work. An unbelieving patient will not be cured by the effect of a placebo. Therefore I believe that any medical device which is misbranded with false labeling and advertising in order to attract the customers and make money should not be encouraged and should be seized.