Drugs/Medical Archive
Stryker Announces Rejuvenate Hip Implant Recall…Quietly
July 5th, 2012. By AbiK
The Canadian Stryker Rejuvenate Hip Implant recall was the tip-off.
For patients who’ve undergone hip replacement surgery and have sat and followed the legal news about the alleged DePuy Hip problems (both the DePuy Pinnacle and the DePuy ASR), and the Zimmer Hip problems (the Durom cup)—both utilizing metal-on-metal componentry that’s alleged to be defective—the Stryker hip recall in Canada had to have sparked the question: why if the same hip implant is recalled there hasn’t it been recalled here?
Well, now it has. Only it’s been a rather quiet recall announcement.
Stryker has announced a voluntary recall of the Stryker Rejuvenate Modular and ABG II modular-neck hip stems. The recall by Stryker was voluntary. The reason the recall was initiated is because of potential risks associated with modular-neck stems. The risks, as reported on the Stryker website, include the potential for “fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.”
As with the previous metal-on-metal hip implant components, which led to hip implant lawsuits, the alleged issue is an increased risk of metallosis—which can occur as the metal hip components rub against each other, thereby releasing particles of cobalt and chromium into the blood. According to Stryker, if you are experiencing pain or swelling at the joint site, you should speak with your hip surgeon.
While the US Stryker voluntary recall does not specify model numbers, the following information and model numbers were identified in the Health Canada recall notification:
- Trade Name
- A) Rejuvenate Modular Neck, 0 DEG
B) Rejuvenate Modular Neck, 8 DEG
C) Rejuvenate Modular Neck, 16 DEG
D) Rejuvenate SPT Modular Stem, Straight Press-Fit Texture TMFZ - Recall Posting Date
- 2012-05-28
- Manufacturer
- Howmedica Osteonics Corporation
- Recall Start Date
- 2012-04-30
- Recall Number
- 73679
- Hazard Classification
- Type II
- Model or Catalog #
- A) NLS-300000B, NLS-340000B, NLS-380000B, NLS-420000B
B) NLV-300800G, NLV-300800Y, NLV-340800G, NLV-340800Y, NLV-380800G, NLV-380800Y, NLV-420800G, NLV-420800Y
C) NLS-301600P, NLS-341600P, NLS-3816000P, NLS-4216000P
D) SPT-070000S, SPT-080000S, SPT-090000S, SPT-100000S, SPT-110000S, SPT-120000S - Lot or Serial #
- A) All lots
B) All lots
C) All lots
D) All lots - Reason for Recall
- Stryker Orthopedics has updated the instructions for use (IFU) for the Rejuvenate Modular Hip System. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and/or corrosion at or about the modular neck junction.
If you’re experiencing pain or swelling in the area of your hip replacement, regardless of which manufacturer and/or model of hip implant you have, speak to your hip surgeon.
Top 10 Lawyer Interviews of the Month (May 2012)
June 29th, 2012. By AbiK
LawyersandSettlements.com publishes hundreds of lawyer interviews each year on the latest legal issues—lawsuits, mass torts, class actions, settlements—that our readers are most interested in. The attorneys—and expert witnesses—our journalists’ interviews provide a birds-eye view into the cases we report on.
Here are the top 10 attorney interviews that readers clicked during the month of May, 2012 (in reverse order):
10. Attorney Tim McCarthy, from McCarthy Law Group, on the consumer fraud class action lawsuit over Starbuck’s quitting its Tassimo coffee maker deal with Kraft Foods for one with Keurig.
9. Attorney Barry Kramer, on patients who have either paid, or have been billed, excessive emergency room charges.
8. Attorney Andy Hollis of Hollis, Wright, and Couch, P.C., on the case against ADHD drug Adderall.
7. Attorney Mark Thierman, on filing a class action lawsuit on behalf of Las Vegas limousine drivers against Bell Trans, Nevada’s largest limousine company, alleging failure to pay minimum wage and overtime.
6. Attorney Dr. Shezad Malik, on Bayer being in the process of settling certain Yasmin, Yaz and Ocella blood clot lawsuits.
5. Medical consultant and analyst Lana Keeton, on the dangers of synthetic transvaginal mesh and transvaginal sling for Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI).
4. Attorney Dr. Shezad Malik, on the Yaz and Yasmin bellwether trials. (See more info on bellwether trials)
3. Attorney Leonard Emma of The Law Office of Randall Crane, on California labor—what “independent contractor” means and employee misclassifications.
2. California Labor Attorney Randall Crane answers the question: “Can I be Fired if I’m Disabled?“
1. California Employee Attorney Donna M. Ballman, P.A., on bullying and harassment on the job.
Oscillo Flu Relief Settlement Preliminary Approval: Here’s What To Do
May 26th, 2012. By AbiK
Remember this one? The Oscillo Flu Relief false advertising class action? Or, for those of you who can pronounce it, the Oscillococcinum class action lawsuit…which basically alleged that a couple of homeopathic ingredients and sugar may not actually do a blessed thing (expect perhaps a placebo effect) on curing or diminishing your flu symptoms.
Well, the class action lawsuit was actually against Boiron and it covered more than Oscillo. Now, it’s got a preliminary approval on its settlement. So here we go with the settlement details…
Am I part of the Oscillo Flu Relief Class Action Settlement?
You are if you purchased Oscillococcinum, Children’s Oscillococcinum, Arnicare, Quietude, Camilia, Coldcalm and ‘other products manufactured by Boiron’ between Jan. 1, 2000 and the present. You’re NOT a part of the class for this settlement if you were a California resident whose only purchase of a Boiron product was of Children’s Coldcalm in California after August 31, 2006.
What do I get as part of the Oscillo Flu Relief Class Action Settlement?
As with all class action settlements, the amount each class member receives will be contingent on how many claimants (ie, class members) submit a claim form. However, class members who file timely and valid claims (see below) are eligible to receive up to $100.00 per household.
For this settlement, a settlement fund of $5 million is being set up to pay claims to eligible Class Members, attorneys’ fees and costs, and the notice and claims administration costs. Boiron (the company that makes Oscillo) is also agreeing to make certain changes to the manner in which it advertises the products involved in the class action lawsuit.
What do I have to do now?
Here are your options to…
Submit a Claim: Do not submit a claim here at LawyersandSettlements.com. You can submit your Oscillo claim form at the claims administrator’s website here: http://www.gilardi.com/boironsettlement/FileClaim.
Otherwise, you will need to send in a completed claim form and, if available, proof of purchase of the applicable Boiron products you’ve purchased to the Claims Administrator (address shown below). Your claim must be postmarked no later than 45 days after the date the Court enters the Judgment.
The Court will hold a hearing on August 13, 2012 at 2:30 p.m. at the federal courthouse at 940 Front Street, Courtroom 11, San Diego, CA 92101, to consider final approval of the Boiron settlement, including payment of reasonable attorneys’ fees and costs to Class Counsel related to obtaining the settlement relief, an incentive award to each of the named Plaintiffs, and related issues.
Object to the Settlement: If you want to object to the Oscillo settlement you have to file a written statement with the Court and serve a copy on Class Counsel, Counsel for Defendants and the Claims Administrator, postmarked by July 14, 2012. Instructions for how to object are explained in the detailed notice at www.gilardi.com/boironsettlement.
Exclude yourself from the Settlement: If you do not want to be bound by the settlement, you must send a letter to the Claims Administrator at the address below requesting to be excluded. The letter must be postmarked by July 14, 2012. If you exclude yourself, you cannot receive a benefit from this settlement, but you can sue the manufacturer of the Products for the claims alleged in this lawsuit. If you do not exclude yourself from the settlement or do nothing, you will be bound by the Court’s decisions.
For more information and to obtain a detailed notice, claim form, list of Products, or other documents, visit www.gilardi.com/boironsettlement or call, toll-free, 877-256-3879, or write to Boiron Claims Administrator, P.O. Box 8060, San Rafael, CA 94912-8060.
Why are there NuvaRing Lawsuits? Here’s NuvaRing by the Numbers…
May 25th, 2012. By AbiK
As NuvaRing lawsuits continue to wind their way through litigation, it’s interesting to look at some of the numbers on the contraceptive—as numbers tend to tell a story.
NuvaRing was also in the news recently for another reason: in a newly published study, apparently longer-term reversible contraception was found to be more effective in preventing pregnancy than shorter-term methods. Longer-term contraception would include IUDs and implants; shorter-term would be birth control pills, patches and rings. The study, published in the New England Journal of Medicine (5/24/12), found longer-term contraception to be 20 times more effective in preventing pregnancy (of course, one of the reasons cited for this was human error–such as forgetting to take the pill).
So here we go…
NuvaRing by the Numbers
2001: Year in which NuvaRing received FDA approval
950+: Number of NuvaRing lawsuits pending, as reported in Merck’s 10-K earnings report, fiscal year 2011
56%: Percent by which FDA study found NuvaRing raised risk of blood clots vs. older birth control pills.
6: Types of serious NuvaRing adverse events alleged in lawsuits (blood clots, pulmonary embolism, deep vein thrombosis, heart attack, stroke, sudden death)
6.5x: Times higher risk for NuvaRing blood clots compared to non-users of hormonal contraception, according to British Medical Journal study (5/10/12)
5,493: Total number of adverse events reported at the FDA AERS database for NuvaRing, 1Q’04-2Q’11*
30: Average age of women who have had a NuvaRing adverse event reported to the FDA*
1,953: Number of NuvaRing adverse events categorized under “Pulmonary Vascular”, 1Q’04-2Q’11*
1,921: Number of NuvaRing adverse events categorized under “Embolism & Thrombosis”, 1Q’04-2Q’11*
1,648: Number of NuvaRing pulmonary embolism adverse events reported, 1Q’04-2Q’11*
1,274: Number of NuvaRing deep vein thrombosis adverse events reported, 1Q’04-2Q’11
*Source: FDA NuvaRing AERS reports via drugcite.com
Actos Heart Attack Victims Back in the Ring for Round #2?
April 26th, 2012. By AbiK
Not long ago the diabetes drug Avandia had all the media focus. Patients who were on the drug were hit with a barrage of information—sometimes confusing, sometimes scary—about Avandia’s link to heart attack. And thus began the mad dash to switch over to Actos. After all, while there were also some studies linking Actos to heart attack (along with the infamous TIDE trial), they were reported to be “inconclusive”. Not concrete enough to stop a flurry of prescriptions.
And the black box warning that Actos received (along with Avandia) back in 2007 was only regarding heart failure risk in the form of congestive heart failure—not heart attack or myocardial infarction.
But some Actos patients had already suffered heart attack. And many had submitted complaints in hopes of an Actos lawsuit v. Takeda, the drug’s manufacturer. But their complaints, for all intents and purposes, seemed to fall on deaf ears—at least where lawyers were concerned.
How could it be? As lawsuits about Actos bladder cancer were sprouting up, Actos heart attack complaints fell by the wayside. And yet, given they share a drug class, thiazolidinediones, there seemed to be such similarity between Avandia and Actos—why, it would be almost intuitive that they could perhaps have similar side effect or adverse event profiles, right? And what about some of those studies—was there anything to them?
Then, something unforeseen happened in the form of former Takeda consultant, Dr. Helen Ge—the Actos whistleblower.
And suddenly, everything—sadly—made sense for those Actos patients who had tried to file Actos heart attack complaints. Only now, was it too late? They had already tried to contact lawyers who had rejected them or not taken up their cause simply because there wasn’t much the lawyers could do with them.
Now, however, there might be.
The Actos whistleblower lawsuit (U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043, U.S. District Court, District of Massachusetts (Boston)) has shone light on Dr. Ge’s assertion that Takeda knew about instances of Actos heart attack but downplayed them—for the sake of increasing their profits.
Dr. Ge claims she was let go from Takeda after she raised concerns over the company’s handling of the Actos safety data—and that officials at Takeda tried to direct medical reviewers, including Dr. Ge, to “change their professional opinion” regarding the potential dangers of Actos heart problems—specifically Actos myocardial infarction.
The whistleblower lawsuit is, in effect, a game-changer for Actos litigation. And former Actos victims might find that where there once was no direct path to an Actos lawsuit, there now might be.
Welcome to Round #2.
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