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`65PHPRO1
`
`1
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`------------------------------x
`
`PROCTER & GAMBLE PHARMACEUTICALS,
`INC., and SANOFI-AVENTIS US, LLC,
`
` Plaintiffs,
`
` v. 06 Civ. 34 (PAC)
`
`HOFFMANN-LAROCHE, INC.,
`GLAXOSMITHKLINE, INC.,
`
` Defendants.
`
`------------------------------x
`
`
`
` New York, N.Y.
` May 25, 2006
` 9:00 a.m.
`
`Before:
`
`
`HON. PAUL A. CROTTY
`
`
` District Judge
`
`
`APPEARANCES
`
`
`KRAMER LEVIN NAFTALIS & FRANKEL, LLP
` Attorneys for Plaintiffs
`BY: HAROLD P. WEINBERGER
` JONATHAN M. WAGNER
` MARJORIE E. SHELDON
`
`DAVIS POLK & WARDWELL
` Attorneys for Defendants
`BY: ARTHUR F. GOLDEN
` JOEL M. COHEN
` CHRISTOPHER H. WITHERS
` JEROME G. SNIDER
`
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
`Biogen Exhibit 2017
`Sawai v. Biogen
`IPR2019-00789
`
`Page 1 of 236
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`65PHPRO1
`
`1
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`------------------------------x
`
`PROCTER & GAMBLE PHARMACEUTICALS,
`INC., and SANOFI-AVENTIS US, LLC,
`
` Plaintiffs,
`
` v. 06 Civ. 34 (PAC)
`
`HOFFMANN-LAROCHE, INC.,
`GLAXOSMITHKLINE, INC.,
`
` Defendants.
`
`------------------------------x
`
`
`
` New York, N.Y.
` May 25, 2006
` 9:00 a.m.
`
`Before:
`
`
`HON. PAUL A. CROTTY
`
`
` District Judge
`
`
`APPEARANCES
`
`
`KRAMER LEVIN NAFTALIS & FRANKEL, LLP
` Attorneys for Plaintiffs
`BY: HAROLD P. WEINBERGER
` JONATHAN M. WAGNER
` MARJORIE E. SHELDON
`
`DAVIS POLK & WARDWELL
` Attorneys for Defendants
`BY: ARTHUR F. GOLDEN
` JOEL M. COHEN
` CHRISTOPHER H. WITHERS
` JEROME G. SNIDER
`
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
`Biogen Exhibit 2017
`Sawai v. Biogen
`IPR2019-00789
`
`Page 1 of 236
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`65PHPRO1 Opening - Mr. Weinberger
`
`2
`
`
`
`
`(In open court)
`
`THE DEPUTY CLERK: Your Honor, this is the matter of
`
`Procter & Gamble v. Hoffmann-LaRoche, docket No. 06 Civ. 34.
`
`For the plaintiff, please state your appearances.
`
`MR. WEINBERGER: For the plaintiffs, Harold
`
`Weinberger, Jonathan Wagner, Marjorie Sheldon, and also the
`
`associate general counsel is Matthew Malloy from Procter &
`
`Gamble, and Margaret Sparks.
`
`THE COURT: Welcome.
`
`THE DEPUTY CLERK: For the defendants.
`
`MR. GOLDEN: Good morning, your Honor. For the
`
`defendants, Arthur Golden, Joel Cohen, Jerome Snider, of Davis
`
`Polk, and Jay Matthews of Hoffmann-LaRoche, and Tina Diaz, from
`
`GlaxoSmithKline.
`
`THE COURT: Thank you, Mr. Golden.
`
`Mr. Weinberger, do you want to make an opening
`
`statement?
`
`You can do it from your table or from the podium.
`
`MR. WEINBERGER: I will do it from the podium.
`
`THE COURT: Whichever is most convenient for you.
`
`MR. WEINBERGER: Thank you, your Honor. I know your
`
`Honor has lengthy findings so I will try to keep this brief.
`
`When I first saw the findings from the defendant, I
`
`realized that this was the proverbial case of two ships passing
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
`Page 2 of 236
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`65PHPRO1 Opening - Mr. Weinberger
`
`3
`
`in the night, because either the defendants have misunderstood
`
`or have misstated what this case is all about.
`
`We are not seeking to prevent them from disseminating
`
`scientific data, whether it is subgroup data or otherwise. We
`
`don't dispute that some of this data is very interesting, that
`
`it is relevant, that doctors are entitled to know about it.
`
`That is not what this case is about.
`
`We are seeking to enjoin something very, very
`
`specific, and that is, telling doctors that Boniva has been
`
`proven to reduce the risk of nonvertebral fracture. It is what
`
`the cases call an establishment claim. There are so many cases
`
`about it because in the advertising and promotional world it is
`
`a very powerful claim to say that you have clinical proof of
`
`something.
`
`Nowhere in the findings that I saw from defendants do
`
`they dispute that they intended to make or are making an
`
`establishment claim that they have proven that Boniva is
`
`effective to reduce the risk of nonvertebral fracture.
`
`They refer to Boniva's nonvertebral fracture, but they
`
`studiously, I am sorry, avoid addressing the issue of whether
`
`they have proof. They refer to Boniva's nonvertebral fracture
`
`efficacy as an aspiration -- these are quotes -- a
`
`scientifically valid proposition, and a legitimate scientific
`
`debate. But they don't say that the BONE study proves that
`
`Boniva has nonvertebral fracture efficacy.
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
`Page 3 of 236
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`65PHPRO1 Opening - Mr. Weinberger
`
`4
`
`Rather than address these issues, most of these
`
`findings, and I suspect most of the evidence they are going to
`
`put on here, is largely going to be addressed to what we regard
`
`as issues that don't go to the core issues before you.
`
`First of all, they spent at least 25 percent of their
`
`findings attacking our perception survey, which I will come to
`
`a little later in this opening, but I would submit is largely
`
`irrelevant today based on the evidence that has been uncovered
`
`in discovery.
`
`Second, they spend another 25 percent of their
`
`findings attacking our marketing materials and activities, even
`
`though they have never moved for injunctive relief with respect
`
`to any of them, and I think we are going to show that they have
`
`taken extreme liberties with the record -- miscited testimony,
`
`misquoted documents. But even if what they were saying is
`
`true, the law is clear that that doesn't preclude injunctive
`
`relief when you are dealing with matters of public health.
`
`So in our view this is, despite the reams of materials
`
`we submitted to you, this is actually a simple case. There are
`
`two issues. Are they communicating claims of proven
`
`nonvertebral fracture efficacy, are they making an
`
`establishment claim. Number one. And number two, are those
`
`claims false.
`
`The law is clear that if they are making those claims,
`
`the issue that we have to prove is that the testing that they
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
`Page 4 of 236
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`65PHPRO1 Opening - Mr. Weinberger
`
`5
`
`are citing to support those claims doesn't support those
`
`claims. That is all.
`
`The issue is not whether Boniva might work for
`
`nonvertebral fractures. The issue is not whether there might
`
`be some evidence, whether it is likely or that it is assumed,
`
`but is it proven.
`
`Now, what you will hear is that there is one pivotal
`
`clinical trial that is relevant here, and that is called the
`
`BONE study. The BONE study was an osteoporosis trial, and it
`
`was what they call powered to determine the incidence of
`
`vertebral fractures between placebo and Boniva.
`
`There was a secondary end point. What is common in
`
`these trials is they are also looking to see if there is a
`
`difference on other characteristics, and one of them was for
`
`nonverbal fractures. There is no dispute that when the data
`
`was analyzed they did not show a difference between placebo and
`
`Boniva in nonvertebral fracture efficacy.
`
`That doesn't mean that Boniva was shown not to be
`
`effective for nonvertebral fracture efficacy, because the study
`
`wasn't powered to show that. What it means, however, is it
`
`wasn't proven. Because the way it works, you power a study for
`
`a particular end point. If the study doesn't show, if it is
`
`not powered for that end point and the study doesn't show a
`
`difference, then there may be a difference or there may not be
`
`a difference. You don't know. However it is powered, if it
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
`Page 5 of 236
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`65PHPRO1 Opening - Mr. Weinberger
`
`6
`
`shows a difference, it is real.
`
`It is sort of like if you lose something on a football
`
`field and you only send five people to look for it and they
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`don't find it, it might still be there, but if you send a
`
`thousand people to go to look for it, then you know it is not
`
`there. If you send five people out and they find it, then it
`
`is there. So that is really what this is all about.
`
`So there is no dispute that they did not show a
`
`difference. Indeed, numerically there were more nonvertebral
`
`fractures of people who took Boniva than there were on the
`
`placebo.
`
`So that study clearly didn't show it, and, as I will
`
`describe later, what they did was they started slicing and
`
`dicing the data in the study, after the study was over and
`
`after it was out, to see if they could find something that
`
`would support some efficacy for Boniva in nonvertebral
`
`fractures. So they looked at what are called T-scores.
`
`T-score is a measure of bone density. Let's look at
`
`it, and you will hear what that means, but let's look at it
`
`minus 2, let's look at it minus 3, let's look at it minus 2.5.
`
`And they finally found one where they showed a statistical
`
`difference between Boniva and the placebo, and that was at
`
`minus 3. 13 percent of the entire study population is in that
`
`subgroup.
`
`What about the rest of the 87 percent? The rest of
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
`Page 6 of 236
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`65PHPRO1 Opening - Mr. Weinberger
`
`7
`
`the 87 percent of course showed no difference. Not only didn't
`
`it show a difference, again, directionally in favor of the
`
`placebo and not Boniva.
`
`All the other cut points that they looked at did not
`
`show a difference. This was the only one. That's the primary
`
`basis on which they are saying that they have proven
`
`nonvertebral efficacy, and we will come to the science of that
`
`in a minute.
`
`When we filed this complaint, the case that we
`
`presented to your Honor in that complaint is very different
`
`from the case that we are now presenting, and I guess it tells
`
`you that sometimes discovery does what it is supposed to do.
`
`We focused in that complaint on two television
`
`commercials -- a detail aid, which was used with doctors, and a
`
`web site. As your Honor undoubtedly knows, in the Lanham Act
`
`area if a claim is expressly made, you don't need a survey to
`
`show that it is being communicated. If a claim is not being
`
`expressly made, you need a survey.
`
`So the television commercials that claim of
`
`nonvertebral fracture efficacy was not expressly made, so we
`
`conducted a survey. It was not expressly made in the detail
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`aid, so we conducted a survey. It was expressly made on the
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`web site, so there is no survey.
`
`We also alleged, because we had some information at
`
`the time from feedback we were getting from doctors and from
`
` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
`Page 7 of 236
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`65PHPRO1 Opening - Mr. Weinberger
`
`8
`
`market research, that the sales representatives for Roche and
`
`Glaxo were going around and telling doctors that they had
`
`proven efficacy for nonvertebral fractures, but we didn't,
`
`obviously, didn't have a huge amount of evidence to demonstrate
`
`that.
`
`What we have learned in discovery has really changed
`
`this case completely, because discovery has revealed that in
`
`fact this is part of an orchestrated, intentional campaign to
`
`tell doctors and consumers that they are the same, they have
`
`the same proven efficacy as the other two drugs in this field,
`
`Actonel and Fosamax.
`
`In their clinical trials, they were able to prove,
`
`even though it wasn't powered, they were able to prove on the
`
`secondary end point efficacy in some aspect of nonvertebral
`
`fracture risk reduction. For Actonel, it was a composite of
`
`seven different sites, and for Fosamax it was at the hip.
`
`The FDA has allowed those companies to put that
`
`information in the label for the product, but did not allow
`
`Boniva to put in anything about a nonvertebral fracture
`
`efficacy. In fact, required them to report the results of the
`
`BONE study that they didn't show nonvertebral fracture
`
`efficacy.
`
`So the evidence is going to show that Roche knew from
`
`the time before they launched this product that they had a
`
`serious competitive problem. They knew that Merck and Procter
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` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
`
`Page 8 of 236
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`65PHPRO1 Opening - Mr. Weinberger
`
`9
`
`& Gamble were going to try and tell doctors, we have proven
`
`data on nonvertebral fracture efficacy, and they knew that that
`
`was a serious problem for them and could seriously impact their
`
`ability to compete in the marketplace.
`
`Their market research showed them that promoting the
`
`dozing convenience -- they dose once a month; the others dose
`
`once a week -- was not enough, that doctors and consumers
`
`wanted to know that the drugs had the same efficacy and that
`
`doctors wanted to see that you had proven efficacy just like
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`Fosamax and Actonel.
`
`So before they entered the market, they also knew
`
`before they entered the market that many doctors had the view
`
`that all these drugs had similar efficacy, that there was
`
`so-called class effect. This is a quote. They determined to
`
`"exploit" the belief in the class treatment to create the
`
`"perception" of equal efficacy for Boniva.
`
`These insights are what drove the campaign.
`
`You will see, Judge, that the documents are just
`
`replete with evidence that this was a purposeful campaign to
`
`communicate proven efficacy. I am not going to show you any of
`
`the documents now, you will see them, but there are admissions,
`
`in fact, from the marketing director at Roche that that is
`
`exactly what they were trying to prove, that is exactly what
`
`they intended to prove, and that they succeeded in proving
`
`that.
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` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
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`Page 9 of 236
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`65PHPRO1 Opening - Mr. Weinberger
`
`10
`
`There are call notes that we got in discovery,
`
`hundreds and hundreds of them, from their reps that talk about
`
`proven efficacy, that talk about proven nonvertebral efficacy.
`
`There are instructions to the sales reps telling them to
`
`deliver that message.
`
`Just let me give you a little flavor of it. If you
`
`can put the demonstrative up.
`
`THE COURT: This is what we were talking about before
`
`in the robing room?
`
`MR. WEINBERGER: This is a piece of evidence.
`
`If you could blow up just the Fern Heinig testimony.
`
`This is what the marketing director said. They
`
`decided to promote the post hoc analysis as proof of
`
`nonvertebral efficacy.
`
`They mean to suggest that all of these drugs -- they
`
`are called bisphosphonates -- have been proven to reduce the
`
`risk or incidence of all types of fractures.
`
`They sought to communicate that Boniva was effective
`
`for vertebral and nonvertebral fractures, and that it was
`
`proven to be effective for vertebral and nonvertebral fracture
`
`reduction and that they were successful.
`
`If you could now go to the call notes.
`
`We just picked out a couple of them, but there is one
`
`after another, and this is what they purportedly told the
`
`doctors.
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` SOUTHERN DISTRICT REPORTERS, P.C.
` (212) 805-0300
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`Page 10 of 236
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`65PHPRO1 Opening - Mr. Weinberger
`
`11
`
`They detailed that Boniva was proven in fracture for
`
`nonvertebral and vertebral. They used the BONE trial to prove
`
`Boniva's efficacy for prevention of hip fractures. Proven
`
`fracture protection at both vertebral and nonvertebral sites.
`
`This is based on a trial where they showed no
`
`difference between placebo and the drug. In fact, there were
`
`more incidences of nonvertebral fractures on the drug than
`
`there were on the placebo. That is the basis for this.
`
`If we could look at the next piece. This is what the
`
`sales reps were told to say to the doctors after they told them
`
`about the data.
`
`Does this answer your question regarding the proven
`
`efficacy of Boniva for nonvertebral fractures? Does this data
`
`effectively establish for you the efficacy of Boniva with
`
`nonvertebral fractures?
`
`Shortly after the launch, I think you also see that
`
`they actually bolstered or enhanced the strategy and became
`
`even more aggressive in promoting the results of this subgroup
`
`analysis, because they weren't meeting their market share
`
`projections and their sales projections. They had no intention
`
`of changing course, despite what we have learned in discovery.
`
`The only way they are going to stop is if, your Honor, you stop
`
`them.
`
`In fact, they rolled out in the middle of this case a
`
`new consumer print ad and a new detail aid. If you remember, I
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` SOUTHERN DISTRICT REPORTERS, P.C.
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`65PHPRO1 Opening - Mr. Weinberger
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`12
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`said a couple of minutes ago that we did a survey on the
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`original detail aid because it was just an implied claim. Now
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`it is an express claim.
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`Can we see the detail aid, which is Exhibit 86.
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`This is the best copy we have.
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`Basically on the right-hand side you will see, your
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`Honor, it says: Boniva provides nonvertebral fracture
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`protection in high-risk patients. There is a chart with a
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`percentage. The cases are very clear, when you do that, you
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`are saying I have a clinical test that proves this, and that is
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`what they are saying. It is no longer a matter of debate about
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`what they are saying; they are admitting it.
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`So with that in hand, your Honor, let me address the
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`survey issue, which they have spent so much of their time.
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`At this point the survey is relevant to only three
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`things. It is relevant to two versions of the television
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`commercial -- those are still airing -- and it is relevant to
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`the old detail piece, which for all I know they are not even
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`using. It is not relevant to what the sales reps are telling
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`the doctors, because that is expressed. There are no
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`implications there at all. It is not relevant to this piece.
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`It is not relevant to any express claim because the law doesn't
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`require a survey for that.
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`Now, we are not walking away from the survey. I think
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`the criticisms that have been made here border on the
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`65PHPRO1 Opening - Mr. Weinberger
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`13
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`outrageous. They hire somebody to go and check the
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`backgrounds, so-called criminal backgrounds, of people who go
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`out in the shopping malls and interview people and bring them
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`into the mall, who aren't even hired by the survey research.
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`They found two of them had felony convictions and a few of them
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`had misdemeanors. Somehow that is supposed to affect the
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`integrity of the data collection process.
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`The guy who did this work isn't even going to be here.
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`If you look at the criminal records, so-called criminal
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`records, they say, We can't guarantee that the person who we
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`are giving you the report is the person you are asking about
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`without fingerprints.
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`So these things are not reliable and they are not
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`relevant. The fact that someone smoked marijuana doesn't mean
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`they can't interview somebody in a shopping mall.
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`They got a handwriting expert who nitpicked the
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`questionnaires to death and found this one is on blue paper and
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`there one is on white paper and used one pen to sign this and
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`one pen to sign that. None of it is material to the issue. In
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`fact, our survey expert backed all the questionable ones out,
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`so-called questionable ones, and there was no difference in the
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`result.
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`More importantly, the survey only proves that they
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`have been successful in communicating the message that they
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`intend to communicate.
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`65PHPRO1 Opening - Mr. Weinberger
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`14
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`So the evidence is clear, they want people to think
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`that they have proven efficacy the same as the others, and the
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`survey just shows in these two television commercials they
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`succeeded. That is all it shows.
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`The case law is clear that where we have evidence of
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`intent even on an implied claim, you don't need a survey. The
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`intent has to be egregious. But I don't know what could be
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`more egregious than intending to say something that you know
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`isn't true, and you will see that they know it isn't true.
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`Now let me turn to the second major issue.
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`We know that they are communicating it. The next
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`question is, is it false?
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`Judge, I don't think you are going to have to believe
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`our experts, although we have some very distinguished experts
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`who are going to testify -- Dr. Bilezikian from Columbia,
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`Dr. Marks. You will get this from their experts, except for
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`one.
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`Their experts and our experts agree that the subgroup
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`data does not prove that Boniva is effective to reduce the risk
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`of nonvertebral fractures in the overall population or even in
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`the so-called high-risk population. The reason is that this
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`kind of subgroup analysis, we cherry pick data after a trial
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`has been closed and you look for a result that will help you,
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`and where the other side of the subgroup, that is, the rest of
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`the data, is inconsistent with the subgroup and where no other
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`65PHPRO1 Opening - Mr. Weinberger
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`15
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`subgroup shows a difference, can be nothing but a statistical
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`accident.
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`A statistical significance means if you do something
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`20 times, 19 times, that you are going to get the same result
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`19 times. It is not a coin flip. So if you flip a coin 20
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`times and 19 times it comes up heads, then that coin is
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`probably not balanced, and that is what it means, 95 percent
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`confidence level.
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`But if you do enough tests on data, what you are doing
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`is the second time it is now one out of ten. The third time it
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`is one out of five. So statisticians will testify, all of
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`them, that a result like this given the data here could be
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`purely by chance, and you can't simply use the same statistical
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`analysis that you would use if you were looking at the data as
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`a whole.
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`So the literature is clear, the testimony is clear,
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`this data is interesting. What you use it for is to say, OK, I
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`now have a hypothesis that maybe this drug is effective for a
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`higher, more severe risk population. Now I have to go out and
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`do the clinical trial. You cannot rely on this data.
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`The other thing that they are going to rely on is the
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`fact that in this trial there are certain surrogates for
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`fracture risk reduction. For example, bone mineral density.
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`Bone mineral density you will hear about. One of these things
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`these drugs do is increase bone mineral density. They also
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`65PHPRO1 Opening - Mr. Weinberger
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`16
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`decrease bone turnover markers.
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`What they are alleging is that because they increase
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`bone mineral density and decrease bone mineral turnover markers
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`in nonvertebral sites, they therefore have proven fracture risk
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`reduction.
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`The short answer to that is they didn't. The short
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`answer to it is, even though they increased bone mineral
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`density in the study, they didn't decrease the risk of fracture
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`risk. And the reason is, you will hear from the experts, there
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`really is no established correlation between those.
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`It is true that a decreased low bone mineral density
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`increases the risk of fracture. But whether increases in bone
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`density decrease the fracture risk and whether that is linear
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`or correlate is highly debateable. Again, their experts will
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`admit that.
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`THE COURT: Mr. Weinberger, you said your opening was
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`going to take about 15 minutes. We are now into a half an
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`hour. So could you please sum up.
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`Also, could you give me your view on some of the
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`defendants' responses, so I have in mind what your response is,
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`to the defenses of unclean hands, the FDA hasn't said anything
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`about this, and you waited too long anyway.
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`MR. WEINBERGER: Yes. I am going to turn to that
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`right now.
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`First of all, I think the fact that you submit
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`65PHPRO1 Opening - Mr. Weinberger
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`17
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`material to the FDA has nothing to do with whether there is a
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`Lanham Act violation. They submitted the TV ads. The FDA
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`doesn't do surveys to see if there are implied claims also.
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`The FDA doesn't know.
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`THE COURT: If the FDA believes that the advertising
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`is false, they tell you to stop it, don't they?
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`MR. WEINBERGER: Absolutely, but the fact that they
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`don't doesn't mean there is no implied claim in there. But
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`remember, Judge, that the major part of this case right now has
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`to do with what their sales reps are going around saying which
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`FDA has no knowledge of at all. We have not been allowed to
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`tell them that because all this material is being disclosed
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`under confidentiality orders.
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`The sales detail aid, which is the recent one in which
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`they are making the express claim, has been submitted but it
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`hasn't been approved for anything.
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`So there is a line of cases which says, if you are
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`advertising based on what is in the label, you have a safe
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`harbor. But not only are they not doing that, their
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`advertising is contrary to the label, which says they haven't
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`been proven. So the FDA is not a defense.
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`In terms of the delay, they are not claiming laches
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`now; they are claiming it relates to irreparable injury.
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`Irreparable injury is actually presumed in these cases where
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`you are making a comparative claim, which they are, and even if
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`65PHPRO1 Opening - Mr. Weinberger
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`18
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`you don't name the other drug, which they don't, in a market
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`that is very small, you don't have to do that. I think we
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`cited in our supplemental findings Judge Chin's opinion in
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`Listerine, where he held that.
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`Moreover, there hasn't been any unreasonable delay.
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`THE COURT: You were in that case, too, right?
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`MR. WEINBERGER: Yes.
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`There hasn't been any unreasonable delay here. Our
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`client attempted to go the regulatory route. The FDA is often
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`overburdened and often doesn't respond to these things. But we
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`attempted to do that.
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`We then had to do a survey, and we moved
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`expeditiously. You may recall we were here and tried to get
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`early hearing dates, and I just don't think there is anything
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`to this defense.
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`In terms of the unclean hands, I will say two things.
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`One, the unclean hands defense rarely bars injunctive relief
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`where you have a public health issue, and this is clearly a
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`public health issue. The reason being that even if my client
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`was going around saying bad things, the remedy is they should
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`bring a motion and try and enjoin both of them. The public
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`shouldn't be getting misinformation on public health issues.
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`But second of all, I think you will see our clients
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`have never authorized any of the messages that they claim our
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`clients have authorized. Our sales reps do. They have some
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`65PHPRO1 Opening - Mr. Weinberger
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`19
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`call notes where the sales reps are saying that, yes, that
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`happens. You get sales reps going off on their own. But
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`contrast to what they are doing, we have told the sales reps,
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`you are not to say this. We told them this as late as two
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`weeks ago when they filed their proposed findings. We have
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`told them, we reiterated to them, you can't say this.
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`If they were saying this with respect to what their
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`sales reps were saying, we wouldn't be here today.
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`Last point, your Honor. I would just refer you to the
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`Zeneca v. Eli Lilly case, which I also tried, which I think is
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`really on all fours here. In fact, this is the stronger case,
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`because in Zeneca v. Eli Lilly, the secondary end point, which
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`is what they were relying on, actually shows statistically
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`significant difference in favor of the drug. That is what they
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`were relying on and Judge Koeltl said that is not enough
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`because the FDA said it is not enough, and he accepted the
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`experts.
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`Here, they are relying on data where they haven't even
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`shown a statistically significant difference. Yes, in Zeneca
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`it was off-label promotion, but that is irrelevant to the
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`Lanham Act. That is an FDA regulatory issue.
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`Lanham Act, the question is, is it true, is it false.
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`That is the only issue. I submit to you that the establishment
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`claim here is clearly false.
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`THE COURT: Thank you, Mr. Weinberger.
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`65PHPRO1 Opening - Mr. Golden
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`20
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`Mr. Golden.
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`MR. GOLDEN: Good morning, your Honor.
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`THE COURT: Good morning.
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`MR. GOLDEN: First, what I would like to do is give
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`you a readable copy of the sales aid, the current sales aid,
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`which started being used mid-March, and the FDA has had it
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`since mid-March.
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`The only thing I point out, if you look at the page
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`which is numbered 5 that Mr. Weinberger was referring to, it
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`does refer to the post hoc, but it clearly identifies it as a
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`post hoc subgroup. And the first bullet point says, In the
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`entire population, the difference between -- there was no
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`difference between placebo and the drug. So the disclosure is
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`there. According to Mr. Weinberger he doesn't object to our
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`using that as long as we disclose the information.
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`Secondly, although I don't agree with very much of
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`what he said, I do agree this has become a much simpler case.
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`But the reason it has become a much simpler case is because it
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`changed in what the plaintiffs are claiming, and that is
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`because the original claims, the advertisements, the sales aid,
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`the web page, are claims that they couldn't substantiate. But
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`they have never withdrawn them. In fact, a number of weeks ago
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`when I asked if they would withdraw their survey, the answer
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`was no.
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`So those claims are in the complaint, those claims are
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`65PHPRO1 Opening - Mr. Golden
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`21
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`the basis of this motion, and we just can't give up on them,
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`and we didn't. I wish we had known this because we both spent
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`a lot of effort on that.
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`The other thing that I am going to tell you about in a
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`little while is, Mr. Weinberger flashed up on the screen a
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`question of does this answer the question of proven vertebral
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`efficacy, but he hasn't shown you the answer. I am going to
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`let you hear the answer, which is really the way we answered
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`the question. So we obviously have a different view.
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`I hope I will keep to my time promise. I guess we all
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`know how good lawyers are at that.
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`But I want to put in context some of the things that
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`they said and some of the things that they are claiming in this
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`case that we just don't think are accurate.
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`Starting at the beginning, we are dealing with two
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`drugs here, Actonel and Boniva. Actonel is Procter & Gamble's
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`drug; Boniva is the Roche drug. They are both approved by the
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`FDA for treatment and prevention of osteoporosis in
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`postmenopausal women. Merck's product, Fosamax, is the third
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`and senior member of this class -- bisphosphonates is the n
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