FDA Requires Suicide Warnings for Chantix and Zyban

Written On July 2, 2009 By Bob Kraft

NBC Nightly News (7/1, story 6, 0:30, Williams) reported, “The FDA says patients taking Chantix [varenicline] and Zyban [bupropion] should be watched closely for any signs of mental illness. There have been a growing number of reports of suicide, among patients who take the drugs.” Regulators stressed, however, that the agency “is not trying to scare people away from the medicines because, as they put it, quitting is the most important thing.”

The New York Times reports that Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration, said, “Stopping smoking is a goal we should all be working towards,” adding that patients “should just be careful.” Chantix-maker Pfizer “will add a so-called black box warning” to the drug’s “packaging information.” GlaxoSmithKline, Zyban’s maker, will also “expand its existing black box warning on Wellbutrin [bupropion], citing suicidal thoughts by patients who use it for depression, to include Zyban.”

The Wall Street Journal reports that both Pfizer and Glaxo claim “there is no evidence that their drugs actually cause suicides or mood swings.”

From the American Association for Justice news release.

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CDC Releases New E. Coli Figures

Written On July 2, 2009 By Bob Kraft

CNN International reports, “The toll of the nationwide E. coli outbreak linked to tainted cookie dough has continued to mount, federal health authorities said Tuesday.” So far, the CDC said, “Seventy-two people infected with a strain of E. coli O157:H7 with a particular DNA fingerprint have been reported from 30 states,” and 51 “have been confirmed as having the outbreak strain; confirmation was pending on the others.”

In the Wall Street Journal Health Blog, Shirley Wang writes, “This is the same plant that refused to give FDA inspectors access to certain records in the past.” Also it is “still a mystery” how the E. coli “ended up in the product.” Normally, “the concern with eating raw cookie dough usually is…salmonella since it can be found in raw eggs.”

From the American Association for Justice news release.

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FDA Panel Recommends Smaller Acetaminophen Doses, Painkiller Bans

Written On July 1, 2009 By Bob Kraft

The CBS Evening News (4/30, lead story, 3:05, Couric) reported, “An FDA panel recommended today that prescription Vicodin [hydrocodone bitartrate and acetaminophen] and Percocet [oxycodone and acetaminophen] be banned, and that over-the-counter Tylenol, Excedrin, Nyquil, and Theraflu contain stronger warning labels…The problem, according to FDA advisors, is that they all contain acetaminophen, which can cause liver damage.”

The FDA “panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect,” the New York Times reports in a front-page story. “The two drugs combine a narcotic with acetaminophen,” and the panel’s vote to “recommend a ban on the combination drugs was one of 11 it took” at the meeting. The experts also recommended “that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills…to 325 milligrams, from 500,” and “to reduce the maximum daily dosage to less than 4,000 milligrams.”

The Wall Street Journal notes that the panel “of 37 doctors, pharmacists, and researchers voted on the recommendations Tuesday after spending two days discussing steps the FDA should take to reduce the number of acetaminophen overdoses.” Gerald Dal Pan, director of the FDA’s office of drug surveillance, said, “Whatever we do on any of these options, it will really affect the whole healthcare system.” The agency also noted that the recommendation to pull “from the market a number of prescription products” may “affect 240 pending drug applications.”

“But some on the panel opposed a sweeping withdraw of” prescription acetaminophen combination drugs “that are widely used to control severe, chronic pain,” the AP reports. The panel decided that “if the drugs stay on the market, they should carry a black box warning, the most serious safety label available.” Notably, “drug companies avoided the most damaging potential outcome with the defeat of [a] proposal to pull NyQuil and other over-the-counter cold and cough medicines that combine acetaminophen with other drugs.”

From the American Association for Justice news release.

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Mothers Push for Singulair “Black Box” Warning

Written On June 30, 2009 By Bob Kraft

The Cleveland Plain Dealer reported that the FDA “recently told the makers of Singulair and three less widely used asthma drugs — Accolate, Zyflo and Zyflo CR — that the drugs’ labels must list a dozen mood and behavior changes as possible side effects.” The article focuses on a group of mothers who had pushed for the warning. “The group’s goal now is to get a ‘black box’ warning for Singulair.”

From the American Association for Justice news release.

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GM Agrees to Take Responsibility for Future Liability Claims

Written On June 29, 2009 By Bob Kraft

The AP reported General Motors “has agreed to take on responsibility for future product liability claims, removing what could have been a sizable roadblock” on the company’s way to a “quick sale of its assets” and emergence from bankruptcy. GM “wants to sell the bulk of its assets to a new company and leave behind unprofitable assets and other liabilities such as product-related lawsuits.” But in a “concession to consumer groups and state officials who had threatened to block the sale because of product liability concerns, the new company will now assume responsibility for future claims involving vehicles made by the old company.”

The Wall Street Journal reports that the agreement “represents a partial victory for more than a dozen state attorneys general and several consumer-advocacy groups.”

The Washington Post reports, “Those with past claims would have to pursue the GM left behind in bankruptcy with nothing but unwanted assets, debts and other liabilities. That means these consumers are likely to recover little, if anything.” On Friday “Rep. André Carson (D-Ind.) introduced legislation that would require automakers to purchase liability insurance if they are owned by the federal government or have federal loans. This insurance must protect against past and future claims, even after a bankruptcy filing.

From the American Association for Justice news release.

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Reports Indicate Nestle Plant Denied FDA Requests During Previous Inspections

Written On June 26, 2009 By Bob Kraft

The Wall Street Journal reports, “The Nestle USA plant at the center of a federal probe into an E. coli outbreak involving cookie dough refused to give inspectors access to pest-control records, environmental-testing programs and other information, according to newly released inspection reports covering the past five years.” Among other things, the documents show that in September 2006, “managers at the Danville, Va., plant refused to allow a Food and Drug Administration inspector to review consumer complaints or inspect its program designed to prevent food contamination.” One year prior to that inspection, “officials at the Nestle plant presented another FDA inspector with a list of things it wouldn’t do,” including “review the firm’s consumer complaint file,” allow photography, “sign affidavits or receipts and…provide specific information on interstate commerce.”

From the American Association for Justice news release.

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Friday Fun

Written On June 26, 2009 By Bob Kraft

I love the Jaywalking segment of Jay Leno’s now-former Tonight Show. That’s one of the few times when I can feel intellectually superior to other people!

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Matrixx Recalls Zicam Nasal Cold Products

Written On June 25, 2009 By Bob Kraft

The Associated Press is reporting that Matrixx Initiatives Inc. has started the recall of Zicam nasal cold remedies. Here are excerpts from the article:

Matrixx Initiatives Inc. said Wednesday it started a previously announced recall of Zicam nasal cold remedies following last week’s Food and Drug Administration warning that the products were unsafe.

Meanwhile, the company is being investigated by the Securities and Exchange Commission over the FDA warning letter.

The Scottsdale, Ariz., company said the recall was voluntary. Still, it occurred as the FDA warned consumers to not use the nasal cold remedies due to hundreds of reports of patients losing their sense of smell. Matrixx said it disagrees with the FDA’s safety warning, but “voluntarily” recalled the product to cooperate with the regulatory agency.

The FDA also alleges the products were unlawfully marketed. Matrixx also disagrees with that allegation.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, though it maintains the nasal spray does not harm users’ sense of smell.

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Schumer to Introduce Veterans’ Malpractice Bill in Senate

Written On June 25, 2009 By Bob Kraft

New York state’s Times Herald-Record reports, “Sen. Charles E. Schumer announced Wednesday he is introducing the Carmelo Rodriguez Military Medical Accountability Act, which will give military service members the right to pursue civil actions against the military for medical negligence experienced while receiving treatment for injuries unrelated to their service.”

From the American Association for Justice news release.

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Seventy Cookie Dough E. Coli Cases Reported in Thirty States

Written On June 24, 2009 By Bob Kraft

KWTX-TV Waco, TX reports, “Seventy people in 30 states have been infected with a strain of E. coli O157:H7 and 41 of those cases have been linked to an outbreak associated with eating raw prepackaged cookie dough, including three in Texas.” According to the CDC, “most of the patients reported eating refrigerated prepackaged Nestle Toll House cookie dough products raw.” So far, “the FDA has received no reports of deaths associated with the products.”

The Dallas Morning News points out that “the FDA and CDC are warning people to not eat any varieties of prepackaged Nestlé Toll House refrigerated cookie dough because they may be linked to an outbreak of E. coli. Nestlé has voluntarily recalled all of these Nestlé Toll House refrigerated cookie dough products and advises that you should either throw them away or return them to your grocery store for a refund.”

KGO-TV San Francisco reports, “San Carlos teenager filed a lawsuit against food-giant Nestle on Monday, saying she became horribly ill after eating raw cookie dough. The FDA is investigating whether the dough is contaminated with E. coli bacteria. Nestle has already issued a recall.”

USA Today adds, “Theories on how E. coli got into the dough include cross-contamination or a sick worker,” the FDA’s Acheson says. But “for this particular bug, it doesn’t take many (bacteria) to make you sick; 10 to 100 is enough.”

From the American Association for Justice news release.

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Some Physicians Fail To Inform Patients About Abnormal Test Results

Written On June 23, 2009 By Bob Kraft

The CBS Evening News (6/22, story 8, 2:00, Couric) reported that “no one wants to hear bad news from their doctor, but a” new “report…says keeping patients in the dark about abnormal test results is happening with much more frequency.”

NBC Nightly News (6/22, story 4, 2:30, Williams) reported that the study suggests “that one out of every 14 times doctors fail to share abnormal test results with their patients.”

The New York Times reports that investigators “reviewed the records of 5,434 patients at 19 independent primary care practices and four based in academic medical centers.” The researchers “extracted records that contained abnormal results for blood tests or X-rays and other imaging studies, and then searched for documentation that the patient had been properly informed of the problem in a timely way.” According to the Times, “after accounting for” several “ambiguous cases, the researchers found that of 1,889 abnormal results, there were 135 failures to inform.”

The AP reported that the study, published in the Archives of Internal Medicine, found that “few medical practices had explicit methods for how to tell patients, leaving each doctor to come up with a system.”

HealthDay reported that while “the study found no difference in failure rates between facilities that relied exclusively on paper records and those that used only electronic filings, medical practices that used a hybrid of paper and electronic record-keeping had the highest failure rates.”

From the American Association for Justice news release.

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Report: Counsel Without Malpractice Insurance Should Tell Clients

Written On June 22, 2009 By Bob Kraft

The Texas Lawyer reports that the Grievance Oversight Committee, which is appointed by the Texas Supreme Court, recently recommended that the court adopt a rule requiring lawyers who do not carry legal malpractice insurance to disclose their lack of coverage to clients.

This has been a controversial issue for several years in Texas. Personally, I’ve had malpractice insurance since I began practice, so a decision either way won’t affect me. There are interesting arguments both for and against, and I’m sure there will be many voices heard in the next few weeks. Here is the beginning of the article:

In June 2008, the State Bar of Texas board of directors balked at taking a position on whether to require lawyers to disclose whether they have professional liability insurance coverage after a Bar task force that studied the issue voted 6-5 against recommending such a rule. The task force took that vote in May 2008.

But the State Bar may have to take another look at the issue. In its June 1 report to the Supreme Court, the oversight committee recommended that the high court direct the State Bar to implement a rule requiring a lawyer in private practice, when engaged by a client, to inform the client in writing if the lawyer does not have professional liability coverage with limits acceptable to the Bar — for instance, insurance in the amount of at least $100,000 per claim and $300,000 in the aggregate. The committee further recommended that, if an attorney’s insurance lapses or is terminated during the representation, he or she notify the client of that fact.

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USA Today: Lawyers and Doctors Must Compromise on Malpractice

Written On June 22, 2009 By Bob Kraft

USA Today says in an editorial that the “only thing” trial lawyers and doctors “have in common” on medical malpractice “is that they’re both wrong. Doctors overestimate the degree to which lawsuits drive up medical costs (malpractice costs account for less than 2% of all health care spending, according to the Congressional Budget Office). Lawyers underestimate the degree to which even a few outsized verdicts spread fear and influence doctors’ behavior.” Unless “doctors and lawyers move from the extremes of the malpractice debate, the public will be denied what it wants most a reduction in the medical errors that occur all too often.”

From the American Association for Justice news release.

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State Farm’s Rate Case Mocks Texas Insurance Regulation

Written On June 21, 2009 By Bob Kraft

No additional comment is necessary about this editorial from the Dallas Morning News today:

State Farm is masterful at working the legal system. For six years, it has danced in and out of court to thwart the Texas insurance department’s order to refund millions to policyholders in alleged overcharges.

State Farm says it has done nothing wrong and owes nothing. However, the Office of Public Insurance Counsel, a state-funded advocate for consumers, pegs the refund at about $1 billion. The state insurance department’s staff, whose commissioner, Mike Geeslin, eventually will decide who’s right, puts the cost at $350 million.

Consumers are right to find this galling. State Farm collects premiums and conducts business as usual while policyholders continue to wait for expected refunds.

One wonders whether there is any real accountability for a big insurance company when its rates are called into question. Before insurance reform a few years ago, insurers complained of lengthy regulator reviews that prevented them from charging new rates in a timely fashion. So lawmakers loosened the reins and set up an appeals system that they thought insurers would accept in good faith. Instead, the result is marathon stonewalling.

State Farm’s action is a blatant challenge to the state’s authority to regulate rates. If the company prevails, no other major insurer whose rates are called into question will ever again settle outside a courtroom. For instance, Farmers Insurance recently filed for a rate hike. Anyone believe that if its rate request is rejected, Farmers will roll over quietly?

Gov. Rick Perry is expected to call lawmakers back into a special session to decide the future of the Texas Department of Insurance, which wasn’t reauthorized during the just-completed regular session. In addition to that work, lawmakers should fix this unfair review process.

State Farm policyholders certainly are free to take their business elsewhere, which could do more to promote insurance competition than any measure regulators would demand. But shopping around now doesn’t provide those policyholders with satisfaction or refunds.

This is a mockery, and it must end.

Posted in Insurance Company or Government Misconduct Comments (0)

Matrixx Withheld 800 Zicam Consumer Complaints From FDA

Written On June 19, 2009 By Bob Kraft

Bloomberg News reports, “Matrixx Initiatives Inc. said today it didn’t turn over to US regulators 800 consumer complaints about side effects linked to its withdrawn Zicam nasal spray and swabs.” The company halted sales of “the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell.” The agency “found 800 reports of consumer concerns in May during a routine inspection,” according to William Hemelt, acting president and chief operating officer of Matrixx. He added that “he was told by lawyers that a 2007 regulation requiring companies to turn over reports of serious side effects didn’t apply to the complaints received by Matrixx.”

Dow Jones Newswires reports that the company “is defending its Zicam cold and allergy products,” seeking “to meet with the agency to discuss the scientific data concerning the products and the safety concerns the FDA raised.” Hemelt said, “We are hopeful that if we can tell our story to the FDA, that maybe we can get them to change their mind.” He commented that “the safety concerns are ‘erroneous’ and said that the agency made no effort to communicate its concerns with the company prior to this week.”

From the American Association for Justice news release.

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Friday Fun

Written On June 19, 2009 By Bob Kraft

OK, this site isn’t really fun, but it could be helpful, and it does relate to fun things like vacations.

Onebag.com is “packed” full of tips for traveling light, or at least lighter. Speaking as the world’s worst packer, I can tell you that this site will help you lighten your load on vacations or business trips. If you have trouble going on an overnight trip without taking four suitcases, check it out.

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Reports Indicate At Least 843 Homeopathic Ingredients Linked To Side Effects

Written On June 18, 2009 By Bob Kraft

The AP reported, “Zicam and hundreds of other homeopathic remedies – highly diluted drugs made from natural ingredients – are legally sold as treatments with explicit claims of medical benefit.” These products “don’t require federal checks for safety, effectiveness, or even the right ingredients,” but “many scientists view homeopathic remedies as…mostly harmless because the drugs in them are present in such tiny amounts.” One analysis, however, “found that more than 800 homeopathic ingredients were potentially implicated in health problems last year.” And, although “the FDA has set strict limits for alcohol in medicine, especially for small children…they don’t apply to homeopathic remedies.”

From the American Association for Justice news release.

Posted in Consumer Information, Product Liability or Medical Devices Comments (2)

FDA Warns Against Use of Zicam Nasal Spray and Swabs

Written On June 17, 2009 By Bob Kraft

ABC World News (6/16, story 5, 2:05, Stephanopoulos) reported, “The Food and Drug Administration today told the makers of one of the country’s most popular cold medications, Zicam, to stop selling its nasal spray and swabs. In the last ten years, about 130 consumers have filed complaints, saying they permanently lost their sense of smell after using Zicam.”

The CBS Evening News (6/16, story 6, 1:30, Ashton) reported that “the FDA is not responsible to regulate” the safety of products like Zicam, “an over-the-counter remedy containing some natural ingredients” before it “comes to market,” but the agency is “responsible to regulate its safety after it’s been on the shelf.” NBC Nightly News (12/6, story 4, 0:25, Williams) added that Zicam manufacturer Matrixx “has suspended shipments of the products, but says the warning is not supported by scientific evidence and is asking the FDA for a review.”

Wall Street Journal reports that William Hemelt, Matrixx’s acting president and chief operating officer, said, “This isn’t a new issue for us. We’ve certainly studied it for many years, and we think our products are safe.” The agency warned against the use of “nasal zinc-containing products, which are sold as Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs.” Regulators “also warned against Zicam Cold Remedy Swabs, Kids Size.” But, “the FDA’s action doesn’t affect other Zicam products.”

Commenting on the products, Dr. Margaret Hamburg, FDA commissioner, “said the incidence of anosmia associated with Zicam ’strikes us as a fairly large problem,’” the New York Times reports. The company “paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell” in 2006, and “hundreds more such suits have since been filed.”

The Los Angeles Times reports that the company will be required to “receive FDA approval” if it “wants to market the products in the future,” Deborah Autor, director of compliance for the FDA’s Center for Drug Evaluation and Research, explained. The company may have received 800 reports “of anosmia…associated with the use of the products from doctors and consumers,” but has failed to “forward such reports to the FDA.” Autor said that the agency has “asked Matrixx to provide” regulators with the reports.

The AP reports that the company said “it will consider withdrawing the products.” Meanwhile, “government scientists say they are unaware of any data supporting Zicam’s labeling, which claims the drug reduces cold symptoms, including ’sore throat, stuffy nose, sneezing, coughing and congestion.’”

From the American Association for Justice news release.

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Wolfgang Puck Toaster Ovens Recalled Over Fire Hazard

Written On June 16, 2009 By Bob Kraft

From the Web site of the U.S. Consumer Product Safety Commission:

The following product safety recall was voluntarily conducted by the firm in cooperation with the CPSC. Consumers should stop using the product immediately unless otherwise instructed.

Name of Product: Wolfgang Puck Toaster Oven/Toasters

Units: About 1,500

Importer: Frontgate of West Chester, Ohio

Manufacturer: Kingpower Electrical Appliances of China

Hazard: The toaster oven can remain “on” after the toast pops up, posing a fire hazard.

Incidents/Injuries: The firm has received three reports of the toaster remaining on after the toast popped up. No injuries have been reported.

Description: The recalled toasters have model number WPTOT010 and date code 3608 or 3908 on an Underwriters Laboratories (UL) label, which is affixed to the back of the unit. The black and silver toasters have “Wolfgang Puck” stamped on the lower front right corner. They feature a silver handle on the oven door, three black knobs for controlling cooking, and a black push-down lever for toasting. Two slots for toasting bread and similar products are located on the top of the toaster. Toasters with model number BTOT0010 or WPTOT010 and date codes 0207, 0407, 0607, 0807, 4508, or 0309 are not included in this recall.

Sold by: Frontgate catalogs nationwide from November 2008 through March 2009 for about $100.

Manufactured in: China

Remedy: Consumers should stop using the recalled toaster/toaster ovens immediately and contact W.P. Appliances for instructions on returning the toaster/toaster ovens for a free replacement. All known purchasers have been notified directly by mail.

Consumer Contact: For additional information, contact W.P. Appliances toll-free at (800) 275-8273 between 8:30 a.m. and 8 p.m. Monday through Friday, and Saturday 9 a.m. to 5:30 p.m., or e-mail the firm at ovenrec@wphousewares.com.

Picture of Recalled toaster oven

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AMA to Consider Whether to Adopt “Bare Below the Elbows” Dress Code

Written On June 15, 2009 By Bob Kraft

Oh great, one more thing to worry about when you go to the hospital – germs on the sleeves of your doctor. The Wall Street Journal Health Blog reports that the American Medical Association is going to consider recommending a new dress code for hospitals, and it will be “bare below the elbows.” Here are excerpts:

One of the policy questions that AMA delegates will consider at their annual conference next week is whether doctors should forgo their iconic white coats for something a little more casual — and a little less dangerous for patients. The measure would urge hospitals to adopt dress codes of “bare below the elbows,” to avoid carrying bacteria between patients via coat sleeves.

According to the CDC, nearly 100,000 U.S. patients died in 2002 from infections contracted in hospitals. There has been no conclusive evidence linking infected cuffs to any of these deaths — studies have been done showing that bacteria like MRSA and C. difficile exist on sleeves, but there’s no proof that those germs actually get passed around that way. But backers of the change in dress code argue that as long as there’s the slightest potential of transmission, everything possible should be done to avoid it.

The British National Health System has already adopted a policy, banning ties, long sleeves, jewelry and white coats, as the BBC reported. Scotland went so far as to establish a uniform dress code that includes a short-sleeve requirement.

One irony, notes the BBC, is that the spanking white coat was borrowed from lab scientists and introduced in hospitals in the 19th century in part to help prevent the spread of contamination.

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