Defective Products Archive
After Alcohol Wipe Screw-Ups, Triad Decides to Play with Makeup
October 18th, 2012. By AbiK
Ok, could be makeup. Could be some anti-aging wonder. Could be your run-of-the-mill hand soap. Who knows? The initial reports regarding Triad Group’s foray into cosmetics have been a bit lacking in detail as to what exactly will be coming of the manufacturing lines at Triad’s Hartland, WI production plant.
Triad, if you recall, was at the heart of the alcohol prep pad, alcohol swab and alcohol swabstick, aka alcohol wipe recall of last year—the one connected to the death of 2-year old Harrison Kothari in Texas who contracted acute bacterial meningitis caused by Bacillus cereus bacteria. The Kotharis have settled with Triad—as have a dozen others who filed contamination lawsuits (details of the settlements have not been disclosed).
Fast-forward a year. The Milwaukee Journal Sentinel reported that Triad, which filed for bankruptcy protection on the heels of its $5 million insurance policy being drained on the lawsuits just mentioned, has indicated it would like to re-establish itself as a cosmetics company.
Every cat has nine lives, right?
The Journal Sentinel quoted Triad’s COO, Eric Haertle, as saying at the company’s first meeting with creditors in bankruptcy court, “We are in the infancy stage of these opportunities. We have talked to industry vendors. I am encouraged and optimistic about the support we are receiving if we can put a plan together and resume operations.”
What’s interesting here is not so much that Triad even wants to emerge like a phoenix from the ashes—hey, it’s a business wanting to cut its losses and get on with things—no, the interesting thing is their costume change; they’ll now wear the i.d. of “cosmetics company” rather than that of “medical device” company—and that has benefit for a company whose odds of reincarnation under their former classification are next to nothing.
See, in order for Triad to go back to being a medical device company and manufacturing as it had before, it faces some intense scrutiny by the FDA. According to the Journal Sentinel, both the FDA and Triad would need to agree to the FDA’s consent decree which would impose a $15,000 per day fine—per violation—should Triad fail to comply with FDA policies. Additionally, the decree would subject Triad to FDA inspections without prior notice–and those inspections could cover everything from equipment to raw materials to finished products to packaging. The decree also calls for the company to post a $4 million bond.
No small undertaking to set up shop again.
But, there’s an escape hatch: re-establishing itself as a cosmetics company means less rigorous regulation and oversight by the FDA. And given that the consent decree to operate as a medical device company again could cost Triad millions—with no guarantee they’ll even pass with flying colors—well, the land of lipstick bullets, lotions and potions suddenly has tremendous appeal.
On second thought, maybe there is a clue as to what cosmetics will be coming off Triad’s production line—those Triad alcohol swabsticks look a lot like those cotton swabs used to smudge eyeliner (for that smoky eye look) or to clean up little makeup mistakes…hmm…just wondering…
MSNBC Video: Maybe Propecia Side Effects Don’t Ever Go Away
July 13th, 2012. By AbiK
Not good news for the men who allege they’ve been affected by Propecia side effects including sexual dysfunction, erectile dysfunction and even infertility. Check out the msnbc video below—and if you’re considering legal help yourself after taking the hair loss drug, you can fill out a Propecia complaint form here.
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.
Alert: Whirlpool Dishwasher Fires Lead to Class Action Lawsuit
November 18th, 2011. By AbiK
A class action lawsuit is always news around here, but a lawsuit that arises from a multitude of consumers complaining about fires erupting from their Whirlpool dishwashers is cause for an APB. So please pass this along for everyone’s safety.
A class action lawsuit has been filed in California alleging that Whirlpool (manufacturer of Whirlpool, KitchenAid and Sears Kenmore dishwashers) knew of a product defect in their dishwashers but hid that information from the public.
According to a grassroots consumer complaint website (kitchenaidfire.com), Whirlpool dishwasher owners report that the fires appear to have started in the machines’ control circuit boards. The video from WPRI.com above shows where the dishwasher fire originated for one owner.
Oreck Vacuum Class Action, Again (Oreck Air Purifier, too)
October 26th, 2011. By AbiK
Separated at Birth? Oreck Halo and Close Encounters of the Third Kind
Third time’s a charm? Seems we’ve been covering the Oreck germ-killing claim filings for a while now—indeed, we were posting about it back in 2007 when a lawsuit was filed claiming that an Oreck air purifier did not alleviate allergy symptoms (that one was thrown out).
Then just last spring we posted about the Oreck class action lawsuit—Ruscitti v. Oreck Corporation 1:11-cv-03121. In that one, plaintiffs allege Oreck made false claims regarding the Oreck Halo vacuum’s ability to kill germs; specifically, to “kill and reduce virtually all bacteria, viruses, germs, mold, and allergens that exist on carpets and floor surfaces”. You can read our interview with the plaintiffs’ attorney on that one, too.
The Oreck Halo apparently claimed to use UV light to knock out those bad germs. Pictures of the vacuum in use conjure up a scene straight out of Close Encounters of the Third Kind—clearly the Halo designer must’ve had a childhood fixation with the flick (see separated at birth image above—seriousl
y).
Aside from whatever the inspiration was for the vacuum, it’s the advertising that’s at issue. As the ad at right depicts, the Oreck Halo was touted with the headline, “When the light is on, the germs are gone” —and there’s that graphic of the sideways bracket under the word “Kills” that just hangs there as if to literally suck all those bad viruses, mites, bacteria…right up off the ad itself. Why, this would be an asthmatics dream, right?
Wrong—and the FTC didn’t think so either…
In the midst of all these lawsuits, the FTC came down on Oreck for false and deceptive health claims, which led to Oreck coughing up a fine of $750k last May. Oreck, as a quick web search confirms, also stopped selling the Halo vacuum. (They do still sell Oreck Halo vacuum bags, though—for those who’d already drank, or bought, the Kool-Aid®).
Ok, so now we’re at number three…
Another Oreck class action lawsuit has been filed—just last Friday—in California seeking over $5 million in damages. What are the damages you ask? Well, again, it’s about false claims regarding the Halo and Oreck’s ProShield air purifier and their ability to kill germs. Rewind that tape…here’s the heart of the matter straight from the lawsuit: “Defendants’ claims are not adequately supported by credible, scientific testing or other substantiation and are not true”.
The plaintiffs in the new Oreck Halo class action are Roxy Edge of Los Angeles, CA and Linda Gonzalez of Broome County, NY.
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