Drug Recall Lawyer Blog

We have been writing a lot about imminent Yaz settlements. Let's be honest. We want to gin up traffic for the phase "Yaz settlements" because we want to get as many cases as possible.

But when I say "Yaz settlement" - okay, I'll stop, I'm annoying even myself - I am talking about Yaz stroke, heart attack, blood clot, deep vein thrombosis, pulmonary embolism, and other similar Yaz injuries. For every one of these types of Yaz leads we have gotten, we have received 10 cases alleging a gallbladder injury.

Bayer is reportedly holding the line on these cases and have no intention of settling the Yaz/Yasmin gallbladder lawsuits that have been filed in the MDL. A new Boston University study concludes that there is no evidence in these data that drospirenone- or levonorgestrel-containing OC use brings an increased risk of gallbladder disease compared to women on birth control without drospirenone- or levonorgestrel.

This is hardly game set and match for lawsuits that link gallbladder injury to Yaz/Yasmin, but you can expect this study to strengthen Bayer's resolve to fight these cases out longer in the MDL.

The FDA has announced the recall of single capsule packet RegenErect, as it has been discovered that an active drug ingredient is not listed on the label.

Labeled as a dietary supplement, it has been determined that RegenErect contains Tadalafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Erectile Dysfunction is a common problem in men with these conditions, and as such, consumers may seek these types of products to enhance sexual performance.

RegenErect has been sold over the internet to consumers in the United States of America and Puerto Rico, and given as samples at public events. It is a blue capsule, and sold individually in foil packets with a UPC code of 816860010055.

A recall has been announced of seven lots of Norgestimate and Ethinyl Estradiol Tablets, due to a packaging error, causing the possibility for the pills to be out of sequence.

The affected pills are the Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. It has been determined that the blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation. This has additionally caused the lot number and expiration date to be visible only on the outer pouch.

This product is used as an oral contraceptive indicated for the prevention of pregnancy. Though the packaging defect does not pose a health risk, the packaging error can cause the daily regimen to be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

Lot numbers of affected packs of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic), are as follows:

NDC: 68462-565-29

Lot Numbers - Expiration Date:

• 04110101 - 07/31/2013
• 04110106 - 07/31/2013
• 04110107 - 07/31/2013
• 04110114 - 08/31/2013
• 04110124 - 08/31/2013
• 04110129 - 08/31/2013
• 04110134 - 09/30/2013

• More Birth Control Recalls Due to Packaging Errors

Approximately 574,000 bottles of Infants’ Tylenol Oral Suspension, are being recalled.

The recall affects the grape flavor, 1oz. bottles of Tylenol Oral Suspension, and has been made as a precaution after receiving a small number of complaints from consumers who reported difficulty using the Infants’ Tylenol SimpleMeasure dosing system. SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.

No adverse events have been reported, and the risk of a serious adverse medical event is remote.

• Affected Lot Numbers Include: BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00 with a UPC Code of: 300450122308

• Liquid Acetaminophen for Infants

The idea of an MDL is to consolidate discovery, figure out what the cases are about, and whether they can be settled without a gazillion trials. So you do some discovery and, more often than not, you try a few cases and see if you can limit or even eliminate trials getting sent back to their home jurisdictions for trial.

But in any piece of mass tort litigation, the quality of the individual cases is going to vary wildly. There are a lot of reasons for this that are case specific, but one value driver thread that runs though every case is the quality of the plaintiff. There is no question that juries are going to pay more (and may even be more likely to find liability) in cases where you have a plaintiff that the jury likes and respects. So that begs the question: which cases get tried first? Plaintiffs' lawyers look for good facts with a Mother Theresa-like plaintiff and defendants look for confounding facts Idi Amin-like. This we know.

So which cases are chosen to go first? One of the authors of the defense oriented Drug and Device Law Blog crashed the plaintiffs' put on seminar, Mass Torts Made Perfect, and listened to what the judges who spoke there had to say. This was their summary:

Judges are all over the map on how to select bellwether trials. There is still some support for letting each side pick their favorite cases, but it is possible that the best cases are not representative enough to mark out settlement values. Plus, plaintiffs can subvert the system by dismissing the defense picks at the last minute. Judges don’t like that. And here’s a piece of good news: most judges think it makes no sense to create a bellwether trial with multiple plaintiffs.

It is a tough issue. The perfect answer would be to pick the "middle of the road" case in different categories of injury. But who picks what the middle of the road is? It is clearly a tough issue and no one really seems to have a great answer for how the picking of bellwether cases should be done.

Last month brought changes to sixty-three (63) medical product labels (up from 40 changes in December), 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, please 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:

Accupril (quinapril hydrochloride)
Accuretic (quinapril HCl/ hydrochlorothiazide)
Altace (ramipril)
Avalide (irbesartan/hydrochlorothiazide)
Avapro (irbesartan)
Azor (amlodipine/olmesartan)
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide)
Diovan (valsartan)
Diovan HCT (valsartan/hydrochlorothiazide)
Exforge (amlodipine/valsartan)
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide)
Lotensin (benazapril)
Lotensin HCT (benazapril/hydrochlorothiazide)
Lotrel (amlodipine besylate and benazepril hydrochloride)
Mavik (trandolapril)
Micardis (telmisartan)
Micardis HCT (telmisartan/hydrochlorothiazide)
Tarka (trandolapril/verapamil hydrochloride)
Teveten (eprosartan mesylate)
Teveten HCT (eprosartan mesylate/hydrochlorothiazide)
Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide)
Univasc (moexipril hydrochloride)
Uniretic (moexipril hydrochloride/hydrochlorothiazide)
Ceftriaxone for Injection and Dextrose Injection in Duplex Container
Evoclin (clindamycin phosphate)
Mavik (trandolapril)
Micardis (telmisartan)
Micardis HCT (telmisartan/hydrochlorothiazide)
Micardis HCT (telmisartan/hydrochlorothiazide)
Twynsta (telmisartan/amlodipine)
Xenical (orlistat)
Chantix (varenicline)
Erbitux (cetuximab)
Fanapt (iloperidone)
Fazaclo (clozapine)
Gralise (gabapentin)
Morphine Sulfate Oral Solution,
Morphine Sulfate Tablets
Nexium (esomeprazole sodium)
Nexium (esomeprazole magnesium)
Performist (formoterol fumarate)
Pradaxa (dabigatran etexilate mesylate)
Vimovo (naproxen/esomeprazole magnesium)
Vytorin (ezetimibe/simvastatin)

• December 2011 Medication Label Changes
• November 2011 Medication Label Changes
• October 2011 Medication Label Changes
• September 2011 Medication Label Changes
• August 2011 Medication Label Changes

Novartis got successive wins last week in jury trials in Kentucky and Missouri, in the Zometa lawsuits. Plaintiffs in both cases alleged that Zometa caused osteonecrosis of the jaw (ONJ), which is just an awful condition that can lead to chronic pain and disfigurement, and is difficult to treat.

The battlefield in both of the lawsuits, as is often the case in drug cases, was the adequacy of the warning. Novartis apparently convinced these jurors that it had properly warned about the osteonecrosis of the jaw side effect that has come for thousands with intravenous bisphosphonate medications like Zometa and Aredia.

Pfizer Inc. has recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic), as an investigation found that some of the blister packs may contain an inexact count of inert or active ingredient tablets, and that the tablets may be out of sequence.

These products are oral contraceptives indicated for the prevention of pregnancy. These tablets were manufactured and packaged by Pfizer Inc. and labeled under the Akrimax Pharmaceuticals brand.

As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected product (the full list of lot numbers is provided here) should notify their physician and return the product to the pharmacy.

These products are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing of this product is important in avoiding the associated risks of an unplanned pregnancy.

There will be lawsuits here but I don't know what to make of them. Surely, there are potential wrongful birth suits. But the damages are the difference between the cost of having a child you did not want and the joy you get from that child. If you argue in court that your healthy child is more of a burden than the cost warrants... well, you are not a very nice person.