Saturday, February 23, 2013

FDA announces Class I recall of DePuy LPS Diaphyseal Sleeve

The FDA announced a Class I recall of the DePuy Orthopaedics LPS Diaphyseal Sleeve that was manufactured from 2008 to July 20, 2012, after reports of fractures and loosening. The recall was initiated February 15 and on January 4, DePuy issued an urgent medical device recall for the product, which is used in knee arthroplasty revision surgery.

The taper connection of the LPS Diaphyseal Sleeve to the Diaphyseal Sleeve Base may be insufficient for loads possibly transferred to the junction during normal gait in some patients, according the FDA notice.
“DePuy is not recommending revision or additional follow-up in the absence of symptoms of patients with this implanted device,” the FDA stated. “However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing these symptoms.”

 http://www.healio.com/orthopedics/knee/news/online/%7BA2DAE9FD-6AFC-43CE-940E-9D4719E63F25%7D/FDA-announces-Class-I-recall-of-DePuy-LPS-Diaphyseal-Sleeve

Suing a cruise line like Carnival? Options limited, usually to Florida Courts

Having seen the many people on news reports, in internet segments, and elsewhere talking about what they plan to do after the cruise ship debacle, here are some interesting reads:

Cruise typically lines prohibit passengers from suing over emotional distress — the kind that can result from nearly a week of overflowing toilets, scarce food and crushing boredom.

Passengers may only sue over real physical injuries. That provision is contained in the 10 to 15 pages of conditions, couched in a thicket of legalese, that accompanies each cruise ticket.
And those contracts go largely unread.


The bar against distress claims is one of several limits on a passenger's right to sue a cruise line.


Among the terms and conditions of the contract are provisions about where someone can file suit. Carnival, like other big lines such as Royal Caribbean and Norwegian, specify that all cases must be filed in Miami federal court.

 One must file suit within a year, damages are capped at $675,000, and some cruise lines require a prospective plaintiff to give notice of a planned lawsuit six months before actually filing.

 http://articles.sun-sentinel.com/2013-02-16/news/fl-stranded-carnival-triumph-payments-20130215_1_cruise-line-carnival-triumph-future-cruise

Cruise ships departing from U.S. ports are deemed common carriers pursuant to the Shipping Act of 1984, 46 U.S.C. §1702(6). Common carriers owe their passengers a heightened duty of care in protecting them from physical harm and ensuring they arrive at their destinations safely. This special duty of care owed to passengers includes protection from crew members' assaults, rapes, and other criminal attacks.

 Cruise ships departing from U.S. ports are deemed common carriers pursuant to the Shipping Act of 1984, 46 U.S.C. §1702(6). Common carriers owe their passengers a heightened duty of care in protecting them from physical harm and ensuring they arrive at their destinations safely. This special duty of care owed to passengers includes protection from crew members' assaults, rapes, and other criminal attacks.

Tuesday, February 05, 2013

FoodState Recalls Bottles of MegaFood One Daily Supplements Due to Lack of Child-Resistant Packaging

From the CPSC

Hazard:
The packaging is not child-resistant as required by the Poison Prevention Packaging Act. The supplement tablets inside the bottle contain iron, which can cause serious injury or death to young children if multiple tablets are ingested at once.

http://www.cpsc.gov/en/Recalls/2013/FoodState-Recalls-Bottles-of-MegaFood-One-Daily-Supplements/

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