Report: J&J willing to pay more than $400m to settle Pinnacle hip cases

Johnson & Johnson

Johnson & Johnson (NYSE:JNJ) is willing to put more than $400 million on the table to settle consumer allegations that its Pinnacle line of metal-on-metal hips were defective and caused problems including metal poisoning, according to a new report from Bloomberg.

Officials at the New Brunswick, N.J.-based company agreed to payments of approximately $125,000 per case on average to resolve about a third of the Pinnacle hips suit pending against the company, according to the report, which references people familiar with the settlement.

So far, J&J has settled or is in the process of settling approximately 3,300 out of 10,000 lawsuits targeting its Pinnacle line of hip-replacement devices, Bloomberg reports.

The $125,000 average payout would mean the company would need to pay approximately $413 million to settle the 3,300 cases, according to the report.

The medical giant is looking to resolve all remaining pinnacle cases before another trial begins next month, Bloomberg said, though the company remains in talks with lawyers for residual hip recipients who have sued.

The settlements mark the first payout after seven years of litigation over the metal-on-metal hip implants which were removed from the market in 2013, according to the report.

J&J has not yet officially commented on the settlements.

The company is set to return to court next month in Dallas, facing allegations from five Pinnacle-hip recipients that it rushed its Pinnacle device to the market and misled doctors about the device’s safety, according to Bloomberg.

Johnson & Johnson is reportedly seeking to settle cases with separate groups as handled by individual lawyers rather than one global settlement, the same tactic it used to resolve vaginal mesh cases.

In August, the Texas Northern District Court entered an approximately $246.1 million final judgement against J&J subsidiary DePuy Orthopaedics after a jury found J&J liable for defects and fraud related to Pinnacle hips.

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In2Bones intros ‘see-through’ implant for flat feet

(Image courtesy of In2Bones)

Orthopedic surgical device developer In2Bones announced the global launch of its “see-through” PitStop implant for children and adults with flat feet.

One of the most common foot deformities, flat-foot often starts during adolescence and continues into adulthood. In2Bones (Memphis, Tenn.) developed the PitStop subtalar implant to restore the stability of a patient’s arch during the walking process.

Several traditional metallic sublatar implants can be limiting because of material’s stiffness compared to the adjacent bones, causing pain and biomechanical adaptation in some cases. In2Bones makes the PitStop from PEEK, which is softer and more elastic than metal in hopes it will lead to increased and long-term patient tolerance. PEEK also won’t show up on X-rays.

The company also published a micro website to provide healthcare providers with surgical animations and videos, surgical technique guides, case studies and patient support materials.

In2Bones is a global designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the hand, wrist, elbow, foot and ankle.

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Nexxt Spine launches Saxxony posterior cervical spine system

saxxony-nexxt-spineNexxt Spine has received FDA 510(k) clearance and has commercially launched its Saxxony Posterior Cervical Thoracic System.

The system is designed to stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments through posterior screw fixation.

“The Saxxony System adds a robust posterior complement to our well received anterior cervical fixation offering as we continue to innovate and grow our fusion portfolio,” Andy Elsbury, president of Nexxt Spine, said in a press release.

Get the full story on our sister site, Medical Design & Outsourcing.

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OrthoPediatrics announces pricing of common stock offering

OrthoPediatricsOrthoPediatrics (NSDQ:KIDS) said today it will price an underwritten follow-on public offering of 1.5 million shares of its common stock at $27 per share.

The company said it plans to use the proceeds of offering to invest in implant and instrument sets for consignment to its customers, fund research and development activities, expand its sales and marketing programs and working capital and general corporate purposes.

The offering is expected to close on or around December 11, 2018, according to a regulatory filing. The Warsaw, Ind. company has also granted the underwriters a 30-day option to purchase up to an additional 225,000 shares of its common stock at the public offering price.

In May, OrthoPediatrics won FDA 510(k) clearance for its Femur pediatric nailing platform. The company’s Femur system is designed to accompany two pediatric-specific nail offerings and is an upgrade to an earlier version of the device. OrthoPediatrics said the clearance of the device is the “next step” in the evolution of its intramedullary nailing franchise.

The company’s shares opened at $27.25 today, and had climbed to $30 by noon Eastern time.

 

 

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Bruin Biometrics lands second SBIR award for ortho device

Bruin Biometrics (BBI) said it has won a $1.4 million Small Business Innovation Research (SBIR) Phase II program award from The National Institute of Arthritis and the musculoskeletal and skin division of the National Institutes of Health.

BBI (Los Angeles) uses biometric sensor technology to aid clinicians in the early detection and monitoring of chronic, preventable conditions. The award will help advance the detection capabilities, design and clinical evaluation of the company’s OrthoSonos, a novel acoustic emission device for orthopedics.

Get the full story on our sister site, Medical Design & Outsourcing.

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Doc inventor wins $113m in royalties spat with Medtronic

Medtronic logo updatedA state court jury in Indiana last week reportedly awarded a $112 million decision to a local spine surgeon turned medical device inventor in his five-year royalties dispute with Medtronic (NYSE:MDT).

Dr. Rick Sasso sued Medtronic in 2013, alleging that the world’s largest medical device maker shorted him on their royalties deal for the Vertex cervical spine system he helped develop, according to the Indianapolis Business Journal.

Sasso licensed some of his early inventions to Sofamor Danek, about a year before its $3.3 billion merger with Fridley, Minn.-based Medtronic in January 1999, the newspaper reported. Further deals for spine stabilization devices followed, including some that eventually hit the market under the Vertex brand. The company agreed to pay him 2% of net sales for eight years or the life of the patent if it it is used in a device covered by a valid patent claim. Sasso argued that the Vertex system is covered by several valid patents and that Medtronic left out other products that used Vertex components, undercounting the sales calculation for his royalties.

The $112.5 million verdict lodged Nov. 28 culminated a five-year campaign that saw Sasso lose several battles. In 2015 an Indiana state court found that he never transferred his patent to his corporation, meaning it could not have licensed the technology to Sofamor Danek. Medtronic, having already paid Sasso some $23 million, didn’t owe him anything more, according to the ruling, which was later upheld by the Indiana state appeals court.

After amending his complaint three times, Sasso found favor with a six-person Marshall County Circuit Court jury last week, which deliberated for six hours after a trial that lasted nearly a month, according to the business journal.

In a quarterly regulatory filing, Medtronic said it has “strong arguments to appeal the verdict” and plans to file post-trial motions appeal if necessary.

“The company has not recognized an expense in connection with this matter because it does not currently believe a loss is probable under U.S. GAAP,” the company said in the filing.

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Wishbone Medical picks up pediatric device maker Response Ortho

WishBone Medical acquires Response OrthoWishBone Medical said this week that it acquired Turkish pediatric fixation device maker Response Ortho for an undisclosed amount.

Istanbul-based Response’s portfolio includes 30 pediatric orthopedic systems; WishBone had eight before the acquisition, the Warsaw, Ind.-based company said.

Eighteen of the Response Ortho products are cleared or approved for the U.S. market. Wishbone said it’s opursuing 501(k) clearance for the others.

“With the acquisition of Response Ortho, we are thrilled about our pediatric orthopedic product offerings. The combination of Response Ortho’s thirty product systems and WishBone’s eight product systems will give WishBone Medical the broadest product portfolio in pediatric orthopedics worldwide,” founder, chairman & CEO Nick Deeter, who also founded OrthoPediatrics, said in prepared remarks. “These pediatric orthopedic products can be delivered in sterile packed, procedural kits anywhere in the world, next day, to the surgeons that care for children.”

“We are excited that Response Ortho is now part of WishBone Medical. Our primary focus has been outside the U.S., and we will now be able to offer these innovative orthopedic product systems everywhere. Having more than 50 years of combined experience, Nick and I understand the unmet needs and will provide global solutions to children with orthopedic issues,” added Response Ortho CEO Sehmuz Isin.

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United Orthopedic wins FDA nod for E-XPE hip liner

United Orthopedic Corp said today that it won FDA clearance for its E-XPE vitamin E highly cross-linked polyethylene hip liner.

The Irvine, Calif.-based company said that the E-XPE is a next-gen version of its highly cross-linked polyethylene blended with vitamin E intended to improve wear resistance and maintain oxidative stability and mechanical properties.

United Orthopedic said that accelerated aging tests showed that its E-XPE inserts and liners exhibited a 60% to 75% reduction in gravimetric wear, respectively.

“Oxidation continues to be a concern for surgeons. Over time, wear of conventional polyethylene can generate debris in the joint, triggering local inflammation that results in bone loss which is one of the biggest causes of late-term failure in hip and knee replacements. Clearance of our E-XPETM, a vitamin E highly cross-linked polyethylene, provides surgeons with an alternative implant for their patient. Our vertically integrated manufacturing process affords us the flexibility to design, manufacture and distribute implants or instruments that address many of the most significant needs in the orthopedic industry,” prez Calvin Lin said in a press release.

Last May, United Ortho said that it launched a trial of its U2 total knee arthroplasty system and enrolled the 1st patient in the trial.

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Zimmer Biomet recalls bone stimulators on contamination risk

Zimmer Biomet logoZimmer Biomet (NYSE:ZBH) recalled nearly 1,400 bone stimulators on the risk that they could be contaminated with bacteria or chemicals, the FDA said yesterday.

The Class I recall, denoting the risk of serious injury or death, covers 1,360 implantable bone growth and spinal fusion stimulators made and distributed between February 2015 and March 2018, including Zimmer Biomet’s Osteogen, SpF Plus-Mini and SpF-XL stimulators, the federal safety watchdog said.

The devices are designed to stimulate healing after spinal fusion procedures or long-bone breaks. The voluntary recall was launched Feb. 19 “due to a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue,” the FDA said.

“The lack of adequate validation and controls may or may not cause serious side effects for the patient including infection, tissue death, additional surgery for wound treatment and/or device removal, impaired wound and bone healing, the need for long-term antibiotic therapy, the potential for secondary gastroenteritis, swelling and infection around the spinal cord (epidural abscess), paralysis, damage to other organs or death,” the agency warned.

It’s the latest regulatory stumble for Warsaw, Ind.-based Zimmer Biomet, which received a warning letter from the FDA last summer over quality violations found during 2016 and 2018 inspections there.

The FDA inspected the North Campus facility in Warsaw just before Thanksgiving 2016, documenting numerous violations in a Form 483 m notification. The company’s lengthy reply that December detailed its actions in remediating the problem, noting that company-wide audits put in place after the $14 billion merger of Zimmer and Biomet had already turned up problems at the site. Zimmer said it cleaned house after the inspection, replacing five operations and quality executives as it sought to bring the facility back into compliance.

But a re-inspection last April resulted in another Form 483 and then the warning letter flagging “continuing, significant violations of the quality system regulations” found during the April 2018 inspections, including failure to show that its process for corrective and preventive actions can ensure that the plant meets finished product specifications and the lack of adequate training procedures. The inspectors also found problems with the North Campus facility’s design validation processes, its handling of non-conformance reports and its CAPA implementation, according to the warning letter.

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SIG Medical wins FDA nod for Advantage Rib fracture repair device

SIG Medical

SIG Medical said this week it won FDA 510(k) clearance for its AdvantageRib anterior system, a rib fracture system.

The newly cleared AdvantageRib anterior system includes anatomically contoured titanium plates intended to closely fit patient anatomy and screws, and is intended to be used through a traditional anterior approach. The system also features straight plates to allow the surgeon to create a construct to fit challenging clinical scenarios.

“We are thrilled to have achieved this approval and now have the most comprehensive portfolio of rib fracture products. The AdvantageRib family of products is truly revolutionary and will change how suffering patients are treated.  Surgeons now have choices as to how best to treat their patients, in both a traditional manner or with our novel system that is on the forefront of improving how rib fractures are managed.  Today is a huge leap for us and the medical community as a whole,” product dev & marketing VP Andrew Davison said in prepared remarks.

Screws included with the system include self-drilling, self-tapping, locking and non-locking screws in a range of different sizes to fit varying anatomy, SIG Medical said.

“We have a world class team, working capital, and now the most complete line of products to lead the market in fixing fractured ribs. The AdvantageRib family of products will have a significant impact on the algorithm of care for decades to come and I am proud to be part of such an exciting movement,” prez & CEO Ken Kremer said in a press release.

The device is the second rib fracture system that the Hershey, Penn.-based company is commercializing, according to a press release.

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