Plaintiffs Build Case Against Diabetes Drug
In the wake of a new study linking the Type II diabetes drug Avandia to a 43 percent increase in the risk of a heart attack, the plaintiffs' bar is building its failure-to-warn case against GlaxoSmithKline, the drug's manufacturer.

. . .

Meanwhile, personal injury lawyers have been fielding a steady stream of calls since the study came out. Both [attorney] in Philadelphia and Karen Barth Menzies of Baum Hedlund in Los Angeles are currently evaluating cases.

. . .
Plaintiffs' lawyers said the unprecedented race to hold a congressional hearing was a political move to push pending drug safety legislation to the front burner.

Members of Congress were "trying to use Avandia as an illustration to justify legislation to reform the FDA," said Menzies, who attended the hearing.

. . .
After the Nissen study came out, Glaxo published interim results of its own study, indicating no increased risk of heart attack.

But Menzies said testimony at the hearing made it clear that GlaxoSmithKline was on notice of a potential elevated risk of heart attack from the drug as early as 1999.

Diabetes expert Dr. John Buse testified that when he raised a concern about an increased risk of heart attacks from Avandia in 1999, the drug maker subjected him to intimidation tactics and characterized him as a liar.

"When I heard that, my eyebrows went up," said Menzies. "From a legal perspective, I thought, 'Wow, that's notice as early as 1999 when the drug hadn't even been on the market a year.' If they have something that puts them on notice there is a risk, they have an obligation to warn."

 . . .
When deciding whether to take a case, plaintiffs' attorneys will have to "rule out other risk factors," said Menzies, who is also speaking at the Avandia conference. "We'll be looking at whether a person's condition worsened at the time he or she started taking the drug."

 

FDA Colludes With Merck To Avoid Vioxx Liability - Part II
"The FDA admittedly does not have the resources or manpower to achieve a perfect record," says Baum Hedlund attorney Karen Barth Menzies, "nor does it provide remedies to the victims when it fails."

"State product liability laws," she notes, "provide remedies and an invaluable safeguard."

In addition, she says, preemption eliminates one of the few methods available to obtain safety and efficacy information about a drug that companies do not publish and often hide from the FDA. "Civil lawsuits," Ms Menzies points out, "have uncovered internal company documents to which not even FDA is privy."

 

FDA and Glaxo Share Blame for Avandia Disaster
According to plaintiffs attorney, Karen Barth Menzies of Baum Hedlund, a law firm that has been litigating drug related cases against Glaxo since 2001, "The relationship between FDA and the drug industry is disturbing. We've seen internal correspondence between GSK and the FDA that would cause anyone to question the objectivity and regulatory effectiveness of the FDA. Apparently the FDA has failed yet again to protect the public - to the benefit of pharmaceutical industry profits. This failure, and FDA's derogatory attitude towards Dr. Nissen's study, should sound an alarm to all healthcare providers, patients and legislators that the problem is systemic. Patient safety commands serious change in the agency and the industry."

Already, legal conferences are being scheduled to discuss the legal implications of this latest drug safety scandal. Karen Barth Menzies is an invited speaker at an upcoming legal conference regarding Avandia. The conference will include Avandia's background, the science behind the drug, its side effects as well as the FDA's role in regulating Avandia.

 

Antidepressant Drugs
F.DA, Manufacturers Agree To Strengthen
Suicide Warnings For Antidepressants
"We are getting closer to warnings that match what the internal, unpublished data owned by the drug companies (and not entirely seen by FDA) show regarding a risk for antidepressant-induced suicidality and violence," Karen Barth Menzies of Los Angeles' Baum Hedlund law firm said in a May 3 press release.  "Unfortunately, this new warning, rather than simply and accurately informing the public that this side effect can occur in some people - no matter their age, instead gives the false perception that some age groups are entirely safe while others are not."

 

FDA Protects SSRI Makers With Misleading Suicide Warning
. . .
Attorney Karen Barth Menzies is one of the nation's most relentless advocates in the legal field when it comes to pushing the FDA to add warnings about adverse events to the labels of SSRIs. In fact, she has traveled to Washington to speak on behalf of SSRI victims numerous times.

"As I stated in my testimony before the FDA in December 2006," Ms Menzies notes, "it is not the FDA's job to promote the virtues of particular drugs nor is it FDA's job to suggest what treatment people should receive for a particular medical problem."

"Even the FDA's Dr. Robert Temple said as much during the December hearing," she points out.

"Yet that is what the FDA has done with its announcement of the expanded warnings on antidepressants," she says.

"Aside from the very serious risks of these drugs," she explains, "there is an overarching issue related to their over-prescription and drug manufacturers preying on vulnerable people by telling them they have a disease that must be treated with their medication."

A partner in the Baum Hedlund law firm, Ms Menzies considers the FDA's expanded warning a hollow victory. "While it appears that the FDA has finally taken the issue more seriously," she notes, "it is 20 years and thousands of lives too late."

In addition, in the agency's press release and accompanying Q & A document, Ms. Menzies warns, "The FDA has made some seriously misleading statements that will lead patients and physicians into a false sense of security."

Ms Menzies says she believes "without question" that drug makers are putting pressure on the FDA. "Despite the controversy over the failures of the FDA in the past several years," she points out, "it appears that the FDA simply cannot muster the guts to act without industry influence."

. . .

For over a decade and a half, Attorney Menzies points out, SSRI makers have enjoyed enormous financial benefits from their manipulations of the clinical trial data and the FDA continues to ignore all evidence aside from data provided by the drug companies. "The FDA is ignoring," she says, "independent analyses conducted by scientists in the field, as well as historical and foreign regulatory actions dating back over 20 years."

Ms Menzies states that clinical trial data from before SSRIs were even approved, signaled the suicidality risk. Documents obtained in litigation show that as early as 1984, Eli Lilly was aware of an increased risk of suicidality with Prozac.

Attorney Menzies calls the FDA's statement that "scientific data does not show an increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality," "extremely misleading."

"Rather than accurately informing the public that suicidality can occur in some people at any age," she notes, "this new warning gives the false perception that certain age groups are entirely safe while others are not. I know for a fact from my review of internal drug company documents that that is not true," she says.

. . .

Ms Menzies reports that there is a big push to switch people over from taking antidepressants to antipsychotics under the guise that people aren't depressed after all, they actually have bipolar disorder. "It is a very cleverly orchestrated marketing scheme and it's a continuation of the manipulation of a vulnerable population," she says.

 

FDA's drug rule splits the courts
Challenges focus on failure-to-warn ban
. . .
According to [plaintiff’s lawyer], the lower court judge essentially bought the drug company's argument that "the FDA says 'there shouldn't be a lawsuit.'"

Such deference to the FDA alarms Karen Barth Menzies, a plaintiffs attorney at Los Angeles firm Baum, Hedlund, Aristei, Goldman & Menzies. She believes that preemption affords pharmaceuticals too much protection, and that "lawsuits are the only meaningful safety check that remains" for victims of egregious conduct by drug companies.

Having successfully defeated preemption arguments in recent drug lawsuits, Barth Menzies argues that the role of the FDA is to oversee drug-approval procedures and monitor safety, not adjudicate wrongdoing. That, she said, is the justice system's job.

"The FDA is not designed to provide an avenue for determining whether a drug company knew about a risk, but withheld or downplayed it," Barth Menzies said. "Litigation, with its discovery tools, is designed precisely for this purpose -- to determine what a drug company knew and, most importantly, when." She added that the FDA's regulatory role "is parallel to, not in conflict with, the judiciary system."

Barth Menzies also noted that the FDA statement in its preamble "is not a ruling, nor does it have the force and effect of law as the FDA did not go through the proper administrative procedures that would be necessary for such authority."

 

Judge rules $63.8 million settlement in Paxil case fair

A Madison County judge Thursday deemed a $63.8 million settlement fair and reasonable for a class-action suit against the makers of Paxil and Paxil CR.
. . .
The lawsuit claimed GlaxoSmithKline promoted the drugs -- usually used to treat depression and anxiety -- for children and adolescents while withholding negative information about the drugs' safety and effectiveness. Members of the class include all U.S. residents who bought the drugs for their children.
 . . .

By eliminating the cap for undocumented claims and increasing the amount of money, attorney Michael Baum said more people will come forward to make claims

"It simplified the process for a large portion of the class who would make claims," Baum said.

 

40 UNDER 40
Young lawyers chalk up impressive achievements and exert influence
The following 40 attorneys were culled from nominations The National Law Journal received from readers, the advice of legal associations and our own research on lawyers who would still be under 40 by May 2, our publication date. Though in no way comprehensive, the list attempts to identify 40 of the leading young attorneys in various areas of law across the country who, we expect, will continue to exert influence in the legal profession. We looked for evidence of extraordinary achievements early on in their careers.  . . . The achievements of these young lawyers are indeed impressive.
. . .

Karen Barth Menzies, 38 Baum Hedlund, Los Angeles office

 

Lawyers Win More For Plaintiffs In Glaxo Settlement
A judge has amended the terms of a $63.8 million nationwide class action settlement reached in 2006 by drug maker GlaxoSmithKline, allocating more of the massive sum to consumers.
...

In a statement released Thursday, Los Angeles law firm Baum Hedlund said the new settlement plugged a loophole that allocated just $15 each to their clients - plaintiffs who had no proof they bought Paxil for their children.
Under the amended settlement, the $300,000 cap on these claims will be lifted, affected plaintiffs will be eligible for $100 each. . ..

As part of the original settlement, which was unsealed on Oct. 27, 2006, only plaintiffs who had proof of their Paxil purchase could get full refunds by Glaxo.

“The most important objective in improving the settlement for all potential claimants was accomplished through the objections we filed on behalf of our client,” Baum Hedlund senior partner Michael Baum said in the statement. “Our litigation efforts substantially contributed to the original settlement proposal and the improved amendments to the final settlement.

 

New Paxil Suits Allege Birth Defect Risk
 . . .
Although health risks associated with SSRIs have been under scrutiny for years, warnings related to congenital heart and lung defects have focused specifically on Paxil since September 2005, when its manufacturer, GlaxoSmithKline, first notified doctors of the potential hazard. The company told physicians that preliminary study results suggested an increased risk of congenital malformations associated with the use of Paxil during early pregnancy as compared with other antidepressants.

But this and other warnings came too late for many women, according to lawsuits filed in recent months.

“Many of the women who take SSRIs are in their childbearing years. Regardless of the condition for which Mom was prescribed Paxil, she was not given the opportunity to make an informed choice about the risks of taking Paxil during her pregnancy,” said Karen Barth Menzies, a Los Angeles attorney who represents families whose children suffer congenital defects allegedly caused by the drug. “Glaxo took that opportunity away from her by hiding data and failing to include the warnings on their label. If you asked any of these moms if they would willingly put their baby at risk by taking Paxil, the answer would be an unwavering ‘no,’” Menzies said.

 


California Supreme Court Removes Barrier to Tobacco Injury Lawsuits
SAN FRANCISCO-The California Supreme Court on Thursday removed a legal barrier that prevented sick smokers from suing tobacco companies for damages.
. . .

Thursday's decision will allow tobacco-injury lawsuits to move forward in federal courts in California, and also could influence federal courts in other states with similar legal barriers, attorneys said.

It "allows people who are substantially harmed by tobacco smoking to get compensation for the injuries they suffered," said plaintiffs attorney Michael Baum.

Plaintiffs argued that the 2002 ruling prevented smokers from suing in federal courts because tobacco-related illnesses generally don't arise until years after a person starts smoking.

 

Tobacco Claims Will Start Smoking Again, Thanks to California Ruling
For smokers recently diagnosed with a tobacco-related disease, it's not too late to sue the tobacco industry.
. . .
In the latest ruling, the court essentially found that the state's two-year statute of limitations begins when the smoker is diagnosed with a disease caused by the cigarettes.

'The California Supreme Court has resurrected stalled tobacco cases in the Ninth Circuit,' said Michael Baum, who represented one plaintiff in the trial court.

. . .
But that position, according to Grisham's attorneys, wasn't logical.

'You can't say to somebody, 'Someday, I might develop heart disease,' 'Someday, I might develop cancer.' There's no cat scan or MRI you can point to,' Baum said. 'Those would be frivolous claims.'

 

U.S. Supports Glaxo, Asks Judge To Rethink Blocking of Paxil Ads

. . .
"Within a few days, they started getting extraordinarily sick, throwing up every hour on the hour for two months," said Karen Barth, a Los Angeles attorney for the plaintiffs. They also suffered "electric zaps," she said. "It's as if you were to be charged with electricity through your brain."

 

Secrets of the Drug Trials
. . .The secret emails you weren't supposed to see. The paper trail that reveals how results of drug trials were glossed over to cover up a link with suicide in teenagers. Now GlaxoSmithKline faces trial for fraud.

When you take your child to the doctor you assume the medicine they are prescribed is safe and will help them get better. If your teenager is depressed, you certainly don't expect the drug they're given to make them want to kill themselves. But we've uncovered the story of how one company tried to hide the fact that it's medicine did exactly that. Just watch this.

Reporter: SHELLEY JOFRE
Malibu, California. It's not where you'd expect to unravel one of the biggest medical scandals of recent times, but that's exactly what this team of lawyers has managed to do. What they've found affects all of us here in the UK, anyone in fact who takes prescription medicine.

KAREN BARTH MENZIES
Lawyer, Baum Hedlund
It is all about the profits. Even when they have negative studies that show that this drug is going to harm kids they still spin that study as: "remarkably effective and safe for children."

JOFRE: This apartment is crammed full of boxes containing a story that Britain's richest drug company has fought hard to suppress. There's an embarrassment of secrets here that GlaxoSmithKline really doesn't want you to see, and you're about to discover why.

So it's all stuff from the confidential GlaxoSmithKline archives?

BARTH MENZIES: Yeah, the internal documents, the emails back and forth, the decisions that they make from the bottom to the top.

SHELLEY JOFRE
These trade secrets are usually protected by law but through a series of legal challenges the lawyers have forced many of them into the open. Buried in all these boxes are details about secret clinical trials programme that GlaxoSmithKline began over a decade ago for its antidepressant Paroxetine, it's a drug that's better known in Britain by its brand name Seroxat. It was hailed in the 90s as a wonder drug when it was launched as a rival to Prozac to treat depression and anxiety. GSK later promoted it as a cure for everything from stress to shyness. By the new millennium 100 million Seroxat prescriptions have been written worldwide bringing in 2 billion dollars a year. With the adult market also all sewn up, the company then looked for new ways to make money out of Seroxat.

BARTH MENZIES: If they tested Seroxat for children they would get a six month extension on their patent which means enormous profits. It would become the antidepressant being used worldwide for children in depression.

JOFRE: The documents in these boxes reveal how hundreds of children with depression were recruited from around the world to take part in three large scale clinical trials of Seroxat. The biggest of these was in the US and came to be known as 'Study 329'. Its influence would reach right across the Atlantic to British doctors looking for ways to treat depressed children.

. . .
JOFRE: Next to her daughter's suicide note lay a packet of Seroxat. She instinctively blamed the drug, but she couldn't have known what its maker knew. The company had tested the drug on depressed children six years previously. One group took the drug, the other a placebo - sugar pills. The results were unexpected: Seroxat proved no better than the placebo. In one study seven of the 93 children who took Seroxat had to be taken to hospital. Some had self-harmed like Sharise.

BARTH MENZIES
Baum Hedlund
It should have been the time where they at least by then started warning physicians who prescribing this drug off label to stop prescribing it to children, because not only is it not effective, it's not safe.

Reconstruction

JOFRE: There's no doubt the company knew it had a problem. The product director for Seroxat in the UK admitted as much in an internal memo to senior executives way back in 1998. It's one of dozens of emails and memos seen by Panorama.

Email dated: 14th October 1998

"The results of the studies were disappointing. The possibility of obtaining a safety statement from this data was considered but rejected."

JOFRE: In other words they knew they wouldn't get a children's licence.

. . .

BARTH MENZIES: They figured out ways that they could downplay the risks, blow up out of proportion the supposed benefits or the good sides of the study and really downplay the negative findings.

JOFRE: The next step was to use apparently independent academics to help, like Professor Martin Keller. Head of Psychiatry at a prestigious university his name is worth a lot to companies like GSK.

BARTH MENZIES: They figured out well if we use opinion [leaders] in the field, academics that everybody looks up to and the leaders in the field to sell our product, doctors are going to be far more influenced than by just regular sales representatives.

. . .
KAREN BARTH MENZIES
Baum Hedlund
They didn't tell the regulators or the physicians or parents about these risks or the lack of efficacy, instead they went out and promoted this specific study as remarkably effective and safe for kids.

JOFRE: So what does that amount to in your view?

BARTH MENZIES: . . .That's flawed.
. . .

But the boxes in Malibu reveal that the company did find a clinically meaningful increase in 2004 when forced by the US medicines regulator to go back through its own trial results. Miraculously they discovered a further four children on Seroxat who had become suicidal during study 329.

KAREN BARTH MENZIES
Baum Hedlund
They discovered that there was actually a six fold increase in events relating to suicide.

JOFRE: But how could all of this be missed originally? I mean these people were academics, they were supposed to be objective and they were supposed to be scrutinizing the data!

BARTH MENZIES: It shows that they didn't.

 

Paxil Birth Defect Litigation - Battle of the Decade
. . .
Baum Hedlund, a Los Angeles-based law firm that handles pharmaceutical product liability claims is handling these lawsuits, and has the longest track record of SSRI litigation in the country, representing over 3,000 antidepressant plaintiffs over the past 16 years. The firm currently represents families in dozens of birth defect cases and has five attorneys assigned specifically to SSRI litigation.
. . .

Fighting Preemption
As for industry influence on regulatory agencies, legal experts predict that GSK will file motions in an attempt to dismiss the birth defect cases using the FDA's new preemption policy announced in January 2006, which basically says that state failure-to-warn claims are barred against drug companies if a drug and its label were approved by the FDA.

"In essence," Ms. Menzies says, "the government's position is that unless and until the FDA takes action regarding a safety risk associated with an approved drug, nobody else can -- not a drug company, not another state, and not a plaintiff in a lawsuit."

. . .
However, when it comes to preemption motions, GSK could not be up against more formidable opponents than the attorneys at Baum Hedlund. Ms. Menzies and her Baum Hedlund associate, Robert Brava-Partain, have already soundly defeated preemption arguments by SSRI makers and the FDA in numerous cases, including Witczak v Pfizer, Cartwright v Pfizer, and Zikis v Pfizer.

According to Ms. Menzies, the use of the FDA to shield the industry from liability actually began in 2002, when Mr. Troy began submitting briefs in private lawsuits on behalf of drug companies arguing that state tort failure-to-warn claims should be preempted because the FDA had the final word when it came to drug labeling.

In the first brief in Motus v Pfizer, Mr. Troy argued that even though Pfizer had never asked to strengthen Zoloft's label, any warning would have been false and misleading. "Had Pfizer given a warning as to a causal relation between Zoloft and suicide, the FDA would have disapproved the warning," Mr. Troy wrote in the brief. The court never decided the preemption issue in Motus, because the case was concluded on other grounds.

. . .

Pfizer also tried to use Mr. Troy's brief from the Motus case, in support of a preemption motion in the Minnesota case of Witczak v Pfizer. The judge rejected it, stating:

"State consumer-protection law compliments, rather than frustrates, the FDA's protective regime. This is especially apparent when one considers that prescription drugs were once marketed primarily to trained health care providers -- sophisticated and discerning intermediaries.

"Today, on the other hand, pill-rolling apothecaries and the mortar and pestle have disappeared. They have been replaced by drug manufacturers who urge the use of their drugs in mass-market print and television advertisements targeted directly at the public. Defendant, for example, advertises the drug involved in this case by personifying it as a happy, bouncing-oval cartoon character."

Mr. Brava-Partain, who argued for Mrs. Witczak, praised the ruling. "The Court correctly recognized that drug manufacturers, like Pfizer," he stated, "cannot hide behind the rules and regulations of the FDA when they engage in conduct that harms the public."

The fact is, FDA regulations require drug makers to add a new safety warning whenever there is "reasonable evidence" of an association between a particular hazard and the drug, and that a "causal relationship need not have been proved."

"With respect to the SSRIs," Ms. Menzies states, "drug companies have utterly failed to add warnings to the labels despite far more than reasonable evidence of an association of a serious hazard."

The claim that only the FDA can decide whether there is reasonable evidence to change the label is contradicted by its own inaction when it allowed Wyeth to strengthen the label with a warning about suicide and Effexor in August 2003, without prior approval.

According to Ms. Menzies, immunizing the pharmaceutical industry under the misplaced belief that the FDA is infallible is a threat to public health. "Recent regulatory failures," she states, "demonstrate that the agency is neither infallible nor does it have the capability of policing drug makers' negligent misconduct."

 

JURORS AWARD FAMILY OF AIDS INFECTED HEMOPHILIAC $35.3 MILLION
New Orleans, Louisiana, March 15 -- Jurors awarded $35.3 million to [Baum Hedlund clients] for the death of their son, who was infected with the HIV virus and contracted AIDS for the treatment he used for his hemophilia condition.

The jurors came to this decision after deliberating for three days.

Plaintiffs put on evidence that showed that the medication [the victim] used was plasma-derived medication contaminated from the use of high risk donors with the HIV virus.

The jurors found that two of the medication manufacturers, Cutter Biological and Alpha Therapeutics were strictly liable for product liability, negligence and fraud.

The jurors further found that after [the victim] initially was infected with the AIDS virus (which was unknown to him at the time), the continued use of the Cutter and Alpha-contaminated-product further aggravated [his] condition, exacerbating and accelerating the development of AIDS.

The $35.3 million verdict, with prejudgment interest, comes to a total of approximately $56 million.

After the jurors entered their verdict, the judge ruled that the statute of limitations expired and therefore entered a judgment for zero dollars. Plaintiffs' counsel is confident that this decision by Judge Max Tobias will be overturned on appeal due to the finding of fraud.

The [family's] attorneys; Tom Mull, Jim Orr, Michael Baum and Robert Arceneaux have stated that this verdict by the jurors is a strong vindication of the claims of Hemophiliacs across the country who have suffered and died as a result of their HIV infected medication manufactured by the defendants.

 

The Furor over Antidepressants
Noting a higher risk among young adults,
FDA panel urges suicide label warning
Young adults are at heightened risk of becoming suicidal when they take antidepressants , and warnings on the drugs' labels should be altered to emphasize that potential, a federal advisory committee recommended Wednesday.

. . .
On Wednesday, an FDA advisory committee acknowledged that another group of patients deserves special attention: young adults between the ages of 18 and 24, who also can experience heightened suicidal impulses while taking antidepressants. Although the risks are small, they should be featured in a prominent "black box" warning on drug labels, the committee recommended.

Karen Barth Menzies, [Kim Witzcak’s] lawyer, is among several critics who faulted the FDA's analysis, charging that the agency had relied too heavily on clinical trial data supplied from drug companies that weren't independently verified. Other studies that have come to opposite conclusions weren't given sufficient weight, these critics said.

 

SSRI Experts Head to Washington to Testify Before FDA Panel
On December 13, the FDA’s Psychopharmacologic Drugs Advisory Committee will hold a public hearing to review the suicidality data from the adult selective serotonin reuptake inhibitor (SSRI) studies.
. . .
There is probably no legal expert in the US more qualified to testify about SSRIs than Baum Hedlund attorney Karen Barth-Menzies, and she will be at the hearing with bells on. Over the past 10 years, she has represented thousands of clients against SSRI makers.

By now, the FDA knows that Ms. Menzies makes no secret of the fact that she is outraged about the over-prescribing of these powerful and dangerous drugs to all age groups for nothing more than everyday problems.

This will be Ms. Menzies' fourth time up to bat. She has already testified three times at government hearings. She first spoke at an FDA Psychopharmacologic Drugs and Pediatric Advisory Committee hearing in February 2004, about the increased risk of suicide in children and adolescents taking SSRIs.

At that particular hearing, the famous SSRI litigator concluded her testimony by telling the panel: "Put me out of business for the right reasons. Warn about these drugs."

Many of Baum Hedlund's clients who have suffered tragedies caused by SSRIs will be also be attending the hearing and some will be speaking. However, a number of clients who wanted to testify were not selected by the FDA's new "lottery" system, and will not be permitted to speak. But Ms. Menzies says she plans to speak on their behalf.

She has firsthand knowledge of how the drug companies hid the evidence about the suicide risks. The documents that have been unearthed in litigation reveal that the risk was known in the mid-1980s before the first SSRI, Prozac, was approved for use in the US.

Because of Baum Hedlund's work in the Prozac litigation, Ms. Menzies has the ability to provide the committee with the historical background on SSRIs, including internal company documents that show how and why the SSRI suicide risk with adults was obfuscated 15 years ago during the first FDA advisory committee hearings on the suicide issue.

She will explain exactly how the clinical trial data were manipulated by SSRI makers to skew the statistical analyses of suicidality. "Civil lawsuits," she says, "have uncovered internal company documents to which not even the FDA has access."

 

Dunbar family joins suit against Paxil maker
Suit alleges mother's use of drug caused twins' heart defects
The maker of the antidepressant Paxil has been hit with five new lawsuits claiming the drug caused heart defects with serious health consequences, including the death of a West Virginia toddler. Baum Hedlund, a Los Angeles-based law firm specializing in pharmaceutical product liability claims, filed five lawsuits in Pennsylvania state court Monday charging that use of the drug by pregnant women led to heart defects in their children. The suits also allege that the birth defects led to the deaths of three children, and have seriously impaired the health of two others.
. . .
Karen Barth Menzies, a partner with Baum Hedlund, said those reports, which began in 2005, came too late for many pregnant women.

"It's not only that they waited too long, it's that the warning itself wasn't adequate," she said. "There are so many mothers and physicians out there who still don't know."

 

Parents Of 5 Children Sue Paxil Maker Over Birth Defects, Death
PHILADELPHIA - The use of Paxil during pregnancy resulted in severe birth defects that in some cases led to death, the parents of five children allege in separate complaints filed Dec. 1.

In each suit, filed in the Philadelphia County Court of Common Pleas, the plaintiffs complain that manufacturer SmithKline Beecham Corp., doing business as GlaxoSmithKline, failed to adequately warn consumers and physicians that use of the antidepressant during pregnancy increases the risk of malformations of the heart of the developing fetus.

"Women taking Paxil or other antidepressants are unknowingly subjecting their unborn babies to life-threatening risks that could kill their baby or potentially require their infant to undergo dangerous surgeries and the need for life-long medical treatment," plaintiffs' attorney Karen Barth Menzies of Baum Hedlund in Los Angeles said in a press release regarding the filing of the suits.  "If women knew how real this risk is, they would not chance it - most would do anything within their power to protect their child.  This decision is within their control and they should be fully informed so they can make it themselves, not the drug companies or ill-informed doctors."

 

Glaxo Should Face Class Action Over Paxil Suicides, Lawyer Says
GlaxoSmithKline Plc, Europe's largest drugmaker, should face a class-action lawsuit over claims that teenagers' suicides were caused by the company's Paxil antidepressant, a lawyer for their families told a judge.

Robert Brava-Partain said today he wants to combine seven suits filed by the families of young people who killed themselves or tried to while on Paxil. All of the cases hinge on
whether Paxil caused the acts and whether Glaxo officials knew about the possible side effect, he said.

"The same evidence is going to come in time after time,'' Brava-Partain said at a hearing in Philadelphia. Uniting the suits "will achieve economies,'' he said.

 

New set of Paxil suits are alleging birth defects
A prescription antidepressant that allegedly causes severe birth defects could be shaping into a new phase of litigation over GlaxoSmithKline PLC's Paxil.

Lawyers have filed products liability and personal injury actions in state court in a Glaxo U.S. base, Philadelphia, and in Texas state courts on behalf of mothers who took Paxil during pregnancy and whose infants were born with severe heart defects.
. . .

[Karen Barth] Menzies said that Paxil is the focus of three other types of litigation in which she has been involved for the last decade relating to its effect on prescription users' minds. But a lot more lawyers are taking an interest in its alleged potential for causing birth defects, she said.
. . .

[Karen Barth] Menzies said that Paxil is the focus of three other types of litigation in which she has been involved for the last decade relating to its effect on prescription users' minds. But a lot more lawyers are taking an interest in its alleged potential for causing birth defects, she said.

 

Federalism - Agencies Move to Override State Law
As Part of Federal Rulemaking Process
In a new approach that critics call "silent tort reform," federal agencies under the Bush administration have mounted an aggressive effort in recent months to nullify state product liability laws.
. . .

"There's no other process that puts the pieces together of what a company knew and when it knew it," said Karen Barth Menzies, a plaintiffs' lawyer who is handling a major product liability suit against GlaxoSmithKline PLC over use of the antidepressant Paxil.

"The discovery process in the litigation revealed 'just mounds and mounds of documents' that FDA never saw, Barth Menzies told BNA. The suit alleges that GlaxoSmithKline failed to warn that the drug has been associated with causing suicidal thoughts among users.

"Preemption would close off one of the few avenues by which we learn of safety and efficacy information that pharmaceutical companies do not publish and even hide from the FDA," said Barth Menzies, a partner with Baum Hedlund in Los Angeles.

 

FDA Drug Rule Asserts Federal Preemption
Plaintiffs' Lawyers Prepare For Battle
The new prescription drug labeling rule from the Food and Drug Administration asserts that if a label meets the agency's requirements, state law failure-to-warn suits over the drug's risks are preempted - but plaintiffs' lawyers have vowed to fight.

. . .
But plaintiffs' attorneys say that the FDA's action is another attempt by the Bush administration to inappropriately slide tort reform into federal regulations.

"This is totally unsupportable in the case law and by the factual history of FDA's traditional role,"said Los Angeles plaintiffs' attorney Karen Barth Menzies, who has fought the FDA on this issue for years.

. . .
Barth Menzies, who practices with Baum Hedlund, said that she and others are working with members of Congress to try to get the language removed from the rule.

. . .
"The role of the FDA is to approve medications with the most accurate label based on what it knows at the time," said Barth Menzies. "But it's within the state court's realm to police public health matters. If they want to require safer or stronger methods, they are allowed to do so. That doesn't mean the federal standards conflict with the state ones."

Furthermore, even if a company complied with the FDA's requirements for a drug package insert, "a failure-to-warn claim goes far beyond the label," Barth Menzies argued.

For example, "the company might have included the warning in the label, but neutralized in the way it spoke to physicians about the drug or in any promotional materials," she contended.

[Daniel] Troy claims that the rule still leaves open the option to bring other types of suits. "The only thing this even purports to address is failure-to-warn claims," he said.

[Victor] Schwartz agreed that "this doesn't protect a company against fraud" or breach of warranty claims.

But Barth Menzies contended that the matter isn't that simple, because private citizens can't bring "fraud on the FDA" claims arguing that a drug maker failed to provide information it knew about a drug's risks to the FDA.

 

Prozac Backlash-  Trouble in Prozac Nation
. . .
Some 3,000 similar suits against Glaxo have been filed across the country over the past few years, says Karen Barth Menzies, an attorney at Baum Hedlund, a Los Angeles law firm that has handled many SSRI-related suits.

 

At FDA, Change in Name Only; Legal Business;
New counsel keeps industry-friendly policies put in place by his predecessor
. . .
Karen Menzies, who represents plaintiffs in cases related to Zoloft, notes that Pfizer never asked the FDA if it could warn consumers about the suicide risk, adding that the FDA had information about the suicide risk associated with antidepressants like Zoloft since the early 1990s but did not analyze it.

The contention that the agency would have prevented Pfizer from issuing the warning is "pure speculation by the FDA's attorneys," says Menzies, a partner with Baum Hedlund in Los Angeles. "But the sheer weight of the FDA intervening is very persuasive."

 

Donuts for doctors - Buying the medical profession
. . .
"In early 2004, amid dramatic and emotional public hearings at the United States Food and Drug Administration, Karen Barth Menzies, a Los Angeles attorney, testified about the concerns relating to SSRI use in children. She cited evidence of unpublished company trials, which failed to show any benefit for several of the new pills. She noted: 'The clinical researchers who did these trials on kids and the drug companies themselves, confirmed that there are multiple events of suicidality caused by the drug.'

Several months after this testimony, the attorney general of New York State launched a lawsuit against GSK, alleging that the company fraudulently withheld data about Paxil's safety. He noted that by 'concealing critically important scientific studies on Paxil, GSK impaired doctors' ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety.'"

 

Family: Antidepressant led to man's death
. . .
Robert Brava-Partain, an attorney with the Los Angeles firm Baum Hedlund, said his firm has filed about a dozen Zoloft suicide cases and he knows of about a dozen other Zoloft cases filed by other firms. . . .

Most of the Zoloft cases are being litigated in federal court and are pending, Brava-Partain said. . . .

In antidepressant cases, the hope is drug companies will start warning customers and doctors of the risk of increased suicidal behavior, Brava-Partain said. . . .

"These drug companies are realizing, I hope, that they can't hide this information from doctors and the public,'' Brava-Partain said.

The FDA is studying the issue and in March 2004 required the manufacturers of such antidepressants to issue a "black box'' warning to pediatric patients, Brava-Partain said. The FDA is studying suicidal tendencies in adult patients who take such drugs and in June issued a public health advisory warning of the possibility of increased suicidal behavior, especially early in treatment.

 

Attorney-client privilege applies online, Ninth Circuit holds
. . .
“This is a huge decision for all attorneys, not just plaintiff attorneys,” said Robert Brava-Partain of Baum Hedlund, who argued the case for the firm. “It’s a two-way street. In fact it’s ironic that [GlaxoSmithKline] fought this so hard, since a ruling like this could easily be used against any law firm, for plaintiffs or defendants. It would have undermined all lawyers’ ability to do business.”

. . .
Noting that the questionnaire asked for detailed personal and medical histories, Brava-Partain said, “Clients seeking representation talk about very personal things with a lawyer, whether or not they ultimately hire that lawyer. The policy behind this is, if you didn’t think that information was being treated confidentially, it would discourage you from going out to talk to a lawyer. This is just like an initial face-to-face, preliminary communication in a lawyer’s office.”

“This is a crucial ruling,” said Brava-Partain. “Internet use is ubiquitous. We are moving into a new age, and the court of appeals recognized that.”

 

FDA Urges Monitoring for Suicide in Adult Antidepressant Users
The Food and Drug Administration has issued a public health advisory urging that persons taking antidepressant medications be "closely watched" for worsening of depression and "increased suicidal thinking or behavior."
. . .
Los Angeles attorney Karen Barth Menzies has filed suit against pharmaceutical companies for families of antidepressant users who have committed suicide. She said in a media statement that while the FDA's warning encourages her, the action is some 14 years late in coming.

"While the FDA should have taken this action back in 1991 when first presented the evidence of a suicide risk, we appreciate that the FDA has issued this advisory now instead of waiting," she said. "Now, if physicians and physicians' organizations pay attention to this information, lives will be saved."

 

Drug Manufacturer Loses Bid To Get Personal Medical Data
SAN FRANCISCO - Affirming the importance of attorney-client privilege, a federal appeals court Thursday soundly rejected a drug maker's attempt to get hold of personal medical information solicited through an Internet questionnaire by a plaintiffs' law firm recruiting clients for a mass tort case.

...
Robert Brava-Partain, who argued the case for Baum Hedlund, praised the 9th Circuit for recognizing "how deeply ingrained the attorney-client privilege is in our legal system."
"The ruling basically says ambiguities are resolved in favor of the client, not in favor of the party opposing the privilege,' Brava-Partain said."

 

Pittman Post Trial Press Conference
Statements by Karen Barth Menzies
To follow up on what [Christopher's aunt] said, I think that this is a really serious test of whether the justice system is prepared, whether they’re equipped to fairly deal with violence that’s been caused by Zoloft or an SSRI, much less in a 12 year-old child.

I think none of us can deny throughout this entire trial that this drug had a very significant effect on this boy, who prior to taking this medication was not violent and what can we do about it? I think even the judge was concerned about what we could do about it.

Not one expert from either side disagreed that Zoloft could cause psychosis, hallucinations, mania, the type of behavior Chris suffered. And in our approach of the Solicitor [and their experts] from the very beginning, was to try to advise them as well, meet with them - - give them the information that’s been withheld from them by the drug companies - - by Pfizer.

 

15-Year-Old Sentenced to 30 Years for Murdering Grandparents
LARRY KING, HOST: Joining us now are Andy Vickery and Karen Menzies, the defense attorneys for Chris Pittman. Karen, by the way, specializes in lawsuits against antidepressant makers. . ..

KAREN MENZIES: ... I think the jury was faced with a difficult issue. The problem is, as everybody recognized throughout the trial, Zoloft changed Chris' behavior, and he did in fact suffer side effects that as of last month the FDA is finally requiring Pfizer to warn about.

 

Pittman Trial
Will they appeal the ruling?
The Pittman’s attorney Karen Barth Menzies is with us as is Christopher’s sister, Danielle Pittman Finchum.

. . .
Karen: What I think they do recognize is that it was very prevalent in the whole trial, that Zoloft played a very significant role. I think they were grappling with the concept that a medication can cause a person to become homicidal. You know that I think, unfortunately we’re being faced with these very difficult issues about medicine and what doctors are really told about these drugs.

FOX: Karen, to follow up with you, is that the basis for your appeal or is it that he was very young when the crime was committed?

Karen: Well, it’s two-fold. It involves both of those aspects. There’s a very serious concern that South Carolina statutes that permit a child of 12 years-old to be tried as an adult, we feel is unconstitutional and we’ll be raising that to the appellate court in combination with his inability, as a 12 year-old, on the prescription medication, to be able to tell right from wrong.

FOX: Alright and one last question for you Danielle..do you feel like if your brother had never taken Zoloft, this would have never happened?

Danielle: I have no doubt this never would have happened if he hadn’t taken this. It was a mind altering drug. It altered the way he thought, he altered him as a person. ...

 

Chris Pittman Antidepressants and Violence
. . .
Karen Barth Menzies: "The stronger evidence shows that it was not within Christopher's character at all to behave as violently as he did. And, in fact, as soon as he started taking the medication, everybody saw that his behavior changed. And I think what Pfizer is not telling you is that they have internal documents that they have not provided to the public, they have not provided them to the prosecutor, they have not provided them even to the FDA, that shows that they know that this drug can cause, in some people, violent reactions, including homicide ... "

 

FDA strategy would pre-empt tort suits
. . .
In some ways, tort litigants may be in a better position than the FDA to keep drug companies honest, since they sometimes see evidence that the agency doesn't. Karen Barth Menzies of Los Angeles' Baum Hedlund, who represents thousands of one-time users of the anti-depressant Paxil in a suit against Paxil manufacturer GlaxoSmithKline PLC, said that court-ordered discovery allowed her to see raw data on safety and efficacy, while the FDA saw only the completed write-ups.

Also, Menzies saw the company's internal communications about how to approach the agency, which the FDA never saw, she said. "If we could show you what we see, you'd see how much disdain the drug companies have for the FDA," she charged. The discovery materials are subject to protective order.

 

"Failure To Warn" Suits Boosted by FDA Advisory on Antidepressants
The FDA has issued an advisory asking the manufacturers of certain antidepressant medications to add warning labels recommending that patients treated with these drugs be carefully monitored for sudden signed of becoming suicidal. . .
. . .

Los Angeles plaintiffs' attorney Karen Barth Menzies, who also specializes in these cases, said, "This is a . . .hurdle we have finally gotten over after 12 years."

This warning will raise awareness of a possible risk and cause more potential plaintiffs to come forward, she said, because it "makes people who were not aware that suicide could be caused by the drug [realize] that they might have a lawsuit."

  . . .Baum Hedlund, is handling about 50 individual suicide cases at various states, many of which involve Zoloft, as well as representing about [thousands of] clients in the multi-district litigation over Paxil. Menzies is lead counsel in the Paxil litigation against drug maker GlaxoSmithKline.

 

I-TEAM: Antidepressants
At least 16 million Americans use antidepressants for problems like depression, anxiety and even shyness. When the government recently warned those drugs could bring suicidal thoughts, it was big news for lots of people.

The I-TEAM reports on accusations that drug companies have known for years about the risk of suicide, but failed to warn the public.

. . .
Karen Barth Menzies is [the widow's] attorney. 'It's all about the bottom line," she said. Thursday, she filed a lawsuit against Pfizer. The suit claims Pfizer knew "Zoloft was unsafe" and claims the company had not told [our client's husband's] doctor, or any doctor, about the possibility of suicide. "Because, if they had warned them, the doctor would have been able to treat [our client's husband] in a way that would have avoided the suicide," Barth Menzies said.

 

Antidepressants and Suicidal Behavior
HOST WARREN OLNEY:. . .Karen Barth Menzies is an attorney in Los Angeles for a firm that represents plaintiffs in antidepressant lawsuits. She testified recently before the FDA's advisory committee regarding antidepressants. . .What can you tell us about clients that you have represented and the kinds of things that have happened to them?

KAREN: I think the strong point I'd like to begin with is the distinction between what we are calling depressed suicidality and the mania psychosis and akasthesia reaction that the drugs do cause. I think that is a significant difference because you can see signs of this if the doctors are educated about this side effect they will be able to safely treat the children so that they won't kill themselves or kill others.

WARREN: This is when the drugs are being administered is what you're saying?

KAREN: That is correct. That is what the FDA'S warning discusses. It's early in treatment or when there has been an increase or decrease in dose. So, I've got  examples of some of my clients. I've got 8 year-old boy who was prescribed Paxil. He started having jerky movements and he became violent. He kept complaining about nosiness in his head. These are all clear signs of akasthesia. Within 2 weeks of taking Paxil, he tried to throw himself out of a moving car.

KAREN: . . .there is absolutely no evidence anywhere that these drugs actually prevent suicide. And then going back to the fact that you know, treatment is one thing. But treatment doesn't have to be SSRIs and only SSRIs. Unfortunately that's what a the doctors are doing. [They] see the doctor for a couple of minutes. They throw some drugs at them and then they're out the door.

 

 

Drugs & Supplements
A HarrisMartin Interview with Karen Barth Menzies of Baum Hedlund
. . .
HM: In your opinion, is litigation one of the best ways to get this information to the public?

KAREN: It's the only way. And we have to be tenacious and file numerous motions to compel to force the drug companies to give us the evidence because a lot of the time, it doesn't even come out in the litigation until we go through many motions to compel. It is the classic products liability case where the manufacturer hides the information in a paper storm and we have to spend a lot of time and money trying to find it.

 


"We allege that the drug, Zoloft, was a significant factor in causing Brynn Hartman to commit murder and suicide," Karen Barth Menzies  told ABC News
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Prozac Battle Comes Home; Lenoir Woman's Suicide Case to Be Tried in Charlotte
. . .
"What we're trying to get them to do is warn the doctors and [then] the doctors can warn the patients or their families," said Karen Barth, the Los Angeles lawyer representing the . . . family. "To me, that's reasonable. We're not asking them to take the drugs off the market."

. . .
Lawsuits such as the one filed by [the victim's] husband and children can be hard to prove. Barth and other lawyers specializing in them say most lawyers don't have the expertise to take on such complicated claims

. . .
Barth and other critics say pharmaceutical firms such as Lilly, which racked up about $2 billion in Prozac sales last year, market the drugs without inserting warnings about the possibility of manic, psychotic, homicidal or suicidal side effects.

Barth's California firm is among the few specializing in suing Lilly and other companies that make the class of drugs which treat depression by increasing the brain's levels of serotonin, a substance thought to affect a person's moods.

. . .
Barth in August filed the first class action lawsuit against any of the makers of serotonin-boosting antidepressants, which include Paxil and Zoloft in addition to Prozac. ...

 

Will British Ban Spur FDA to Act?
Critics remain skeptical of the FDA's announced plans to take a serious look at possible links between use of antidepressants by children and violent or suicidal acts.
. . .
Karen Barth Menzies, an attorney with Baum and Hedlund, a Los Angeles law firm that represents alleged victims of SSRIs, tells Insight, "The only reason that the FDA is even looking at this issue is because they don't want to be seen as sitting back doing nothing. We are thrilled with what the U.K. has done and we believe that it only happened because they put together a panel that wasn't biased or had any pharmaceutical connections. But I think the FDA will try to whitewash the issue."

As Menzies sees it, "The FDA's planned methodology for the hearing is to go back and look at the number of suicide events that were recorded during the drug companies' clinical trials. These suicide events were recorded by the researchers at the time with the patients sitting in front of them. The researchers are treating them and seeing exactly how they are reacting. And it was during this evaluation that they recorded the suicide event as a suicide event and in some cases even noted that the suicide event was caused by the drug. Now what you have is the FDA bringing in an 'independent' panel to go back and look at those researchers' assessments, and they are going to determine whether the reported incident was really a suicide event. The only thing that can come from this panel's review of the data is that they get the same number or fewer incidents of suicide events which now will be based on the panel accepting that the researchers' evaluation was correct."

 

US acts on drug suicide warning
Prozac, Seroxat and other commonly used antidepressants of the same class must carry warnings that children and adults might become suicidal while taking them, the American drug regulator said yesterday, increasing the pressure on the UK to act. 
           
The Food and Drug Administration (FDA) stopped short of stating that the drugs can cause some people to want to kill themselves, but made it clear it was a possibility.

  . . .
The FDA says that patients on the drugs must be more closely monitored for suicidal thoughts. Karen Barth Menzies, a lawyer with Baum Hedlund in the US, which is pursuing legal claims against the companies, welcomed the FDA statement, but regretted that it had taken a decade of pressure to get the bold-print warnings manufacturers will now have to include on labeling.
           
"Through our litigation over the past 13 years, we've seen the internal documentation that shows the drug companies have known that their drugs can cause suicide and violence even before the drugs were approved for marketing," she said.
           
"Moreover, both the FDA and drug companies have known that these drugs are only marginally effective in treating depression."

 

Antidepressants on suicide watch
FDA warns that feel-good pills could wind up killing you
. . .
attorney Karen Barth Menzies, who presented a case before the FDA [said], "It's infuriating that these people seek medical help from doctors and end up dead."


 

Prozac: Unsafe At Any Price
. . .    
On Thursday, Eli Lilly announced it was halting development of a new and improved version of Prozac, its top-selling drug. The patent for the new formulation -- which cost Lilly $90 million -- claimed it would reduce ``the usual adverse effects'' of the original Prozac, including ``nervousness, anxiety, insomnia, inner restlessness (akathisia), suicidal thoughts, self mutilation, manic behavior.''
   
Yet almost from the time it was introduced in 1988, Lilly has been maniacally denying claims that Prozac produces violent or suicidal reactions. . . .
   
The damning admissions in the enhanced Prozac's patent will be the center of a [Baum Hedlund] federal lawsuit scheduled to go to trial in Hawaii next summer. This will be the latest round in a legal battle initiated by the children of a man who, while on Prozac, fatally stabbed his wife and then himself. . . .
   
During the first trial, Lilly's lawyers and witnesses repeatedly claimed that violent or suicidal acts are not a side effect of Prozac.. . .
   
The latest suit charges that ``a fraud was committed on the court'' when Lilly failed to disclose the potentially explosive data contained in the patent, which it had purchased three months before the first trial began. ``It is incredible,'' said Karen Barth, one of the attorneys suing Lilly, ``that on the one hand, Lilly vehemently argues to a federal judge and jury that Prozac does not cause suicide and/or violence ... while on the other, pays $90 million for a patent ... which clearly acknowledges Prozac's propensity to increase the risk of suicide and violent behavior.'' If there was no problem with Prozac, then why spend all that money to fix it?

 

Infected hemophiliacs could pursue their cases in the US courts
. . .
The South China Morning Post reported yesterday that Hong Kong hemophiliacs in the mid-1980s were forced to rely on HIV-contaminated blood-clotting medicine sold across the region by a US company - even while it marketed a newer, safer version elsewhere.

. . .

Michael Baum, who practises in Los Angeles, said Cutter had faced a problem in unloading its old stocks of the non heat-treated concentrate. "There was an over production. The company had paid for the plasma and the stocks were in the warehouse and that was their problem. The company then tried to find a market," he said.

Mr. Baum, who has represented HIV-infected hemophiliacs in the US, said Cutter failed to act reasonably. "By October 1984, it had been proven that heat-treating, and in particular Cutter's heat-treating, killed HIV. Thus, at least by then, it was clearly known to be unsafe to continue using non-heat treated products," Mr. Baum said. "Instead of recommending to cease using non-heated product, Cutter and the other manufacturers did the opposite and did everything they could to find markets for their inventories of non-heated products. Hong Kong hemophiliacs were ... misinformed." This misinformation could form the basis for pursuing lawsuits against the US manufacturers, Mr. Baum said.

 

2 Paths of Bayer Drug in 80's: Riskier One Steered Overseas
A division of the pharmaceutical company Bayer sold millions of dollars of blood-clotting medicine for hemophiliacs   medicine that carried a high risk of transmitting AIDS   to Asia and Latin America in the mid-1980's while selling a new, safer product in the West, according to documents obtained by The New York Times.

...
In the United States, AIDS was passed on to thousands of hemophiliacs, many of whom died, in one of the worst drug-related medical disasters in history. While admitting no wrongdoing, Bayer and three other companies that made the concentrate have paid hemophiliacs about $600 million to settle more than 15 years of lawsuits accusing them of making a dangerous product.

...
The new product, meanwhile, was selling briskly, leaving Cutter with a problem: "There is excess nonheated inventory," the company noted in minutes of a meeting on Nov. 15, 1984.

"They needed to get the return for what they invested," explained Michael Baum, a Los Angeles lawyer who has represented dozens of United States hemophiliacs in suits against blood-product companies. "They paid the doctors. They had processed the plasma, put it into vials, kept it in warehouses   and all that expense had already been incurred."