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Larry F., Former Client

"I'm not sure where I would be today if it weren't for Justin and the law firm he is with... You become a part of the family the day you become a client and there is nothing more satisfying... If you want the best, the most terrific, then this is the man you want as your attorney."

Ben C., Former Client

"They're good people, plain and simple. I had the opportunity to work with Justin Demerath on a few issues. One where he had nothing to gain financially and the other, he did. There was no difference in his demeanor, the way he treated me or his intent. He just wanted to help in any way he could."

Herbert F., Former Client

"I want to thank you Justin for a job well done. My case was certainly a difficult one as attested to by the number of rejections I had before your name was given to me... You were up front about my chances for a win, never denying the road blocks that certainly would arise. I was impressed by the professional manner in which you handled my case."

Melanie S., Former Client

"The service I received from Justin Demerath has been unparalleled in every aspect. He is very professional, concise, and empathic towards his clients. My settlement exceeded my expectations on my collarbone injury case, in result of his strong desire for success."

Teresa P., Former Client

"WOW! I haven't seen this kind of customer service in years. Justin visited with me on the phone until all my questions were answered. He was extremely helpful, gracious, pleasant, willing, professional and very nice."

"In the midst of dealing with insurance, body shop, doctors and staff all of whom were 'just doing their job'... Justin was a ray of sunshine on a very gloomy day in my life. He made me feel very comfortable and encouraged me to continue with my questions... Thank you Justin...God bless you."

Jon S., Former Client

"Fantastic Representation. Justin Demerath represented me in a motorcycle accident where I was injured severely. The outcome was a best case scenario based on the realities of the at-fault driver. I received the largest settlement that was available and it turned out well. That was the bottom line, but what I wanted to comment on was Justin's willingness to explain each step of the process and his personal interest in my case. He came to visit me at my house while I was still unable to walk and his competence and ability to put things in simple terms allowed me to feel comfortable to take the details of my case off my plate and put it in his hands."

Nancy C., Former Client

"I am just so impressed in your scientific and legal knowledge. Your commitment and enthusiasm goes beyond compare. Should I ever need your services again or if someone I know needs your expertise, I will not hesitate to give you and call or make a referral."

Jay B., Former Client

"My experience with the insurance companies over the 15 months following the accident was frustrating... I admit I was also reluctant to find a personal injury lawyer, based on the stereotype of personal injury lawyers that I had ... I no longer carry that stereotype with me, I've since learned better."

Cindy R., Former Client

"Great Representation. I was involved in an auto accident two years ago and, after unsatisfactory dealings with the insurance company of the other driver, I hired Justin Demerath to represent me in my claim for medical bills coverage.... Mr. Demerath is a true professional whose compassion for his clients and for the law is first rate."

Motorcycle Accident / Product Liability

Gross Recovery:	$2,275,000.00
Client Net:	$1,285,861
Attorney Fees:	$910,000
Expenses:	$79,138.18
Medical Bills:	In excess of $170,438.09

A Retired motorcyclist was killed as a result of injuries sustained when a commercial truck hit his vehicle due to a defective design in the vehicle. Our firm represented 3 of 4 surviving children of the deceased, as well as jointly representing the estate of the deceased cyclist. The values stated are for all children as well as the Estate.

Disclaimer:
Past case values are not an accurate predictor of future results, nor the value of any potential client's particular situation. These case results are based upon unique and specific factual and legal circumstances. Each case is different. The same or similar results may not be able to be obtained for other clients in similar matters.

Product Liability

Gross Recovery:	$2,025,000.00
Client Net:	$810,153.07
Attorney Fees:	$810,000.00
Expenses:	$58,831.93
Medical Bills:	In excess of $640,000.00

Partial blindness, memory loss, and brain damage suffered by a worker as a result of an unexpected vehicle rollover of a defective product.

Auto Accident

Gross Recovery:	$1,850,000.00
Client Gross:	$1,025,107.50
Client Net:	$690,651.27
Attorney Fees:	$671,000.00
Expenses:	$152,430.75
Medical Bills:	In excess of $339,982.00

Auto accident with a commercial vehicle which ran a red light causing a young man severe injuries that resulted in back surgery and prevented him from returning to work. The commercial vehicle driver was killed in the accident, and toxicology results showed him to be under the influence of marijuana while on the job.

Auto Accident

Gross Recovery:	$1,250,000.00
Client Net:	$671,000
Attorney Fees:	$500,000
Expenses:	$17,000
Medical Bills:	$62,000

After serving two tours in Iraq, our client was hit by a commercial vehicle, suffering multiple broken bones and a spine injury. He was honorably discharged from the military due to his injuries and had a limited ability to earn a living.

Apartment Fire - Negligent Design of an Apartment Complex

Gross Recovery:	$950,000.00
Client Net:	$288,300.20
Attorney Fees:	$378,300.20
Expenses:	$251,730.48
Medical Bills:	In excess of $532,393.34

Following a fire that destroyed their home and badly burned their children, a family of four hired our firm to represent them against their apartment building that lacked the proper fire exits.

Negligence - 18-Wheeler Accident

Gross Recovery:	$900,051.64
Client Net:	$540,305.24
Attorney Fees:	$279,000.00
Expenses:	$65,619.78

Open highway 18-wheeler accident, leading to the death of our client. We represented the Estate of the deceased, the widow of the deceased, as well as two adult children of the deceased when a wheel separated from a trailer. The values stated herein are cumulative.

Product Liability / Defective Machinery

Gross Recovery:	$785,000.00
Client Net:	$494,488
Attorney Fees:	$250,537
Expenses:	$39,975.45
Medical Bills:	In excess of $67,431.47

Construction worker's legs were crushed by a machine when the braking mechanism failed. Our client was in his 50's and unable to work at his chosen profession due to his injures.

Auto Accident

Gross Recovery:	$600,000.00
Client Net:	$330,643.88
Attorney Fees:	$240,000.00
Expenses:	$4,501.59
Medical Bills:	In excess of $101,045.83

Mother and two minor sons were all injured in a multi-car accident in which they were hit from behind by a woman who hit the gas instead of the brakes. Our client's spine was fused in multiple locations, and her ability to earn a wage was limited.

Bus Accident

Gross Recovery:	$410,000.00
Client Net:	$240,693.11
Attorney Fees:	$164,000.00
Expenses:	$5,309.89
Medical Bills:	In excess of $97,892.23

Man injured his spine in an auto accident involving a charter bus on Interstate Highway 35.

Auto Accident

Gross Recovery:	$152,500.00
Client Net:	$84,609.24
Attorney Fees:	$50,325.00
Expenses:	$892.93
Medical Bills:	In excess of $67,119.28

Teenager involved in a single-car rollover accident in which she was ejected from the passenger seat of the vehicle she was riding in and fractured her skull.

Product Liability / Defective Design

Gross Recovery:	$150,000.00
Client Net:	$94,151.42
Attorney Fees:	$49,500.00
Expenses:	$6,348.58
Medical Bills:	In excess of $47,704.60

A wheelchair bound woman suffered broken legs due to the use of a customized shower chair that had faulty engineering rendering it an unreasonably dangerous product.

Auto Accident - Intoxicated Driver

Gross Recovery:	$25,000.00
Client Net:	$16,072.18
Attorney Fees:	$8,332.50
Expenses:	$595.32
Medical Bills:	In excess of $17,892.00

Passenger injured in a vehicle T-boned by an intoxicated teenager who ran a stop light. The maximum amount of insurance was collected.

Auto Accident

Gross Recovery:	$20,000.00
Client Net:	$12,954.73
Attorney Fees:	$6,660.00
Expenses:	$385.27
Medical Bills:	$31,018.92

Single-car accident. Passenger received soft tissue injuries when driver of her vehicle ran off the road to avoid hitting wildlife and flipped the car landing face down. The maximum amount of insurance was recovered.

Skillful and Aggressive Legal Representation

When you or a loved one has endured personal injury or wrongful death, you have the right to seek justice and compensation. O'Hanlon, McCollom & Demerath is committed to providing each and every one of our clients with compassionate advocacy and skillful, tireless, aggressive representation. Our number one priority is providing each client with the most desirable legal outcome to every issue they are facing.

We Value and Respect Every Client

We believe that every client deserves and should receive one-on-one access and attention. Legal issues can be daunting without the protection of knowledgeable and experienced lawyers. O'Hanlon, McCollom & Demerath is dedicated to resolving your unique situation with compassion and diligence.

Superior Client Services

At O'Hanlon, McCollom & Demerath we ensure seamlessly integrated work product and representation through our utilization of state of the art technology and resources. We are committed to providing our clients superior legal representation at every turn.

Commitment to Getting you the Compensation you Deserve

In our efforts to obtain compensation for our clients who have suffered injuries and the related indignities arising from the negligent actions of individuals and corporations, we pledge to provide you with a personalized, "no stone unturned" pursuit in achieving the most favorable outcome on your behalf in what are, undoubtedly, the most important and often life-changing situations you may ever experience.

Our clients never owe any fees unless we obtain financial settlement on their behalf. We will go the distance for you.

Contact Our Personal Injury Attorneys Today

O'Hanlon, McCollom & Demerath offers you a free one-on-one evaluation of your personal injury case. Our clients never pay for our legal services unless we obtain a successful recovery of compensation for you. Contact us today for a free and confidential consultation with our experienced personal injury lawyers.

Kevin O'Hanlon

Kevin O'Hanlon, the founding partner of O'Hanlon, McCollom & Demerath began practicing law in 1974 and has vast knowledge of all areas of litigation. Mr. O'Hanlon became Board Certified in Civil Appellate Law by the Texas Board of Legal Specialization in 1987, and in Civil Trial Law in 1990.

Justin Demerath

Justin Demerath joined the firm as a law clerk during his final year of law school and has been with the firm since that day. He has dedicated his law practice to helping people who have suffered damages at the hands of others in the state of Texas recover monetary compensation. Mr. Demerath has one mission in his work: to fight for the rights of the clients he represents.

Benjamin Castillo

Benjamin Castillo In 2010, Mr. Castillo graduated from The University of Texas at Austin with a Bachelor of Arts in Government. Upon graduation, Mr. Castillo worked as a government and history teacher in the Rio Grande Valley.

Nick Maddox

Nick Maddox is an associate attorney who represents clients in a diverse range of litigation issues. Licensed to practice in both State court and Federal court, Mr. Maddox handles injury, employment, business, and contract disputes.

Amalia Hanley

Ms. Hanley graduated with honors from the University of Notre Dame with Bachelors of Arts degrees in History and Art History. In 1998, Ms. Hanley graduated with honors from the University of Florida School of Law. During school, and continuing after graduation, Ms. Hanley clerked for the Public Defender's Office in Gainesville, Florida, gaining criminal litigation experience in the Misdemeanor Division.

Alice Ward

Alice Ward was born in Ithaca, NY and raised in Jersey City, NJ. The older of two daughters, she graduated from Friends Seminary, a Quaker high school, in 1996. Ms. Ward attended the University of Texas in Austin, attaining a BA in History in 2000. She also became a certified paralegal through Austin Community College.

Adelie Alvarez

Adelie Alvarez grew up in Buda Texas and graduated from Hays High School. She has extensive experience in many areas of law. Since 2006, Adelie has worked for various local Austin attorneys.

Serious Personal Injury

Every year, hundreds of Texans suffer serious injury because of the reckless actions of another. If you were hurt in a car accident or pedestrian accident, or a loved one was injured using a defective product, the personal injury attorneys at O'Hanlon, McCollom & Demerath are here to help.

Wrongful Death

It is unfortunate, but it is usually up to the victim's family to pursue a wrongful death claim after the accidental death of a loved one. At a time when you feel most vulnerable and emotionally exhausted, a lawsuit is the last thing on your mind. But it's important to give it some consideration. An experienced, dedicated Austin injury attorney can help.

Car Accidents

Car accidents carry serious physical and financial consequences. Injuries can leave you unable to work and prevent you from enjoying a normal life. To make matters worse, your insurance company may more committed to its bottom line than your recovery. At O'Hanlon, McCollom & Demerath in Austin, Texas, our main priority, is representing people who have been injured in car accidents and make them whole again.

Motorcycle Accidents

With the freedom and excitement motorcycle riders enjoy comes the risk of serious injury in an accident. Despite the consistent warnings drivers receive to â€œstart seeing motorcycles,â€ thousands of people across Texas are injured in motorcycle accidents. If you have been involved in an accident, you can benefit from immediate representation from an experienced motorcycle accident lawyer .

Truck Accidents

Collisions between commercial trucks and cars or passenger trucks almost always result in life-changing injuries or tragic deaths. Because of the seriousness of these accidents, it's important to work with an experienced Austin personal injury attorney who will protect your rights.

Product Liability

Whether you buy something from a big-box retailer, midsize market, outlet store, mall, or small grocer, you expect the product to be safe. However, sometimes you may buy a product that injures you, and product liability and defective product law dictates who is responsible for this breach of the implied warranty of fitness for the productâ€™s intended uses. The place from where you purchased the product, the company that made the product, or even the company that advertised the product may be legally held responsible for your injury.

Defective Drugs

The defective drug product liability attorneys at O'Hanlon, McCollom & Demerath law firm understand that your injuries and complications may be the result of a defective drug. We are here to help you get the compensation you deserve for your injuries.

Defective Medical Devices

The defective medical device liability attorneys at O'Hanlon, McCollom & Demerath law firm understand that your injuries and complications may be the result of a defective medical device. We are here to help you get the compensation you deserve for your injuries.

Business Litigation

Disputes are an unfortunate, and often expensive, part of doing business. At O'Hanlon, McCollom & Demerath in Austin, Texas, our business litigation attorneys are experienced professionals who can protect your interests if you are embroiled in a legal dispute.

Fatal Auto Accidents

Car accidents are the leading cause of accidental death, bringing pain and grief to hundreds of Texas families every year. If a loved one has died in a fatal car accident, an SUV rollover, a collision with a commercial truck, or a motorcycle crash, you will be facing financial challenges, and we are here to solve your problems.

Defective Machinery / Equipment

Heavy equipment and workplace machinery can be dangerous even when itâ€™s used properly. But when that equipment is faulty, has defective parts, or has been improperly repaired or serviced, even careful users can suffer serious injury or death. The injury lawyers at O'Hanlon, McCollom & Demerath hold companies responsible for negligence in the manufacturing and maintenance of equipment and machinery that leads to injuries and deaths.

Pedestrian Accidents

Bike riders and cycling enthusiasts bear an unfair burden when car and truck drivers do not drive carefully. With so little protection beyond a bike helmet and their quick reflexes, cyclists often suffer severe injuries when a car makes a sudden stop or a truck turns into their path. Sadly, many bicycle accident victims are children. If you have been seriously injured or a loved one has died in a bicycle collision with a motor vehicle or a cycling accident on a dangerous property, you may have a right to financial compensation.

How do I choose the right attorney for my case?

When you or a loved one has suffered an injury, hiring an attorney is one of the most important steps you will take toward seeking compensation from those who are responsible for your injuries. This can be a daunting and complicated process if you have never before hired an attorney and do not know how it all works.

What are my rights as a client?

If you ever have any questions about these rights, or about the way your case is being handled by your attorney, do not hesitate to express your concerns to your attorney. He or she should be readily available to represent your best interests and keep you informed about your case.

What should I do immediately after an accident?

Just after an accident or other event which seriously injures your or a loved one you may not know what to do or where to turn for help, especially when you have been injured by the negligence or wrongdoing of another person, or in many instances, the manufacturer of defective equipment or other products.

What is the Personal Injury Lawsuit Process?

After an accident in which you or a loved one are injured, and you have sought medical attention and have hired an attorney to handle your insurance claim, you may be on your way to becoming a plaintiff in a personal injury lawsuit if the insurance company has refused to make a reasonable offer of settlement on your injury claim.

Could ERISA reduce my claim recovery?

The Employee Retirement Income Security Act of 1974, known as "ERISA", is a federal law that may allow your insurance company, or your employer's health plan, to recover its costs on your claim, from a settlement or trial verdict award you may receive as a result of a personal injury lawsuit. This is known as "subrogation", and is considered to be a complex area of law. Potential subrogation interests should be discussed with your personal injury attorney after his/her review of any subrogation clauses in your insurance policy or your employer's health plan provisions.

What information will my attorney need from me?

When you or a loved one have been injured in any type of accident it is important to keep extensive documentation of the incident and your injuries. Your personal injury attorney will interact with insurance companies and defense attorneys on your behalf, and in order to make a proper claim for all the benefits you are entitled to, this documentation is necessary.

Some of our Victories

Product Liability Victory

Our firm represented a golf course grounds keeper who, due to a mechanical design defect in the industrial mower he was operating, was crushed under the machine when it fell into 15 foot ravine. The client suffered partial blindness, memory loss, and permanent brain damage.

Widow Prevails in Wrongful Death Action

Justin Demerath, in joint representation with his father, Attorney Larry Demerath, represented the widow of a truck driver who was killed when his vehicle struck a large tire that had detached from another truck. Larry and Justin are pictured above with the client.

Successful Settlement

Our firm represented a family in a wrongful death action against a large trucking company when their father was struck and killed by an 18-Wheeler due to a defective brake pedal. The case settled prior to trial. The brothers are pictured above.

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FDA Press Conference on Trasylol I

FTS HHS FDA
Moderator: Peper Long
November 5, 2007
7:30 am CT

Coordinator:	Welcome and thank you all for standing by. At this time all parties will be in a listen-only mode until the question and answer portion of today's call. The call is being recorded. If anyone has an objection, you may disconnect your line at this time. I would now like to turn the call over to Ms. Peper Long. Ma'am, you may begin.

Peper Long:	Good morning everyone and welcome. My name is Peper Long with the Food and Drug Administration's Office of Public Affairs. This is an FDA teleconference for credentialed media only to announce FDA's request for market suspension of Trasylol, a drug used to control bleeding in certain patients undergoing cardiac surgery.

	With me today are: Dr. Gerald Dal Pan, Director of the Office of Surveillance and Epidemiology at FDA's Center for Drug Evaluation and Research; Dr. John Jenkins, Director of the Office of New Drugs at FDA's Center for Drug Evaluation and Research; and Dr. Rafel Rieves, Director of the Office of Medical Imaging and Hematology at FDA's Center for Drug Evaluation and Research.

	Dr. Jenkins and Dr. Dal Pan will make brief remarks and Dr. Rieves will join them for the question and answer segment, which we'll move into immediately following the remarks.

	Reporters will be in a listen-only mode until we open up the call for questions and the News Release accompanying this announcement has been sent to reporters on our media list, and is also posted on our Web site at http://www.fda.gov

	I will now turn the call over to Dr. Jenkins. Thank you.

John Jenkins:	Thank you, Peper. Good morning. This is John Jenkins. I'm the Director of the Office of New Drugs at Cedar. This morning we are announcing that Bayer Pharmaceuticals Corporation has agreed to suspend marketing of Trasylol, also known as a Aprotinin - a drug that is marketed to treat bleeding or to reduce bleeding in patients undergoing cardiac surgery.

	FDA requested this suspension on - last week and Bayer has agreed to implement the marketing suspension. FDA will be working with Bayer over the next several days to implement the details of the suspension which will include a slow phase-out of Trasylol from the marketplace in order to decrease the possibility of shortages of the alternative drugs.

	At this time, FDA cannot identify a specific patient population where we believe the benefit of using Trasylol outweighs the risk. But it's possible that individual doctors may be able to identify unique patients in which they judge the benefits of Trasylol will outweigh its risks.

	Therefore, FDA is committed to exploring with Bayer options on allowing access in a limited manner for those patients if the antics of such access can be established.

	I'll stop there and let Dr. Dal Pan briefly review the reason for the suspension, including the safety (station).
Gerald Dal Pan:	Okay, good morning. This is Gerald Dal Pan. I'm the Director of the Office of Surveillance and Epidemiology at FDA's Center for Drug Evaluation and Research.

	Trasylol, also known as Aprotinin injection, was approved in 1993 and is currently indicated for prophylactic use to reduce blood loss and blood transfusion in patients who are at increased risk for bleeding while undergoing cardiac surgery.

	Two observational studies were published in early 2006, which - and both of them suggested that Trasylol use may increase the risk for kidney damage compared to other drugs.

	So we held an Advisory Committee in September 2006, which focused on kidney damage as well as serious allergic reactions -- known as paper sensitivity reactions -- to Trasylol.

	And after that meeting, FDA narrowed the indicated use in patients at high risk for bleeding from cardiac surgery and we also strengthened the warnings on the label regarding hypersensitivity and kidney damage.

	Now shortly after that September 2006 Advisory Committee Meeting, FDA learned of another study which Bayer had commissioned that suggested Trasylol increased the risk for in-hospital death in cardiac surgery patients.

	Another publication in February of 2007 suggested that Trasylol increased the long term mortality in patients undergoing cardiac surgery.

	So we held another Advisory Committee in September 2007, this one focusing on the mortality risks that those two studies identified. The Committee didn't find the results compelling enough to warrant a withdrawal so the Committee recommended more study.

	Specifically, the Committee recommended a randomized control clinical trial with (unintelligible). Now the Canadian study that was (unintelligible) two weeks ago, was a randomized controlled trial designed to test the hypothesis that Trasylol was superior to other drugs increasing - in decreasing the occurrence of massive bleeding during cardiac surgery.

	And that study was halted because Trasylol appeared to increase the risk for death compared with two other drugs. And based on the preliminary findings of this most recent study, combined with the fact that FDA doesn't expect to receive any (unintelligible) study data for nearly six or eight weeks, FDA requested that Bayer suspend Trasylol pending further review.
Peper Long:	Okay. I think we're ready for question and answer.

Coordinator:	Thank you. At this time if there's any questions on the phone line, please press star 1 on your touchtone phone - star 2 to withdraw. Please record your name.

	We'll stand by for the first question. (Jeanie Whalen), your line is open.

(Jean Whalen):	Hi, it's (Jean Whalen) from the Wall Street Journal. I wondered whether the FDA hadany discussions with the German regulators or Health Canada before making this decision?

	I understand - I believe the German regulator told Bayer to take the drug off of the market rather than requesting. Did FDA act after the German request or the German Demand?

John Jenkins:	Yeah. This is Dr. Jenkins. I can answer that question. We've been in communication with a number of our regulatory partners around the world since we learned about the preliminary results of the (bart) study two weeks ago.

	We have had conversations with our colleagues from Health Canada. We also have had conversations with our colleagues from the German regulatory agency as well as other agencies.

	We were aware that the Germans were considering a marketing suspension for Trasylol, which they did announce this morning. However, FDA's decision was made independently based on our own assessment of the potential benefits and risk of Trasylol.

	Germans do have the authority to require marketing suspension. FDA does not have that specific regulatory authority. However, when we requested that Bayer suspend marketing they agreed and they are working cooperatively with us to effect that marketing suspension.

(Jean Whalen):	May I ask another question or are there others waiting?

Peper Long:	You can have on follow-up question, (Jean). Thank you.

(Jean Whalen):	I just wondered whether FDA feels it was a mistake to not request this drug's suspension or withdrawal earlier given its kind of checkered past over the last few years?

John Jenkins:	Again, this is John Jenkins. I'll start and if Dr. Dal Pan or Dr. Rieves wants to weigh in. I think it's important to recall what this drug is approved for. It's approved to reduce serious bleeding in patients undergoing cardiac surgery where bleeding can often be very serious and even life-threatening.


	So that was the basis for the original approval. As we've learned about the safety concerns from the observational studies, we've taken those data very seriously. And as Dr. Dal Pan said, we've gone the two FDA Advisory Committee meetings for public discussion of these data, most recently in September.

	I think it's best to characterize the meeting in September, that the Committee members were concerned about the findings from the observational data, but the thing that was lacking from the observational data that they were most interested in was a randomized controlled clinical trial.

	And at that meeting, the (bart) study was actually pointed to as a study of that type that might give us more answers. So finding out that the study has been stopped because of mortality, certainly is supportive of what we've seen from the observational data.

	But even as recently as September, the Advisory Committee noted overwhelmingly that they thought the drug should continue to be available on the market.

	Dr. Dal Pan or Dr. Rieves - any comments?
GeraldDal Pan:	No. I don't have any additional comments.

Rafel Rieves:	This is Dr. Rieves. I think it's also notable to consider that we have the preliminary findings from the (bart) study. The indication for Trasylol use is very specific to coronary artery bypass grafting.

	The (bart) study enrolled patients not only undergoing coronary artery bypass grafting, but also valvular surgery. So dissecting out the (bart) study results will be important to - again, considering the overall risk and benefits for Trasylol.
Peper Long:	Okay, next question?

Coordinator:	Our next question comes from (Ed Silverman). Your line is open.

(Ed Silverman):	Hi, good morning. This is (Ed Silverman) with (Farm A lot). I just wanted to clarify my understanding of the surgery for which the drug is approved. You said for valve surgery - is it approved for CABG (and valve)? Is it approved for CABG?

John Jenkins:	Dr. Rieves, do you want to take that question?

Rafel Rieves:	Yes. It is approved specifically for use in patients at high risk for bleeding, who are undergoing -- and this is important -- coronary artery bypass grafting with cardiopulmonary bypass. As you know, certain coronary artery bypass graft procedures are sometimes performed without cardiopulmonary bypass.
	Trasylol is indicated specifically for use in high risk patients - patients who are at a high risk for bleeding who are undergoing coronary artery bypass grafting with cardiopulmonary bypass.

	It is not approved for use in (unintelligible).

(Ed Silverman):	So is it CABG and valve procedure?

Rafel Rieves:	No, sir. It's solely coronary artery bypass grafting with cardiopulmonary bypass.

(Ed Silverman):	Okay. So it's - so of the three options that I mentioned, it's only CABG?

Rafel Rieves:	It's only CABG, right.

John Jenkins:	Okay, just to clarify - I think I heard Mr. (Sullivan), was part of your question about what happens if a patient was undergoing both bypass and valve surgery at the same time?

(Ed Silverman):	No, but that was my follow-up.

John Jenkins:	Okay. (Wayne), do you want to address that?

(Wayne):	This - it's specifically for coronary artery bypass grafting. The data have - did not support the - of it simultaneous. The procedure - it's indicated specifically for the CABG situation. The valvular use is not included in the product label.

(Ed Silverman):	Okay, thank you.

Peper Long:	Next question, please?

Coordinator:	If anyone else would like to ask a question, please press star 1. I'm showing no further questions.

Peper Long:	Okay, thank you all very much. If you have any questions, you can reach me at (301) 827-0599 or (240) 429-9205. Thank you very much.


Coordinator:	Ma'am, I apologize. We do have one additional question. Would you like to take that at this time?

Peper Long:	We can take one more.

Coordinator:	All right. (Rob Stein) with the Washington Post, your line is open.

(Rob Stein):	Yeah, hi. Thanks very much. I was wondering if you had any estimates on the number of - how commonly this drug is used? And any estimates on how many deaths it might have caused?

John Jenkins:	Dr. Dal Pan, do you have estimates on the use of the drug?

Gerald Dal Pan:	I don't have any estimates with me now on the use of the drug - no.

(Rob Stein):	Might it be possible to have somebody get that to me later?

Gerald Dal Pan:	We'll see if we can - if we have those kinds of estimates.

Peper Long:	We'll see what we have and see what we can get to you, (Rob). I'll get back to you on that.

John Jenkins:	I know that those data were presented at the September Advisory Committee meeting in the transcripts of that and the background package should be available online.

	As far as your second part of your question, it's not going to be possible for us to answer that question. We still only have very preliminary results from the (bart) study plus, in addition to that, cardiac surgery is a complex procedure.

	Effecting out which patients who had serious adverse events in clinical practice that may have been related to Trasylol versus other factors will be very difficult.

	That's why we needed the randomized controlled clinical trial. We're working as well as we can with the Canadian authorities and the Canadian investigators to get additional data.

	But it looks like it's going to be six or eight weeks -- or longer - before we will be able to get any additional information to better tease out the findings from that study.

Peper Long:	Any follow-up?

(Rob Stein):	No, that's okay. Thank you.

Peper Long:	Okay, thank you. All right, that'll end our call now. Again, if you need more information you can contact me at (301) 827-0599 or (240) 429-9205. Thank you.

Coordinator:	That does conclude today's call. Thank you all for joining. You may disconnect your lines at this time.

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FDA Press Conference on Trasylol I