Exhibit C 

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·1· ·exempt snare, which is a different device.· It's not

·2· ·specific for any type of unit, but it can injure, too.

·3· ·That's why not all filters can be recovered.· They have

·4· ·to have -- some of our clients have had to have it

·5· ·surgically removed because you cannot recover with the

·6· ·filter.

·7· · · ·Q· · In any of the cases that you've been

·8· ·specifically retained in, have you seen any indication

·9· ·that the Recovery Cone was implicated in a particular

10· ·patient's injuries?

11· · · ·A· · No, not in the cases I have.

12· · · ·Q· · Have you read any medical literature where the

13· ·Recovery Cone was implicated with a patient's injuries?

14· · · ·A· · I haven't looked for that.· I haven't focused

15· ·on that.· I know that -- I haven't focused on that.

16· · · ·Q· · Okay.· It's your opinion that the Recovery

17· ·filter was adulterated and misbranded?

18· · · ·A· · Yeah.· It didn't perform as cleared.· It was

19· ·cleared as a -- as a permanent filter, and it did not

20· ·perform as a -- it didn't perform like the SNF or any

21· ·other permanent filter.

22· · · ·Q· · Now --

23· · · ·A· · So that makes it adulterated right there.

24· ·It's not the device that's cleared.

25· · · ·Q· · Prior --

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·1· ·report, I think they had signals that there was an

·2· ·issue with the Recovery filter early on in terms of it

·3· ·not performing like the cleared product, and they

·4· ·didn't respond in a -- in a timely manner to ensure the

·5· ·safety of the public.· So that would be a criticism.

·6· · · · · · · · · In terms of their complaint handling,

·7· ·failure investigation, letting products stay out on the

·8· ·market, which was -- were out of spec, not conducting a

·9· ·recall, removing product from the market that was not

10· ·performing the way it was designed, not notifying

11· ·physicians about the potential risks, not ensuring that

12· ·patients were handed these filters that explanted in a

13· ·timely manner, those are criticisms.· I would look at

14· ·that as criticisms of quality assurance post-market

15· ·marketing.

16· · · · · · · · · And then also in terms of quality

17· ·assurance, some of the -- the labeling in terms of

18· ·marketing because that would be some of the claims that

19· ·they are making about the product.· Again, that would

20· ·feed into physician.

21· · · ·Q· · Have you seen any evidence that there -- Bard

22· ·did not appropriately follow federal regulations in how

23· ·it -- in its complaint handling process?

24· · · ·A· · Well, now when you say follow federal

25· ·regulations, that sounds like a legal conclusion. I

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·1· ·think the courts usually determine that; the judge,

·2· ·jury, people about that.

·3· · · · · · · · · In terms of what the regulations require

·4· ·as far as if I was a consultant explaining what the

·5· ·regulations, yes, I would -- I would have said that

·6· ·they should have recalled the product.· And I think I

·7· ·said it in my report in 2004, because to me, it's a

·8· ·prohibited act to sell a product that's adulterated and

·9· ·misbranded.· It's not behaving as cleared in a 510(k).

10· · · ·Q· · I'm not talking about what kind of moves as

11· ·far as the commercial sale of the product.· I'm talking

12· ·about complaint handling.· The FDA has requirements

13· ·that when a manufacturer receives notice of an adverse

14· ·event or a potential adverse event, they are required

15· ·to investigate it.· Isn't that correct?

16· · · ·A· · Yes, they are, and that's just part of quality

17· ·systems 21 CFR 820.

18· · · ·Q· · And they then have to submit a MDR, a medical

19· ·device report, to the FDA regarding that investigation,

20· ·correct?

21· · · ·A· · No, not necessarily.· 21 CFR 803 allows the

22· ·company to make a determination of whether something is

23· ·reportable or not reportable.· Oftentimes companies

24· ·will say if something is in a label, then it's not

25· ·reportable.

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·1· · · ·Q· · BY MR. NORTH:· And so it's your opinion that

·2· ·its off-labeled use of the Recovery filter in 2004 to

·3· ·implant it in a patient contraindicated for

·4· ·anticoagulation and with a history of recurrent

·5· ·pulmonary embolus if they are likewise a bariatric

·6· ·surgery patient?

·7· · · · · · · · · MR. LOPEZ:· Objection to the form.

·8· · · · · · · · · THE WITNESS:· Well, that's a different

·9· ·question, because now you are going through the

10· ·indicated use.· It could be because the company knows

11· ·they have done no research on anything about a

12· ·bariatric patient.· And a bariatric patient is

13· ·anatomically totally different than a patient of normal

14· ·weight.· And so there are new risks in terms of the --

15· ·and the company knows there is risks in terms of the

16· ·inferior vena cava, and they've done no research.

17· · · · · · · · · So let the doctor know they've done no

18· ·research to make sure it's safe.· He may want to put in

19· ·something else.· He may want to consider whether she

20· ·should be on heparin, or the patient.· So let the

21· ·doctor know that this has never been looked at for this

22· ·patient population.· Don't just give him something and

23· ·tell him or her that it's safe to give for a bariatric

24· ·patient, and then when the bariatric patient dies, they

25· ·go, well, they were bariatric patients.· They were

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·1· ·morbidly obese.· They had clots.

·2· · · · · · · · · You can't do that.· That's not -- that's

·3· ·not allowed in terms of the requirements.· It's a

·4· ·prohibited act to sell a device that's not safe and

·5· ·effective and adequately labeled.· You are not

·6· ·adequately informing the physician about this device

·7· ·before he implants it in a patient.

·8· · · ·Q· · BY MR. NORTH:· Is it your opinion that the

·9· ·Recovery filter should have been contraindicated in all

10· ·morbidly obese patients?

11· · · ·A· · Theoretically that would have been one option

12· ·for Bard, particularly since they knew in 2004 the

13· ·complications in bariatric populations were common and

14· ·that they had somehow been involved in promotion of it

15· ·for bariatric use, and now it wasn't safe and

16· ·attracting deaths.

17· · · · · · · · · So to contraindicate it would have

18· ·been -- made perfect sense.· It would have been an

19· ·option for Bard, and they could go into the FDA and

20· ·say, you know, we are aware of off-labeled use.· We

21· ·have never tested it for this.· These patients are

22· ·dying.· To protect public health, we are going to make

23· ·a change in our label and contraindicate it for our

24· ·patients using our filter.· So that would have been one

25· ·option for Bard to protect safety.

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