This is the deposition of Dr. Michael Loper, M.D. Dr. Loper treated James Evans for anosmia, which is the medical term for loss of smell. The following questions-and-answers are typical of the questions a defense lawyer will ask in Zicam litigation.
Q. Any other information that you believe is relevant to your opinions that you hold in this case with regard to the Zicam causing the severe loss of smell other than what we've already talked about here today?
A. Yes, sir.
Q. Okay. What would that be?
A. I think that Mr. Evans lost his smell due to Zicam mainly due to three opinions or subjective opinions. The first is I've already mentioned to you the temporal proximity. In other words, his loss of smell occurred at -- on the same day that he used the Zicam.
My second, I guess I would say, of course this could vary between second and third, but I think it's important that Mr. Evans lost his smell so rapidly that many conditions that I see of smell loss occur slowly over time.
And thirdly, this is not in my medical record, but I recall Mr. Evans telling me that when he sprayed the Zicam in his nose that he got a fairly intense burning, felt something was wrong immediately, and those would be the main reasons why I would attribute his smell loss to the use of Zicam.
And I guess fourthly I would say we've already discussed this, but the lack of anything else that would -- any object finding that would account for his smell loss.
Q. Do you know how long Mr. Evans had suffered from his cold prior to applying the Zicam in his nostrils?
A. No, sir, I don't.
Q. Other than him telling you that it was a mild cold, do you have any way to quantify exactly how severe the cold was that he suffered from that resulted in him applying the Zicam in either nostril?
A. No, sir.
Q. Okay. Did he quantify for you the amount of time that expired or amount of time that transpired between the application of Zicam and when he experienced the loss of smell?
A. If he did, I didn't quantify it.
Q. Okay. And you don't have any recollection either prior to me asking these questions or now, as we sit here in this deposition, as to what period of time would have transpired between the application of the Zicam and the loss of smell?
A. The only documentation -- the only recollection or documentation is that my note in the chart the decreased smell that day.
Q. Okay. And as far as the amount of decrease in smell that day, did you quantify that?
A. I did not.
Q. Okay. Are you aware -- and I apologize if I've already asked this question, but are you aware as to whether or not Mr. Evans applied the Zicam in both nostrils?
A. No, sir, I don't know that.
Q. So as far as when the intense burning occurred, other than it occurred immediately after the Zicam was applied, you're not aware as to which nostril it was applied in prior to the immediate burning occurring?
A. No, sir.
Q. Okay. What other objective findings would be important for you in diagnosing Mr. Evans to attribute the loss of smell to a reason other than the application of the Zicam?
A. I would say if I had a patient who had long-term smell -- or who had smell loss that at some point I might consider x-ray of his sinuses, CAT scan of the sinuses. MRI of the olfactory nerves. At some point in time I would probably want to do a formal smell test.
Q. And so obviously from looking at your file and what comprises your file you were not able to do the CAT scan or the MRI of the olfactory nerves or a formal smell test, correct?
MR. MILES: Object to form.
A. Correct.
MR. WALLIS: All right. I don't have any further questions. Thank you.
DEPOSITION OF ROBERT MICHAEL LOPER, M.D. JANUARY 10, 2008
ROBERT MICHAEL LOPER M.D., having been first duly sworn, was examined and testified as follows:
THE WITNESS: Yes.
DIRECT EXAMINATION
BY-MR. WALLIS:
Q. Doctor, could you state your full name, and spell your last name, please.
A. Yes. Robert Michael Loper, L-o-p-e-r.
Q. And you're an M.D., correct?
A. Yes, sir.
Q. Okay. And what's the business address where we are right now?
A. 1820 Barrs Street, B-a-r-r-s, Jacksonville, Florida 32204.
Q. And have you had your deposition taken before?
A. I have.
Q. Okay. Just kind of-- it's going to be no different than the other depositions you've given. It's going to be question and answer, period. If you answer a question for -- in this deposition, we're all going to assume that you understood the question that was asked. Fair enough?
A. Fair.
Q. So if you don't understand the question, please tell me or tell Mr. Miles and we'll be happy to rephrase the question, okay?
A. All right.
(Defendant's Exhibit-1 was marked for identification.)
Q. Let me hand you first what's been marked as Exhibit 1 to your deposition, and I'll represent to you it's a notice of taking your deposition and ask you just to look at that.
A. Yes, sir.
Q. Have you seen that document before, Doctor?
A. Not that I know of, but my office manager arranges depositions and things of that nature.
Q. Now, items that are described in there and enumerated in there, have you had a chance to look at those items as they're described?
A. Yes, sir.
Q. Is there anything described in there that is a part of your file that -- I see that you brought a folder with you here today. Is the folder that you have in front of you all the information that you have regarding treatment that you rendered to James Evans?
A. Yes, sir.
Q. Okay. Does that file -- would that include your billing as well?
A. No, sir, it would not.
Q. Is there anything other than your billing that would not be in the file that you have there with you right now as it concerns the treatment and care of James Evans that you provided to Mr. Evans?
A. Everything should be here in my file.
Q. Okay. Could I see your file quickly?
A. Yes, sir.
Q. Okay.
MR. MILES: Do you mind if I take a look at it?
MR. WALLIS: Sure.
MR. MILES: Thanks. You can keep going.
MR. WALLIS: Okay. Maybe I should better -- more ask this question of you, Seth. Is Dr. Loper a retained expert, or is he just a treating physician for Mr. Evans?
MR. MILES: He has not been retained as an expert. He is a treating physician, but I believe he has opinions.
MR. WALLIS: Okay. All right. Fair enough.
BY MR. WALLIS:
Q. Doctor, it's my understanding that you saw Mr. Evans, would it be, on one occasion or two occasions?
A. I think one occasion.
Q. Okay. And was that on December 8th of -- and we'll -- obviously any questions that you need to refer to your file is fine.
A. December 8th, '06.
Q. Okay. How did it come about that Mr. Evans came to you, if you know?
A. My understanding is that he was referred by his primary physician, Dr. Goh, G-o-h in Middleburg, Florida.
Q. Do you know Dr. Goh?
A. No, sir, I do not.
Q. Okay.
A. We've shared patients in the past. I've had referrals from him in the past, but I don't know him personally.
Q. Ever met him in a professional setting?
A. Not that I recall.
Q. All right. So Mr. Evans was not a regular patient prior to presenting to you on December 8th of 2006, correct?
A. No, sir.
Q. Okay. What were the complaints that he presented to you with on December 8th of '06?
A. I recall that the patient told me that he had a mild cold or an upper respiratory infection, and that according to my records he used a spray for his nose, Zicam, on December the 5th, and noticed that he had lost his smell later that day.
Q. And in your file, are all the documents that are in your file generated by your office, or do you also have other items in there that may not have actually been generated by your office?
A. The only thing that I know of in my record that's not generated by my office are the legal proceedings with request for records, et cetera.
Q. Okay. In response to a subpoena for records, I received three pages of information. I received this page right here --
A. Yes.
Q. -- which -- the handwritten notes from December 12th of '06?
A. Yes, sir.
Q. And what -- if you could, just kind of give me a brief description of what -- who would create this document in your office as a standard course of business?
A. That would be generated by one of my medical receptionists. They would take the message, a phone message for the patient or the patient's family, relay that message to me, usually the same day, and then a reply would be given to the patient.
Q. Okay. And do you -- does the handwriting on this document, is that familiar to you?
A. It is.
Q. And who would be the person whose handwriting that would belong to?
A. I'm not that familiar. It's either one of two, either Debra or Irami.
Q. Okay. And they're both receptionists or are they nurses by training?
A. They are receptionists.
Q. And you have that document in front of you, correct?
A. Yes, sir.
Q. Could we mark that document -- and I don't want to mess up your file, but I would like to kind of-- we may want to mark individual pages. I don't know how we should do that, just put a sticker on there; is that all right? So we'll mark that one as Exhibit 2.
(Defendant's Exhibit-2 was marked for identification.)
Q. And if you could tell me --just kind of go through with me what was written about Mr. Evans on December 12th of 2006 based upon Exhibit 2?
A. Yes, sir. Patient's wife called. Patient would like Prednisone called in. I called patient and advised Dr. Loper didn't prescribe Prednisone as they discussed, because of his cold. Patient said he took the Zicam because his mom had a cold, and he didn't want to catch it. He says he has no cold symptoms and would like the Prednisone called in to CVS at 282-3828. My office worker's initials are there. Under that it said, called in Sterapred 12-day DS pack. Patient aware. And then my office worker's signature again.
Q. So on December 12th of '06, had you actually -- prior to that date, had you met Mr. Evans?
A. I had.
Q. Okay. And that was on December 8th of '06 you had met him?
A. Yes, sir.
Q. Okay. And you have a record then in your file for the December 8th office visit?
A. I do.
Q. Okay. And let me just make sure, because I think I have a copy. Is that the same note?
A. Yes, sir.
Q. Okay. And I also have what I believe is another document from that December 8th of '06 visit. Is this it right here, Doctor?
A. Yes, sir, it is.
Q. Are these two documents that are dated December 8th of '06, do they document the same information or is it different information?
A. It's the same information. The typewritten page is a short reply to the referring physician consultative letter or consultation letter pertinent to this patient's findings. It's not necessarily a complete, but more of a snapshot of what we did on that visit.
Q. Okay. So if we could, let's go ahead and mark the handwritten document from December 8th of '06 as Exhibit 3. And we'll mark the typewritten document as Exhibit 4.
(Defendant's Exhibit-3 and Exhibit-4 were marked for identification.)
Q. Okay. Exhibit 3, the handwritten document, what -- obviously at the top of that document you have Mr. Evans' name, his address, date of birth, 35 years old. I'm sorry. Date of birth is XX/XX/ of '71. He's 35, correct?
A. Yes, sir.
Q. And then under referring physician it's Dr. Goh?
A. Yes, sir.
Q. And then, what is recorded there under the section, History/Chief Complaint?
A. Patient with mild cold, sprayed Zicam on Tuesday, 12/5, with decreased smell that day.
Q. Okay. And as far as tobacco, what does the plus indicate?
A. Plus means that he does smoke. It doesn't indicate amount, just that he is a smoker. Medications, none. Allergies, Carbocaine and Novocaine. Prior operations, thumb and foot.
Q. Okay. So in the meeting with or the initial visit with Mr. Evans, did he indicate to you the amount of tobacco use that he goes through a day?
A. He did not.
Q. Okay. And you're looking in your file at some other pages, so is there more documentation as to that office visit?
A. Yes, sir, there is. I have your -- saw this in the last two pages near the latter part of my record is a patient information sheet filled out by the patient, usually gives address, et cetera, insurance information, reason for appointment, and then on the second page we take kind of a review of some common medical problems, such as allergies, any medications and tobacco. And I was looking there to see if he had given quantity of tobacco.
Q. Okay. So let's go ahead and mark that two-page document as -- we're up to Exhibit 5; is that right?
A. Yes.
(Defendant's Exhibit-5 was marked for identification.)
Q. And are there any other documents in your file folder now that were generated from your office that we haven't marked?
A. Let me look.
Q. Okay.
A. I have a sheet that's marked Acknowledgment of Receipt of Notice of Privacy Practices. A HIPAA information form. I have -- the patient signed it, probably not pertinent to the case but kind of a standard form. I have another form that -- of the patient's insurance information. They're eligibility to receive medical care under that information. It's computer-generated probably from my office. I have a Xerox copy of an insurance card.
MR. MILES: You want to mark the whole thing as a composite. Let's make that No. 6.
(Defendant's Exhibit-6 was marked for identification.)
A. And I think that's it.
Q. There's one thing that I thought -- saw on there that I thought was like an e-mail.
A. Yes, sir. I looked at that. I will make sure we're talking about the same item. And I don't know that that was generated by my office. Is this the one in question?
Q. Yeah. It's -- it appears to be an e-mail. It's dated December 11th of '06 and it's authored by somebody named Wendy; is that right?
A. Yes, sir.
Q. Would there have been at that time anybody named Wendy that would have been employed by your office?
A. No, sir. I will tell you what I think it is. I gather that this was sent to my office somewhere or another and that the patient's wife's name is Nora, signed by Nora, sent to Debra, who is my office manager, probably is the one the family had contact with, and was probably sent as for your information. So my guess is it's from the patient's wife.
Q. Okay.
A. And these do not correspond to any e-mails that I have addresses at.
Q. So the e-mail addresses don't respond -- either the from or the to subject lines don't correspond to anybody that you're familiar with?
A. No, sir.
Q. Okay.
A. And it looks like this was a fax and it looks like it appears that it was faxed on that date.
Q. December 12th of '06?
A. From the plaintiffs tree surgeon company.
Q. Okay. Why don't we mark then -- let's mark that e-mail as exhibit -- and I'm going in a little bit different order, but Exhibit 7.
(Defendant's Exhibit-7 was marked for identification.)
Q. And then the remainder of your file we'll mark as Exhibit 6. Everything that has not been marked.
A. That would include the routine paperwork?
Q. Right. That will be a Composite Exhibit. And then I probably will need -- I don't -- we don't need to discuss it here in the deposition, but I will need to attach whatever billing records you would have, we will attach that as Exhibit 8.
A. All right.
Q. And I can get a sticker for that. Okay. Let's see. Getting back to the handwritten document dated December 8th of 2006. You have a section there for physical exam, so I'm assuming, obviously, that you undertook a physical exam of Mr. Evans?
A. Yes, sir.
Q. And what did you find in that physical exam?
A. Under nasal exam, I put clear bilaterally, normal nasopharynx, positive deviation to right. Under oral cavity exam, I said normal.
Q. Okay. And was there any other type of examination that you did to Mr. Evans other than the exam that you have now described based upon the documentation in this record?
A. Not to my recollection,.
Q. Okay. Did you undertake any type of x-rays or any other type of diagnostic testing of Mr. Evans?
A. No, sir.
Q. Okay. Any other examinations or testings that you did to Mr. Evans other than what we have now talked about in this deposition?
A. No, sir.
Q. Okay. What was the significance of the physical exam for purposes of your -- the care that you rendered to Mr. Evans?
A. In a patient with loss of smell I'm looking for anything that may give me a clue as to the source of that. Particularly in his case I was looking for anything such as evidence of an infection, polyps, growths, things of that nature. I did not find any growths, polyps, any structural abnormality.
Q. Okay. So what was your opinion as it -- well, you know what, let's go back down here. Let's finish out this document. On the bottom of the handwritten document dated December 8th of 2006, it says impression, and what was your impression?
A. Anosmia secondary to Zicam.
Q. And what is anosmia?
A. Loss of smell.
Q. Okay. And what was the treatment that you recommended for him?
A. I recommended a medication called Nasacort. Nasacort, three times a day for one week, then twice a day for four to six weeks. Under that I noted that no oral steroids due to URI.
Q. What does URI mean?
A. Upper respiratory infections.
Q. And did you diagnose him as suffering from an upper respiratory infection?
A. Not necessarily.
Q. Okay. Why did you put that warning then in there, that qualification there that no steroids due to URI?
MR. MILES: Object to form.
A. According to my records, under the history and chief complaint, I have that the patient had a mild cold, and I don't use oral steroids as freely when a patient has an infectious illness as when they don't have an infectious illness.
Q. Okay. And would a steroid be like the Prednisone?
A. Yes, sir.
Q. Okay. All right. And then just to finish out that document, you've got CVS, which I'm assuming is where you called in the Nasacort?
A. Yes, sir.
Q. Okay. All right. Let's go on to the next document that's dated December 8th of '06. That would be the typed written one. I think we numbered that as Exhibit 4 --
A. Yes, sir.
Q. -- is that right? And kind of just give me the information that's on that document.
A. I stated the patient's name, date of birth, referring physician, Dr. Goh. The date of XX/XX/06.
Chief complaint, 35-year-old with sudden loss of smell four days ago after using Zicam.
Findings: Clear nasal cavities bilaterally.
Impression: Severe loss of smell secondary to Zicam.
Recommendations: Begin an extended trial of Nasacort AQ.
Q. Okay. And so the recommendations would have been consistent with the treatment that was handwritten on the -- on Exhibit 3, correct?
A. Correct.
Q. Okay. Did you notice anything unusual as far as the condition of Mr. Evans' turbinates?
A. No, sir, I don't have any documentation.
Q. Okay. And is it your testimony that there wasn't any presence of swelling, inflammation or polyps in Mr. Evans' nasal -- either nasal cavity?
A. Yes, sir.
Q. Yes meaning there wasn't any?
A. There was, no, yes, sir, no swelling.
Q. Okay. And so December 8th would have been the only time that you actually physically saw Mr. Evans, correct?
A. Correct.
Q. So what occurred on December 12th was entirely a phone conversation and it involved Mr. Evans' wife calling in to somebody from your staff, correct?
A. Correct.
Q. All right. And that was the exchange that we talked about that had to deal with the patient requesting Prednisone, correct?
A. Yes, sir.
Q. All right. Did you at any time after December 8th of '06 ever meet or run into Mr. Evans again?
A. Not to my recollection.
Q. All right. And at the time that you examined Mr. Evans and gave your impression and your treatment for his condition, did you have a prognosis for the complaints that he was complaining of on December 8th of '06?
A. No, sir, I did not.
Q. Okay. Have you formulated any prognosis of Mr. Evans since December 8th of 2006?
A. The only information I have about the patient is -- and I really -- I guess really there's not information about the patient. Mr. Miles and I have talked on one occasion, but I don't know that we necessarily discussed his condition now, so I would say, no, I do not have any knowledge or opinion about his condition at present beyond this visit.
Q. Okay. And so when was the conversation that you had with Mr. Miles?
A. Yesterday.
Q. Okay. And was that a face-to-face meeting or was that over the phone?
A. Over the phone.
Q. And how long did that conversation last?
A. 20 minutes.
THE WITNESS: It was actually the day before yesterday, correct?
MR. MILES: Day before yesterday and we actually met in person one time before that.
THE WITNESS: About this?
MR. MILES: About -- yeah, about James. Remember, I came here that time, we vaguely recognized each other?
THE WITNESS: Gotcha. We did.
BY MR. WALLIS:
Q. So let's go back. The first time that you-all met was a face-to-face meeting, correct?
A. I would say, yes, but as you see my recollection is slim.
Q. Okay.
MR. MILES: I'm not that memorable.
MR. WALLIS: I won't pass any judgment on that.
Q. But at any rate, in your file there's no documentation as to that meeting with Mr. Miles when you-all met face-to-face?
A. Unless it's in one of those typewritten sheets that says that Mr. Miles had time to meet me on X date, which I have not reviewed and I have no knowledge of.
Q. Okay. Where would those typewritten sheets be?
A. They would be in this record. If Mr. Miles sent me a letter from his office on his stationery and said, will you -- we had -- I talked with your secretary and I've arranged a meeting for X day, that's in here, it could be in here.
Q. But at any rate, if it's not in the file that you have in front of you, it's not somewhere else in your office?
A. No, sir, it would not, and I would not generate anything handwritten or otherwise on my part had he and I met on a certain date.
Q. Okay. Why is that?
A. The medical record is for my documentation of the patient's condition. I'm not going to document this deposition in the medical record. It's evidence that we have met because of the letters that have been exchanged, but I don't document anything personally.
Q. Okay. So do you have any recollection as to what you and Mr. Miles discussed when you had your face-to-face meeting for purposes of this case?
A. No, sir, I don't.
Q. Okay. Do you recall approximately when that meeting would have taken place?
A. No idea.
Q. Okay. Could it have been -- I mean, are we talking -- can you even give me an estimate? Has it been within the last calendar year? Was it prior to 2007?
A. Well, I can guess, because if I saw the patient on 12/8/06 then probably we met in '07.
Q. Okay.
A. And that's the best that I can do.
Q. And so then fast-forward the other interaction you would have had with Mr. Miles would have been two days ago and that would have been over the telephone, correct?
A. Yes, sir.
Q. Do you recall how long that conversation took place?
A. Probably 20 minutes.
Q. And do you recall what was discussed during that conversation?
A. Yes, sir, I do.
Q. And what was discussed during that conversation?
A. That I was not going into the deposition as an expert witness. That I was as an examining physician or a clinical physician, and that that was about the gist of what we talked about.
Q. So during that conversation over the telephone with Mr. Miles, did you give him any of your impressions or your opinions concerning the condition that Mr. Evans presented to you on December 8th of 2006, or how he came to suffer from the condition or complaints that he presented to you with?
A. Yes, sir.
Q. Okay. And what did you tell Mr. Miles with regard to your opinions concerning his condition or what caused that condition?
A. I told him that I thought that Mr. Evans had lost his smell from spraying Zicam in his nose.
Q. Okay. Have you had any prior experience with treating patients that have used Zicam?
A. Yes, sir.
Q. Okay. And how many times have you come -- or experienced patients that have used Zicam?
MR. MILES: Object to form.
A. I recall only one other.
Q. Okay.
MR. MILES: Let me just object. You asked him if he's had other patients that used the Zicam. I think you meant used it and had an adverse reaction or just ever used it?
MR. WALLIS: My first question is ever used it.
MR. MILES: And I don't know if you understood the question.
A. I did and I don't know -- obviously most patients are not going to come in and say, I'm here to see you about my sinuses, and, oh, by the way I used Zicam a year ago. So basically to clarify, I have had one other patient who was thought to have an adverse reaction to Zicam and I wouldn't be aware of any other patients who -- whether they used Zicam on occasion or did or did not have complications.
Q. Okay. And before we go on, the one question I had is after your treatment of Mr. Evans, did there ever come a time that you recommended Mr. Evans go and seek medical treatment from another physician for purposes of treating complaints that he might have related to you or did relate to you that he suffered from on December 8th of 2006?
A. I have no recollection or documentation of such.
Q. Okay. So the one other patient that you believe had an adverse reaction from Zicam use, would that one other patient have presented to you prior to Mr. Evans presenting to you on December 8th of '06?
A. Yes, sir.
Q. Okay. And do you recall the specifics of that patient without naming the person?
A. Not at all.
Q. Okay.
A. I know that I have because it -- if you would, this jarred my memory or that I have that ability to recall that. But I don't recall the patient's name and out of several thousand charts I couldn't find the chart if I wanted to, nor would I recall the date or the specifics.
Q. But it was -- it did precede this December 8th of '06 office visit by Mr. Evans?
A. It did.
Q. Okay. All right. Have you yourself ever used Zicam?
A. No, sir.
Q. Is there any reason why you have never used Zicam?
A. No, sir.
Q. Do you have any friends or family members that to your knowledge have ever used Zicam?
A. No, sir.
Q. Have you -- do you recommend to your patients that they use Zicam?
A. No, sir.
Q. Do you specifically recommend to your patients that they not use Zicam?
A. The conversation as far as I know has never come up other than in the two patients that we've mentioned.
Q. Okay. So you haven't made it a policy in the course of your practice to discourage patients from using Zicam?
MR. MILES: Object to form.
A. I have not.
Q. Okay. On either the two occasions where patients have presented to you with complaints that you attribute to the use of Zicam, have you on either of those two occasions ever communicated your concern to any healthcare officials, specifically with the federal government, as it concerns side effects of using Zicam?
MR. MILES: Object to form.
A. No, sir.
Q. Did you ascertain with Mr. Evans whether when he used the Zicam did he follow all the instructions that accompanied the Zicam?
A. No, sir, I did not.
Q. Do you know if Mr. Evans, did he tell you that he sniffed the Zicam when he applied it in either of his two nostrils?
A. I don't recall.
Q. As far as your -- as far as the opinions that you have concerning the loss of smell being secondary to Zicam, what are kind of the bases for that opinion?
A. Temporal proximity being the number one.
Q. And so with regard to temporal proximity and me not being, obviously, a medical care provider -- I'm not even pretending to be that -- you're talking about the time frame between the using of the Zicam, according to Mr. Evans, and when he lost, according to him, his sense of smell?
A. Yes, sir.
Q. Okay. So as far as attributing the loss of smell to the Zicam, you're not basing that upon any studies or any published articles or peer-reviewed articles that, in your opinion, attribute the loss of smell to Zicam use?
A. If you would state that again.
Q. Okay. Are there any studies, any peer-reviewed articles or any case reports that, in your opinion, would support your opinion that the severe loss of smell that Mr. Evans suffered was secondary to Zicam use?
A. I'll assume that you're speaking of a medical article that I would use as a basis of making a diagnosis. And in that instance, I would say not that I recall reviewing.
Q. Okay.
A. But I would like to say that with the first patient I had, and with Mr. Evans, I did review information in articles related to people who had claimed to have lost their smell with Zicam.
Q. Okay. And when you say articles, can you give me specifics on the articles?
A. Most of the information that I recall reviewing was available on-line, perhaps legal cases, television reports, news reports, things of that nature.
Q. Okay. And when you're talking about these legal cases, television reports or news reports, obviously I have to ask the question, do you have those here in your office that you could refer to them or bring them --
A. I do not.
Q. -- to this deposition? Okay. So at some point in the past you reviewed these legal cases, television and news reports, however, you didn't retain the documentation for those specific references; is that correct?
A. Correct.
Q. Okay. Do you remember the searches that you ran on-line to pull up these legal cases, television and news reports?
A. Not specifically.
Q. Okay. You don't remember the names of any of the -- any of the media by which you would have gotten that, such as Fox News or any of the other websites and where you went to obtain that information?
A. No, sir, I don't.
Q. Do you remember the names of any of the cases?
A. I remember bits and pieces of the articles. I understand that the company is based in Arizona, Matrixx Initiatives. That there are legal cases that were generated in Arizona by a large legal corporation in Phoenix, if I recall. That there were 300-some odd cases that were settled for 12 million. That there are people who -- medical experts who feel that Zicam is the causative factor, particularly Dr. Terry Davidson in San Diego and a Dr. Jafek, J-a-f-e-k, who I think is in Denver. I understand that there was an inquiry or an investigation by the FDA at some point in time, and I'm not sure of the basis for the FDA investigation. And that's probably what I recall seeing on the Internet along with some various and sundry other comments on Zicam.
Q. Okay. But as far as specific citations to where I can get the same information that you referred to prior to making your diagnosis of Mr. Evans, it's your testimony that you can't produce that information for me?
A. Correct.
Q. Okay. Is it Dr. Terry Davidson --
A. Yes, sir.
Q. -- in San Francisco?
A. San Diego.
Q. Did you in any way interact or exchange information with Dr. Terry Davidson before you made your diagnosis of severe loss of smell secondary to Zicam?
A. Ask me that question again?
Q. Did you in any way interact with or exchange information with Dr. Terry Davidson prior to giving your diagnosis or impression that Mr. Evans experienced severe loss of smell secondary to Zicam?
A. Concerning Mr. Evans or Zicam either one?
Q. Yes, sir.
A. No, no contact with Dr. Davidson concerning that.
Q. Okay. Did you have any contact with Dr. Davidson?
A. I lived in San Diego for ten years. I did my specialty training in San Diego. I met Dr. Davidson on more than one occasion. I haven't seen Dr. Davidson personally or spoken with him in over 20 years.
Q. Okay.
A. But I have had personal contact with him in the past.
Q. Okay. And that would have been all professional-related or training-related --
A. Yes, sir.
Q. -- to your areas of expertise?
A. Yes, sir.
Q. How about Dr. Jafek?
A. Don't know him or anything about him other than what I've mentioned to you.
Q. So no interaction with Dr. Jafek prior to you forming the impression that Mr. Evans suffered a severe loss of smell secondary to Zicam?
A. Correct.
Q. I have a whole bunch of questions on testing and testing that was done or your recollection of interpreting testing that has been done with regard to Zicam and whether it does or doesn't cause any type of side effect which may include loss of smell. I can go through all that, but I'm gathering from your testimony here now you can't recite for me specific tests that have been performed to either prove or disprove that Zicam can cause a loss of smell; is that correct?
MR. MILES: Object to form.
A. I mentioned to you that I have done Internet searches and that's probably been on two occasions, could possibly be more, but concerning my first patient and my second patient. Both of those are in the distant past. And I am sure that in those Internet sites there were mention of articles or scientific studies either performed by Zicam or by others, if I recall the studies by Zicam, which found no side effects from their medication or bad effects such as anosmia. And so to answer your question, I'm aware of such things distantly and minimally, but that would be the full extent of my knowledge about studies.
Q. So as far as reciting for me the protocol that was followed in any test leading up to the conclusions that were documented as a result of that test, you couldn't recite for me what type of protocol was followed; is that correct?
A. Correct.
Q. Okay. And as far as criticisms of any of the tests, could you provide me with any specific criticisms of the test and specifically the protocol that was followed of the test in order to either discredit or credit the test that was performed as it concerned whether or not Zicam resulted in any loss of smell?
A. I recall distantly that there was criticism of the testing by Zicam in that in their studies it showed no loss of smell, that the subject numbers were small.
Q. Okay. And so the criticism you're talking about is criticism that would have been rendered by -- do you recall who the criticism was --
A. No, sir, I don't.
Q. -- was originated with?
A. No, sir, I don't.
THE WITNESS: Can we break for a second?
MR. WALLIS: Yes.
(Break taken.)
BY MR. WALLIS:
Q. Okay. Doctor, we're back on the record. Do you have any opinion as to how much Zicam would need to pass through Mr. Evans' nasal cavity and come into contact with the olfactory membrane in order to result in the sudden loss of smell secondary to Zicam?
A. No, sir.
Q. And you haven't undertaken any kind of studies or anything like that to in any way quantify that?
A. No, sir.
Q. Do you have any opinion as to the effect that the deviated septum had on the ability of the Zicam to come into contact with the olfactory membrane?
A. No, sir.
Q. Are you aware as to whether or not Mr. Evans, in fact, applied the Zicam in each nostril as he was undertaking the application prior to him presenting to you on December 8th of 2006?
A. No, sir, I don't know that.
Q. Are you aware -- can you recite to me any specific tests that have been administered that would prove or support your opinion that Mr. Evans' severe loss of smell was secondary to Zicam use?
A. No, sir. I would think there would be no test available for that.
Q. The -- is it asnosmia (phonetic)? Is that how I pronounce it?
A. Anosmia.
Q. I didn't butcher it too bad. Loss of smell, correct?
A. Yes, sir.
Q. And as far as loss of smell, anosmia, obviously that's a condition that you and your practice have -- you've run into that before with your patients, correct?
A. Yes, sir.
Q. Okay. And what are some common causes o anosmia?
A. Common cold, influenza, head trauma and several nasosinus conditions.
Q. Would nasosinus conditions be like anatomical defects or anatomical obstructions?
A. Yes, sir, it could.
Q. Okay. Are there some anosmia conditions that are what fall under the category of just idiopathic as far as an unknown cause?
A. Yes, sir.
Q. Okay. What percentage of anosmia cases are caused by the conditions that you have recited for us here in your deposition, if you were to attach a percentage to those?
A. Are you asking of the things I've just named of all anosmics, how many would be included in that -- in those conditions?
Q. Yes, sir.
A. You mean trauma, nasal conditions, obstructive events, et cetera?
Q. Yes, sir.
A. I haven't named all the possibilities and I don't know that I could name every possibility, but I would say that the things I've mentioned probably would account for 90 percent or so if not a little bit more of all cases of anosmia.
Q. Okay. Are there social factors that would -- could also account for anosmia in a patient such as, you know, I guess I don't know if age would be a social factor but --
A. Yes, sir.
Q. -- would you consider that a social factor or is that --
A. I guess so.
Q. And, like, alcohol would alcohol use?
A. Not that I know of.
Q. Okay. And what about tobacco use?
A. Probably so.
Q. Okay. Any opinion as to the percentage of cases of anosmia that would be attributable to tobacco use or age?
A. I would think that in an elderly population that age would be a fairly common cause of smell loss. I don't know of anyone that I could say I felt that total smell loss was attributed to tobacco alone nor have I seen any studies that would validate that conclusion.
Q. Okay. So generally tobacco use -- if a patient suffers from anosmia and they used tobacco on a regular basis, it would be your opinion that that tobacco use wouldn't be the sole cause of the anosmia, correct?
A. Probably so.
Q. So it would be in conjunction with another factor such as probably one of the factors that you named here?
MR. MILES: Object to form.
A. Yes, sir. And just to clarify, anosmia is by definition total loss of smell. There are patients with diminished smell and you could classify those under hyposmia, which hyp is lower smell or diminished smell, and so in general when we talk or speak of anosmia, in this situation I'm talking about total loss of smell versus someone who has diminished or lesser smell.
Q. Okay. Would you disagree with me with regard to the statement that there are probably two to four million people in the United States that experience anosmia?
A. I have no basis for that.
Q. Okay. Have you ever reviewed the instructions that are on the packaging that accompanies the Zicam?
A. No, sir, I haven't.
Q. Okay. So if I were to ask you would you agree with me that if the instructions on the package are followed that you couldn't give me a percentage on the likelihood that the actual Zicam product would come into contact with the olfactory epithelium?
MR. MILES: Object to form.
A. I have no opinion since I don't know what the direction says.
Q. Okay. Fair enough. Doctor, I've asked you questions throughout the deposition. Obviously all of your answers have been based upon a reasonable degree of medical certainty; is that correct?
A. Yes, sir.
Q. Okay. Any question that I have not asked of you as you sit here now that you think is important that is an answer that you believe would impact the opinions that you had here with regard to the severe loss of smell being secondary to Zicam use that we haven't already talked about?
MR. MILES: Object to form.
A. Yes, sir.
Q. Okay.
A. You want to proceed?
Q. Any other information that you believe is relevant to your opinions that you hold in this case with regard to the Zicam causing the severe loss of smell other than what we've already talked about here today?
A. Yes, sir.
Q. Okay. What would that be?
A. I think that Mr. Evans lost his smell due to Zicam mainly due to three opinions or subjective opinions. The first is I've already mentioned to you the temporal proximity. In other words, his loss of smell occurred at -- on the same day that he used the Zicam.
My second, I guess I would say, of course this could vary between second and third, but I think it's important that Mr. Evans lost his smell so rapidly that many conditions that I see of smell loss occur slowly over time.
And thirdly, this is not in my medical record, but I recall Mr. Evans telling me that when he sprayed the Zicam in his nose that he got a fairly intense burning, felt something was wrong immediately, and those would be the main reasons why I would attribute his smell loss to the use of Zicam.
And I guess fourthly I would say we've already discussed this, but the lack of anything else that would -- any object finding that would account for his smell loss.
Q. Do you know how long Mr. Evans had suffered from his cold prior to applying the Zicam in his nostrils?
A. No, sir, I don't.
Q. Other than him telling you that it was a mild cold, do you have any way to quantify exactly how severe the cold was that he suffered from that resulted in him applying the Zicam in either nostril?
A. No, sir.
Q. Okay. Did he quantify for you the amount of time that expired or amount of time that transpired between the application of Zicam and when he experienced the loss of smell?
A. If he did, I didn't quantify it.
Q. Okay. And you don't have any recollection either prior to me asking these questions or now, as we sit here in this deposition, as to what period of time would have transpired between the application of the Zicam and the loss of smell?
A. The only documentation -- the only recollection or documentation is that my note in the chart the decreased smell that day.
Q. Okay. And as far as the amount of decrease in smell that day, did you quantify that?
A. I did not.
Q. Okay. Are you aware -- and I apologize if I've already asked this question, but are you aware as to whether or not Mr. Evans applied the Zicam in both nostrils?
A. No, sir, I don't know that.
Q. So as far as when the intense burning occurred, other than it occurred immediately after the Zicam was applied, you're not aware as to which nostril it was applied in prior to the immediate burning occurring?
A. No, sir.
Q. Okay. What other objective findings would be important for you in diagnosing Mr. Evans to attribute the loss of smell to a reason other than the application of the Zicam?
A. I would say if I had a patient who had long-term smell -- or who had smell loss that at some point I might consider x-ray of his sinuses, CAT scan of the sinuses. MRI of the olfactory nerves. At some point in time I would probably want to do a formal smell test.
Q. And so obviously from looking at your file and what comprises your file you were not able to do the CAT scan or the MRI of the olfactory nerves or a formal smell test, correct?
MR. MILES: Object to form.
A. Correct.
MR. WALLIS: All right. I don't have any further questions. Thank you.
CROSS-EXAMINATION
BY-MR.MILES:
Q. Just a few questions. Could you give us the benefit of your educational background and medical training?
A. Yes, sir. I'm board certified in the American Academy of Otolaryngology, which is the national governing board of my specialty, ear, nose and throat. I became board certified 1983. I'm in private practice here at St. Vincent's since 1986. I'm presently chief of surgery for the hospital.
Q. And how long have you been chief of surgery for St. Vincent's Hospital?
A. July '06.
Q. Is that an appointment?
A. Yeah. It's elected.
Q. Okay. Is there a term for that or are you --
A. Three-year term.
Q. Three-year term limit?
A. Can be repeated, yes, sir.
Q. When you saw James Evans, did you see him as a patient or a litigant?
A. Patient.
Q. And have you been retained by anyone in this case as an expert witness?
A. No, sir.
Q. Have you ever examined James Evans as a litigant rather than a patient?
A. No, sir.
Q. When you rendered your care, did you render it to James Evans as a patient or a litigant?
A. Patient.
Q. When you came up with your diagnosis, did you create that diagnosis for James Evans as a patient or a litigant?
A. Patient.
Q. And what was the purpose for creating a diagnosis for James Evans as a patient?
A. As a means of explanation for the patient and as a means of beginning treatment.
Q. And the treatment that you recommended he begin, was that for the purpose of dealing with James Evans' anosmia?
A. Yes, sir.
Q. And the reason that you recommended that treatment was -- strike that.
The basis for the recommendation of that treatment was what?
A. To try to improve his smell.
Q. Make him better?
A. Yes, sir.
Q. You listed a number of causes, potential causes for anosmia and I wrote down common cold, influenza, head trauma, nasosinus conditions.
A. Yes, sir.
Q. Did you see any objective indication of James Evans suffering from a common cold?
A. No, sir.
Q. Did you see any objective indicia of James Evans suffering from influenza?
A. No, sir.
Q. Did you see any objective evidence of James Evans suffering from head trauma?
A. No, sir.
Q. Did you see any objective evidence of James Evans suffering from nasosinus conditions?
A. No, sir.
Q. You spoke about the differing onset of anosmia based upon the causation. Can you describe for us generally what the onset of anosmia caused by the common cold would be?
A. I think it's variable. It could be within a short period of time or it could be gradual over the course of the cold.
Q. When you say a short period of time, do you have any idea how short a period of time that onset could occur?
A. No, sir. What happens in most situations is that someone with a common cold will realize after the cold is over -- realize actually during the cold, which we all pretty much have a subdiminishment of smell and when the cold is over realize that it has lingered or is greater than what they thought it should be.
Q. So is it possible to have a sudden onset of anosmia due to a common cold?
A. I would think it could be.
Q. Is it possible to have a sudden onset of anosmia due to influenza?
A. Yes, sir.
Q. Is it possible to have a sudden onset of anosmia due to a nasosinus condition?
A. I would think there would be circumstances where it would be possible.
Q. Is it possible to have a sudden onset of anosmia due to tobacco use?
A. Probably unlikely.
Q. Did you feel it necessary to review clinical trials of Zicam or formal studies of Zicam before making a diagnosis of James Evans' condition?
MR. WALLIS: Objection, form.
A. I did feel with the first patient that we've mentioned that since there was the first patient that it was my duty to further investigate.
Q. And with respect to James Evans, did you feel the need to do any additional literature review or study in order to make a diagnosis?
A. Yes, sir, I did.
Q. And you said you performed -- you described for us how you performed that --
A. Yes, sir.
Q. -- literature review. Prior to performing that literature review, did you have a differential diagnosis for James Evans?
A. In -- differential meaning did I have a different diagnosis, no, sir, I did not. I felt that it was Zicam.
Q. How early in the examination of James Evans did you believe that his anosmia was caused by Zicam?
A. I don't recall the exact moment or the duration.
Q. Within the period of his physical examination?
A. Yes, sir.
Q. And you've explained to us what that diagnosis was based upon?
A. Yes, sir.
Q. Can you tell us the methodology that you used in diagnosing James Evans as suffering from anosmia secondary to Zicam?
A. I used history and physical, which are the basis for making the exam, along with the third component being laboratory exam, which I did not do on Mr. Evans. But in my -- in obtaining the history, the patient's recollection of what occurred, and then my physical exam, the lack of finding other explanations for his smell is what formulated my diagnosis.
Q. In addition to Mr. Evans' history and your examination of him, did you utilize your training as an otolaryngologist?
A. Yes, sir.
Q. Did you utilize your background as an otolaryngologist?
A. Yes, sir.
Q. Did you utilize the experience that you've accumulated over the course of, at that time, 23 years as a board-certified otolaryngologist?
A. Yes, sir.
Q. Did you apply scientific methodology that you learned both in medical school through your training and in your experience as an otolaryngologist to reach that diagnosis?
A. I did.
Q. Do you have an opinion as to how anosmia caused by a toxic substance in the olfactory nerve would feel to a patient?
MR. WALLIS: Objection, form.
A. If you would, ask me again?
Q. Do you have an opinion as to how a toxic substance which was able to the reach the olfactory nerve of a patient would feel subjectively to that patient?
MR. WALLIS: Objection, form.
A. In patients that I have had that have had chemical toxicity, most describe some type of intense burning or pain with the chemical toxicity if it is acute.
Q. Similar to that described to you by James Evans?
MR. WALLIS: Objection, form.
A. Yes.
Q. Did you use any different scientific or medical methodology in reaching the diagnosis of anosmia secondary to Zicam for James Evans that you have for any of your other patients over the course of your 20-plus years of practice?
MR. WALLIS: Objection, form.
A. No, sir.
Q. Ballpark, how many patients have you used that same scientific and medical methodology for over your 20-plus years of board-certified practice?
MR. WALLIS: Objection, form.
A. Tens of thousands.
Q. During your examination of James Evans, you testified that you saw no polyps, correct?
A. Yes, sir.
Q. And what was the significance of that to you?
A. Polyps are indicative of a long-term nasosinus problem or condition.
Q. So the presence of polyps -- strike that.
Would the presence of polyps indicate a nasosinus condition as the potential cause of the anosmia?
A. Yes, sir.
Q. You also testified that during your physical examination of James Evans you saw no evidence of infection. Was that significant?
A. Yes, sir.
Q. Would the presence of and evidence of infection indicate to you a potential cause for the anosmia?
A. It would.
Q. What cause would that indicate?
A. Viral injury.
Q. Similar to influenza or a common cold?
A. Yes, sir.
Q. And would the absence of that evidence of infection lead you to preclude those as potential causes for the anosmia?
A. Not necessarily.
Q. Okay. While not solely leading you to rule out that as a cause, would it be a part in your ultimate determination of a diagnosis?
A. It would.
Q. An important part?
MR. WALLIS: Objection, form.
A. Not necessarily.
Q. Okay. Explain to me why or why not it would be an important part of your ultimate diagnosis?
MR. WALLIS: Objection to form.
A. A patient with a mild cold may have no objective findings.
Q. Do you have an opinion as to whether a mild cold versus a more severe cold could cause anosmia?
A. Yes, sir, but I'm not sure it's scientific. I've always thought that subjectively that to lose smell completely would logically be caused by a worse cold or a worse influenza, but I'm not sure that that's validated by studies in patients with anosmia thought to be due to virus.
Q. You haven't reviewed or investigated that? That's based anecdotally on your patient experience --
A. Correct, yes, sir.
Q. -- over the course of your practice, correct?
A. Correct.
Q. And you said that you examined Mr. Evans for growths and saw none. What was the import of that?
A. A growth would be like a polyp indicating a preexisting nasosinus condition.
Q. And the absence of that would --
A. Narrow my diagnosis.
Q. You said you examined Mr. Evans for a structural abnormality and found none.
A. I found that he had a septal deviation as noted in the record, and I used that finding as -- in part of my differential.
Q. In what way did you use that finding?
A. I didn't feel that even though he had a structural abnormality, i.e., the septal deviation, that it was pertinent to acute loss of smell since septal deviations are long-term conditions and preexisting conditions.
Q. And the onset of anosmia due to a septal deviation would be more gradual?
MR. WALLIS: Objection to form.
A. Yes, sir.
Q. Have the opinions that you've given me during my questioning come within a reasonable degree of medical probability?
A. Yes, sir.
MR. MILES: No further questions.
REDIRECT EXAMINATION
BY-MR. WALLIS:
Q. Do you have any opinion, Doctor, that based upon Mr. Evans' -- the condition of his nose and specifically with regard to the septal deviation, if he had applied Zicam as it was instructed, based upon the literature that accompanied that product with him, how much Zicam would have even made it to his olfactory membrane when he applied it prior to December 8th of 2006?
MR. MILES: Object to form.
A. No, sir.
Q. Okay. The only other question or I guess it's a request, if we could get the billing records.
A. Yes, sir.
Q. I don't know if we could.
MR. WALLIS: Did I give you a number for that?
MR. MILES: I think it's 8.
Q. Then I have a sticker for the notice.
MR. WALLIS: There's a sticker for the notice.
MR. MILES: 8.
MR. WALLIS: And is that it?
MR. MILES: That's it for me.
MR. WALLIS: Okay. No other questions. Thank you, sir. Obviously, read or waive?
THE WITNESS: I'll waive.
(Defendant's Exhibit-8 was marked for identification.)
(Deposition concluded at 5:11 p.m.)
