The A.H. Robins company purchased the rights to the Dalkon Shield IUD in 1970 and began aggressively marketing it in 1971 despite limited testing. This led to over 4 million women using the faulty product, which had a dangerous multifilament tail that caused infections, miscarriages, and deaths in some cases. The company faced over 300,000 lawsuits due to the health issues and costs of over $2 billion, resulting in the company declaring bankruptcy in 1985.

1. A.H. Robbins
‘The Dalkon Shield’

2. Company
A.H. Robbins
Industry
Pharmaceuticals

3. Stakeholders
-Owners or Shareholders of the company
-FDA –Government
-Management of A.H. Robbins
-Consumer (Women)
-Physicians
-Inventor

4. A small, family-owned pharmaceutical company best
known as the manufacturers of Chap Stick and
Robitussin cough syrup
Purchased ownership of the Dalkon Shield, a new
intrauterine device (IUD) at the time
120 years without any Product liability lawsuit

5. The Dalkon Shield
- An Intrauterine Device (IUD)
- Developed by Davis
- In 1970 the A.H. Robins Company acquired the Dalkon Shield from the
Dalkon Corporation, founded by Hugh J. Davis, M.D.
- In 1971, Dalkon Shields went to the market, beginning in the United
States and Puerto Rico, spearheaded by a large marketing campaign.
- At its peak, about 2.8 million women used the Dalkon Shield in the U.S.
- At the time of its introduction, the Dalkon Shield was promoted as a
safer alternative to birth control pills
- By 1975, there were more than four million Dalkon Shields in use all over
the world

6. Reasons for Popularity
- Interest in birth control measures had dramatically increased in the
1960s, and big profits were being made from contraceptives
- Negative side effects from oral contraceptives. (birth-control pills)
Women had the desire to seek out better contraceptives that seemed to
have no side effects and be effective as well.
- Davis wrote a book and several articles promoting his device over the
others.
- At this time, there were over 70 IUDs on the market. IUDs were
increasingly popular among physicians, because they were not associated
with the demonstrated adverse effects of the Pill and had a high "use-
effectiveness" ratio

7. Problems
- Dalkon Shield had had precious little testing before Robins purchased
the rights to it.
- The major problem with the Dalkon Shield was the “tail” that allowed for
its removal by a physician.
- The Dalkon Shield had a multifilament tail—it was made up of hundreds
of pieces of plastic that proved to be an efficient breeding ground for
bacteria.
- This tail could introduce bacteria into the user’s uterus, and the result
could be severe sepsis that could cause massive infection, sterility,
miscarriage, or death.

8. Effects on Consumers
- Increased rate of pregnancy-associated complications leading to
hospitalization
- A total of 16,994 physicians responded, yielding 3,502 unique case
reports of women hospitalized in the first 6 months of 1973.
- The CDC estimated that a total of 7,900 IUD related hospitalizations
occurred during this 6-month period
- Annual device-related hospitalization rate of 5 per 1000 IUD users.
- Survey provided 5 reports of device-related fatalities, with 4 of these
related to severe infection
- CDC estimated an IUD-related fatality rate of 3 per million users per year
of use, which it compared favorably to the mortality risks associated with
pregnancy and other forms of contraception.

9. Aftermath
- More than 300,000 lawsuits were filed against the A.H. Robins Company
– the largest tort liability case since asbestos.
- The cost of litigation and settlements (estimated at billions of dollars) led
the company to file for Chapter 11 bankruptcy protection in 1985.
- As a result, Robins sold the company to American Home Products
- In 1976, the Medical Device Amendments to the Food, Drug, and
Cosmetic Act mandated the U. S. Food and Drug Administration, for the
first time, to require testing and approval of "medical devices", including
IUDs

11. Consumer
Safety
Product
Liability
Manipulative
Tactics
Falsified
Advertising
Ethical Issues

12. Consumer safety
 In 1971 Robbins began to market and sell the Shield on the basis of
Davis’s “limited analysis” aggressively.
 Though he commissioned a major long-term study to reinforce Davis's
results. But, he started marketing before getting full results of the study.

13. Consumer safety: Unethical In light of
Virtue Theory
 We seek happiness for its own sake, but happiness occurs as we search
for other virtues.- Aristotle
 The search for profits is best achieved when a business gives its highest
priorities to values other than the sought for profits

14. Falsified Advertising
 Robin is guilty of advertising, they new relatively untested, undependable
and therefor potentially dangerous.
 Critics claimed Robins has been involved in directly ordered prolonged
institutional cover up of the short-term and long term possible side effect
of the shield.

15. Falsified Advertising :Unethical in the
light of utilitarian argument
 Unethical in the light of utilitarian argument
 Anything that interferes with freedom distributing goods and
service is a distortion of the market and therefore unethical.
 Making false claims about a product therefore unethical.

16. Manipulative Tactics
 In spite of many claims of faulty product design , the company has
steadfastly maintained that there were no special dangers inherent in
device.
 Their continuous theme has been that doctors , not the device, have
caused any infections associated with the shield.
 Beside claim user abuse as poor personal hygiene malfunctioning,

17. Manipulative Tactics :Unethical In light
of
 Ethical advertising and marketing strategies is the avoidance of
Manipulative Tactics
 Tom L. Beauchamp defines , manipulation as” a broad category that
includes any successful attempt to elicit a desired response from another
person by noncoercively altering the structure of available choices.
 Also include overstating the effectiveness of the product.

18. Company’s intentions
 A very reputed company.
 Davis tested the device on 640 women and the results were positive.
 Executives strongly recommended this device.
 The company started a long-term study on this device, and primary
results of the study were also positive.
 Some negative results showed up. Management thought, maybe it was
the problem of doctors and users.
So we can say that, the intention was not bad from the company
perspective. And again, they took liability for their product after continuous
negative results.

19. Products Liabilities:
 After continuous negative results, the company withdraws the product
from the market.
 They spend 4 million dollar in advertising (for the withdrawals and
remove).
 The company send withdrawals letter to 120,000 doctors.
 They advertised that, they would bear all cost of removal the device from
the users.
 The company also asked to the users for any money claim against the
company.
So, ethically they are less liable than it seems.

20. Alternatives
 1.Delay the purchase of the Dalkon Shield
• More time for conclusive reports, divert funds to other operations
• Risk losing the opportunity to purchase Dalkon Shield
 2.Purchase Dalkon Shield, wait for accurate results and implement
changes
• Results in a good product - improve brand recognition
• Time consumption, increased costs
 3.Purchase the Dalkon Shield and immediately sell it
• Reduce costs
• Potential risk for consumers

21. profit maximizing
Chosen Alternative ( 3)
 A ruthless profit maximizing organization with no care for their consumer
risk chose the third alternative.
 Short- term profit maximized
 In the long term , it end up with bankruptcy.

22. Summary
In favor of Robins:
1. Devi’s Survey
2. Primary Survey report
3. Intention
4. Awareness Creation
Against Robins:
1. Launching without proper survey
2. Consumer Manipulation & Advertisement Falsification
3. Product Liabilities