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Archive for September, 2010

Amgen recalls anemia drugs Epogen, Procrit due to glass flakes

September 27, 2010

The Wall Street Journal (9/27, Gryta) reports Amgen Inc. has recalled some lots of anemia drugs Epogen [epoetin alfa] and Procrit. The drugs sold by Johnson & Johnson have been recalled due to concerns they may contain glass flakes that are very thin. Amgen said the issue came about as a result of the interaction of the medications with glass vials. To avoid the problem in the future, Amgen will limit the shelf life of the drugs to 12 months, from 36 months, for single-dose vials and 15 months for multiple-dose vials. J&J spokeswoman Lisa Vaga said the company will do “everything we can to ensure customers and patients continue to have access to” Epogen and Procrit.
According to the AP (9/24, Johnson), the “glass flakes…could cause blood clots, swelling of veins, immune system reactions and other problems.” The company said “the flakes are barely visible in most cases, and they have fielded no complaints or reports about problems that can be directly tied to them.” Amgen said “the flakes are caused by the interaction of the drug with glass vials over the product’s shelf life.”
Bloomberg News (9/27, Randall, Waters) reports, “Epogen is Amgen’s fourth-best-selling product, with $2.57 billion in sales last year.” Procrit “brought in $2.25 billion for J&J, which licenses the drug from manufacturer Amgen.” The drugs “are used to stimulate red blood cells in patients with anemia caused by HIV treatment, chronic renal failure or chemotherapy.” The “recalled lots were old and the glass flakes, known as lamellae, developed as a result of long-term interaction between glass storage vials and the drug.”
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Avandia Restricted

September 23, 2010

If you have Diabetes or know someone who has the disease, you’ll want to read this announcement about Avandia. The New York Times reported that in a highly unusual coordinated announcement, drug regulators in Europe and the United States said Thursday that Avandia, the controversial diabetes medicine, would no longer be widely available.The drug’s sales will be suspended entirely in Europe, while patients in the United States will be allowed access to the medicine only if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of the drug’s substantial risks to the heart. Patients now taking Avandia may continue to do so.

Abbott Announces Similac infant formula recall

September 23, 2010


Parents, please take note…
The CBS Evening News (9/22, story 7, 0:15, Couric) reported, “There’s a new food recall today, the makers of Similac are voluntarily recalling five million containers of powdered baby formula across the US, Guam and the Caribbean. Some were found to contain insects.”
The Chicago Tribune (9/23), citing Abbott, says “the recall comes after reports by two consumers of contamination and an internal quality review of an area of the plant in Sturgis, Mich., where beetles or their larvae were found.” The “recalled products involve powdered Similac in plastic containers, and in 8-ounce, 12.4-ounce and 12.9-ounce cans.”
The Wall Street Journal (9/23, Rockoff) says a company spokeswoman said Abbott expects to record lost sales of $100 million in the third quarter because of the recall. The AP (9/23, Perrone) also covers the story.


Former FDA official urges agency to look into LASIK

September 23, 2010


On its website, ABC News (9/22, Carollo) reported, “A former Food and Drug Administration official who helped get the vision correction surgery LASIK approved back in the 1990s but later spoke out against the procedure is taking his concerns directly to current regulators at the FDA.” Yesterday, “Morris Waxler, who is now an independent regulatory consultant, filed a citizen’s petition…urging the agency to take steps to stop what he calls ‘the epidemic of permanent vision problems’ caused by LASIK.”
According to “Waxler’s analysis of FDA data, half of LASIK patients experience side effects, and more than a third continue to need glasses or contacts,” ABC World News (9/22, story 6, 1:55, Sawyer) reported. After being asked if he “would you ever recommend LASIK to somebody” he cares about, “knowing what” he “knows now,” Dr. Waxler replied, “No, absolutely not.” While the “industry counters that most LASIK side effects are minor or temporary, and that complications are much lower with today’s modern LASIK,” the agency nevertheless is “now reviewing the procedure.”

Chuck E. Cheese Recalls Light-up Rings Due To Ingestion Hazard

September 20, 2010

Parents, nothing against Chuck E. Cheese, but if you’ve taken your kids there recently, then you need to read this.

In cooperation with the U.S. Consumer Product Safety Commission and Health Canada, CEC Entertainment, Inc., of Irving, Texas, is voluntarily recalling about 1,100,000 Light-up Rings and 120,000 Star Glasses. If crushed or pulled apart, the plastic casing can break into small pieces and possibly expose the batteries, posing an ingestion hazard to children. If ingested, the batteries may be damaging to either the stomach, intestine, esophagus or nasal mucus membrane.

NYTimes urges Senate to act on Paycheck Fairness Act

September 20, 2010


The New York Times (9/20) editorializes that annual earnings data released last Thursday by the Census Bureau show that “full-time women employees still make, on average, only 77 cents for every dollar earned by men,” confirming “a lingering gender gap that depresses women’s pay by thousands of dollars,” which “poses an immediate challenge for the Senate, where important legislation aimed at combating gender-based wage discrimination now hangs in the balance” the Paycheck Fairness Act. According to the Times, “with scant time remaining in the Congressional session, the Senate must act quickly to pass the bill or it will die.”


FDA begins review of Actos drug injury reports

September 20, 2010


If you take Actos for diabetes, read this.
The Wall Street Journal (9/20, Dooren) reports that on Sept. 17, the Food and Drug Administration has begun a safety review of the  Actos drug injury reports that have been made, examining possible links between longer term exposure to the drug and an increased risk for bladder cancer.“The agency said Friday that five-year results from an ongoing study show that patients who have taken Actos for the longest period of time had a higher risk of bladder cancer,” the AP (9/18, Perrone) reported. “Bladder cancer was also more prevalent in patients who had taken the largest cumulative dose of the drug.”

No link between new Pampers diapers, rashes

September 18, 2010


Parents, you may want to keep an eye out for this if you use New Pampers. The AP (9/2) reported that The US Consumer Product Safety Commission and Health Canada  haven’t yet found a link between Pampers Dry Max diapers and some babies’ unusually severe diaper rash. Claims that the new version of Procter & Gamble’s biggest-selling brand can cause severe rashes triggered lawsuits as well as the government probes. CPSC says it cannot rule out that some babies may react differently to the new product, especially those who are sensitive to materials in Dry Max.

Medical errors cost $19.5 Billion

September 15, 2010


The Kansas City Business Journal (9/13, Van Dyke) reports, “Even as medicine has advanced, the number of medical errors – conditions and injuries obtained in the hospital – has hovered around 1 million a year. These errors cost the system, especially hospitals, billions of dollars a year.” A study “published this year by the Society of Actuaries” estimated “that hospitals had more than 1.5 million medical errors in 2008, with the hefty price tag of $19.5 billion.”
If you feel you have been the victim of a medical error, talk to your attorney. You can Ask Marvin Lundy any questions at no cost to you.


Dietary Supplement Risk Prompts Investigation By U.S. Health Regulators

September 15, 2010


The Associated Press (9/14, Perrone) reports that “Almost a year after studies showed the diet pill Meridia [sibutramine] increases heart attack and stroke risk, US health regulators announced they will consider pulling the Abbott Laboratories’ drug off the market.”
Do you use this dietary supplement? If so data “released in November showed patients with heart disease taking the drug had a more than 11 percent risk of cardiovascular risks compared with 10 percent of those taking a placebo. European regulators have already pulled the product off the market in January.” The FDA “said Monday that it is considering a range of options for the drug, including simply adding more warning labels,” and on Wednesday “an outside panel of experts will weigh in on the course of action FDA should take.”
Talk to your doctor to make sure you aren’t facing a dietary supplement risk from products you’re using. Also, contact your attorney to find out your options. Have a question? Ask Marvin Lundy at