Drug Recall Lawyer Blog

Zometa Case Lost on Statute of Limitations

Wed, 16 May 2012 14:51:11 -0500

A New Jersey judge in the Aredia/Zometa state court cases found that a Zometa plaintiff's lawsuit had been dismissed, applying Virginia's statute of limitations.

The facts of this case are, like many of the other in the Aredia/Zometa cases, sad. Plaintiff, a resident of Virginia, developed osteonecrosis of the jaw after allegedly receiving infusions of Zometa.

Everyone agreed that Virginia's substantive law applied. The court found that, if the substantive law of Virginia governs plaintiff's damage claims, the defendant has the right to assert applicable affirmative defenses under Virginia law.

At no additional charge, the court threw in a little lecture for plaintiffs:

Statutes of limitations are enacted to provide certainty for litigants and to prevent the litigation of stale claims. Judicial cherry picking whereby a litigant argues simultaneously in favor of two separate states' period of limitations, as [plaintiff does] in this case, threatens to render statutes of limitations meaningless.

You can find the court's opinion here.

April 2012 Medication Label Changes

Wed, 16 May 2012 08:57:44 -0500

Last month brought changes to forty-three (43) medical product labels (slightly up from 39 changes in March), 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:

Aceon (Perindopril Erbumine)
Altace (Ramipril)
Atacand (Candesartan Cilexetil)
Sporanox (Itraconazole)
Zortress (Everolimus)
Advicor (Niacin Extended-release/Lovastatin)
Altoprev (Lovastatin Extended-release)
Amturnide (Aliskiren, Amlodipine and Hydrochlorothiazide)
Premarin (Conjugated Estrogens,USP)
Tekamlo (Aliskiren and Amlodipine)
Tekturna (Aliskiren)
Tekturna HCT (Aliskiren and Hydrochlorothiazide)
Vagifem (Estradiol)
Valturna (Aliskiren and Valsartan)
Viracept (nelfinavir mesylate)
Beyaz (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium)
Cimzia (Certolizumab Pegol)
Krystexxa (Pegloticase)
Levaquin (Levofloxacin)
Levemir (Insulin Detemir [rDNA origin])
Neupro (Rotigotine)
Nutropin (Somatropin [rDNA origin])
Prandimet (Repaglinide and Metformin HCL)
Safyral (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium)
Sutent (Sunitinib Malate)
Synagis (palivizumab)
Tarceva (Erlotinib)
Victoza (liraglutide [rDNA])
Votrient (Pazopanib)
Xgeva (Denosumab)
Yasmin (Drospirenone and Ethinyl Estradiol)
Yaz (Drospirinenone and Ethinyl Estradiol)
Zegerid (Omeprazole and Sodium Bicarbonate)

Wright Profemur Hip Class Action Lawsuit

Tue, 08 May 2012 09:00:31 -0500

Wright Profemur Hip Lawsuits

Last week, the federal judge overseeing the Wright Medical hip implant MDL lawsuits named the plaintiffs' co-lead and co-liaison counsel. These lawyers will help scores of other lawyers in directing the federal lawsuits involving hip implants.

The Wright Medical hip implant MDL is a "class action lawsuit for discovery" that was approved back in February. It consolidated lawsuits stemming from concerns about defective hip replacements from a number of hip manufacturers. The problem began with the DePuy hip implant recall. Plaintiffs' hip replacement lawyers realized pretty quickly that researchers were finding that the problem was not just with DePuy, but with metal on metal hip implants in general. There are two other ongoing hip MDLs: the original, the DePuy ASR metal-on-metal hip in the Northern District of Ohio, and another for the DePuy Pinnacle metal-on-metal hip.

One big piece of evidence against these metal-on-metal implants is new. Two months ago, the Lancet, a top-notch British medical journal, published new failure rates of the metal-on-metal hip replacements using data from the National Joint Registry of England and Wales. The conclusion was grim: Metal-on-metal stemmed articulations give poor implant survival compared with other options. They concluded that these implants simply should not be used.

McKesson Drug Price Settlement Is $190 Million

Mon, 30 Apr 2012 13:31:26 -0500

Drug wholesaler McKesson Corp. has settled charges against it, agreeing to pay more than $ 190 million for government claims that it reported inflated drug prices that caused federal government - specifically Medicaid - to overpay for drugs.

McKesson put out the same press release that goes out in every single one of these cases:

We did not manipulate drug prices, and did not violate any laws. However, when we weighed our conviction that we did not violate any laws against the inherent uncertainty of litigation, we determined that this settlement was in the best interest of our employees, customers, suppliers and shareholders.

The government really should do something about this. These settlements always come with this "we did nothing wrong" language. I think this makes it harder for other companies to truly learn the lessons of these cases. If there is a real dispute as to liability, the government should try the case and let the jury decide what really happened.

Zoloft Birth Defect Lawsuits Consolidated

Fri, 20 Apr 2012 10:06:18 -0500

Lawsuits alleging birth defects caused by the antidepressant Zoloft/sertraline were consolidated on Tuesday before Judge Cynthia M. Rufe in the U.S. District Court for the Eastern District of Pennsylvania. About 92 federal lawsuits - and counting - will be included in this MDL.

What does this mean for Zoloft birth injury plaintiffs? The cases are technically not a class action, but the cases are merged together for discovery on issues that are common to all of the Zoloft birth defect lawsuits. The upside for individual Zoloft birth defect lawyers is the efficiency of pulling together resources to really discover what Pfizer knew about the harmful effects their drugs had on unborn children whose moms were on Zoloft.

March 2012 Medication Label Changes

Fri, 13 Apr 2012 09:05:21 -0500

Last month brought changes to thirty-nine (39) medical product labels (way down from 65 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, 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:

Atacand HCT (candesartan cilextetil/hydrochlorothiazide)
Benicar (olmesartan medoxomil)
Sporanox (itraconazole)
Twynsta (telmisartan/amlodipine)
Zestoretic (lisinopril/hydrochlorothiazide)
Zestril (lisinopril)
Benlysta (belimumab)
Celexa (citalopram hydrobromide)
Enablex (darifenacin)
Incivek (telaprevir)
Janumet (sitagliptin and metformin fixed-dose combination)
Januvia (sitagliptin)
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
Lidocaine in 5% Dextrose Injection
Magnevist (brand of gadopentetate dimeglumine)
Revlimid (lenalidomide)
Reyataz (atazanavir sulfate)
Treximet (sumatriptan and naproxen sodium)
Votrient (pazopanib)
Zometa (zoledronic acid)
Zmax (azithromycin extended release)

Merck Sues Over Vioxx. Really.

Mon, 09 Apr 2012 11:13:04 -0500

Merck can proceed with a lawsuit against the Kentucky Attorney General for violating its constitutional due process rights in its claims against Merck involving Vioxx. Why? A federal judge has found that Kentucky improperly struck a contingency fee arrangement with plaintiffs' lawyers to bring a lawsuit against Merck for their marketing of Vioxx.

Is this a new trend? Last year, a South Carolina judge allowed a similar claim by AstraZeneca against the South Carolina AG. My question for Merck and AstraZeneca is whether the juice is really worth the squeeze. If you are Merck, you can't be happy about anything that happened with Vioxx other than the fact that you settled the cases for a few billion less than you originally throught. Is it possible that you are losing the war even if you win this petty technical battle with Kentucky? I don't think you gain a ton of moral high ground by screaming that you sued me for doing something wrong with the wrong lawyers. I can't see John Q. Public covering your back on this. You have a lot of great products that are not hurting people. Spend your time talking about them and let your mistakes fade away.

Pharmalot has more on the story.

Counterfeit Version of Altuzan/Avastin

Wed, 04 Apr 2012 09:06:23 -0500

The FDA has announced that there is a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab) that has been obtained by some medical practices. Lab tests have confirmed that the Altuzan, an injectable cancer medication, contains no active ingredient. Altuzan, the brand name for Avastin in Turkey.

The FDA first warned in February that a counterfeit supply of the widely-used Avastin had turned up in the U.S. The Wall Street Journal has traced that supply through a network of firms in Canada, Barbados, the United Kingdom, Denmark, Switzerland, Egypt and Turkey.

Read more: http://www.foxnews.com/health/2012/04/04/fda-finds-new-batch-counterfeit-avastin/#ixzz1r527ZHxg

Medical practices obtained the counterfeit Altuzan through foreign sources. Packaging or vials found in the U.S. that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit, and should not be used. The products should reported to the FDA, and be retained and securely stored until further notice.

Avastin is approved for metastatic colorectal and kidney cancer. These are patients with challenging cancers. It takes particular brand of evil to counterfeit Avastin. Do these people go home to families? I complain about the evils of big drug companies in their mad search for profits. But this is like 10,000 times worse.

But you know who is not equally as bad by similarly bad? The medical practices that bought this stuff. What in the world were they thinking?

Did Johnson & Johnson Knowingly Sell Defective Hip Replacements?

Thu, 29 Mar 2012 10:27:07 -0500

Though widely hailed as breakthrough medical devices when they first came onto the market, experts are now recommending that patients avoid them. The onslaught of problems (which seems to span all metal hip implants, regardless of manufacturer) is one reason that Johnson & Johnson has been phasing out their DePuy ASR implants. Of course, the phase out allows a manufacturer to retire a device gracefully, despite the fact that a full-blown hip implant recall is warranted in these cases.

What did Johnson & Johnson (DePuy) Do Wrong To Cause Hip Implant Injuries?

As the authors of the British Medical Journal The Lancet said, the problems with metal hip implants that surgeons have discovered, could have been determined with adequate pre-market studies and regulation. If Johnson & Johnson did their homework, there would be a lot fewer people with these hip implant problems. The reality, though, is that a medical device manufacturer always makes more money by sending a defective device to the market than they do by canceling a project.

In 2009, the FDA told Johnson & Johnson that it was rejecting the DePuy ASR hip resurfacing system. That letter went one step further by telling Johnson & Johnson that all of the DePuy metal-on-metal implants were suspect because of metal poisoning problems (See Hip Device Phaseout Followed FDA Data Request, New York Times). Regardless, these implants are still being implanted into patients.

Hip Replacement Recall Pay Per Click Advertising

Tue, 27 Mar 2012 14:12:22 -0500

Like most lawyers writing about mass tort drug injury cases, our firm is looking to attract potential hip replacement recall cases.

One means of accomplishing this goal - as opposed to providing real information that is of use to victims which attracts attention from the search engines - is to buy pay-per-click advertising. I'm philosophically opposed to pay-per-click because I feel like 90% of the clicks are other lawyers snooping around to see who is buying the placement.

February 2012 Medication Label Changes

Fri, 16 Mar 2012 10:24:39 -0500

Last month brought changes to sixty-five (65) medical product labels (up from 63 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, 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:

Abilify (aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection
Amturnide (amlodipine/aliskiren/hydrochlorothiazide) tablets
Angeliq (drospirenone and estradiol) tablets
Aptivus (tipranavir) Capsules and Oral Solution
Avalide (irbesartan/hydrochlorothiazide) tablets
Benicar (olmesartan medoxomil) Tablets
Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
Cardiogen-82 (Rubidium Rb 82 Generator)
Crestor (rosuvastatin calcium) Tablets
Crixivan (indinavir sulfate) Capsules
Diovan HCT (valsartan/hydrochlorothiazide) Tablets
EES (erythromycin ethylsuccinate) Granules for oral suspension, Eryc (erythromycin delayed-release) capsules, Ery-Ped liquid and
PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets
Elestrin (estradiol gel)
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets
Famvir (famciclovir) Tablets
Hepsera (adefovir dipivoxil) tablets
Invirase (saquinavir mesylate) Capsules and Tablets
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution
Lescol (fluvastatin sodium) Capsules
Lescol XL (fluvastatin sodium) Extended-Release Tablets
Letairis (ambrisentan) Tablets
Lexiva (fosamprenavir calcium) tablets and oral suspension
Lipitor (atorvastatin calcium) Tablets
Livalo (pitavastatin) tablets
Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets
Mevacor (lovastatin) Tablets
Natazia (estradiol valerate and estradiol valerate/dienogest) tablets
Norvir (ritonavir) oral solution and tablets
Orencia (abatacept) for injection
Ozurdex (dexamethasone intravitreal) implant
Patanase (olopatadine hydrochloride) Nasal Spray
Phendimetrazine tartrate SR 105 mg capsules
Pravachol (pravastatin sodium) Tablets
Premarin (conjugated estrogens) Vaginal Cream
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets
Prezista (darunavir), Oral suspension
Reyataz (atazanavir sulfate) Capsules
Rituxan (rituximab) Intravenous Injection
Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
Simcor (niacin ER/simvastatin) Tablets
Tekamlo (aliskiren/amlodipine) tablets
Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
Valturna (aliskiren/valsartan) tablets
Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets
Vasotec (enalapril maleate) Tablets
Viracept (nelfinavir mesylate) Oral Powder
Vytorin (ezetimibe/simvastatin) Tablets
Xalkori (crizotinib) Capsules
Yasmin (drospirenone/ethinyl estradiol) tablets
Zocor (simvastatin) Tablets
Zyvox (linezoid) Tablets and Oral Suspension

Yaz Class Action Lawsuit Dismissed

Thu, 15 Mar 2012 13:09:30 -0500

A federal judge dismissed a Yaz class action lawsuit. No, not the Yaz/Yasmin/Ocella lawsuits where women were injured from taking Yaz. This was a different lawsuit seeks class action status to California women who alleged not physical harm but economic injury. The lead plaintiff's argument was in interesting one: they picked YAZ as an oral contraceptive, as opposed to selecting an equally effective cheaper oral contraceptive, because of the direct-to-consumer advertisements containing material omissions regarding the limitations and/or approved uses of Yaz.

Maybe this claim makes sense. I don't know. But the judge shot down the idea of the lead plaintiff because she is a friend and co-worker of one of the class attorneys. The court addressed the problem with the plaintiffs in many of these economic injury class action claims:

Given that the potential recovery for plaintiffs is minimal compared to the potentially high amount of attorneys' fees that may be awarded, Ms. Burns may be more concerned with helping to maximize the monetary return of her 'good friend' and co-worker (counsel's wife) than with her duty to zealously advocate on behalf of the class' interests," the judge said. "Considering this, the Court finds that Ms. Burns is not sufficiently independent of class counsel and does not satisfy the adequacy of representation prong.

I'm inclined to agree. I think courts have to be a little more circumspect with economic class action cases, even those involving an awful product like Yaz. The plaintiff and proposed class representative, was a good friend of the plaintiffs' attorneys wife. The wife told the soon to be lead plaintiff at work that her husband was having difficulty locating a suitable class representative. I don't handle these type of no-injury economic loss cases. So I don't know how to frame my position on this legally. But if you can't find a good plaintiff, you probably should not be representing the class in my opinion.

Problem with Metal Hip Replacements

Fri, 09 Mar 2012 12:02:06 -0500

It is easy to forget what a rarity hip replacement surgery used to be. Today, people with artificial hips are ubiquitous. Direct costs of hip and knee replacements exceed $35 billion in the United States. More than 285,000 hip replacements are performed annually in the United States and it is projected that total joint replacement will increase to 4 million patients annually due to the aging population. Until very recently, hip replacements have been applauded as a wonderful, revolutionary way to get people back on their feet with less or no pain. But with this revolution came medical device makers looking to make as much money, and get as much market share, as possible.

The temptations for hip makers was extraordinary. Hip replacement surgery may be recommended in cases where hip pain limits daily activities, continues while resting (night or day), limits the ability to move or lift the leg, or in cases where pain relief is not provided by physical therapy, walking supports or anti-inflammatory drugs. Hip replacement surgery has a high rate of success, due to improvements in surgical techniques and technology. Total hip arthroplasty (total hip replacement) involves removing the damaged bone and cartilage and replacing it with prosthetic components. These components did not come cheaply but health insurance companies readily admitted that this was the appropriate treatment for people with compromised hips.

Though many hip replacement surgeries are successful, there is risk for infection, failure, and other adverse effects. Concerns have been raised in peer reviewed publications relating to metallosis, the build up of metal debris in soft tissues or blood. Reports are generally restricted to metal-on-metal devices, or those constructed with acetabular polyethylene liner. Metal-on-metal devices often contain cobalt or chromium. Although the occurrence is rare (occurring in approximately 5.3% patients), it is a serious complication associated with these devices. Metallic debris can occur due to malpositioning of the implant, subluxation, or jamming of the femoral head.

Does Warning Start the Statute of Limitations?

Thu, 01 Mar 2012 15:27:49 -0500

Most drug injury lawyers assume that the statute of limitations begins to run when the appropriate warning is placed on the drug or medical device. In mass tort cases, if you have a case that is past the state's statute of limitations, you can't find a lawyer to file your case for you.

I'm not a fan of strict construction of statute of limitations. The bright line leads to too many unjust results. Plaintiffs file cases all the time that get delayed and delayed by defense tactics. There is no reverse statute of limitations, the "Geez, you guys drug this thing out so long and the witnesses have forgotten everything so liability is established" rule. So not erring on the side of plaintiffs is a long established tradition in the law that no one even questions anymore. But that does not make it any less dumb.

Oh, right, back to the blog post. The New Jersey Supreme Court ruled that Accutane ulcerative colitis plaintiff timely filed her lawsuit because she had no reason to know that Accutane could cause inflammatory bowel disease in spite of the fact that a warning had been issued earlier in 2003.

Good result. You can read more about this case here.

Yaz Gallbladder Injury Settlements: Houston, There Is a Problem

Mon, 27 Feb 2012 14:25:11 -0500

More YAZ Lawsuit Information

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.