Thursday, July 26, 2012

Prempro Settlements Total: $896 Million So Far

You can find the story, including the litigation scorecard, by Jeff Feeley for Bloomberg News here.

H/T How Appealing

ADL

 

July 26, 2012 in Prempro | Permalink | Comments (0) | TrackBack (0)

Prempro Settlements Total: $896 Million So Far

You can find the story, including the litigation scorecard, by Jeff Feeley for Bloomberg News here.

H/T How Appealing

ADL

 

July 26, 2012 in Prempro | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 16, 2010

Prempro Verdict Roundup

Date

Compensatory

Punitive

9/15/2006

1.5

0

2/1/2007

0

0

2/1/2007

2.4

0

10/1/2007

11.66

33

10/1/2007

11.66

33

10/1/2007

11.66

33

3/1/2008

2.75

27

10/1/2009

3.7

75

11/29/2009

6.3

28

2/22/2010

3.45

6

2/25/2010

0

0

average

5.007272727

21.36363636

 


ADL

March 16, 2010 in Prempro | Permalink | Comments (1) | TrackBack (0)

Friday, February 26, 2010

Defense Verdict for Wyeth in latest Prempro Case

After six hours of deliberation yesterday, a Pennsylvania jury reached a defense verdict in the case of Foust v. Wyeth.  This case comes on the heels of a number of plaintiffs victories.  Just this past Monday a jury issued a verdict for the plaintiff in Singleton v. Wyeth, finding $3.45 million in compensatory damages and $6 million in punitive damages.

In Foust, the jury found for Wyeth on causation.  One reason might be this, as reported by The Legal Intelligencer:

In an unusual aspect of the case, Foust's identical twin sister, Carol, took an HRT drug but did not get breast cancer. Both the plaintiffs and the defense sought to use Carol Foust's lack of cancer to their advantage in making arguments to the jury.

You don't see those kinds of facts every day.  The jury did find that Wyeth failed to adequately warn consumers about the risk of the drug.

h/t George Conk

ADL

February 26, 2010 in Prempro | Permalink | Comments (1) | TrackBack (0)

Tuesday, November 24, 2009

Plaintiff Verdicts in Prempro Trials

In the hormone replacement therapy (HRT) litigation, plaintiffs won substantial verdicts in two trials in state court in Pennsylvania.  In the trial that concluded yesterday, the jury imposed punitive damages of $28 million on top of the $6.3 million in compensatory damages it had already awarded to plaintiff Donna Kendall.  In the other case, the court yesterday unsealed a punitive damages verdict of $75 million for plaintiff Connie Barton, who had been awarded $3.7 million in compensatory damages. When the Barton punitive verdict was reached in late October, the court took the unusual step of sealing the amount of punitives (see here and here) while the Kendall trial was pending.  Here's an excerpt from today's Philadelphia Inquirer article:

Pfizer Inc. has been hit with more than $100 million in two punitive-damage awards - one decided and the other unsealed yesterday - from Philadelphia juries.

Both cases involve Prempro, a hormone-replacement drug made by Wyeth, which recently was acquired by Pfizer. Plaintiffs said the drug was linked to their breast cancer.

The total includes $28 million awarded yesterday to Donna Kendall of Decatur, Ill.

In the second case, Philadelphia Common Pleas Court Judge Sandra Moss yesterday unsealed a verdict reached earlier this year that awarded $75 million in punitive damages to another Illinois resident, Connie Barton, over her Prempro-linked breast cancer. ...

About 1,500 of 10,000 similar cases are pending in Philadelphia, a common jurisdiction for large liability cases, attorneys say.

With the momentum in plaintiffs' favor and 10,000 cases remaining, one has to wonder whether Pfizer will seek some sort of global settlement.  We can't help comparing Pfizer's position to the position of Merck before it settled the Vioxx litigation.  After a similar but slightly higher number of trials, Merck abandoned its try-every-case-individually strategy and negotiated a mass aggregate settlement.  Merck, however, settled when it had a favorable trial record; so far the defendants have not prevailed in most of the HRT trials. 

HME

November 24, 2009 in Prempro, Trial | Permalink | Comments (3) | TrackBack (0)

Wednesday, October 28, 2009

Confidential Verdicts

I was thinking about Erichson's post on the Prempro punitive damages verdict that has been temporarily sealedl so as not to bias the jury in subsequent trials.  This is a very curious aspect of the law to me - why shouldn't juries know how other juries have decided cases?  I am not sure where I come out on the question, but consider the following.

There are a lot of complaints that jury verdicts are inconsistent, even random, too high, too low, in any event different from what judges and lawyers think is the appropriate award for a given case.  Studies of historical jury verdicts, like those conducted by Neil Vidmar, show that there is some variability in jury verdicts that is not accounted for by the legally relevant facts of the case.  Surveys like those conducted by Michael Saks et al. demonstrate by and large agreement between judges and lawyers about case valuation, but more variability among lay persons (potential jurors).  Saks attributes this to the fact that jurors don't have a point of comparison, and the way judges and lawyers value cases is comparatively.

So why not give jurors a sense of what other juries have done, and let them decide what they think the appropriate amount of damages is in a given case.  Do we think juries will be too influenced by the number, that it will set a floor or a ceiling on their findings?  If we think variability of jury verdicts is a bad thing then wouldn't giving jurors a sense of other cases help limit that variability except where cases are legitimately different and deserving of different awards?  The doctrine of remittitur permits judges to compare jury verdicts and lower outlier verdicts, so the concept of  comparative valuation isn't foreign to our procedural regime.

ADL

October 28, 2009 in Aggregate Litigation Procedures, Prempro, Procedure | Permalink | Comments (3) | TrackBack (0)

Tuesday, October 27, 2009

Sealed Verdict in Prempro Punitives Trial

Yesterday, a Philadelphia jury found for the plaintiff in the punitive damages phase of a trial involving Prempro, the hormone replacement therapy.  How much Wyeth (now a unit of Pfizer) must pay Connie Barton, however, remains secret.  Judge Sandra Moss, who oversees the Prempro state court litigation in Philadelphia, ordered the verdict sealed because another Prempro trial had begun and the defendant requested the order to prevent biasing the other jury.  Until the verdict is unsealed, only Barton, her lawyers, and Wyeth's lawyers may see the verdict.  In the compensatory damages phase, which concluded last month, the jury awarded Barton $3.7 million.  Here's the report from Bloomberg about yesterday's verdict.

HME

October 27, 2009 in Prempro, Trial | Permalink | Comments (4) | TrackBack (0)

Monday, January 26, 2009

Pfizer to acquire Wyeth

Pfizer and Wyeth today announced that Pfizer will purchase Wyeth for $68 billion, as anticipated.  The deal, as today's NY Times article notes, stands out in the current financial climate:

The deal not only create a pharmaceutical behemoth but would be a rarity in the current financial tumult: a big acquisition that is not a desperate merger of two banks orchestrated by the government.  It will also be the first big merger backed by Wall Street in months. While credit has been notoriously tight of late, five banks have agreed to lend Pfizer $22.5 billion to pay for the deal. Pfizer, which has roughly $26 billion in cash, would finance the remainder through a combination of cash and stock.

Every major pharmaceutical company has experienced mass tort litigation, and these two are no exceptions.  Pfizer defended the Celebrex and Bextra litigation, and earlier the Bjork-Shiley heart valve litigation.  Wyeth (formerly American Home Products) took a huge hit in the fen-phen litigation, and more recently has faced mass litigation over its Prempro and Premarin hormone replacement therapy products.

Last May, Amy Schulman joined Pfizer as its general counsel.  Before going in-house at Pfizer, Schulman headed the mass tort practice at DLA/Piper and was lead counsel for Pfizer in the Celebrex-Bextra litigation.  In December, Pfizer hired Bradley Lerman as its litigation chief.  As a partner at Winston & Strawn, Lerman defended McDonald's in the fast food litigation and worked for Phillip Morris in the Engle tobacco class action.

HME

January 26, 2009 in Fen-Phen, Medical Devices - Misc., Pharmaceuticals - Misc., Prempro | Permalink | Comments (0) | TrackBack (1)

Thursday, July 10, 2008

Judge Overturns Punitive Damage Award in Prempro Case

Arkansas district judge Bill Wilson overturned an Arkansas jury's punitive damage award of $27 million to Donna Scroggin. The award included $2.75 million in compensatory damages. Judge Wilson based his decision on discarding plaintiff's expert evidence from Dr. Suzanne Parisian, a former FDA official. Scroggin sued Wyeth for inadequately warning her of the increased risk in breast cancer from Prempro. After taking the drug for 11 years, she developed breast cancer and underwent a double mastectomy. The Wall Street Journal story can be found here and the Associated Press story can be found here.

ECB

July 10, 2008 in Prempro | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 20, 2008

Judge Reduces Jury Verdict in Premarin & Prempro Case

This morning's Wall Street Journal reports that a district court judge in Nevada reduced a jury award against Wyeth from $134 million to $58 million.  The damages included both compensatory and punitive damages based on the theory that the drugs Premarin and Prempro caused plaintiffs' breast cancer.  The judge was concerned that the amounts represented "the result of passion and prejudice."  Here's an excerpt of the story:

Washoe County District Court Judge Robert Perry granted the drug maker's motion to find the damages excessive. He ordered the award reduced to about $58 million -- $23 million in compensatory and $35 million in punitive damages.

The judgment had been the largest award to date against the Madison, N.J., company, which faces about 5,300 similar lawsuits across the country.

All involve the drugs Premarin, an estrogen replacement, and Prempro, a combination of estrogen and progestin.

Judge Perry said the jury's judgment of $35 million in compensatory and $99 million in punitive suggested the amounts were "the result of passion and prejudice."

"The court believes that this reduction in damages adequately compensates plaintiffs for the serious consequences which the jury found to have been caused by defendant, while also serving to punish defendant and deter others from similar conduct," he wrote.

ECB

February 20, 2008 in Prempro | Permalink | Comments (1) | TrackBack (0)

Tuesday, October 30, 2007

Summary Judgment for Wyeth in Minnesota HRT Lawsuit

A Minnesota judge granted summary judgment for Wyeth today in a hormone replacement therapy (HRT) lawsuit.  Here's an excerpt from the Reuters story:

A judge in Minnesota has dismissed a product liability lawsuit against Wyeth, granting the drugmaker's motion for summary judgment in a case in which a woman blamed the company's hormone replacement therapy for her breast cancer, Wyeth said on Tuesday.

In dismissing the case that had been scheduled to go to trial in January, Judge George McGunnigle of the Hennepin County District Court in Minneapolis found that the plaintiff, Patricia Zandi, had not offered any scientifically valid evidence to support her claim that she had developed breast cancer as a result using Wyeth's Premarin and Prempro.

The decision is bound to dampen some of the momentum for HRT plaintiffs generated by the recent Reno verdict.

HME

October 30, 2007 in Prempro | Permalink | Comments (0) | TrackBack (0)

Monday, October 22, 2007

Follow-up on Prempro Trial

An Associated Press story in today's Reno Gazette Journal follows up on the Nevada Prempro plaintiffs' verdict.  The main point of the article -- No alarm on Wall Street over Wyeth case -- is that the financial markets are not particularly concerned about the litigation over the Prempro and Premarin hormone replacement therapy (HRT) drugs, and are treating the $134 million verdict ($35 million compensatory damages and $99 million punitive damages) more as an aberration than an omen.  As one financial analyst put it, as quoted in the article, "Unlike Wyeth's diet drug litigation, the Premarin/Prempro is widely viewed as more of a headline risk than a long-term financial risk."  Of course, after fen-phen, almost any Wyeth litigation risk would appear small by comparison.

HME

October 22, 2007 in Prempro | Permalink | Comments (0) | TrackBack (1)

Monday, October 15, 2007

Punitive Damages in Nevada Prempro Trial

A jury in Reno today lashed Wyeth with a $99 million punitive damages verdict in a three-plaintiff Prempro lawsuit in Nevada state court.  The massive award was predictable given how events unfolded in the case last week.  On Wednesday, the jury rendered a compensatory damages verdict totaling $134.5 million.  When Judge Robert Perry learned that the jury was confused about compensatory and punitive damages, he ordered the jury to reconsider the amounts, and the jury came back with a total compensation verdict of $35 million.  Today, the jury returned to consider punitive damages, and unsurprisingly hit Wyeth with essentially the same amount it had intended as punishment last week. An AP story on the Houston Chronicle website -- Punitive Damages Awarded in Wyeth Case -- reports on today's punitive damages verdict:

Jurors awarded $99 million in punitive damages Monday to three Nevada women who claimed hormone replacement drugs distributed by pharmaceutical giant Wyeth caused their breast cancer. A Wyeth attorney said the award would be appealed. ...

After lawyers for both sides gave closing arguments again on Monday, the judge instructed the five-man, two-women jury to move to the punitive stage of the trial to consider whether the company's actions were so "reprehensible" that additional damages were warranted to punish it and discourage such behavior in the future. ...

The jurors returned at 1 p.m. Monday, two hours after they began deliberations following an impassioned plea by one of the plaintiffs' lawyers to return a large enough judgment to "get the attention and hold responsible" a company with a net worth of $14.6 billion.

HME

October 15, 2007 in Prempro, Punitive Damages | Permalink | Comments (1) | TrackBack (0)

Friday, October 12, 2007

Prempro Jury Confused; Damages Reduced

If Wednesday's verdicts in the Nevada Prempro case seemed implausibly large for compensatory damages, here's the explanation:  the jury was confused about the difference between compensation and punitive damages.  Although for now, this means a substantial reduction in the verdicts, under the circumstances it cannot be considered good news for Wyeth.

According to this Reno Gazette-Journal article -- Jurors to reconsider Prempro damages -- the judge instructed the jury to reconsider its damages calculations:

Jurors in the Wyeth trial were sent back to the jury room this morning to reconsider the amount of damages the company must pay after they told the judge that they were confused about punitive damages when they ordered the company to pay millions on Wednesday.

The jurors told Judge Robert Perry that they included punitive damages in the total they awarded three women who had sued Wyeth, claiming its hormone replacement drugs caused their breast cancer.

... After learning of the confusion, Perry sent the jury back and said they must first recalculate the past and future damages, and then said he would hold a hearing with witnesses before the panel would decide punitive damages.

Later today, an article by AP writer Sandra Chereb -- Jury Cuts $100M From Award Against Wyeth -- reported that upon reconsideration, the jury reduced the total verdicts from $134.5 million to $35 million:

A jury on Friday slashed $100 million from a judgment against pharmaceutical giant Wyeth after it conceded a previous award was improper because it was intended to punish the company for its hormone replacement drugs.  Washoe District Judge Robert Perry instructed the five-man, two-woman jury to reconsider a $134.5 million compensatory award issued Wednesday after questions were raised about whether the judgment included punitive damages.  Perry said the matter was brought to his attention by a bailiff, who overheard discussion in the jury room.  "If we don't correct it now, we'll be trying this case again," the judge said.  After deliberating for about three hours, jurors on Friday awarded $35 million to three Nevada women for past and future medical expenses, as well as physical and emotional pain and suffering. ...

Perry twice denied a motion by Wyeth lawyer Dan Webb to declare a mistrial over the jury's confusion.  Webb argued that jurors were predisposed to punish the company before the punitive phase of the trial had begun.  The judge said jurors raised questions expressing their confusion during the initial deliberations, but Wyeth lawyers wouldn't allow an explanation. ...

The revised compensatory damage verdicts include $10.5 million for Jeraldine Scofield, $12 million for Arlene Rowatt, and $12.5 million for Pamela Forrester.  The jury will return Monday to decide whether to impose punitive damages.  Given the jury's premature attempt to punish Wyeth with an extra $100 million or so, there cannot be much doubt about how the punitive damages phase will turn out next week.

HME

October 12, 2007 in Prempro, Punitive Damages | Permalink | Comments (0) | TrackBack (0)

Thursday, October 11, 2007

Big Plaintiffs' Verdict in Nevada Prempro Trial

Yesterday, a Nevada jury hit Wyeth Pharmaceuticals with a $134.5 million verdict in a three-plaintiff hormone replacement therapy case.  According to a story in the Reno Gazette-Journal -- Jury Orders Wyeth to Pay Out Millions -- the jury found for the plaintiffs on negligence, product defect, and causation, found that Wyeth "concealed a material fact about the safety of the product," and found by clear and convincing evidence that Wyeth "acted with malice or fraud":

A Washoe County jury has ordered pharmaceutical giant Wyeth to pay more than $43 million each to three Northern Nevada women who claimed in a lawsuit the company's hormone-replacement drugs caused their breast cancer.

The jury said Premarin, an estrogen replacement, and Prempro, a combination of estrogen and progestin, were defective products and found Wyeth was negligent in producing, marketing and selling the drugs.

The bad news for Wyeth is that this was merely the compensatory damages phase; jurors will return tomorrow to decide punitive damages.  Yesterday's verdict broke down as follows:  for Jeraldine Scofield, $7.5 million in past damages and $36 million in future damages; for Arlene Rowatt, $7.5 million in past damages and $36 million in future damages; and for Pamela Forrester, $7.5 million in past damages and $40 million in future damages.  A year ago, Wyeth settled with Carol McCreary, a fourth HRT plaintiff who had been part of the same lawsuit.

The article notes that Wyeth is facing about 5300 HRT lawsuits involving about 7800 plaintiffs.

The Wall Street Journal reports that the financial markets do not seem particularly troubled by the Nevada verdict or by the Prempro litigation, which pales in comparison to the woes Wyeth faced in fen-phen.

HME

October 11, 2007 in Prempro | Permalink | Comments (0) | TrackBack (1)

Wednesday, February 21, 2007

Wyeth Loses Prempro Trial

A jury found that Prempro caused the plaintiff's breast cancer and awarded Jennie Nelson and her husband $3 million, in a retrial of a Philadelphia HRT case.  Here's an excerpt from today's Philadelphia Inquirer story:

A Philadelphia jury blasted the drugmaker Wyeth yesterday for failing to warn a patient about breast-cancer risks of its hormone drug Prempro and awarded the Ohio woman and her husband $3 million in damages.

It was the second - and biggest - loss in litigation over Prempro. Wyeth has headquarters in Madison, N.J., with pharmaceutical operations in Collegeville. It has won two Prempro cases, has settled at least one, and has three more trials scheduled for this year.

Wyeth indicated it would appeal yesterday's verdict.

"We respectfully disagree that there is any scientific basis to support the jury's finding of a causal link between Wyeth's hormone therapies and the plaintiff's breast cancer," Barbara R. Binis, a Wyeth defense attorney from the Philadelphia office of Reed Smith L.L.P., said in a statement.

The company has said it faces about 5,000 cases over its hormone-replacement drugs, including Prempro and Premarin.

But plaintiffs' attorneys say cases involving at least 10,000 people have been filed nationwide in federal and state courts, including roughly 1,800 people in Philadelphia's Court of Common Pleas. Almost all involve breast cancer.

A Reuters story -- Jury awards plaintiff $3 million in Wyeth Prempro case -- notes that this was a retrial:

A previous Philadelphia jury also found in favor of the plaintiff, Jennie Nelson, in October. But the judge threw out that verdict and declared a mistrial, leading to the retrial that concluded on Tuesday.

The original jury at the Philadelphia Court of Common Pleas had awarded Nelson and her husband $1.5 million in compensatory damages. This time, Nelson was awarded $2.4 million and her husband $600,000.

The reason for the mistrial declaration was not disclosed at the time, with Nelson's attorney saying only that it was due to extraneous circumstances. There has been speculation since that the verdict may have been overturned as a result of juror misconduct.

The first Nelson trial (a phased trial using a reverse bifurcation structure) and the court's mistrial ruling had attracted attention from those looking for early signs of where the Prempro litigation might be heading.

HME

February 21, 2007 in Prempro | Permalink | Comments (0) | TrackBack (0)

Sunday, February 18, 2007

Wyeth Wins Prempro Trial in Federal Court in Arkansas

Article in the Wall Street Journal -- Jury Finds for Wyeth In Hormone-Drug Trial, by the Associated Press:

A federal jury ruled for Wyeth Pharmaceuticals on Thursday in the latest lawsuit claiming that the company's hormone-replacement drugs cause breast cancer.

After deliberating for more than a day, a jury in Little Rock sided with New Jersey-based Wyeth in a case filed by Helene Rush of Little Rock.

In her lawsuit, Ms. Rush accused the drug maker of negligence in its hormone replacement therapy. More than 5,000 similar suits have been filed across the country.

Ms. Rush, 72 years old, was diagnosed with breast cancer in 1999. Her attorneys say she took Wyeth's estrogen-progestin hormone therapy for nearly a decade.

Lawyers for Wyeth said Ms. Rush likely would have developed breast cancer regardless of whether she took Premarin and Prempro because of genetic and health factors, such as weight gain and a history of smoking.

BGS

February 18, 2007 in Prempro | Permalink | Comments (0) | TrackBack (0)

Friday, February 2, 2007

Texas Prempro Case Dismissed

A Texas judge has dismissed a hormone replacement therapy case on the verge of trial, based on FDA preemption, according to this Bloomberg article in today's Asbury Park Press -- Cancer Suit Against Wyeth Dismissed:

Madison-based Wyeth said a judge dismissed a lawsuit brought by a woman who claimed she developed breast cancer as a result of using the company's menopause drug Prempro.

Judge Caroline E. Baker of Houston said the woman couldn't accuse Wyeth of failing to warn about risks associated with Prempro because drug labels are regulated by the U.S. Food and Drug Administration, according to a Wyeth statement. Wyeth lawyers have said the company did what the FDA told them to do.

The trial was scheduled to begin on Monday, Feb. 5.

HME

February 2, 2007 in FDA, Prempro | Permalink | Comments (0) | TrackBack (2)

Tuesday, January 30, 2007

Judge Denies Prempro Punitive Damages

In the Prempro trial of Mary Daniel v. Wyeth, the jury yesterday rendered a verdict for the plaintiffs for $1.5 million in compensatory damages and finding a basis to move to a punitive damages phase, but today the judge ruled as a matter of law that the evidence was insufficient to hold Wyeth liable for punitive damages.  In an interesting twist, however, the judge apparently has decided to allow the jury to hear the evidence on punitives and to render a verdict -- under seal -- in case her ruling is reversed on appeal.  Here's an excerpt from the Reuters report by Jon Hurdle:

A judge on Tuesday agreed with Wyeth that there was insufficient evidence for a jury to find that the drugmaker acted recklessly in marketing its Prempro hormone replacement therapy, but allowed the punitive damage phase of the trial to proceed pending an appeal of the ruling.

However, Philadelphia Court of Common Pleas Judge Myrna Field ordered that any punitive damage award will not be made public unless an appeals court overturns her ruling.

A jury on Monday found that Wyeth failed to properly warn about the cancer risks associated with Prempro and that the drug was responsible for plaintiff Mary Daniel's breast cancer. It awarded Daniel and her husband some $1.5 million in compensatory damages.

The jury also found that Wyeth's conduct was malicious or showed reckless indifference, a finding that under Pennsylvania law would send the jury back to determine additional punitive damages to be paid by the Madison, New Jersey-based company.

While Field ruled in Wyeth's favor, effectively setting aside that part of the jury's verdict -- a ruling that would limit Wyeth's liability to the $1.5 million -- she agreed to allow punitive damages deliberations to proceed under seal after Daniel's attorneys said they would appeal the ruling.

The judge accepted arguments by lawyers for the plaintiff that a decision by an appeals court to overturn her ruling would necessitate a new trial, and that to keep costs down the jury should be allowed to come up with a punitive damages figure that would be kept under wraps, but could be used by the appeals court if necessary.

As a matter of judicial process, it's comparable to the granting of a renewed motion for judgment as a matter of law (JNOV) after denying the initial motion and allowing the jury to deliberate.  The goal is to avoid the inefficiency of a retrial in the event of appellate reversal of the legal ruling.  But Judge Field's action presents two twists on the usual situation.  First, the judge announced her ruling to the lawyers before proceeding to the punitive damages phase.  Even if a judge knows that she intends to grant JNOV, it must be rare for the judge to announce that intention before the jury deliberates, much less before the lawyers present the final round of evidence.  Second, the judge apparently ordered that the final phase and the jury's verdict be conducted under seal.  Ordinarily, the trial and verdict would be accessible to the public even if the judge chooses to grant JNOV.

HME

January 30, 2007 in Prempro, Punitive Damages | Permalink | Comments (0) | TrackBack (1)

Do Product Recalls Increase Mass Tort Exposure?

In a news account of yesterday's verdict for a plaintiff in the Prempro litigation, an analyst was quoted as saying that Wyeth's exposure is smaller than it would be if the FDA had recalled the product:

Linda Bannister, an analyst at Edward Jones, said Prempro is a minor cloud hanging over the company, with Wyeth's risk limited by the fact that the drug remained on sale. "It's not a situation like Vioxx or fen-phen," she said, referring to the 2004 withdrawal of Merck's arthritis drug Vioxx, and the 1997 recall of two Wyeth drugs used in the fen-phen diet cocktail. ... "If the U.S. Food and Drug Administration advises that a product be removed from the market, a company's (financial) risk is significant," Bannister said, because the product is deemed very defective or potentially harmful.

This raises the interesting question of the relationship between product recalls and liability.  The comparison of Merck and Wyeth resonates on a day when Merck is reporting 4th quarter profits down 58% due in part to Vioxx litigation while Wyeth reports 4th quarter profits up 17% due in part to Prempro hormone replacement therapy (HRT) sales.  Bannister's point is that if product recalls are triggered by strong scientific evidence of a link between the product and the alleged harm, then they can be expected to correlate with a greater likelihood of liability.  Evidence of general causation, after all, bears on both the causation and liability elements of tort claims.  She could have added (and perhaps she did; we have only the reporter's snippet of the quote) that a product recall itself is a triggering event for mass litigation, as a recall generates publicity that attracts the attention of lawyers and potential plaintiffs.  Thus, it's fair to say that as a general matter, really massive liability tends to accompany products that have been removed from the market.  Think asbestos, Dalkon Shield, and fen-phen.

But there's another side to recalls that cuts the other way.  To whatever extent the product is causing harm or increasing risk, the longer the product stays on the market, the more potential liability it creates.  When the product remains on the market, it's also harder for a defendant to anticipate the future stream of claims and to quantify the remaining risk.  In this sense, Prempro resembles other litigation-generating products such as Zyprexa, Oxycontin and tobacco.

If a manufacturer knows that its product creates an unreasonable risk of harm, then most would agree that regardless of regulatory action, the company itself faces a moral, legal, and business imperative to remove the product from the market.  But sometimes the evidence is debatable and the moral duty unclear, although the risk of litigation remains high.  In those situations, the company faces the difficult decision of how to balance the upsides and downsides -- as to both business and litigation risks -- of keeping a product on the market.

HME

January 30, 2007 in FDA, Fen-Phen, Prempro, Vioxx | Permalink | Comments (0) | TrackBack (1)