A federal investigation into the relationship between medical device companies such as knee and hip replacement manufacturers and the orthopedic surgeons who use these devices has revealed a murky, ethically challenging, and sometimes illegal relationship between the two. Four of the world’s largest medical device manufacturers got caught up in this investigation and agreed to pay $131 million to settle the federal probe. The companies included Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc., and Smith & Nephew Inc. A fifth company, Stryker Corporation, cooperated with the federal government and was able to avoid paying fines. However, just last month Stryker received a subpoena from the criminal division of the Justice Department regarding possible bribes to foreign officials in violation of the Foreign Corrupt Practices Act. Stryker’s problems are not solely the criminal probes. Stryker had to recall its Trident PSL and Trident Hemispherical Acetabular Cups used in hip replacement surgery. The recall came one week after the FDA issued a warning letter about manufacturing defects in Stryker’s New Jersey plant.
When doctors are receiving fees for choosing a particular medical device the ethical lines become very blurry quite quickly. This is what prompted the federal probe. Doctors have an ethical duty to pursue what is best for the patient regardless of his/her “consulting relationship with a medical device company. If doctors receive consulting fees with companies who make the devices the doctors are using to implant in patients that relationship must be monitored and evaluated. “Although many of these payments were for legitimate services, others were not,” Gregory E. Demske, assistant inspector general for the U.S. Department of Health and Human Services, told a Senate panel last month.

Amgen and Wyeth have added the black box warning to the arthritis drug Enbrel after the drug has been linked to infections including tuberculosis. Enbrel is designed to work by soaking up an inflammatory protein called TNF. Enbrel had already had a bold warning placed on its prescribing label. The black box warning label will be the most serious warning issued by the FDA. Other arthritis drugs such as Vioxx have run into trouble in the last few years because of a link to heart attacks. Enbrel appears to have no such issue. However, the link to infections, especially tuberculosis warranted the black box warning label.

Listeria monocytogenes, an organism that is capable of causing serious and sometimes fatal infections in those with weakened immune systems, the very young and the elderly is the culprit for the latest food recall. Slade Gorton & Co. has recalled its ICYBAY langostinos because the ready to eat food product may be contaminated with the listeria monocytogenes. The product retails in one pound, clear plastic package marked with UPC 0-73129-61672-8 on the top and with an expiration date of June 2009 and is distributed under the brand name of “ICYBAY”. The product also was distributed to wholesale accounts, also under the “ICYBAY” brand, in five pound clear plastic packages containing either 70-90 count, 90-125 count or 120-150 count. This recall involves production dates of July 18, 2007 through August 13, 2007 and/or Julian dates of 199 through 232.

Informative FDA video explaining the Bard Kugel Hernia Mesh recall.

Please visit our Kugel Hernia Mesh Recall website.
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An Alaska courtroom is revealing some interesting facts about Eli Lilly’s marketing practices concerning it’s schizophrenia drug, Zyprexa. What we’re learning is something we’ve suspected and been able to infer for years about the big drug companies. They are always looking to expand their market, often beyond what the FDA has approved. Now we’re beginning to see the actual inner workings of a large pharmaceutical company in their ruthless efforts to expand usage of their drugs. We’ve known that Lilly has aggressively campaigned to expand the approved market for Zyprexa since 2000. What we didn’t know is that a top official at Eli Lilly intimated (the language is couched and careful) that Zyprexa should be marketed for off-label use. The NY Times is reporting that an email sent by John C. Lechleiter, an Eli Lilly official who is about to become the company’s top executive, wrote an e-mail message in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators. The email message is part of testimony in the state of Alaska’s case against Eli Lilly in which the state is seeking reimbursement for medicaid patients who used the drug and developed diabetes as a result.

As a result of finding contaminants in 20 of the 28 lots of heparin in a Chinese factory, the FDA will now inspect all heparing entering the United States. The contaminant remain unknown but it mimics the actual heparin and is known to have been linked to 19 deaths in the US as well as 80 allergic reactions in Germany. While this is a positive step in the right direction, the question must be asked, why does it take a crisis for the FDA to take proper steps and precautions to ensure the public safety? We all know the FDA is understaffed and underfunded but when it comes to public safety, the federal government shouldn’t tolerate such a breach in safety. When the nation’s drug supply or food supply is exposed to danger the federal government should have practices and procedures to make sure the public is kept safe from the threat. That’s just common sense.
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FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine
Containing Hydrocodone
Agency gives new safety information on proper use of Tussionex as a cough suppressant
The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events–including death–associated with the misuse and inappropriate use of this potent cough medication.
Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours (“extended-release”).
“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” said Curtis Rosebraugh, M.D., M.P.H., acting director of the FDA’s Office of Drug Evaluation II. “Today’s action is an example of the FDA working with drug manufacturers throughout a product’s lifecycle to keep health care professionals and patients informed of new safety data.”
Adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children. These reports reveal physicians and other health professionals are sometimes prescribing, and patients are sometimes taking, more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved.
Highlights of the FDA’s recommendations to health care professionals include:
Tussionex should not be used (is contraindicated) in patients less than 6 years old. FDA has received reports of death in children less than 6 years of age who have been prescribed Tussionex.
Consult the prescribing information to determine the correct dose and dosing frequency of Tussionex. Tussionex is an extended-release formulation that should not be prescribed at an interval less than 12 hours.
Discuss with the patient the amount of and frequency of Tussionex to be given. Instruct patients not to take, and parents not to administer Tussionex more frequently than every 12 hours.
Highlights of the FDA’s recommendations to patients include:
One of the two ingredients in this long-acting cough product is hydrocodone, a narcotic. Too much hydrocodone can cause life-threatening breathing problems and death. Call your doctor right away if you have taken this medicine and have trouble breathing, slow heartbeat, severe sleepiness or cold, clammy skin.
For Tussionex, use a medicine syringe or other device designed to measure liquid medications. A household teaspoon or tablespoon should not be used because the spoons vary in size and you may receive too much or too little of the medicine. Ask your doctor or pharmacist if you are unsure how to measure the medicine.
If the cough is not controlled despite taking the prescribed dose at the recommended interval, talk to your doctor.
The manufacturer of Tussionex Pennkinetic Extended-Release Suspension (UCB Inc, Smyrna, Ga.) has agreed to update the labeling, including information that Tussionex should not be prescribed to or used in children less than 6 years of age, as well as the need for accurate dosing.

This month, Ford Motor Co. issued another truck recall because the weld connecting a bracket and the front seat could potentially crack. This particular recall covers F-250 through F-550 Super Duty trucks. These trucks were manufactured in Ford’s Louisville plant. Ford trucks have been plagued by manufacturing defects and product recalls for the past few years making both investors and consumers jittery about the quality of the Ford products. Some of the recalls in the past included cracked fuel tanks, ignition switch defects, brake problems, drivetrain, and steering issues. This isn’t good for the industry and particularly troublesome for one of America’s best known manufacturing companies.

Heparin blood thinner video, from YouTube related to Baxter outsourcing.
Discussion on China and Germany related to Heparin recall.

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From The FDA:
FDA Public Health Update
Recall of Heparin Sodium Injection and Heparin Lock Flush Solution (Baxter)
The Food and Drug Administration is issuing this update to inform the public that
Baxter Healthcare Corporation has extended its recall of multi-dose vials of heparin sodium for injection to also include single-dose vials of heparin sodium for injection.
As a precautionary measure Baxter is also recalling its heparin lock flush products. The heparin source manufacturer for lock flush solutions is the same as that for Baxter’s heparin sodium for injection.
Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the US market.
Since FDA learned of the adverse events associated with the Baxter multi-dose heparin vials, the Drug Shortages Team at FDA has been working closely with APP, the other supplier in the US for heparin multi-dose and single-dose vials, to determine their manufacturing capacity. With the verification that APP can now adequately supply the US market Baxter is voluntarily recalling all of its multi-dose and single-dose vials. FDA has also confirmed that there are multiple U.S. suppliers of heparin lock flush products with substantial inventory, making a shortage of these products unlikely.
The recall notice issued by Baxter provides instructions to healthcare providers and institutions regarding the identification and disposition of their product they may have in their inventories. The only Baxter heparin-containing products that will remain on the market are large volume parenteral solutions containing 200 Units of heparin per 100 cc in 500 and 1000 cc total volume bags. No adverse events have been reported in relation to the large volume solution. The heparin source manufacturer for the large volume solution is different from that of the products being recalled.
On February 11, 2008, the FDA issued a public health advisory informing the public about reports of serious adverse events in patients who received bolus injections of heparin sodium primarily from multi-dose vials manufactured by Baxter Healthcare Corporation. A description of the clinical settings and characteristics of the cases of serious adverse events that resulted in the public health advisory can be found at
FDA Heparin Information Page
The underlying cause of adverse events reported for Baxter’s heparin sodium is still unknown and remains under investigation. FDA investigators and scientists are working independently and in collaboration with the Centers for Disease Control and Prevention, and Baxter to discover the underlying cause of the adverse events.
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I know I blogged about this just a day or so ago but I can’t let this one go. Bishop Gianfranco Girotti actually said that the first task of the bishops was to protect the reputation of the Catholic Church! I couldn’t believe what I was reading! This bishop actually admitted that the priority of the hierarchy was to protect its own reputation, the hell with the victims and their welfare. Once again, they betray themselves as men who have one mission and that is to protect and defend the church which they understand to be the bishops and the priests. The people are only accidental. The fact that such an important official would say such a thing in public belies a greater truth: the Church (understood as the bishops and priests) are only interested in one thing, and that is self-preservation. Victims of priest abuse are obstacles to that end. To say the church is in need of reform is indeed an understatement!
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