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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 II

FTS HHS FDA US
Moderator: Peper Long
November 5, 2007
11:45 am CT

Coordinator:	I would like to thank all participants for holding all lines will be on listen only until the question and answer portion of today’s conference I also did want to inform participants today’s call is being recorded, if you have objections you may disconnect at this time. I’d now like to turn the call over to Peper Long, thank you, you may begin.

Peper Long:	Thank you, good morning and welcome my name is Peper Long with the Food and Drugs Administrations Office of Public Affairs.

	This is a FDA Teleconference for credentialed media only to announce that 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. John Jenkins, Director of the Office of New Drugs at FDA Center for Drug Evaluation and Research, Dr. Gerald Dal Pan, Director of the Office of Surveillance and Epidemiology at FDA Center for Drug Evaluation and Research, and Dr. Dwaine Reeves, Director of the Office of Medical Imaging and Hematology also at FDA Center for Drug Evaluation and Research.

	Dr. Jenkins and Dr. Dal Pan will make brief remarks, and then Dr. Reeves will join them for the question and answer segment which will 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 out to our media list, but it’s posted as well on our Website at http://www.FDA.gov/.

John Jenkins:	Thank you Peper and good morning everyone, as you know we are announcing that Bayer Pharmaceuticals has agreed to suspend marketing of Trasylol in the United States at FDA’s request.

	Trasylol is a drug that is approved to treat, or to reduce bleeding in patients ongoing a particular type of cardiac surgery known as coronary artery bypass surgery. And in specific surgery where patients are also on cardio pulmonary bypass.

	FDA made this request for our marketing suspension to Bayer late last week, and Bayer agreed to that request and is working cooperatively with FDA at this time to implement that suspension.

	We planned for a phase out of the product from the marketplace in an orderly way so that there will not be undue harm to patients because there could be drug shortages for the alternatives that are used to treat the same condition.

	FDA made this decision after considering further the information from the recently halted Canadian study commonly referred to as BART - BA- R-T, which was stopped two weeks ago by the Data Safety Monitoring Committee due to an apparent increase in (depth) in patients treated with Trasylol compared to the other two agents that were being studied in that trial.

	Over the past couple of weeks FDA has had interactions with the Monitoring Committee and the investigators to attempt to obtain more information about the results from that study.

	It became clear to us that it was going to be six weeks or longer before we will receive any additional information, therefore we decided that it was appropriate to suspend marketing in the interim until we can learn more about the specifics of those data.

	FDA decided that we could not identify at this time a specific patient population for the benefit of using Trasylol would outweigh the serious risk identified in the BART study.

	That said however we understand and recognize that there maybe situations where individual doctors determine that for a particular patient the benefit of Trasylol may outweigh its risk, and therefore FDA is committed to exploring with Bayer options that would allow those doctors to obtain Trasylol under a IND program.

	The details of that program have not yet been sorted out, but we are continuing to work with Bayer on that process.

	I’ll stop there and let Dr. Dal Pan make a few comments about the safety findings before we open it up for questions.

Gerald Dal Pan:	Good morning this is Gerald Dal Pan from the Office of Surveillance and Epidemiology.

	Trasylol also known as aprotinin injections was approved in 1993 and is currently indicated for prophylactic use to reduce blood loss and blood transfusions in patients who are increased risk for bleeding while undergoing cardiac surgery

	One observational study published in early 2006 suggested that Trasylol use may increase the risk for kidney damage compared to other drugs are used to prevent bleeding. A second observational study published around the same time confirmed the risk of kidney damage.

Peper Long:	These two studies led FDA to convene an advisory committee in September of 2006 which focused on kidney damage and certain serious allergic reactions known as hypersensitivity reactions that can occur with Trasylol use.

	After that meeting FDA narrowed the indicated use in patients at high risk for bleeding from cardiac surgery or from a cardiac artery bypass grafting surgery, and strengthen the warnings in the label regarding hypersensitivity and kidney damage.

	Shortly after the September 2006 Advisory Committee Meeting, FDA learned of another study which Bayer had commissioned that suggested Trasylol increase the risk for in-house (unintelligible) in cardiac surgery patients.

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

	This led FDA to convene another advisory committee in September 2007 which focused on the mortality findings.

	The committee didn’t find the results compelling enough to warrant a withdraw, so the committee recommended more studies where needed, and specifically the committee recommended a randomized controlled trial was needed.

	The Canadian study that Dr. Jenkins just referred to the BART Study, was a randomized control trial designed to test the ability of Trasylol to reduce serious bleeding compared to other agents during cardiac surgery.

	And the study was halted because Trasylol appeared to increase the risk of death compared to the other two drugs used in that study.

	And based on the preliminary findings of this most recent study – the Canadian BART Study, combined with the fact that FDA does not expect to receive study data for at least six weeks and perhaps longer, FDA requested that Bayer suspend Trasylol pending further review of the data. That’s it

Peper Long:	All right thank you very much for your remarks, now we’ll move into a question and answer session.

	I’d like to remind everyone to please limit yourself to one question and one follow-up.

	So if we’re ready for the first question.

Coordinator:	Sure at this time if anyone would like to ask a question you can press star 1, that’s star 1 to ask a question.

	And our first question comes from (Andrew Bridges) your line is open.

(Andrew Bridges):	Hi thank you for taking my question and doing this I guess twice in the day.

	In light of the passage of (Padofo) and the obviously strong emphasis there on drug safety, was this withdraw done any differently than you would have done previously and you were able to move more quickly or was anything done differently and if so how?

John Jenkins:	Yes this is John Jenkins, I’ll start the answer and see if Dr. Dal Pan wants to add.

	My brief answer would be no I don’t think this was handled any differently that we would handled it previously. And I would point out that I think you’re referring to FD Triple AAA or FDAAA the new legislation...

(Andrew Bridges):	The new amendment that’s exactly...

John Jenkins:	...that (unintelligible) about a month ago. The safety provisions, the new regulatory authority included in that law do not go into effect until March of 2008.

(Andrew Bridges):	Oh.

John Jenkins:	So really the ability of the FDA to manage safety issues has not been changed yet with the passage of that law.

	So I think we - we handled this the way we’d would normally handle drug safety issues as Dr. Dal Pan mentioned we have been to two advisory committee meetings to review the observational data.

	And at the most recent advisory committee meeting there was a very strong view expressed that we knew that controlled clinical trials that answer this question.

	And at that meeting the BART study was pointed to as just the type of studies that would answer this question.

	So the fact that it was stopped early for an adverse finding laid very heavily in our decision to go forward with the request for marketing suspension. Gerald anything you want to add?

Gerald Dal Pan:	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.

	I think that summarizes it.

(Andrew Bridges):	Thank you very much.

Coordinator:	Our next question comes from (John Wilkerson) your line is open.

(John Wilkerson):	Yes thank you, what - why can’t you get the data for the next 6 weeks from the BART Study?

Man:	Well the study is being run by a group of investigators in Canada, and we have had contact with them they are in the process of obtaining all the data and looking at it themselves.

	We do not have any regulatory authority to require them to provide us any additional data at this point.

	We are working with our colleagues that help Canada the Canadian equivalent of FDA to try to obtain the additional data as quickly as possible.

(John Wilkerson:	Okay and the second question actually I was going to ask the same question as the AP did.

	But, is, can you envision any of the new authorities that you don’t yet have that come into effect in March ’08. Could you have used any of those new powers in this case had you had them?

Man:	Well I think the three main new authorities that are in the FD Triple AAA legislation are the ability to require risk evaluation and mitigation strategies which we formally called risk maps - or risk management plans, the ability to require a specific cross marketing studies, and the ability to require labeling changes.

	I don’t know that I want to speculate how we might have used any of those authorities differently. We think we proceeded in any orderly way as we learned about the safety signal as Dr. Dal Pan said in 2006 from the observational studies

	We reviewed those data, presented them to an advisory committee in September of last year once we became aware of additional observational studies that suggested a mortality risk, we reviewed those data in great detail and presented them again to advisory committee this past September.

	So I don’t think we would have handled things differently under the new authorities, but we don’t have those authorities yet so it’s hard to speculate and apply them retroactively.

John Wilkerson):	Okay, thanks.

Coordinator:	My next question comes from (Susan Edelman) you line is open.

(Susan Edelman):	Yes thank you, I wanted to find out how many deaths linked to Trasylol has the FDA been made aware of either through these outside studies or your own adverse incident report.

John Jenkins:	Well as far as - this is Dr. Jenkins again...

(Susan Edelman):	Mmm-hmm.

John Jenkins:	...as far as the study itself - the BART study we do not have those details at this point.

	The only information we were provided were the relative rates of death comparing the three arms of the study which I believe were approximately 1.5 and 1.6 for the rate of reported death.

	The other study drugs versus Trasylol I don’t know if Dr. Dal Pan wants to address any other parts of that question in regarding adverse event reports.

Gerald Dal Pan:	Right so to examine the issue of mortality associated with Trasylol or any kind of agent given during cardiac surgery. Adverse event reports that are in our air system are generally not helpful.

	And the reason for that is that mortality did something that does accompany cardiac surgery, there is a mortality rate associated with it and trying to (tease) apart all the different factors that lead to that aren’t possible in individual case reports.

	In fact when we - the data from the 66,000 person observational study were presented at the advisory committee in September, data collected in a reasonably systematic way.

	Even (unintelligible) advisors had trouble assigned (closality) to Trasylol. So it was really...

(Susan Edelman):	I just...

Gerald Dal Pan:	...the randomized clinical trial that they were looking for.

(Susan Edelman):	Well I need to just find out what - how many deaths are linked to Trasylol as possibly then cause that you have to further investigate.

	How many deaths have been reported to the FDA?

Gerald Dal Pan:	Well we don’t have that number right now.

(Susan Edelman):	Can you get that for me?

Gerald Dal Pan:	Well see what we can do.

(Susan Edelman):	Thank you.

John Jenkins:	This is Dr. Jenkins, I would also refer you to the transcript and the briefing documents for the Advisory Committee that are available on our Website from the September 2007 meeting.

	A lot of the information was presented there and slides both from the FDA the sponsor.

(Susan Edelman):	Okay.

Peper Long:	Next question.

Coordinator:	Once again if anyone would like to ask a question you can press star 1 that is star 1 to ask a question.

Peper Long:	May I please ask those reporters asking questions to identify their publication or media outlet.

Coordinator:	Okay our next question comes from (Anna Matthews), and once again please state your affiliation.

(Anna Matthews):	I’m with the Wall Street Journal, forgive me if this has already been stated or I missed it. But I think Dr. Jenkins you mentioned that the rate of reported deaths for the other two drugs in the BART study was 1.5 and 1.6 I assume I that was - those were percents?

	I was wondering what was the rate for Trasylol.

John Jenkins:	No, no what I said was that the relative rate of reporting.

(Anna Matthews):	Ah.

John Jenkins:	...that we received from the BART investigators was that the rate for the other drugs versus the rate for Trasylol - the ratio was 1.5 for one drug, and 1.6 for the other drug, and those approached statistically significant fee values, but we don’t even know which of the other two drugs was Drug A, and which of the other two drugs was Drug B they have not provided us with that information.

	So that was not a incidence rate that was relative rate of 1.5 and 1.6.

Gerald Dal Pan:	This is Gerald Dal Pan, we don’t know the total number of deaths in the BART Study. So we don’t know what proportion of patients with Trasylol died, we don’t know what proportion of patients with the other agents died.

	We know that the ratio of those is approximately 1.5 for each of the two agents.

	But we don’t have the level of detail to note the absolute risk.

John Jenkins:	And one other follow up I would offer is that Trasylol in the United States is specifically indicated for use in coronary artery bypass surgery in patients who are also receiving cardio pulmonary bypass.

	It's our understanding that the BART Study also included patients undergoing valvular cardiac surgery which would not be part of the improved indication for the US labeling.

	We don’t know how many of the patients and the risk ratios for patients undergoing bypass surgery versus valve surgery.

	So there is a lot of information from the BART Study we would really like to be able to review in greater detail. But it’s clear that we’re not going to have those data for some time

(Anna Matthews):	Can I ask a brief follow up just clarifying?

John Jenkins:	Yes.

(Anna Matthews):	So, the risk - those relative ratios - just to make sure I’m going to understand them correctly, essentially patients were dying at a 50% higher rate with Trasylol than with Drug A whatever it might have been.

	And, a 60% higher rate with Trasylol than for Drug B whatever it might have been, that difference did not achieve the physical significance but came close and we don’t know the absolute risk for any of the three drugs.

John Jenkins:	I think that’s all correct - Gerald any other comments?

Gerald Dal Pan:	I actually thought it was 1.5 for both drugs, but we could check that.

(Anna Matthews):	Dr. Jenkins has 1.5 and 1.6.

Gerald Dal Pan:	I have 1.5 and...

John Jenkins:	Dr. Reeves do you recall?

Dwaine Reeves:	1.5 - right, 1.5 it’s 1.5 for both drugs.

(Anna Matthews):	Okay.

John Jenkins:	Okay my mistake, so 50% increase for the other two drugs versus Trasylol. A perched conventional statistical significance meaning a .05 P Value but they had not achieved that level by the time the study was stopped.

	But as you may know the stopping rules for safety in a (unintelligible) analysis of a controlled clinical trial are more conservative than they are for stopping for efficacy.

	So approaching traditional .05 is still considered to be a worrisome signal.

(Anna Matthews):	And valvular cardiac surgery means valve replacement essentially? Is that - could I describe it as that?

John Jenkins:	That would one type of valve surgery there could be others. Again we don’t know the you know, the background of what all the surgical procedures were that were included in the BART Study, but one type of valvular surgery would be valve replacement.

(Anna Matthews):	Okay, and I’ll shut up this is one more question, do you how many of the - I think it was 3,000 patients had been enrolled when they halted the study?

John Jenkins:	We do not.

(Anna Matthews):	Thank you.

Coordinator:	Once again to ask a question press star 1 and our next question comes from (Andrew Bridges) and please state your affiliation sir.

(Andrew Bridges):	): I’m with the Associated Press, thanks for allowing me a follow up. What degree of coordination was there among the various agencies. I guess the Germans ask that it’d be withdrawn or demanded I guess. You asked to help Canada I guess also wade in as well as others.

	Were you able to coordinate with your colleagues abroad or how did this all come about at once.

John Jenkins:	Yes this is Dr. Jenkins, we have information sharing agreements with many of the regulatory agencies around the world. And as we were reviewing the results of the BART study in the past couple of weeks we’ve had frequent communications with them and they’ve shared information and they’re communications with us.

	We were aware that the German Regulatory Agency was considering a withdraw - a suspension action toward the middle of last week. I would say though that the FDA decisions to request the marketing suspension was one that we reached independently of the German authorities or any other regulatory agency.

Peper Long:	I think we have time for one more question.

Coordinator:	Okay once again to ask a question press star 1.

Peper Long:	Okay if anybody else has any additional questions you can call me my name is Peper Long I’m with the FDA Office of Public Affairs.

	I can be reached at 301-827-0599, or 240-429-9205 thank you very much.

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FDA Press Conference on Trasylol II