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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 Tables, 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.

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 will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

Much to the objection of Bayer Healthcare, Mirena IUD lawsuits at the federal level have been centralized into a 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.

The FDA proposed last month that makers of automated external defibrillators (AEDs) be  required to submit premarket approval (PMA) applications for these devices.  Why?  They have receive 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 literally 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?

Should all transvaginal mesh products be recalled?

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.

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 will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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.

The Sixth Circuit ruled that a plaintiff’s warning and design defect claims in a shoulder injury may proceed, overturning an entry of summary judgement.
This is a big win in a tough case on behalf of a 17 year-old girl who used a pain pump after arthroscopic surgery on her shoulder. Her doctor chose a Breg Pain Care 4200 pain pump to control the Plaintiff’s pain for four days after the surgery. The Plaintiff suffered from glenohumeral chondrolysis, a condition in which the shoulder cartilage is permanently destroyed, as a result, allegedly, of her use of the Breg pain pump that will necessitate multiple shoulder replacements for this young girl in the future. Awful, right?

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The Chantix MDL judge ruled Monday that the 2009 black box warning on drug’s label sufficiently provided a warning as a matter of law that suicidal and violent acts may result in taking Chantix. But, ultimately, the court punted the question of how that impact that statutes of limitations to individual courts, presumably by individual federal courts who hear the case after remand.
You can read the opinion here.