J&J’s DePuy Ortho faces $247m ruling in Pinnacle bellwether trial NOVEMBER 17, 2017
A Dallas federal jury this week ruled that Johnson & Johnson (NYSE:JNJ) and its DePuy Orthopaedics must pay $247 million to six patients claiming to be injured by its Pinnacle metal-on-metal hip implants, according to a Reuters report.
The verdict is the fourth test trial in Dallas federal court over the metal-on-metal Pinnacle hips, with over 9,000 cases pending.
Surgeon sues J&J’s DePuy in royalties dispute OCTOBER 31, 2017
A surgeon who helped Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes Spine develop instruments and implants for spine procedures wants a Massachusetts federal court to overturn an arbitrator’s ruling that the company doesn’t owe royalties on the products, according to a lawsuit filed last week in the Bay State.
Dr. Carl Lauryssen and his company, Jordan Consulting, helped develop the Mountaineer OCT spinal system and thethe C1 drill guide for occipito-cervico-thoracic spinal fusion procedures. The parties inked the development deal in 2003, but by November 2014 the arrangement had soured, leading Lauryssen and Jordan to file for arbitration. They alleged that DePuy breached the contract by underpaying royalties owed on the Mountaineer system and failing to pay royalties for the C1 drill guide, according to an Oct. 27 complaint filed with the U.S. District Court for Massachusetts.
DePuy’s counterclaim alleged that the royalties arrangement ended in March 2010 and sought to recoup royalties paid to Jordan and Lauryssen. Last month the arbitrator denied all of Jordan and Lauryssen’s claims and agreed that the royalty deal expired in March 2010, but denied DePuy’s bid to recoup any royalties, according to the complaint.
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From former employees of "johnson & johnson".
【 FDA issues Class I recall for select J&J Sterilmed Agilis steerable introducer sheaths 】 JANUARY 3, 2018 （2018年1月3日）
The FDA yesterday issued a recall for Johnson & Johnson (NYSE:JNJ) subsidiary Sterilmed’s reprocessed Agilis steerable introducer sheaths over issues with possible air embolisms, labeling the recall as a Class I.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
Sterilmed’s Agilis steerable introducer sheath is designed for the insertion and positioning of cardiovascular catheters in the heart, including the left side of the heart through the interarterial septum.
The devices are being recalled over issues with the incorporated hemostatic valve, designed to prevent blood flow back through the valve. The FDA noted that these valves may fail due to an improper seal of the sheath hub which could allow blood to leak back to the hub, resulting in the device’s cap falling off or a possible difference in pressure that could allow air into the circulatory system causing an air embolism.
The improper sealing occurs due to a lack of glue used to reattach the cap to the hub after reprocessing, while too much glue could block the sheath valve and make the device unusable. Results from the issues include serious health consequences for patients, including death, according to the FDA.
The federal watchdog said that patients with lower body mass index may be more at risk if blood loss occurs, and smaller patients and patients with pre-existing decreased pulmonary reserves may be extra susceptible to air embolisms.
The federal watchdog said that the recall affects 112 devices manufactured and distributed between January 1, 2017 and May 5, 2017, with product code PNE and model numbers STJ408309, STJ408310, STJG408324. All product lots are indicated in the recall, according to the FDA release.
Sterlimed instructed users of the device to examine inventory for affected devices and return unused products to the company.
FDAはこれをクラスIのリコールとしています。これは最も重大なリコールです。 これらのデバイスを使用すると、重大なけがや死亡を引き起こす可能性があります。 The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death./