Cigarettes pack more nicotine - The Boston Globe: "State study finds a 10 percent rise over six years
By Stephen Smith, Globe Staff August 30, 2006
Even as measures to discourage smoking grew more stringent in recent years, a new report indicates that the nicotine content of cigarettes rose, making it tougher for smokers to quit.
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Sign up for: Globe Headlines e-mail Breaking News Alerts From 1998 to 2004, the amount of nicotine that could be inhaled from cigarettes increased an average of 10 percent, the study by the state Department of Public Health found. Nicotine is the chemical that causes cigarettes to be addictive, and the study, released yesterday, found higher levels in all classes of cigarettes, including those branded ``light.'"

H&R Block Settlement Approved by Federal Judge

A $39 million settlement was approved in a class action lawsuit against H&R block. The class claimed they paid excessively for refund-anticipation loans and will each be receiving $78 in the settlement. The case had been rejected twice before the final settlement would cover 1.7 million loans made between April 1994 and December 1996. Mike Robinson, Fort Wayne 08/30/2006

Federal Court Throws out Third Party payor case



Briefs and Other Related Documents
Only the Westlaw citation is currently available.
United States District Court,N.D. California.
In re BEXTRA AND CELEBREX MARKETING SALES PRACTICES AND PRODUCT LIABILITY LITIGATION,
This order relates to All Celebrex Purchase Claims Actions.
No. M: 05-1699 CRB.

Aug. 16, 2006.


MEMORANDUM AND ORDER RE: MOTION TO DISMISS PURCHASE CLAIMS MASTER CELEBREX COMPLAINT
CHARLES R. BREYER, District Judge.
*1 These putative class action lawsuits arise out of the marketing and sale of the prescription drug Celebrex. Now pending before the Court is the Pfizer defendants' motion to dismiss. After carefully considering the papers filed by the parties, and having had the benefit of oral argument, as well as further briefing after argument, the Pfizer defendants' motion is DENIED in part and GRANTED in part with leave to amend.

Federal judge throws out third-party Payor claim claiming preemption

The FDA is not competent to monitor the safety of drugs in the marketplace. The GAO wrote a clear and concise report reaching this and other conclusions in 2006. If FDA has inadequate resources and authority to ensure safety of drugs in the marketplace, because they cannot truly appreciate the evolving risks, then how can the FDA possibly be the final arbiter of an appropriate label? Not possible.
The preamble assumes the FDA actually knows what should be on product labels. The reality according to the GAO is much different.
FDA, by the way, agreed with the conclusions of the GAO, calling them reasonable. But FDA has had no comment, far as I know, about the GAO's recommendations for improving the system.

Tax Code on Emotional Damages Tossed - New York Times: "Tax Code on Emotional Damages Tossed
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By THE ASSOCIATED PRESS
Published: August 22, 2006
Filed at 6:52 p.m. ET
WASHINGTON (AP) -- The federal government may not tax the money plaintiffs receive as compensation for emotional distress and other intangible injuries, a federal appeals court said Tuesday.
The U.S. Court of Appeals for the District of Columbia Circuit struck down as unconstitutional a portion of the tax code that said only compensation for physical injuries is tax exempt."

Lens Solution Caused Eye Infections, Report Says - New York Times: "Lens Solution Caused Eye Infections, Report Says
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Placitella comments:
I can see clearly now the truth has come. Medical research has removed all obstacles in our way.

By BARNABY J. FEDER
Published: August 22, 2006
Federal disease control experts and leading eye doctors have formally concluded that Bausch & Lomb�s ReNu with MoistureLoc was the only contact lens solution contributing to an outbreak of potentially blinding fungal eye infections earlier this year.
But the researchers� report, to be published Wednesday in the Journal of the American Medical Association, says it remains unclear how the product caused the problems.
And an accompanying commentary by two academic researchers, meanwhile, argues that further study is needed to gauge the safety profile of all the various brands of �multipurpose� lens-care solutions on the market that, like MoistureLoc, are used for cleaning, storing and moistening soft contact lenses.
The research report challenged Bausch & Lomb�s argument that a major factor in the outbreak was customers� failure to properly clean their lenses and regularly replace the storage solution."

Law.com - Ark. Judge to Hear First of 4,500 Suits Over Prempro: "Ark. Judge to Hear First of 4,500 Suits Over Prempro
Andrew DeMillo
The Associated Press
August 22, 2006
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As lawyers argued over which evidence should be allowed, a judge in Little Rock, Ark., Monday delayed jury selection in the first trial of 4,500 lawsuits filed nationwide that challenge Prempro, a hormone-replacement therapy that some women say causes breast cancer.
Linda Reeves of Benton, Ark., sued drug maker Wyeth, claiming she developed breast cancer after taking Prempro for eight years. Helene Rush of Little Rock has argued similar claims in a federal suit against the drug maker. Rush has an Oct. 10 court date.
Prempro is a widely prescribed estrogen-progestin combination used to treat premenopausal symptoms, such as hot flashes.
While plaintiffs say Wyeth was more worried about money than patient safety while developing the drug, the drug company wants jurors to see its request -- made to the Food and Drug Administration in 1983 -- for a study about the effects of combining estrogen and progestin. Reeves' lawyers want the evidence limited, saying jurors could be overwhelmed by such a huge file and miss its key portions.
Lawyers for both sides argued about the evidence before U.S. Magistrate Judge Henry L. Jones Jr. on Monday as Jones filled in temporarily for U.S. District Judge William R. Wilson, who will preside over the trial. Jones pushed back jury selection to Tuesday. "

Kansas City Star 08/25/2006 Benzene lawsuit settled by consumers: "Benzene lawsuit settled by consumers
Certain drinks have been reformulated since case involving customers in KC, elsewhere began.
By DAVID GOLDSTEIN
The Star�s Washington correspondent
WASHINGTON Consumers in Kansas City and elsewhere have settled a lawsuit alleging that two soft drink makers sold products that contained excessive amounts of cancer-causing benzene.
The companies, In Zone Brands Inc. of Austell, Ga., and TalkingRain Beverage Co. Inc of Preston, Wash., have already reformulated certain products to eliminate the alleged presence of benzene, according to the settlement.
The lawsuit was filed in the Superior Court of the District of Columbia. Besides consumers in Kansas and Washington D.C., consumers � all parents � also filed lawsuits in Massachusetts, New Jersey and Florida.
�It�s progress,� said Neil Sader, a Kansas City attorney who represented a local plaintiff. �There�s no reason for these problems not to be addressed.�
His client, MeLisa Gonzalez, a Blue Valley School District teacher, said last spring that she sued the companies to make sure her children were drinking safe products.
Attorneys for In Zone and TalkingRain could not be reached for comment.
The American Beverage Association, the industry trade group, has insisted that soft drinks are safe."

Wichita Eagle 08/26/2006 Coca-Cola latest target of benzene lawsuit: "Coca-Cola latest target of benzene lawsuit

This is the lawsuit that could tip the Coke and Pepsi challenge or maybe 7-Up is better altogether.

BY STEVE PAINTER
Eagle Topeka bureau
TOPEKA - Lawyers sued Coca-Cola in federal court in Kansas City, Kan., on Friday as they sought to dismiss complaints against two other soft-drink makers over levels of benzene in their products.
The amended complaint claims tests show benzene at 13 parts per billion in Coca-Cola's Vault Zero beverage, well above the 5 ppb limit established by the U.S. Environmental Protection Agency as safe for drinking water.
A Coca-Cola spokesman said in a statement that Vault Zero is safe and the lawsuit is without basis.
Benzene is a known carcinogen linked to leukemia.
Separately Friday, Consumer Reports magazine said its own tests of soft drinks that contain vitamin C and sodium benzoate found benzene levels of 2 ppb or more in five of them."

US seeks to delay W.R. Grace's asbestos case - The Boston Globe: "US seeks to delay W.R. Grace's asbestos case
By The Washington Post August 25, 2006
WASHINGTON -- Federal prosecutors plan to appeal a series of rulings they say will undermine their upcoming conspiracy case against chemical maker W.R. Grace & Co, according to court papers.
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Sign up for: Globe Headlines e-mail Breaking News Alerts William Mercer, the US attorney in Montana, is seeking a delay in the Sept. 11 trial, citing a government appeal of three rulings by US District Court Judge Donald Molloy that significantly hamper the prosecutors' criminal case.
Grace is accused of violating the Clean Air Act and knowingly poisoning former workers and other residents of a Montana mining town with deadly asbestos fibers."

Drug Maker Will Pay Fine for Promoting Off-Label Use - New York Times: "Drug Maker Will Pay Fine for Promoting Off-Label Use

In a story that has largely run under the radar screen, today's settlement has the capacity to change how the pharmaceutical industry markets its products now in the future. The following is an account from the Associated Press.


By THE ASSOCIATED PRESS
Published: August 30, 2006
BOSTON, Aug. 29 � The Schering-Plough Corporation agreed on Tuesday to pay $435 million and plead guilty to conspiracy to settle a federal investigation into marketing of its drugs for unapproved uses and overcharging Medicaid for certain drugs.
Schering-Plough said it would pay $255 million to resolve civil aspects of the previously disclosed investigation. A subsidiary, the Schering Sales Corporation, will pay a criminal fine of $180 million and plead guilty to one count of conspiracy to make false statements to the government. The agreement is subject to court approval.
Schering-Plough said the settlement resolved an investigation by the Justice Department and the United States attorney�s office in Boston that began before a new management team took over at the company in April 2003.
�With this agreement, we are putting issues from the past behind us,� said Brent Saunders, senior vice president for compliance and business practices.
Shares of Schering rose 53 cents, to $20.94, on Tuesday.
The agreement comes two years after Schering-Plough agreed to pay $346 million to settle charges that it paid a kickback to a health insurer to protect the market for its allergy drug Claritin.
The investigation that led to Tuesday�s settlement began in 2001.
Investigators found evidence that Schering-Plough marketed drugs for off-label uses. Off-label uses have not been approved by government regulators, although doctors can individually choose to prescribe drugs for those purposes.
One such drug was Temodar, which the Food and Drug Administration in 1999 approved to treat"

Ban on Sale of Skin Lighteners Proposed - New York Times: "Ban on Sale of Skin Lighteners Proposed
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By THE ASSOCIATED PRESS
Published: August 30, 2006
The Food and Drug Administration proposed a ban on over-the-counter sales of skin-lightening products, saying possible health risks cannot justify their being sold without a prescription. The creams typically contain a drug called hydroquinone, a possible carcinogen also linked to a skin-disfiguring condition, the F.D.A. said. While the actual risk of the drug is unknown, the agency said, the products should be restricted to prescription use under medical supervision. An estimated 65 companies in the United States sell roughly 130 different skin-bleaching creams and other products that contain hydroquinone, the agency said."

Federal Vioxx verdict partially overturned

Today the federal court in Louisiana overturned the $50 million damage award to a former FBI agent. The judge determined that no reasonable jury could give that much. The judge left intact the liability findings both as to compensatory and punitive damages. No doubt the spin doctors will be playing with this one for a few weeks. This finding by the court which in many respects as favorable to the plaintiffs will not the least bit slow the prosecution of these claims. The following is a news account:

Federal Judge Vacates $51 Million Vioxx Verdict, Orders New Trial NEW ORLEANS -- A jury award of $50 million to compensate a retired FBI agent for a non-fatal heart attack he suffered after taking Vioxx for 31 months was 'grossly excessive' and a new trial on the issue of damages must be held, a federal judge ruled today. In Re: Vioxx Products Liability Litigation, MDL No. 1657 (E.D. La.). Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana said that '[n]o reasonable jury could have found that [plaintiff Gerald D. Barnett] was entitled to $50 million in compensatory damages' from Merck & Co. Inc. because of a heart attack he suffered in 2002. Judge Fallon noted that the jury's findings for Barnett on his negligent failure-to-warn and deceit-by-concealment claims were reasonable, as was the jury's $1 million punitive damage award, but the judge cited case law in declaring that the compensatory damage award was 'so excessive that no reasonable juror, unswayed by passion or prejudice, could have awarded that amount.' For more on this developing story, Click Here

Plaintiffs' suits against companies decline: "

While you can not deny the statistics, the following is a fairly biased story riddled with the politics that surround class-action in mass tort litigation. Read it with a grain of salt.


Plaintiffs' suits against companies decline
Monday, August 28, 2006
By Paul Davies, The Wall Street Journal

Companies involved in many of the largest and most controversial legal clashes of recent decades are seeing a sharp decline in the number of lawsuits filed against them.
In recent months, judges have dismissed or challenged tens of thousands of individual cases, in matters ranging from claims of lung damage from asbestos and silica dust to allegations that the diet drug fen-phen caused heart problems. Moreover, fewer new claims like these are being launched, as state and federal courts and legislators attack the methods used by some attorneys to round up plaintiffs for large-scale litigation.
There is no comprehensive count of claims, but a look at several key areas -- particularly asbestos and silica claims -- shows large-scale litigation against single products, known as 'mass torts' and 'class actions,' is on the wane.
'The future of mass torts and class actions is very much in question,' said Geoffrey Miller, a New York University School of Law professor who teaches a course on issues in large-scale litigation.
This year, new securities-fraud class-action lawsuits are down 45 percent, to 61 through June from 111 in the first half of 2005, according to a new study.
Among the factors behind that drop: the federal indictment in May of the leading securities class-action law firm, Milberg Weiss Bershad & Schulman LLP, which is accused of paying individuals to file suits. The firm filed just 17 lawsuits in the first six months of 2006, down from 55 in 2005's first half -- and hasn't filed a class-action case since its indictment.
Another contributor is a federal judge's finding last year that nearly 10,000 claims "

Law.com - Suit Against Infants' Tylenol Gets $5 Million Verdict: "Suit Against Infants' Tylenol Gets $5 Million Verdict
Gina Passarella
The Legal Intelligencer
August 7, 2006
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A wrongful death action filed by the family of a dead 1-year-old against the makers of Infants' Tylenol resulted in a $5 million verdict from a Philadelphia jury last month.
A. Roy DeCaro and David F. Binder of Raynes McCarty represented the family of a 1-year-old child who plaintiffs claimed died from acetaminophen toxicity after being given dosages of the concentrated over-the-counter drug for three days. "

Law.com - Federal Judge Rules Tobacco Firms Deceived Smokers and Violated Racketeering Laws: "Federal Judge Rules Tobacco Firms Deceived Smokers and Violated Racketeering Laws
The Associated Press
August 18, 2006
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A federal judge ruled Thursday that the nation's top cigarette makers violated racketeering laws, deceiving the public for years about the health hazards of smoking, but said she couldn't order them to pay the billions of dollars the government had sought.
Judge Gladys Kessler of the U.S. District Court for the District of Columbia did order the companies to publish in newspapers and on their Web sites 'corrective statements' on the adverse health effects and addictiveness of smoking and nicotine.
She also ordered tobacco companies to stop labeling cigarettes as 'low tar,' 'light,' 'ultra light' or 'mild,' since such cigarettes have been found to be no safer than others because of how people smoke them. "

Placitella comment: this is a judge like former judge Lee Sarokin of principal and conviction.

Judge Higbee overturns Vioxx verdict

State Judge Vacates Jury Verdict in N.J. Vioxx Case ATLANTIC CITY, N.J. -- A New Jersey state judge has vacated a jury verdict for Merck & Co. Inc. and ordered a new trial for a postal worker who blamed his heart attack on his two-month use of Vioxx. Judge Higbee said that evidence uncovered since the Nov. 3, 2005, verdict showed that Merck failed to report material cardiovascular safety data connecting increased risk of heart attack with use of Vioxx for less than 18 months, according to Seeger Weiss.

Federal Jury Finds Merck Failed to Warn of Vioxx Risks NEW ORLEANS -- A federal jury has awarded $50 million in compensatory damages to a retired FBI agent who suffered a non-fatal heart attack in 2002 after taking Vioxx for 31 months. In Re: Vioxx Products Liability Litigation, MDL No. 1657 (E.D. La.).

The jury then retired to consider the punitive damage claim. The punitive damage claim was upheld with an additional $1 million award. This is the third punitive damage finding by a jury in less than one year.

New Jersey Supreme Court protects consumer rights to bring class actions

The Rehoboth case was published this week. The case stands for the proposition that waivers of class action rights are unenforceable contracts of adhesion. This is a great case for consumers and the public health in general. The New Jersey Supreme Court continues to be on the forfront of consumer protection.

Bush action declared unconstitutional

Today's historic opinion by Judge Anna Diggs Taylor Declaring Unconstitutional the Bush & NSA's Surveillance Program The opinion contains very strong criticisms of Bush's blatant violations of the 4th & 1st Amendments, the Separation of Powers, and FISA, among other things. The opinion appears to grant the injunctive relief plaintiffs request enjoining the surveillance program's continuation.

20. Some 550 Suits Target Boston Scientific Over Guidant Heart Devices
"Boston Scientific Corp. now faces about 550 individual and class-action lawsuits related to problems with Guidant heart devices that became public last year, according to a Boston Scientific regulatory filing. Boston Scientific, a Natick, Mass., medical-device maker, acquired Guidant in April for about $27.5 billion.

Placitella comment,

The number of cases being filed are increasing every month as news travels amongst the patient population. It is impossible at this point to estimate where this litigation is going.

Evelyn Pringle: Lawsuits Multiply For Johnson & Johnson�s Charite Spine Disc: "Lawsuits Multiply For Johnson & Johnson�s Charite Spine Disc
Evelyn Pringle

According to the Institute of Medicine, over a million Americans are severely injured each year by medical devices. In 2002 alone, the FDA received more than 111,000 reports of adverse events involving medical devices.
That number has increased since the Charite artificial spinal disc was approved for use in the US in October 2004. As of July 2006, there have been more than 130 serious adverse events reported to the FDA associated with its use.
Examples of the serious adverse events include: migration of the artificial disc resulting in either removal of the disc or maintaining the disc, both followed by fusion; pedicle fractures; subsidence or a settling of the disc into the bone; and nicking of an vein or artery.

Placitella comment:

Dozens of cases have already been filed. This litigation is being watched closely by consumer advocates and attorneys.

Asbestos Case Nets $10.3 Million Verdict
Pam SmithThe RecorderAugust 10, 2006
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Image: Comstock Images
A San Francisco Superior Court jury awarded $10.3 million in economic and non-economic damages Monday in an asbestos case brought by a 60-year-old man allegedly suffering from mesothelioma.

Placitella comment

Unfortunately the plaintiff will not see most of that verdict. The case was tried against one remaining defendant and the court will subtract the responsibility of the other defendants. Thus what would appear to be an extremely large payment of the plaintiffs in reality will not be.

Is the weather Cooling For Merck

In the event you have not heard, the following is a news account of Vioxx verdict in California. Everyone watching the trial, including hopeful plaintiffs lawyers, predicted the loss. According to one lawyer who has been attending the trial and keeping me up-to-date in his report yesterday stated "it will be a miracle if the plaintiff wins as even I was not convinced of the Vioxx usage on anything more than an as needed basis."

Keep the faith. There will be many 100° days for Merck in the future.

Chris


Merck Wins Vioxx Trial in L.A.

A jury concludes that the painkiller didn't cause a Northridge man's heart attack.
By Lisa Girion, Times Staff WriterAugust 3, 2006
A Los Angeles County jury cleared Merck & Co. of liability for a Northridge man's heart attack, in the first Vioxx case to go to trial in California.The jury concluded that Stewart Grossberg, a retired construction manager, failed to prove that the blockbuster painkiller was responsible for his heart problems.
ADVERTISEMENTThe verdict, which is Merck's fifth win in eight Vioxx trials, was seen as important for the company because it came in Central Civil West, a courthouse known as "The Bank" for its record of granting huge awards in product liability cases.The plaintiff's loss in "a notoriously favorable jurisdiction [is] going to make the plaintiffs' lawyers lower their sights for settlement and discourage the appetite for trial," said David Berg, founding partner of a Houston law firm and author of "The Trial Lawyer: What It Takes to Win."Still, because Grossberg's case was considered weak, legal experts viewed the verdict as only a qualified victory for the nation's fourth-largest drug maker. Vioxx plaintiffs' lawyers vowed to continue the fight."There's a lot of cases stacked up after this one," said Brian Katabek, a Los Angeles lawyer who was not involved in the trial but who represents plaintiffs on a statewide Vioxx litigation steering committee.Merck faces more than 16,000 suits nationwide, including about 2,500 in California under L.A. County Superior Court Judge Victoria Chaney.Thomas Yoo, a lawyer and spokesman for Merck's trial team, said the verdict vindicated the company's position that it "acted appropriately in providing information to the medical, scientific and regulatory communities.""We firmly believed that Vioxx was not the cause of this heart attack because the data do not support that infrequent, sporadic use of Vioxx contributes to heart attacks," Yoo said. "At the end of the day, the fact remains that the plaintiff was at high risk for a heart attack regardless of whether he was taking Vioxx."Merck may have a winning trial record, but a handful of plaintiffs have been awarded about $300 million. The biggest share — $253 million — went to Carol Ernst, a Texas woman who blamed Vioxx for the death of her triathlete husband from heart problems. Even if Merck's appeals fail in those cases, damage caps are expected to reduce the awards to less than $50 million.Analysts have estimated that the company could pay as much as $50 billion in judgments, settlements and other litigation costs associated with Vioxx. Merck sold more than $9 billion worth of the drug before pulling it from the market in 2004 after a study found that it increased the risk of heart attacks.Merck stock rose 21 cents to $41.03 on Wednesday. The verdict was announced after the markets closed.It followed a Merck win in July when a New Jersey jury blamed other risk factors for 68-year-old Elaine Doherty's heart attack. Wednesday's win should reinforce the company's stated plan to take every case to trial, lawyers said."Coming on the heels of the defense verdict last month in New Jersey, the tide is slowly turning in Merck's favor," said Peter Bicks, a New York corporate defense lawyer. "The company's strategy of making the plaintiffs prove their case in court is paying off."Northridge resident Grossberg blamed Vioxx, which he took for arthritis pain, for a heart attack he suffered in 2001 at age 66 as well as subsequent medical problems. Like other plaintiffs, he alleged that, despite red flags that the drug could cause serious cardiovascular harm, Merck sought expedited government approval to sell Vioxx and designed a study to deceive the medical community about its safety.Lawyers for Grossberg also argued that Merck documents showed that after its study confirmed Vioxx raised users' risk of heart problems, the company failed to warn patients and physicians and instead mounted an aggressive marketing campaign to blunt any concern.Merck's lawyers contended that Grossberg's other medical problems, including atherosclerosis, predated his use of Vioxx, and that he used the drug only intermittently. After a five-week trial, it took the jury less than a day to decide that Vioxx did not cause Grossberg's heart attack. Jurors also concluded that the New Jersey-based drug maker was not negligent and did not conceal information."We didn't feel that a case was ever made that there is a connection between Vioxx and heart attacks," jury foreman Charles Sullenger said. "In the end it simply boiled down to the burden of proof was not met, in our opinion."Legal experts said the verdict bodes poorly for plaintiffs like Grossberg who used Vioxx sporadically or for a short time, and were in less-than-perfect health when they had a heart attack.But, they said, the verdict should not hurt the cases of once-fit plaintiffs who can demonstrate longer use of the drug. The company has not said how many of the suits involve long-term use.Another Vioxx trial got underway this week in New Orleans in a suit brought by a 62-year-old former FBI agent

Thousands of Recalled Firestone Tires Still on the Road
As Many As 200,000 of the Infamous Firestone Tires Were Missed in Original Recall Effort Putting Lives at Risk
Quote of the week
"I had no idea how dangerous that tire was. ...The treads peeled completely off the tire, my car went out of control. My son didn't even have a chance." - Linda Scudera, mother of Anthony Scudera, who was killed when his Firestone tire blew out, causing the Ford Explorer that he was driving to roll over.
News & Research
Firestone/Ford: A Case Study; How the Civil Justice System Uncovers the Truth for Consumers
Firestone/Ford: Tire Recall Timeline
"Firestone Still Trying to Recall 200,000 Tires Linked to Deaths," Associated Press
"Concerns go back 1 1/2 years before recall," USA Today
Anthony Scudera Killed After a Defective Firestone Tire - Missed in Original Recall - Blows Out on Florida Interstate