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Dr. Suzanne Parisian’s Expert Report in an Ortho Evra Lawsuit

To say that Dr. Parisian doesn’t approve of Johnson & Johnson’s conduct with respect to the Ortho-Evra patch would be an understatement.

104. J&J disregarded its duty and obligations as a pharmaceutical manufacturer, ignored forty-years of oral contraceptive history and science, failed to utilize good scientific methods and appropriate evaluation of its pre-clinical safety signals for design, development, testing and marketing of ORTHO EVRA. J&J's scientists in 1996, had calculated that a 20cm2 patch should be loaded with 60 mcg of EE to deliver a nominal 20 mcg EE per day based on EE skin flux of 0.04 mcg per cm2 per hour. The EE delivery values had been based on PK characteristics of ORTHO CYCLEN OC and were aimed at obtaining a steady state range of 40-50 pg/ml (Audett, 7/23/07, p 254, I. 18-20). However, J&J's development team subsequently made a determination to increase patch EE adhesive loading to 75 mcg to increase the delivery of EE. After increasing the systemic EE delivery for the patch, J&J disregarded the safety signal of increased reporting of thrombotic events during the Phase 3 clinical trials as well as disregarded a February 20, 1998 Leiden-Site report to Dr. Shangold of unacceptable estrogenic side effects suggesting high systemic EE delivery from J&J's clinical investigator Dr. Peter Van der Ark (POE 04854048). J&J also disregarded the coagulation results of CONT-006 (APPENDIX 6 30,109,178,198, 222-225). Furthermore, during its pre-NDA negotiations with the FDA, J&J failed to adequately inform the FDA that as early as 1998 it had been aware of safety signals of increased reports of pulmonary emboli greater than anticipated for a 35 mcg OC. After obtaining the FDA's NDA approval, J&J continued to elect not to provide its own clinical experts , key opinion leaders ("KOL"), physicians and patients with adequate warnings about increased systemic EE delivery and reporting of VTE in its clinical trials in its original ORTHO EVRA label, and communications (APPENDIX 6 ¶ 283-288). J&J was aware that, unlike ORTHO EVRA being sold in the United States, J&J's EVRA patch sold outside the US was loaded with 60mcg of EE. EVRA, and also unlike ORTHO EVRA, had been able to support EE bioavailability to a 35 mcg CILEST OC (NRGEEP-POI-1025) as well as bioavailability to historical data for J&J's clinical trial lot 10607. J&J's actions regarding its follow-up of the safety of increased EE delivery of ORTHO EVRA has shown a disregard for ensuring patient safety and a disregard for its own duty to sell safe and effective products. Such actions by J&J have directly contributed to the injuries and deaths of healthy young women who elected to use ORTHO EVRA for prevention of unintended pregnancy.

Technorati Tags: Ortho-Evra,Ortho-Evra lawsuit

Testimony of Suzanne Parisian Concerning the Ortho-Evra Patch

Expert Witness Suzanne Parisian gave this testimony in an Ortho-Evra lawsuit entitled Arbino v. Johnson & Johnson.

Q. Where does it say it's similar? It just says it contains an estrogen and a progestin.
A. Called a combination hormonal contraceptive. As you know, those have been on the market since 1960. So, the information that you're asking me in one sentence may be lost on them, because they have been using and prescribing combination hormonal contraceptives, and this is being represented to them as a combination hormonal contraceptive.
So, you are asking what would every physician, board certified OB-GYN see when they see that, and I think that you cannot take it out of context. This is being provided to them as a product that is approved by the FDA and is a combination hormonal contraceptive.
So, it may be lost on when you take that sentence out of context and try to say that all OB-GYNs would know there's no information about this product as a transdermal because, obviously, it is now being provided to them as approved.
Also, it's been provided to the FDA as comparable to an oral contraceptive in terms of allowing bridging of data
So, it's not a clear-cut sentence taken out of context and what would be interpreted by all OB-GYNs.
Q. How about the sentence that starts the next paragraph The use of combination hormonal contraceptives is associated with increased risks of several serious conditions, including myocardial infarction, thromboembolism, stroke, hepatic neoplasia and gallbladder disease. And then it continues.
Any reason to doubt that a board certified OB-GYN, in 2001 or 2002, didn't know that combination contraceptives, for at least thirty-five or forty years, were associated with an increased risk of myocardial infarction?
MS. PARFITT: Objection Again, she can't get behind the minds of every board certified OB-GYN. I object to the form of the question
Doctor, if you can respond to the question, okay.
A. Again, the terms are not clear-cut, because you are talking about to an OB-GYN who has used combination hormonal oral contraceptives since 1960, and then you are taking it out of context, because if you look at the paragraph above, you just said that there is no epidemiological data, and then you are coming back here talking about birth control pills. We are switching between transdermal and birth control pills.
So, that second paragraph is providing information that a board certified OB-GYN and a family practitioner, they are not the only ones who prescribe -- OB-GYNs are not the only ones who prescribe birth control pills.
Okay. So, you're talking about family practitioners. You're talking about general practitioners. You're talking about nurse practitioners. You're telling them that this product is of the same risk as an oral contraceptive.
Now, if you know from the data, that's not necessarily true, because up in the paragraph above it, they say there's no data to tell you if this actually performs like an oral contraceptive.
So, in some ways, the second paragraph is speaking specifically about the history of oral contraceptives.
Q. Is there any reason to doubt that anyone, board certified OB-GYN, family practitioner, didn't know in 2000 that there's an increased risk of thromboembolic events associated with hormonal contraception?
MS. PARFITT: Objection The question was just asked, and she gave a very detailed response to the question.
I think in light of the fact we got a late start today, we need to start to move forward and not ask the questions twice.
Q. (By Mr. Winter) You can answer the question, Doctor. That was not the question I asked before.
A. You're talking apples and oranges. Yes, there has been a history, and this is the class labeling. There has been a history of increased risks of oral contraceptives.
Having gone through all the documents and seen even corporate documents, we know, sitting here today, that the company knew that this product did not perform as a birth control pill. But they're actually using class labeling for a birth control pill and telling physicians and all the people who prescribe it from state to state, that this has an increased risk which is associated with birth control pills.
There's never been a transdermal contraceptive product, and that's not what's stated there. It states that they are talking about class labeling, that birth control pills have an increased risk of several serious conditions.
So, if I was a physician who was prescribing a birth control pill, I would see that, and I would read that as being consistent with oral contraceptives, which, as we know, is what the FDA was told, that this product was consistent with an oral contraceptive.

Technorati Tags: Ortho-Evra,Ortho-Evra lawsuit