Talk:Dalkon Shield/Archive 1

Page deletion
I think most of the page has been deleted due to an edit accident or a browser bug. Also, I noticed in the original version that the acronym "UID" was used without noting its expansion. The acronym is actually IUD for "Intrauterine device". A link to the contraceptive might be helpful as well. --Zeke

problem was due to the larger size of one, not the multifilaments. - Omegatron 01:16, Apr 17, 2005 (UTC)

agree. —The preceding unsigned comment was added by Omegatron (talk • contribs) 01:25, 17 April 2005  (UTC)

Lawsuits
First of all, re the Dalkon Shield, there was not a "lawsuit"--there were LAWSUITS. A lot of them. Large amounts of money--including punitive damages--were awarded to many many plaintiffs. THEN, there was a CLASS ACTION lawsuit on top of that. There were not mere "accusations" of damage--the damages were proved in courts of law (in the initial suits, which were litigated) and in medical reports in the class acction, submitted as court testimony, which resulted in Robins' settlement with claimants. This IS documented, in the ref I have cited (and the books).Cindery 22:51, 28 July 2006 (UTC)

PUNITIVE DAMAGES FORCE RECALL OF DALKON SHIELD IUD

Eight punitive damages awards spurred the A.H. Robins Company to recall the Dalkon Shield intrauterine device (IUD).

In one case, a 27-year-old woman suffered a severe pelvic infection requiring a hysterectomy after wearing an IUD for several years. After the surgery, the woman's marriage disintegrated and she divorced. She must take synthetic hormones that increase her risk of developing endometrial cancer.

Evidence established that Robins had known its IUD was associated with a high rate of pelvic disease and septic abortion, that it had misled doctors about the device's safety, and that it had dropped or concealed studies on the device when the results were unfavorable.

See, e.g., Tetuan v. A.H. Robins Co., 738 P.2d 1210 (Kan. 1987).

http://www.unt.edu/lpbr/subpages/reviews/sobol.htm

Above is a link which cites the fact that A.H. Robbins preserved over 900 million dollars in profits/value for its shareholders in the Dalkon Shield bankruptcy (while not making the injured and the dead whole/fully compensating them). The implication in the article as written is that the company was driven into bankruptcy--the company *used* bankruptcy to evade liability, to make off with 900 million dollars instead of adequately compensating victims. Also, while the Dalkon Shield was banned in the U.S. in 1974, A.H. Robbins admitted no liability, and did nothing to inform women who had the Dalkon Shield implanted about the dangers (or to pay for removal). They also continued to sell and market it in countries where it was not banned, in spite of known health risks. (Who WROTE this original entry, anyway--a shill for a pharmaceutical company that sells IUDs??!?? The gist of your argument seems to be that the only thing that's bad about about the Dalkon Shield is that it gave IUDs a bad name.)

The clearest dangers associated with the Dalkon Shield were not "multiple sexual partners," they were 1) criminally, inexcusably LAME/nonexistent safety testing by the FDA and Robins 2) LIES told by Robins about the safety of the Shield.

http://www.highbeam.com/library/docFree.asp?DOCID=1G1:4080010

Above is a link to another article, highlighting such nice details as the fact that Robins own lawyer testified that he destroyed documents, etc.

I also dispute: there were not "accusations" of malfunction--the thing actually DID seriously harm and kill women. Those are not "accusations."

Also, it is not really made clear anywhere that prior to 1976, "devices" were exempt from safety testing by the FDA. The Dalkon Shield was considered a "device," so NO safety testing was required or performed. Robins then went on to AGGRESSIVELY market it as SAFE to MILLIONS of women--a clear lie, with enormously catastrophic public health implications. (This is one of the reasons it was possible for early plaintiffs to obtain punitive damages.)

The story of the Dalkon Shield is a story of inhumane greed. A.H. Robbins spent lots and lots of money to market the Shield...and nothing to test its safety. They ignored early reports that it was harming women, to avoid admitting liability--clearly placing profit over human health (and not doing anything to limit their liabilty, either). When the FDA finally banned it, they still refused to do anything to mitigate the damage to anyone, and in fact continued to sell it outside the U.S. Then they spent millions of dollars on lawyers to save their 900 million dollars from being dispensed to victims. —The preceding unsigned comment was added by Cindery (talk • contribs) 10:51, 25 July 2006 (UTC)

Medical Records in Litigation: the Dalkon Shield story.
Byrne K. AMRO. 1992 Feb;32(5):11-4. Links

The Dalkon Shield was manufactured by A.H. Robins Inc. in the early and mid seventies, before it was withdrawn from sale because of the influx of lawsuits against the manufacturers. The case has become the largest tort case in history, with approximately 200,000 claimants worldwide and will not be wound up for years to come. Slater and Gordon is an Australian firm of solicitors with offices in three states. They have the largest Dalkon Shield practice in the world and represent almost 3,000 claimants. One of their most difficult tasks in preparing the cases is the gathering of medical evidence to substantiate claimants' assertions. This entails collecting relevant medical records from across the country and around the world going back almost twenty years for almost 2,000 women. The project has magnified the importance of accurate and complete documentation, kept intact and made accessible. The influence of medical record administrators is highlighted.

PIP: An Australian law firm represented 3000 Dalkon Shield claimants, the largest number in the world. The manufacturer, A.H. Robins, allegedly did not follow adequate methods of production and sterilization of the IUD, tested and evaluated the IUD in a too short time period, and submitted false claims about its efficiency and safety. A.H. Robins knew of the IUD's defects in March 1972 but physicians continued to insert 1 million Dalkon Shields after that date. Alleged side effects included pain, bleeding, uterine perforations, pelvic inflammatory disease (PID), sterility, septic abortion, ectopic pregnancies, and unplanned pregnancy. Many women who had had a Dalkon Shield had to undergo a hysterectomy and subsequent hormone replacement therapy. 17 US women had died by 1976. A.H Robins stopped making the IUD in the US in 1974 but continued to market them in Australia until 1975. It declared itself bankrupt in 1985. The law firm found it difficult to verify claims of injury caused by the IUD. Specifically the problem centered around poor medical records and policies for destruction of these records. The Dalkon Shield Project accentuated the need for accurate and complete documentation which is preserved unaltered and accessible. The project needed to prove not so much what occurred but what did not occur. Some of its clients could not understand why their records had been destroyed by professional people. The project has made recommendations for medical record administrators (MRAs) to retain medical records and facilitate their retrieval. They could be more cooperative in providing clients and law firms who have fulfilled all requirements with medical records. Sometimes they fear that they are violating client confidentiality. MRAs should be familiar with medical record laws and policies but they should use their professional judgment to make an informed and independent decision to direct the dissemination of information.

[PubMed - indexed for MEDLINE] Cindery 10:35, 30 July 2006 (UTC)

Loretta J. Ross
Powerful testimony from famous human rights activist (and Dalkon Shield victim) Loretta J. Ross, whose papers have been acquired for the permanent collection of the Sophia Smith Library at Smith College:

From: Testimonies of the Global Tribunal on Violations of Women's Human Rights, Compiled by Niamh Reilly, Center for Women's Global Lead- ership, 1994. 3. TESTIMONY GIVEN AT THE NGO FORUM OF THE 1994 IN- TERNATIONAL CONFERENCE ON POPULATION AND DEVEL- OPMENT IN CAIRO, EGYPT http://www.cwgl.rutgers.edu/globalcenter/womentestify/appendix%202.pdf.

Loretta Ross: I actually got introduced as a political activist, and I have about 20 years as a po- litical activist. But the purpose of my talk today is to talk about why I became a political activist. I represent many women of color in the United States whose stories are invisible. The abuses that women of color face in the United States are largely unknown. A lot of people don’t know that they match the abuses that women face in developing countries. My own story started when I was 11 years old. I was raped when I was 11 years old. I was a child to whom too many adults had access. I was a victim of child sexual abuse. This abuse went on so that by the time I was 14 years old I was pregnant. I ended up having that baby at 15, and the abuse continued, so that by 16 I was pregnant again. At 16, I decided that I didn’t want to be a mother of two children so I decided to have an abortion. But I couldn’t get permission from my parents to have an abortion, so I had to forge my mother’s signature. It took so long for me to go through the process of both saving the money and making the decision to forge the signature that I had a very late term abortion. I was well over six months pregnant by the time I had the abor- tion. After I had that abortion, I decided that I didn’t want to even begin to possibly risk getting pregnant again. And so I sought a birth control method that would not fail me as other methods had. So, at age 21, a few years later, I decided to accept the Dalkon Shield, an IUD that is no longer on the market. But if you all remember, the Dalkon Shield was a device that they made free and available to all poor women who asked for it; and I fit all of those criteria. I was a women receiving public assistance, who already had a child, who didn’t want to have more children; so, of course, I was able to get a Dalkon Shield inserted into me totally for free. Two years later, I started developing major problems. I began to suffer from all types of infections that I kept going to the doctor for. They kept telling me that I had some form of venereal disease, some kind of STD. They kept treating me for all of these diseases for well over six months that it later turned out I didn’t have. What I had was a defective Dalkon Shield. One night I almost passed out while I was at home. I ended up calling a taxi to go to the hospital. If you live in a poor neighborhood you get to the hospital quicker if you call a taxi than if you call an ambulance. When I got to the hospi- tal I was barely conscious. I remember them putting me on a stretcher. Within a half an hour they were wheeling me into surgery. On my way to surgery they put a piece of paper in my hand that I signed. When I woke up eight hours later I had been sterilized. My entire reproductive organs had been removed. I was 23 years old at the time. What had happened medically was that my fallopian tubes had ruptured as a re- sult of the Dalkon Shield, so my entire reproductive career lasted from age 14 to age 23. They didn’t tell me why. They couldn’t tell me why I had been ster- ilized. All they could tell me was that I was that unlucky woman that they didn’t catch in time. But they never explained to me why through six months of treatment, it never occurred to the head of the OB/GYN facility at a major hospital to remove my Dalkon Shield. Even when I was admitted to the hospi- tal in a coma, I still had the Dalkon Shield in me. They never removed that until it was part of the surgery.

This is actually a story about victory though; even though up until that time I had been a victim. Fortunately, I was so angry at what had happened to me that I immediately found a lawyer, and I became the first black woman to sue the maker of the Dalkon Shield, A.H. Robbins. It turns out that they knew more than five years before mine was inserted that it was unsafe, yet they were still making it freely available to women, like me, who got their health care through public family planning clinics. It also turned out that the hospital I was treated at knew that the Dalkon Shield was unsafe. But because it was a teaching hos- pital, they wanted their students to see what would happen to a Dalkon Shield patient who did not have it removed for six months. So I sued them, too. I actually made a commitment in that moment that I would make sure that all the things that had happened to me would never ever, ever happen to another black woman in America without somebody like me being there to fight for her. At the time these things were happening to me, my parents didn’t understand, my community didn’t understand, and the woman’s movement such as it was at the time didn’t understand. They didn’t understand that we who were black, who were poor, who were women of color, had a special kind of human rights abuse that America saved just for us, and that we had to be as vigilant in fighting to protect our lives as anything because the rest of the world simply did not care. This doctor told me that what happened to me was a mistake, but as I pursue the fight to get rid of his medical license, I’m going to convince some- body that licensing that man was the real mistake.

Tone of phrasing
Cindery - thanks for the expansion of the story of Dalkon - interesting reading. The tone of phrasing though could do with a copyedit (good for a magazine article but seems a little too emphatic (?POV) in its conclusions for an encyclopaedia). That there were reported problems, lawsuits and product withdrawal is true enough. As an example: "Bacteria wicked from the vagina to the uterus was resulting in pelvic infection that caused PID, which in turn resulted in ectopic..." - I think this would read better with a little rephrasing - eg. "it was felt that bacteria ..." or, given that initially the underlying mechanisms for these patients presenting as they did had yet to be elucidated, perhaps: "It was later proposed that bacteria...".

In essence I'm not doubting the claims made, just the emotive tone of language used could do with a tweek. Previously there was a link to "Was the Dalkon Shield a safe and effective intrauterine device? The conflict between case-control and clinical trial study findings." . I'll be the first to admit I have not read the full literature on the subject, but as this paper suggests, is there not at least some room to suspect that the article as it currently stands is stating details as scientific facts, rather than as reasonably good theories. Of course the wick-theory has a lot to commend it, and no IUD since has used entwined multiple threads. Dalkon was an early IUD and so user technique could not have been as good as it is today (I'm not suggesting this was or was not full cause of problems, but it must have played at least a little part - i.e. some degree of operator issues rather than purely device-problem). Also today in UK, any routine IUD insertion is always done after prior microbiology screening swabs and, despite this, an automatic dose of antibiotic to cover the insertion proceedure; routine antibiotic cover (vs only if prior swabs positive) was not part of insertion protocol some 15 years ago during my training - so protocols do improve over time. David Ruben Talk 11:51, 3 August 2006 (UTC)

hi david, the problem i have with that pubmed citation is that i think it's false. apparently, someone did a study which indicated that the iud is not popular in the US as it is in europe, because people remember the dalkon shield. so whenever a new iud comes out, a huge pr campaign comes out, too--trying to minimize/spread disinfo. minimizing/falsifying the dalkon shield is like minimizing asbestos, or the pinto. it was a terrible tragedy...

blaming it all on the string isn't accurate, either. have you looked at a d shield? they are hideous. hugh davis thought that to be effective, an iud had to cover a lot of space in the uterus. (based on no research.) the shield is the *only* iud ever designed that's so big/covers so much territory. and the spikes! they tore into women on insertion, and tore into them/embedded themselves when they were inside (aiding and abetting infection). it looks like a medieval torture device. one doctor wrote, just of insertion problems,"i have found this to be the most horrible thing ever perpetrated on womanhood. and i have inserted every other kind of iud." but aside from its design flaws, the other problems were multifactorial, too: no fda testing. the inventor lied. the manufacturer lied. when it became apparent women were getting very sick, they continued to lie...and then they blamed the victims and exported their back stock...and even though they were sued, it didn't cost them anything. *it was a cost-effective decision* like the pinto. (they knew the pinto had flaws but they did the math and realized it would be cheaper to pay out wrongful death suits for a minority than to recall all the pintos--that was the big scandal.)

moral concerns about minimizing the suffering of so many people resulting from deliberate negligence for profit aside, the other concern i have is that *the same social conditions exist for another faulty device to harm so many people.* just because the fda safety tests device now doesn't mean they are safe. millions of dollars are spent on misleading direct-to-consumer marketing, and insidious persuasion to doctors. hugh davis' publication of "the shield: a superior modern contraceptive" still happens everyday--*all the devices may not be as harmful*, but product reviews in pubmed aren't a reliable place to find that out. that's a serious problem, and the real reason something like the dalkon shield happened, and could happen again (does happen--like with vioxx.) I know for a fact that many ethical, well-meaning, conscientious doctors gave patients the dalkon shield. they didn't know. how could they know? thad earl--one of the dalkon partners (a doctor who was paid a consulting fee of 30,000 a year--big money in 1972--to encourage women to use the shield and to insert them--realized that people were being hurt and said so, for example. he had no way of knowing he was hurting people until it was too late. doctors relied upon hugh davis' article in a prestigious medical journal.

my insistence on the complicated (and factual) explanation for why and how the dalkon shield hurt people is that what i have seen lately --saturating web media with the launch of mirena--is "you can trust us, iuds are safe now. it was the string. now there's fda testing. besides, those women were sluts and only a few people died, anyway. the real shame is that lawsuits inhibit development of new iuds." an identical campaign was launched for the last new iud. (same people--population council.)

i'm really insistent on the truths that it's not always safe to trust a "reliable" source when there's a profit motive for a corporation, and so much industry hijack of science/medicine, so much pressure on doctors, so much misleading advertising--i don't want people to hate iuds, i want them to protect themselves from the system until they can change it, is what i mean...by thinking critically about who pays for what they read/why they think what they think/what risks they are actually taking.

anyway, sorry to ramble and hope that makes my point(s) clearer.

i know a huge problem with the article right now is that none of the refs are included as footnotes. that, as you know, is not my strong suit. and some citations come from the books--which are not online.

i am aware that i have strong feelings about the shield--but i'm pretty well-informed on the subject. i don't think this has to be a completely medical article in tone, because it does touch largely on social issues--the fields of law, consumer advocacy, for sure. and peripherally on huge social phenomena such as "population control" women's rights, etc. the dalkon shield stopped being merely a medical device after it started to kill people...then it became much, much more complicated. but if you would like to make adjustments for more NPOV tone that would improve the article in ways that i am not able to see/haven't seen, i would be grateful. i think though that there is not "another side" to this story. it's overwhelmingly and factually a story of heinous corruption, at every stage. finding "another side" to the dalkon shield is like citing holocaust deniers as reasonable stakeholders in a "controversy" about whether the holocaust happened. really. (did you read the barbara ehnrenreich article? it's an excellent pice of journalism.  and another reason i see red when a pharma-bought web article says "only a few women died" or even "16".  there were 33 in the states...but thousands and maybe more uncounted in the third world... ) Cindery 08:51, 4 August 2006 (UTC)

"That didn't dampen Robins' enthusiasm, and irrespective of the warning it continued to towards production and sales"
 * I take your points re not just a medical topic (are regulatory, social, polital etc issues). Likewise I too doubt there is another side. Still tone needs a little copyediting for an encyclopedia. Example: accepting at face value all the aspects of possible problems that you mention (size, shape, insertional difficulties) these in themselves suggest the "against device" viewpoint has internal POV discrepancies, as the article can not be then too absolute in stating that the bacterial wicking effect of the string was purely responsible for infections (something to do with the device was, and string probably major part of this), so a little qualification seems needed, eg "generally mostly ascribed upon the use of a multi-filament string..." or something a lot less clumsy. Of course real lesson learnt was need for better testing, diclosure of obtained results and regulation. Who knows, maybe the shape would have been unimportant if a monofilament thread had been used, and would only have made insertion process more awkward and more user "off putting" by its aggressive looking shape, compared to later simpler IUD designs ? David Ruben Talk 13:46, 4 August 2006 (UTC)
 * As for references, yes much of this is analysis of situation (vs specific statistical values) and so general sources needed for article. So whilst this article is clearly going to rely heavily on References rather than Footnotes, is there any way to use Harvard citation style in the text (ie in brackets lead author name and year) for some of major assertions made.
 * Further example of a copyedit (unless the choice of words can be directly attributable to one of the referenced sources).
 * An alternative rewording might be along lines of:

"Despite the memorandum, Robins continued to proceed with production and sales".
 * It has already been mentioned what the memorandum stated, and the start of parapraph used the verb "informed" whereas now "warning" is chosen. Alternatives might have been "advised", "cautioning", "highlighted" etc. all of which have various subjective shades of meaning - the alternative I gave above avoids having to choose.
 * Subjective journalistic emotive words of "dampen" & "enthusiasm" are likewise problematic. Was the "enthusiasm" their genuine honest (but deeply flawed) belief, or their external face of confidence despite their genuinely held private concerns ? I would suspect a bit of both, but that as a personal opinion is inappropriate in an encyclopadia with a WP:No original research policy. The rewording avoids having to guess at the precise motives (in the absence of a source we can cite as having this precisely worded opinion) yet retains the clear meaning of the company's launch being unaffected by the information given to the directors.
 * Finally alternative is shorter and thus, to my way of reading, seems more direct and "punchy" in what is conveyed. David Ruben Talk 13:46, 4 August 2006 (UTC)

"robins marched hastily toward production and sale" is a direct quote from the trial lawyer (ref cited.) i would agree could be changed, but is a quote. it's a summary--the facts it summarized are not just the memorandum to robins execs, but the fact that other safety tests were set to go forward. robins cancelled them in favor of selling it without further testing. (so, they were told there was a problem with the design AND they declined further testing which was already set to go.) could put that in instead. but without some "summary" here and there, article risks being too long? agree "marched hastily toward production and sale" sounds subjective. but it makes robins look better than the longer explanation, which was they cancelled further testing even though they knew shield was poorly designed...

robins was also told about the "wicking" by one of their own employees, before tatum published his study to that effect. he was told to shut up, that safety tests didn't pay his salary.

thad earl was one of the original four partners in the dalkon corp.--and he told everyone else it was dangerous. they ignored him.

there just isn't any evidence that any enthusiasm robins had about the shield was anything other than enthusiasm to make as much money as possible before anyone found out their product was defective, unfortunately...but they did seem quite enthusiastic about that. "enthusiastic" is pretty mild language, considering "malevolently criminal negligence" is more accurate...

will work on refs when i have time--it's a big project... Cindery 19:30, 4 August 2006 (UTC)


 * Thanks for clarification - as a minimum therefore the "robins marched hastily toward production and sale" needs to be flagged as a quote (I tend within text to both italicise with use 2 single quotes and enclose in a double quote, i.e. " .... " ) and a ref link given immediately after this. "malevolently criminal negligence" would be too far; i'ld also need a lawyer to explain it to me I think - eg what "criminal negligence" is not "malevolently", vs "non-criminal negligence" - no please don't explain :-)  My preference is still somewhat for the shorter non-poetic version, but I agree it does works well as the quote. Would be good if other editors were to chip in now and offer their tuppence of opinion re style of writing, else this risks (unintentionally) seeming like its just 2 editors nit-picking in a vacuum :-) David Ruben Talk 22:43, 4 August 2006 (UTC)

marketing
i think marketing was just as crucial as lack of safety testing, etc. without the false and misleading advertising to doctors and consumers--and the huge amount of money spent on campaigns to those groups--the shield, while it would have *reached* the market, would not have been *mass-consumed.* Cindery 22:59, 4 August 2006 (UTC)

notes on mumford
(dalkon shield revisionist from pubmed citation)

maybe you recognized him from the quinacrine article already? (he's one of the two quinacrine cranks--the one who was fired from FHI for writing the 300 page screed about how the vatican is threatening the national security of the US by forbidding abortion. just my opinion/sorry for soapboxing, but if you ask me they are both nuts--the right wing "population controllers" and the religious zealots who oppose abortion. far too much of birth control/abortion public discourse and policy has been appropriated by those two groups to the detriment of everyone else...

mumford is not a medical doctor--he has a ba degree in agricultural sciences and a phd in population studies. (which sort of says it all--he wants to treat the population like animals...)

he is a member of the right wing group "Americans for Immigration Control," and author of article such as "What is it to be an American Conservative?" and "Abortion--a National Security Issue." i mean, i'm ferociously pro-choice, but not as a national security issue! his point is not that women should have access to safe, legal abortion, but that the US needs to provide abortions to third world countries to prevent revolutions, protect "our" economic interests, etc. he's also in favor of de-populating the US of poor people/immigrants via sterilization/birth control/abortion--he has a political agenda that has nothing to do with women's health and safety or autonymy (although the rightwing population controllers have become better at appropriating pc language that makes it sound like that's what they're in favor of...) Cindery 06:56, 5 August 2006 (UTC)

here is mumford's cv: http://www.population-security.org/mumford_CV.html

Original research: undergraduate class paper
There is a large block quotation citing "a 1997 ethics group project paper by four students in a University of Minnesota undergraduate History of Science course." (It may be found here.) Verifiability requires that sources must be published by reliable sources. I think the block quote must go. However, the paper itself does cite several sources; an equivalent paragraph could be written directly from the original sources. Any other suggestions? Peppergrower (talk) 12:01, 16 December 2007 (UTC)

Unsourced trivia
The trivia section here is unsourced. I'm moving it over to the talk page until someone can find sources for it. Also, it would be good to integrate the statement about the Harvard Law Library into the main article, and place the other two under a section titled something like "In popular culture." (See Handling_trivia.)

Peppergrower (talk) 12:46, 16 December 2007 (UTC)