Original subtitles

Previously on The Practice.

I got a lewd and lascivious schedule for trial this morning, but Judge Hilla,

she's ordered me to get co -counsel.

Why? Something about how I never want a trial. Bobby, it's bad for us to even be

associated with Harlan Bassett. He's a nice guy. Yeah, and the world's worst

attorney. I do not want to be in court with that man.

If I have you guys on board as co -counsel, I know I could chip the

up. Every time I sign up with you, I end up getting embarrassed.

That's not going to happen this time.

What's this case and what's our involvement? Product liability against a

company that injured a little girl, Harlan. This guy ponies you up every

told him I'd join him for a settlement conference. That's all it will be.

Gentlemen, come right in.

That's John Raverson. You know him? The man is one of the top three civil

litigators in Boston.

Our client has directed us not to settle. We just beat the EPA for over

million on injuries that weren't even as bad.

They beat the EPA, Mr. Bassett. Now, while I salute your last -minute

in signing them up for shock value, we know who opposing counsel really is.

Eugene, this is Christine and Annie Mullen, our clients.

Hello. That drug did this to her?

Every bit of it.

Six months ago, she was completely healthy.

Annie, you up for a fight?

Yes. You tough enough to take on the drug company?

I'll be as tough as I need to be.

The big hurdle is causation, proving the drug caused Annie's liver failure.

And do we have to prove it beyond a reasonable doubt?

No. Well, that's the criminal standard.

The burden here is the preponderance of the evidence.

Where is Harlan?

He should be right in.

Mr. and Mrs. Mullen, we don't think we'll win.

Our goal here, if we can do well enough, that we might win.

Then we should be able to settle because Hayden Laboratories can't risk losing.

Does that make sense?

Yeah, I think so.

Let me check on Harland.

Harland, the Mullins are waiting.

Could you take the meeting, Eugene?

Take the meeting? It's a pre -trial. They want to talk to you. I'm just...

What's wrong?

I'm having a little anxiety.

It's nothing. Had it before, it goes away.

What goes away? What exactly are you feeling?

My breathing gets a little hard.

Just need a few minutes.

So, should I tell them to wait?

No.

I'm okay.

Herman?

Okay.

Can't get there.

I want to do one more test, but from everything I can see, it was just an

anxiety attack. Your heart looks fine. Thank God.

We can keep you overnight, or you can leave. No, I gotta leave. I'm in trial

six hours.

Harland, I think we can get a continuance. I wouldn't be so sure,

judge said the last one was final.

But this is medical. You had a near heart attack.

That's the problem.

Could I have a second?

Absolutely. I'll check back.

I sort of faked a heart attack.

What do you mean you sort of faked a heart attack?

He wasn't going to give me any more time, so I grabbed my chest and I said I

to go to my doctor.

He says if this happens again, then somebody else is going to have to try it

because the case is going forward no matter what.

You're the only one who can try this case. We don't know it well enough.

Which is why I ought to be checking out tonight.

Hand me my pants, would you?

So you're going forward?

He says he's ready.

Exhibits? They've been delivered to the courthouse.

Do you guys have any chance? That is an encouragement, Eleanor. The first chance

you get to settle.

Don't worry.

Are we ready?

We're ready.

All right.

Annie Mullen came to me with a sinus infection.

I first treated it with another antibiotic.

When that didn't work, I prescribed Reflexin.

Reflexin. This is also an antibiotic?

That's correct.

And what happened?

After taking the drug, she almost immediately went into acute liver

ultimately resulting in two transplants.

In your medical opinion, ma 'am, did Reflexin cause this liver failure?

I cannot state it to a medical certainty.

But I can think of no cause other than the reflexin.

Objection. Doctor, did you know that reflexin was dangerous?

Objection. No foundation.

Sustained.

What were your expectations regarding the safety of this antibiotic, Doctor?

I was aware that it hadn't been tested on children. But neither are about 80 %

of the drugs on the market today.

Obviously, I didn't consider it to be dangerous.

If I did, I wouldn't have prescribed it.

But this is an adult drug.

Yes, but we have to prescribe adult drugs to children because the

companies test so few of them on kids.

And to your knowledge, do many pediatricians prescribe adult drugs to

We all do, routinely.

Doctor, would you tell the court how you first learned about reflexin? The same

way I hear about all new drugs.

The company sends out a rep. He's called a detail person to promote the product.

Did this detail person say anything about the safety of Reflexum? He

it to me as very safe.

Did he warn you about giving it to kids?

No, he did not.

Doctor, you were sued by the Mullins and you settled out of court, did you not?

On the advice of my lawyer, I settled the claim, yes.

Now, as part of that settlement agreement, you agreed to assist the

pursuing her claims against other parties.

Yes. But I only agreed to tell the truth, which is what I've done here.

The literature that you received from my client's detailed person included

all labeling information, did it not, Doctor?

Yes. And I show you a copy of that information now marked and identified as

Exhibit A. Could you read the highlighted section?

Not proven safe and effective for children under 16 years of age.

And yet you prescribed it to a 13 -year -old girl?

It's done all the time.

Thank you, Doctor.

Mr. Bassett, redirect.

Can you think of anything else?

No. You got what you can from her.

And you don't want to get Raverson another whack across.

Right.

Tell the judge you have nothing further.

Nothing further from this witness, Your Honor.

Looking at the biopsy on her liver, I concluded to a reasonable degree of

medical certainty that drug toxicity was the cause for the failure.

Do you know which drug caused this toxicity?

It had to be the reflexin.

Two weeks after she took it, she needed an emergency transplant.

She had no medical history that made her susceptible, and I found no other

factors that would have contributed to the failure.

Okay, doctor.

Can you tell us why the reflexin would have caused her liver to fail?

All drugs are metabolized through either the liver or the kidneys, and sometimes

the drug can simply overwhelm the liver.

Can it attack children in particular?

Children are especially vulnerable.

They have immature livers.

And for a number of reasons, they cannot be treated simply as small adults.

That's why this drug should have been tested on children.

Was it?

No.

Are you aware of any research or data that suggests reflexin causes liver

failure? Hayden's own data indicated abnormal levels of liver activity.

That's from their own study. Now, in this data that you refer to, what

of the participants had an elevated liver function?

I believe it was 2%. 2 %?

Are there other drugs on the market that cause similar levels of elevated liver

activity? Yes.

A few? Many?

Many. Do you know how many people would die if we took them off the market?

Objection. Speculative.

Sustained. Doctor, you spoke about children being especially vulnerable.

Isn't it true that children's livers are typically more resilient than adults?

Typically, yes, but not always.

Thank you, Doctor.

It was a good start.

Solid. It was?

It seemed like the doctors admitted they weren't sure.

Well, we knew they'd have to.

That's what we talked about last night. Proof is tough.

But Harlan did a good job.

Why is he breathing into that bag?

It works.

I do it all the time. You get more oxygen that way.

So, what's next?

Annie's next.

You ready, Annie?

You're going to have to be brave up there.

I'm ready.

You're going to do great.

While she's testifying, I do not want you to move.

Not at all.

Not at all.

She's our case, Harlan.

Now, if they're going to budge on settling Annie's testimony, we'll have

it. We need every juror's eyes on her.

Okay.

We're almost there, aren't we?

We haven't even finished putting in our case.

After that, they put on a defense.

Right.

Let's go.

I threw up a lot, but I thought it was a stomach flu.

Then I was on the bus to school, and I passed out.

What happened?

They said my liver stopped working, and I needed another one.

And then?

Then I got really sick for a few weeks.

My eyes and skin turned yellow, and I lost all this weight.

Then they found a new liver.

So you got a transplant?

Yeah.

But it didn't work.

Tell us how it didn't work.

My body started to reject the replacement liver.

I got really sick.

It took a long time to fight another one.

Longer than the first one?

Yes.

I wasn't as high on the list anymore because they thought that my body would

reject the next liver too.

Is everything going to be okay now?

I don't know.

My body's still having some problems.

They have me on these anti -rejection pills that I have to take every day for

the rest of my life.

That makes me more likely to get stuff like infections and cancer.

Annie, what if you need a third transplant?

I probably wouldn't get it.

I'm too far down the list.

Thank you, Annie.

I'm very sorry about your illness.

Annie, I know that everybody in this room wishes you a complete recovery.

Thank you.

I'm going to just ask you a few questions. If at any time you want to

break, I'm sure we can do that.

Okay?

Okay.

When the doctors were diagnosing you, Did they

ask whether you had taken any other drugs or taken too many pain relievers?

I think so.

Yeah. Do you remember what your answer was?

I told them that I hadn't, except for the other antibiotics.

Okay. You know, they were asking about other possible reasons your liver

Yes.

You also told them you hadn't drunk alcohol, right?

Yeah. Now, Annie.

Remember a sleepover at your friend Robin Cohen's house a few weeks before

fell ill?

I think so.

If we brought Robin here and asked whether you and the other girls drank

her father's liquor cabinet, what would you say?

I hardly had anything.

So you had some.

Yes.

You didn't tell that to the doctors, though, did you?

No.

Are there any other things you didn't tell the doctors?

No.

Okay.

Prior to your taking Reflexin, you'd taken other antibiotics, right?

Yes. And you'd had a flu a few weeks before this?

Yes. Did you take any cough medicine?

Yes. Pain relievers?

Yes.

Okay, Annie. That's actually all I have.

And again, let me extend my wishes that you have a complete and healthy

recovery.

Thank you.

Annie, how much alcohol have you had in your life?

I've had like two sips of vodka.

That's it.

I hated it.

And did you tell the truth to the doctors for all the other questions they

you? Yes.

Thank you, Annie.

Eugene's going to dinner with the defense lawyer.

They've now seen our case.

If we're going to get an offer, this would be the time.

It's a good sign that he's willing to have dinner, right?

We hope.

I'm sorry.

Sorry?

Why, sweetheart?

For not telling you about that sleepover?

And the alcohol?

Hey, you did great up there.

That was just a cheap trick. It'll backfire. You watch.

The doctor said, John, toxicity to the liver causes failure. He ruled out

everything but reflexin.

I thought I crossed him, okay?

But the bottom line is, it's in the record.

Plus, we have a very sympathetic little girl.

You're preaching to the choir.

I've been trying to convince Hayden to offer something.

Trust me, I don't like going up against little girls.

So what gives?

I think they're angry.

Your client?

The pediatrician dropped the ball here, Eugene. I'm not saying doctors don't

prescribe off -label. I know they do.

But she should have at least monitored the girl.

Now, for her to settle out with a promise to testify against the drug

She's not the first doctor to do that.

Exactly. Which is why they're so angry.

Give me something.

Come on, admit it.

Harlan Bassett has done better than you thought.

If it were up to me.

But it isn't.

Okay.

We'll just keep going.

Their first witness is the hepatologist.

Dr. Peter Kendall.

Reflexin is not the most likely cause of Miss Mullen's liver damage.

Can you be sure of that, Dr. Cameron?

Viral infections are the most common cause of liver failure in children.

This girl was coming off a stomach flu, and that's probably the very infection

that led to her liver injury.

Can you state this to a medical certainty, Doctor? Not a certainty.

You have to understand that the cause of most cases of liver failure in children

is unknown.

So in a majority of cases...

There's no cause found.

That's correct, but here we know she had a viral infection, which we can isolate

as the most likely culprit.

Doctor, isn't it true that the vast majority of stomach flus do not cause

failure? Neither do most drugs.

But the speed at which Annie's liver failed is more consistent with drug

toxicity, isn't it? In general, yes.

You can't rule out reflexin as cause of Annie's injuries, can you?

Well, the question is not... You can't rule it out, can you?

No.

And, Doctor, how many times have you testified for drug companies?

I can't be sure.

More than 50? Yes.

More than 100?

Probably. And in all these appearances, have you ever testified for a plaintiff?

No, I haven't.

I'll take him to the witness room.

Am I crazy? Or is Harlan... He was good just then.

He was.

Eugene, we've put in our case, we just had their first witness, and we're in

this. Nobody's laughing in there.

Yeah, but now come their big guns.

I know.

But nobody's laughing.

For a drug to be approved in the United States, it needs to go through an

incredible testing process.

When you say incredible, I mean hundreds of millions of dollars.

First comes testing on a cellular level, then animals.

The last step is clinical trials on humans.

Then what?

Then the company turns over its clinical data to the FDA medical officers.

They review the data. Then they convene an advisory panel of outside independent

specialists who give an opinion, which the FDA may or may not follow.

What does it mean to have approval from the FDA?

It's the gold standard.

Meaning? The United States has the safest, most rigorous pharmaceutical

process in the world. Many, many drugs are available overseas that are

prohibited here for safety reasons.

In fact, a number of states limit the liability of drug manufacturers from

if their product is FDA approved.

Objection. Sustained.

Jury will disregard.

From your review of the data.

Did Hayden Laboratories comply with testing requirements for Reflexin?

Absolutely. Thank you, Doctor.

In the last four years, 11 different drugs have been pulled off the market

the FDA approved them. Isn't that correct?

Yes. Direct.

Painkiller linked to liver failure? That was one of them.

Objection. This trial's about reflexin. They opened the door, Your Honor. This

witness testified that the FDA's approval was the gold standard.

Objection overruled. Elotronex, irritable bowel syndrome, suspected

five deaths.

Yes. Propulsed, heartburn, suspected in over 300 deaths.

Yes. Seldane, Resolute, the list goes on. All approved by the FDA, all pulled

because of safety concerns. The fact that these drugs were withdrawn shows

the system works, that the FDA investigators are doing their job.

Think the 20 million Americans who took those drugs believe the system works?

Objection. Sustained. The fact that the FDA approved Reflexin doesn't establish

it's safe, does it, Doctor?

There are never any guarantees.

I am extremely proud of Reflexin. It kills bacterial infections that can lead

pneumonia and meningitis.

It saves lives every single day.

Are you satisfied, sir, that it's safe?

Absolutely. When used as directed.

Now, here it was not used as directed. It is not intended for children.

Now, I don't believe that reflexin caused Annie Mullen's injuries.

Nevertheless, it should never have been prescribed.

That's why our label is clear. Not proven safe for children under 16.

What else can we do?

We cannot be held responsible for every doctor who ignores our warnings.

Thank you, Mr. Yates.

Eugene.

Can you take this one?

What?

Look, Harland, I don't think we should let what that witness just said hang

the jury.

The sooner we defuse it, the better.

The FDA advisory committee that approved your drug was comprised of 12 doctors,

correct? Yes. And seven of them had financial ties to your company, didn't

We fund research, Mr.

Bassett. I mean, if that qualifies as financial ties, then technically you may

be correct.

Fact is, the drug industry is the major source of funding.

For doctors who study the safety and efficacy of drugs, isn't that right, Mr.

Yates? I believe so. And if a doctor's studies don't come out like you want,

he's not going to get a grant next time around for his research, is he?

That's not true. As part of their compensation, you offer these doctors

options in Hayden Labs, don't you?

Sometimes. You make it in their financial interest to make favorable

These are doctors that you're talking about.

They are going to do what's right.

They're doctors.

They're going to do what's right.

Objection. Argumentative.

Sustained. What's the average review time for FDA approval?

A little over a year.

How long did the FDA review the application for reflexin? We were

expedited review.

How long?

Six months.

Do you think the FDA might have caught the problems with reflexin if they took

the normal review time?

There were no problems to catch.

Really?

No problems to catch.

What is an adverse drug report?

It's a form filled out by a doctor when a patient suffers an unexpected reaction

that might, and I stress might, be related to a prescription drug. I'm

six adverse drug reports, which list reflexin as primary suspect in liver

damage. Four involve children.

You are talking six reports.

Out of two million prescriptions.

But doctors aren't required to file these reports, are they, Mr. Yates? Some

experts estimate six reports translates to 600 actual complications.

I disagree.

You are aware that doctors are prescribing Reflexin to kids, aren't

can do is to make the appropriate warning.

We can't control what doctors do. Yes or no?

You know doctors are prescribing it to kids.

Yes. Hayden Labs made $265 million on Reflexin last year, didn't they?

Objection. Overruled.

$265 million.

How much of that came from off -label use by children?

Some. Some.

Children are good business, aren't they, Mr. Yates?

Objection.

Overruled. You don't test children because you don't want to know what

find. That is untrue. Why do you only test adults when you know your drug is

going to kids?

We limited our research and market to adults because the product is intended

adults. Again, we cannot control what the doctors do.

But when doctors prescribe Reflexin to kids, you don't issue a stronger

You don't do anything about it. You just take the money.

Objection! Sustained.

Truthfully, you have researched children, haven't you?

This is your research.

Six isolated cases is not data, Mr. Baffet.

How about seven?

You did great.

We did great.

So now what?

Closing arguments.

A good close, and we have a chance. I haven't written it yet. You'll do it

tonight.

Can we get together?

We'll be right out.

Here comes the offer.

Oh, my God. What? All right, listen.

We need to pick a number.

I need to go out there with a number.

600. They won't pay 600.

Two. Harlan, you don't have to cave that much. How do you go from six to two?

I'm confused.

Look, liability is still shaky. Last night, the number was zero. Right now, I

think 400 ,000 is possible.

225. That was a half a million dollar cross if I ever heard one.

225 was as high as he authorized me. I'm not playing poker here.

I could convince him to throw in your fees. You took it on a contingency.

another 60 or so.

Let's say goodbye to this at three.

Four. And we'll sign off.

Can't do it, Eugene. Three's the number.

No.

Okay.

We get to do this one more day.

We just turned down $300 ,000.

Lucy?

Guys.

Guys. What time is it? 7 .30.

How late were you up?

We just laid down to take a break at 4 or so. Do we have any coffee?

I'll make some.

I need new clothes.

I can't close in this. You got plenty of time. It's early.

What are you doing?

Nine. Okay, so you don't have plenty of time.

I gotta go home and change.

I'll meet you guys there.

They offered three.

And you turned it down?

I know we can get another hundred if he closes well.

Or it could go back to zero.

Have you ever heard Harlan Bassett close?

It isn't pretty.

He's different this trial, Bobby.

He's in some kind of zone.

In a zone?

When have you ever, ever known him not to screw things up?

If you give him enough time.

We all know to warn our kids about the kind of drugs you buy on the street

corner.

We know to steer them away from shady dealers and back alleys.

But what we don't know is that they are twice as likely to die from the drugs in

our own medicine cabinets.

James and Christine Mullen told their daughter to take her medicine because it

would make her feel better.

Look at her.

A simple antibiotic.

Two weeks later, she lost her liver and her opportunity for a normal life.

The defense would have you believe that her doctor bears all responsibility, but

this ignores one critical fact.

Hayden Labs knew that once reflexin was approved for adults,

it would make its way to children.

Eighty percent of the drugs on the market today are not adequately tested

kids.

Eighty percent.

And it's common practice for doctors to prescribe these medications to children.

Now, knowing this, what does Hayden Labs do?

They slip in the most innocuous warning they can, while at the same time

marketing the drug to pediatricians.

But saying not proven safe or effective is not the same

as warning it could be dangerous.

And they knew it.

It's hard to wage a battle against a big pharmaceutical company.

This is a $100 billion industry.

I'm sorry, Your Honor. I'm loath to object during a closing.

But this is neither relevant... It is relevant.

The revenues they generate are relevant to the extent that they control

research. I'll give you a short leash, Mr. Bassett.

But keep it about the case.

The drug companies.

They fund the research.

They pay many doctors who are in charge of testing whether a drug is safe. And

some drugs get to the market that are unsafe.

In the last four years alone, 20 million Americans took drugs that were pulled

off the market because of safety reasons.

20 million.

And I submit.

that when reflexin is finally tested on kids, it too will probably be pulled.

But Hayden Labs, they're not going to test it, ladies and gentlemen. Not if

can help it.

The problem with test results is you're stuck with them.

And they don't want any test proving what Annie Mullen already knows, that

drug can cause liver failure.

It caused hers.

They don't care, ladies and gentlemen. They don't give a damn. And the FDA?

They rely on clinical and advisory panels that are bankrolled by these

In the end, it's not about safety.

It's not about compassion.

It's not about little girls like Annie.

It's about money.

That's all they understand.

Go back to that jury room and return with a number that'll make them

That was very impassioned.

However, cases are decided on fact and merit, not passion.

Fact. The cause of most liver failure in children is unknown.

Fact. It's much more likely that Ms. Mullen's stomach flu caused her liver

failure than any drug she took.

Fact. The FDA reviewed Reflexin.

and found it to be safe and effective when used as directed.

Fact, the FDA still approves Reflexin.

Fact, we warn doctors not to use it on children under 16.

Fact, Ms. Mullen's doctor read that warning and still prescribed it.

Mr. Bassett would have you believe that the evil pharmaceutical companies are

out there killing people for profit.

Reflexin.

is in the family of antibiotics that have saved millions of lives.

All right, yes.

The drug companies fund research. Does this mean that the findings are bought?

Absolutely not, and there is no evidence to suggest otherwise.

They pay for this research to get it done, to be able to discover life

medicines. We all live longer, more enriched lives because of those

Reflexin is one such.

Life -saving medication.

Now, do we know some doctors might possibly prescribe it to children?

Yes.

So we clearly warn them.

Not proven safe for children.

You know, what else can we do?

What else can we do?

No matter what happens, Harlan.

You tried a great case.

I still wish I could have done more with the medicals.

There isn't more.

It's not like the truth is out there somewhere.

I don't know how I'm ever going to be able to repay you.

Me?

I just bet there. Yeah, right.

400. Hang on.

I need a second with co -counsel.

I don't know how to advise you.

I can't say we're going to win, but if we win, they should be more than full.

What does your gut tell you?

Only that I gotta throw up.

No matter what, we gotta run it by the client.

If they're offering four, you think they'd go higher?

Oh, this lawyer doesn't really play that way. He just puts it out.

Now, that's not to say we couldn't chip it up some, but... Harland, six months

ago, we put ourselves in your hands.

Let's go to verdict.

Harlan. They never thought we'd get this far, Eugene.

Let's go to verdict.

Let me see if I can get it up to six. No.

Let's go to verdict.

You understand, Mr. Mullin, that this... I understand that Harlan took us here.

I'm going to follow his instinct.

Jerry's back.

Who's Jerry?

Jury.

The jury's back.

Let's go.

And Eugene, I'm sure.

Okay.

600 ,000.

No.

Can you get a read?

No.

Mr. Foreman, have you reached a verdict?

We have, Your Honor.

What say you?

In the matter of Ann Mullen v.

Hayden Laboratories, we find in favor of the plaintiff, Ann Mullen.

And we order the defendant to pay compensatory damages in the amount of $5

million.

The defendant moves for a judgment notwithstanding the verdict.

The evidence never established causation, and no reasonable jury could

it did.

In the alternative, we're entitled to a new trial.

Denied.

Members of the jury, this concludes your service. Your judgment is so entered,

and you are dismissed with thanks from the court.

How about that?

Yeah.

You look like you're about to cry.

Yeah.

And if you tell anybody, I'll kill you.