Ortho Evra Lawsuit

They're heeere:

Johnson and Johnson's Ortho-McNeil Pharmaceutical Inc. unit is being sued on behalf of a woman who had been using the company's Ortho Evra contraceptive patch.

The suit, filed by Parker & Waichman LLP, alleges the woman suffered a pulmonary embolism after using the patch for seven months.

The law firm said Monday, after the financial markets had closed, that recent reports have indicated that the risk of developing blood clots, pulmonary embolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral-contraceptive use.

The firm alleges that Ortho-McNeill was aware of the increased medical risk and failed to adequately warn patients.

It's not clear what "recent reports" the law firm is referring to. I do hope it's not this [mis]report from last year. Nor this more recent article, AP finds more fatalities from birth control patch than expected (via feministing).

Briefly, from the article:

... since the patch came on the market in 2002 ... the AP found 23 different deaths associated with the patch. The primary cause of death in those reports isn't always clear -- some mention suicide, others abortion. Doctors who reviewed the 23 cases found about 17 that appeared to be clot-related, including 12 from last year.

So, the AP review found:

23 total deaths from 2002-2004

17 clot-related deaths in patch users from 2002-2004

12 of which occurred in 2004

AP's analysis [if you can call it that]: out of all the reported deaths (23), it's not clear six are at all related to patch use (suicide, termination, etc.). [It's quite possible they're referring to these six cases. No way to tell for sure.]

This leaves us with 17 cases, over two years. For these cases, we don't know what the cause of death was. [It's unclear why AP's reviewers were unable to determine cause of death--were the records incomplete, or were they inconclusive? Unfortunately, AP doesn't link to the reports they obtained from the FDA.] However, because most of these cases appear to be clot-related, we assume they are. Moreover, based on this assumption, we go one step further and assume the blood clots were caused by using the patch. Since, in 2004, there were 12 clot-related deaths, the rate of deaths appears to be 3 out of 200,000.

So, does the birth control patch cause more fatalities than expected? This is one question you won't find the answer to by reading the AP article.

Bottom line:

Case reports of deaths need to be fully investigated by formal epidemiological studies. Until this is done, a casual relationship remains questionable. At the present time, no evidence suggests that the transdermal patch is associated with an increased risk of death compared with combination oral contraceptives.*

Not that a lack of evidence should in any way stop lawyers from filling lawsuits.


*Grimes DA, Mishell DR Jr. Assessing Rare Event Reports: A Numerator in Search of a Denominator. Dialogues in Contraception. Fall 2004;8(7):7.