Articles Posted in Uncategorized

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pills2The Food and Drug Administration (FDA) has considered changes to its labeling rules regarding generic drugs.  The changes could provide generic drug users with more protection.

Currently, those that have been injured by a brand-name drug can win compensation from the manufacturer if it can be shown that the drug was unreasonably dangerous or that the warning label did not disclose the risks properly.  Those injured by a generic medicine?  Not so much.  Those injured by a generic medicine can’t hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.  Crazy, huh?

All of that could be changed by a new rule that the FDA expects to formally propose in September.  The new rule would “revise and clarify procedures for changes to the labeling” of approved drugs.  This will include both brand names and generics.  This change would either enable or require (not yet clear based on the information provided by the FDA) drug makers to announce possible changes to their warnings while the FDA is considering the warning.

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medicationThe FDA has shut down 1,677 sites for selling counterfeit or substandard medication, or for selling drugs without appropriate safeguards. Other sites received regulatory warnings.

While the prices look good, you never really know what you’re getting.  These products can have too much or too little of the active ingredient that people need for the treatment of their disease, and some could have toxic ingredients.  Several of the sites had sleek interfaces and names that could easily be confused with legitimate pharmacies.  Walgreens-Store.com, for example – the drugstore chain is actually Walgreens.com.

Though many of the sites present themselves as Canadian, most of them are based overseas – China, India, Pakistan, all around the world.  The National Association of Boards of Pharmacy recently performed an analysis of over 10,000 websites and found that 97% did not fully comply with state and federal regulations. 88% didn’t require a valid prescription, and almost half of them sold medicines lacking FDA approval.

 

 

 

 

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painA Georgia federal jury ruled for the Defendant this week, determining that Mentor Worldwide LLC was not negligent in its design, manufacture, and sale of the ObTape pelvic mesh.

Also known as a vaginal sling, the Plaintiff was implanted with the ObTape in December 2004 to treat bladder prolapse and urinary incontinence.  Six months later, she was diagnosed with vaginitis and a doctor found that the mesh had extruded into her vagina.

She filed suit, claiming that the ObTape caused vaginal erosion and required surgical removal.  She further claimed that the pore size of the ObTape was insufficient to allow for the tissue to become integrated into the device.  She said the mesh created a propensity for infection and/or abscess, resulting in an unreasonably high rate of infection, abscesses, tissue erosion, and mesh extrusion.

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A recall of one lot of Advance Pharmaceutical’s 81mg Enteric Coated Aspirin tables is being recalled as it may contain Acetaminophen 500mg tablets.

Affected by this recall is the over-the-counter drug product, Rugby label Enteric Coated Aspirin Tablets, 81 mg, Lot 13A026.  Packaged in bottles of 120 tables, the NDC code is 0536-3086-41, UPC code is 3 0536-3086-41 9, and the expiration date of 01-2015.

The recall was announced after a complaint of the error was reported.  Consumers may be inadvertently taking Acetaminophen instead of Aspirin, which may cause severe liver damage to those who take other drugs containing acetaminophen.

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Last month brought changes to fifty-three (53) medical product labels (way up from 35 changes in February), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you can view the detailed summary, which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

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mirenaiudlawsuitMuch to the objection of Bayer Healthcare, Mirena IUD lawsuits at the federal level have been centralized into multidistrict litigation or MDL. The cases will be transferred to a U.S. District Court Judge in the Southern District of New York.  This makes the claim a mini-class action.  What does this mean?  The Mirena lawsuits are consolidated for discovery purposes.  They become one class case for a while.  If a global settlement of these Mirena lawsuits cannot be achieved, they will be sent back to their individual states for trial.

Last week, we told you that similar consolidation was being reconsidered at the state level, where more than 60 Mirena IUD lawsuits are currently pending.  Currently, there are only about 40 lawsuits in federal court, however, it is anticipated by some plaintiffs’ attorneys that several thousand cases will be filed by women who have experienced complications from Mirena IUD.

If you used Mirena and experienced complications, including surgical removal, infection, or Pelvic Inflammatory Disease (PID) and want to inquire as to whether you have a lawsuit, contact our Mirena defect lawyers at 1.800.553.8082, or online here.

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The FDA proposed last month that makers of automated external defibrillators (AEDs) be required to submit pre-market approval (PMA) applications for these devices.  Why?  They have received 45,000 reports – not a typo – of failures of these devices in the last 8 years.  My gosh, I’m surprised they are so ubiquitous that they even have been used 45,000 times.

But these things – these literal life and death machines – have had 8 recalls in the last eight years.  Pathetic.  The problems usually involve the AEDs powering off during use, error messages caused by software anomalies, or just component failure.

I don’t trust these things. Yet I still dutifully carry one on the court when I play tennis with my father.  Can you imagine the horror of needing to use one of these things and you are getting an error message?

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Should all transvaginal mesh products be recalled?

transvaginalmesh

Should we get rid of the vaginal mesh product completely?

It is a fair question. These products – and we see juries starting to prove this point – are a train wreck.  These companies – all of them, it seems – were chasing profits and ignoring the harm they were causing women.  It really is as simple as that.

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Last month brought changes to thirty-five (35) medical product labels (up from 27 changes in January), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you can view the detailed summary, which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

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On Friday, a federal jury in Utah ordered Wyeth and Pharmacia & Upjohn Co to pay a hormone replacement therapy plaintiff $5.1 million after finding that her breast cancer was caused by Premarin, Provera, and Prempro and that the defendants failed to adequately warn about the risk of breast cancer and these drugs. Interestingly, the jury did not find the defendants liable on the strict liability failure to warn, and the negligent design defect claims.

The problem with these cases for the defendants is that they ask the jury to check their common sense at the door. Defense experts testified that the plaintiff’s breast cancer was the most common type occurring in women, regardless of their hormone therapy drug use. She also had other risk factors for breast cancer, including dense breast tissue.

In closing arguments, one of the defense lawyers said: “We don’t know what caused her first breast cancer mutation. But we know that without that mutation she would never have developed breast cancer.” In other words, set aside the studies that show these drugs cause breast cancer because she probably would have gotten it anyway because she had, you know, dense breast tissue. Please.