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Ethicon 3/6
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J&J, Ethicon Hit For $5.7M In Calif. Pelvic Mesh Trial
Mar 5, 2015 | Law 360
By Kat Greene
A California jury on Thursday saddled Johnson & Johnson’s Ethicon Inc. unit with a $5.7 million verdict, siding with a woman who claimed her doctor had given her an older... -
$5.7M Verdict Against Pelvic Mesh Maker in Test Case
Mar 5, 2015 | The National Law Journal
By Amanda Bronstad
Johnson & Johnson lost a $5.7 million verdict on Thursday in the first test case over one of its newest pelvic mesh slings, which is among dozens of similar devices named in thousands of lawsuits across the country. -
J&J Ordered to Pay $5.7 Million Over Incontinence Implant
Mar 5, 2015 | B,oomberg
By Jef Feeley
Johnson & Johnson was ordered by a California jury to pay $5.7 million to a woman who said one of the company’s Abbrevo vaginal-mesh implants eroded inside her, forcing her to have surgery, in the first verdict over that device. -
UPDATE 2-Johnson & Johnson Ordered to pay $5.7 mln in California Mesh Trial
Mar 5, 2015 | Reuters
By Jessica Dye
A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo... -
Calif. Ethicon Abbrevo Transvaginal Mesh Trial Ends in $5.7 Million Verdict for Plaintiff
Mar 5, 2015 | Harris Martin Publishing
A California jury has awarded a transvaginal mesh plaintiff $5.7 million in compensatory and punitive damages on her claims that Johnson & Johnson and Ethicon Inc. hid the risks associated with their Gynecare TVT Abbrevo Sling System. -
Local woman wins $5.7 million in lawsuit against Johnson & Johnson
Mar 5, 2015 | The Bakersfield Californian
By Courtenay Edelhart
A jury returned a $5.7 million verdict Thursday in favor of a 50-year-old Tehachapi woman who had sued Johnson & Johnson and a subsidiary over a medical device that has generated a slew of similar lawsuits nationwide -
**Breaking News* Verdict In! $5.7 Million for Ms. Perry in her Pelvic Mesh Trial
Mar 5, 2015 | Mesh Medical Device News Desk
By Jane Akre
During its fourth day of deliberations, the jury in the product liability trial of Perry v. Ethicon finally decided for the plaintiff, Coleen Perry and awarded her $5.7 million. -
Scope Blamed for Superbug Infections Not FDA Cleared
Mar 5, 2015 | Medical Device and Diagnostic Industry
By Marie Thibault
...In March 2012, Bloomberg News reported that Johnson & Johnson had sold a vaginal mesh implant for three years, between March 2005 and May 2008, without FDA clearance...
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J&J, Ethicon Hit For $5.7M In Calif. Pelvic Mesh Trial
Mar 5, 2015 | Law 360
By Kat Greene
A California jury on Thursday saddled Johnson & Johnson’s Ethicon Inc. unit with a $5.7 million verdict, siding with a woman who claimed her doctor had given her an older, heavier version of a pelvic mesh product that will cause her a lifetime of pain.
The jury awarded plaintiff Coleen Perry $700,000 in compensatory damages and $5 million in punitive damages after deliberating for three days, court records show. Perry had sued Ethicon, Johnson & Johnson and her doctor in California state court over injuries from her TVT Abbrevo mesh.
Ethicon and J&J will appeal the verdict, a spokesman for Ethicon said in a statement Thursday.
“We have strong grounds for appeal as we believe the evidence showed the TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development and marketing of the product,” the spokesman said. “We have always made patient safety a top priority and will continue to do so.”
Tens of thousands of plaintiffs have sued pelvic mesh-makers over complications with the products, alleging the mesh, which is placed in women to manage stress urinary incontinence and pelvic organ prolapse, is responsible for a litany of injuries.
In West Virginia, a federal jury in September hit Ethicon with a $3.3 million verdict over its TVT-O transvaginal sling, finding in favor of plaintiff Jo Huskey on all counts, including strict liability, design defect, failure to warn and negligence. Punitive damages were not awarded.
And other companies that make pelvic mesh products have also been hit with big-dollar verdicts by juries that sided with the plaintiffs who complained of erosion of the mesh that caused severe pain and necessitated more surgeries, among other injuries, court records show.
Boston Scientific Corp. was dinged for $73 million in September by a Texas state jury that found the company’s Obtryx-brand transvaginal sling was defectively designed and caused severe injuries, the company’s first loss in pelvic mesh litigation.
And a West Virginia judge in January refused to dismantle a $2 million verdict against C.R. Bard Inc. despite the company’s protests that the August verdict wasn’t supported by enough evidence.
But Ethicon has had some success in the pelvic mesh litigation. On Monday, the Fourth Circuit refused to undo the company’s win in multidistrict litigation, finding that plaintiff Carolyn Lewis hadn’t sufficiently shown that a different warning by Ethicon as to the TVT’s alleged risks would have changed her doctor’s decision to prescribe the device. Lewis had appealed a lower court’s ruling that granted summary judgment to Ethicon on her failure-to-warn claim.
Representatives for the plaintiff didn't immediately respond to requests for comment late Thursday.
Coleen Perry is represented by Richard Freese, Tim Goss and Calle Mendenhall of Freese & Goss PLLC, Tom Cartmell of Wagstaff & Cartmell LLP, Stewart R. Albertson ofAlbertson & Davidson LLP and Peter de la Cerda of Edwards & de la Cerda PLLC.
The defendants are represented by William Gage, Burt Snell and Harold T. Pinkley ofButler Snow PLLC, Kim Schmid of Bowman and Brooke LLP and Joshua J. Wes and Su Lin of Tucker Ellis LLP.
The case is Perry et al. v. Luu et al., case number S-1500-cv-279123, in the Superior Court of the State of California, Kern County. -
$5.7M Verdict Against Pelvic Mesh Maker in Test Case
Mar 5, 2015 | The National Law Journal
By Amanda Bronstad
Johnson & Johnson lost a $5.7 million verdict on Thursday in the first test case over one of its newest pelvic mesh slings, which is among dozens of similar devices named in thousands of lawsuits across the country.
The verdict, by a jury in Bakersfield, Calif., is the latest to hit Johnson & Johnson, whose Ethicon Inc. subsidiary has lost verdicts over its other mesh devices. The trial, which began on Jan. 26, was the first over Ethicon’s TVT-Abbrevo device, which is used to treat urinary incontinence caused from sudden movements. The plaintiff, Coleen Perry, had alleged that she had pain and continued urinary problems after having the device implanted in 2011.
The jury, in Kern County, Calif., Superior Court, found that the device was defectively designed and that Ethicon failed to warn doctors of its problems, according to a recording of the verdict on Courtroom View Network. Jurors also awarded $700,000 in compensatory damages and $5 million in punitive damages.
Johnson & Johnson immediately said it planned to appeal.
“We have strong grounds for appeal as we believe the evidence showed that TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development and marketing of the product,” Ethicon spokesman Matthew Johnson said. “TVT Abbrevo has been deemed safe and effective by regulators and practitioners alike.”
Peter de la Cerda at Edwards & de la Cerda of Dallas, one of the lead plaintiffs attorneys in the case, said, "We could not be happier for Mrs. Perry." He added, “The jury’s verdict shows thoughtfulness for the serious and life-altering injuries she sustained from the TVT Abbrevo. The jury’s verdict also sends a clear message to Ethicon Inc. and Johnson & Johnson—the concerned citizens of California will not stand for these manufacturers’ improper conduct in designing and marketing the TVT Abbrevo.”
Ethicon is one of seven manufacturers being sued over pelvic mesh devices. The verdict comes as Ethicon began trial on March 2 in a bellwether case from among more than 23,000 lawsuits in U.S. District Court for the Southern District of West Virginia. Ethicon lost the first trial in that docket on Sept. 5 when a jury in Charleston, West Virginia, awarded $3.27 million.
U.S. District Judge Joseph Goodwin dismissed the first bellwether case before trial ended for lack of evidence. On March 2, the U.S. Court of Appeals for the Fourth Circuit affirmed that decision.
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J&J Ordered to Pay $5.7 Million Over Incontinence Implant
Mar 5, 2015 | B,oomberg
By Jef Feeley
Johnson & Johnson was ordered by a California jury to pay $5.7 million to a woman who said one of the company’s Abbrevo vaginal-mesh implants eroded inside her, forcing her to have surgery, in the first verdict over that device.
Jurors in state court in Bakersfield deliberated for more than three days before concluding Thursday that J&J’s Abbrevo mesh sling was defectively designed and officials of J&J’s Ethicon unit failed to properly warn doctors and consumers about the device’s risks. The panel awarded Coleen Perry $700,000 in compensatory damages and $5 million in punitive damages over the mishandling of the device.
The verdict is the first to find fault with the Abbrevo sling, which J&J introduced in 2010 as its latest innovation for treating incontinence in women. Analysts say the market for such devices is expected to top $1.7 billion by 2017.
“The message here is that Johnson & Johnson can’t defend the safety and reliability of its newest” incontinence sling, Richard Freese, one of Perry’s lawyers, said Thursday.
J&J officials said they planned to appeal the verdict because company executives don’t think they mishandled the device.
“The evidence showed the TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development and marketing of the product,” Matthew Johnson, an Ethicon spokesman, said in an e-mailed statement.Organ Damage
J&J, based in New Brunswick, New Jersey, faces more than 30,000 lawsuits accusing Ethicon of making improperly designed vaginal inserts that damaged women’s organs and made sex painful.
In June 2012, J&J voluntarily pulled four lines of mesh inserts, including the Prolift implant, off the market. It still sells the Abbrevo and other incontinence-sling lines.
The decision to stop selling the Prolift and other mesh inserts came six months after regulators ordered J&J and more than 20 other makers of such devices to study organ damage and other health complications blamed on the products, which treat incontinence and shore up weakened pelvic muscles.
Many of the vaginal-mesh cases against J&J and other implant makers have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia, for information exchanges and bellwether trials. J&J alerted Goodwin in 2012 that it was ending sales of some lines of inserts.Settlement Talks
Boston Scientific Corp., C.R. Bard Inc. and other makers of vaginal inserts targeted in suits had talks last year about settling cases over the devices, according to people familiar with the discussions. J&J has refused to participate in settlement talks about its inserts, the people said.
In the California case, Perry, a retired caterer, said she got her Abbrevo sling implanted in 2011 to treat incontinence. Erosion problems with the device forced her to have surgery to remove part of it the following year, according to court testimony.
Along with the findings about the device being defectively designed and Ethicon officials’ failure to adequately warn about its risks, the California jury concluded that company officials “negligently misrepresented” facts about the sling’s safety, Freese said.
J&J’s lawyers argued during the eight-week trial that the Abbrevo sling was the “gold standard” for treating incontinence and that Ethicon officials properly tested it before putting it on the market.
A jury in state court in Dallas last year concluded the design of a TVT-O incontinence sling implanted in a woman was flawed and she deserved $1.2 million in compensatory damages. The TVT-O sling remains on the market.
The California case is Perry v. Luu, 1500-CV-279123-LHB, Superior Court of California, Kern County (Bakersfield). The J&J consolidated cases are In re Ethicon Pelvic Repair System Products Liability Litigation, 12-md-2327 U.S. District Court, Southern District of West Virginia (Charleston).
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UPDATE 2-Johnson & Johnson Ordered to pay $5.7 mln in California Mesh Trial
Mar 5, 2015 | Reuters
By Jessica Dye
A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo, one of numerous transvaginal mesh products that are the subject of thousands of lawsuits.
Following more than three days of deliberations in Kern County, California, jurors found Ethicon liable for problems with the TVT Abbrevo's design and for failing to warn about its risks, according to a lawyer for plaintiff Coleen Perry.
Perry was awarded $700,000 in compensatory damages and an additional $5 million in punitive damages after jurors in the Bakersfield court found Ethicon's conduct amounted to "malice," her lawyer said.
The verdict is the fourth win for plaintiffs suing Ethicon over transvaginal mesh. More than 36,000 lawsuits have been filed against Ethicon in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse.
The Abbrevo, one of Ethicon's newer models of mesh products, was cleared for sale by the U.S. Food and Drug Administration in 2010 to treat stress urinary incontinence. Perry, who was implanted with it in 2011, said she began experiencing a "pulling-type" pain almost immediately after surgery.
Perry said the mesh began to erode in her body, causing pain that she said she expects to last the rest of her life, according to testimony Reuters saw on Courtroom View Network.
Ethicon's lawyers said the product was thoroughly vetted before it hit the market and that doctors considered the mesh used in the Abbrevo to be the "gold standard" for incontinence treatment.
Peter de la Cerda, a lawyer for Perry, said the verdict sent a "clear message to Ethicon" about its "improper conduct in designing and marketing the Abbrevo."
Ethicon spokesman Matthew Johnson said the company believed it has strong grounds for appeal. Ethicon stands behind the safety and effectiveness of the Abbrevo, as well as its development and marketing, he added.
Ethicon won one trial over mesh in federal court in West Virginia, where another trial over its mesh products started on Monday.
Ethicon, Boston Scientific Corp and C.R. Bard are among seven companies facing more than 70,000 mesh injury lawsuits in federal court and thousands of additional cases in state courts.
The case is Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123.
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Calif. Ethicon Abbrevo Transvaginal Mesh Trial Ends in $5.7 Million Verdict for Plaintiff
Mar 5, 2015 | Harris Martin Publishing
A California jury has awarded a transvaginal mesh plaintiff $5.7 million in compensatory and punitive damages on her claims that Johnson & Johnson and Ethicon Inc. hid the risks associated with their Gynecare TVT Abbrevo Sling System.
After deliberating for four days, the jury, sitting in the Kern County Superior Court, awarded plaintiff Colleen Perry $700,000 in compensatory damages and $5 million in punitive damages. The trial began on Jan. 26, with Judge Lorna Brumfield presiding.
The jury by a 9-3 split found the Abbrevo device was defectively designed, and 10-2 found defendants failed to warn Perry's ...
Sibscription required, for full story please see: http://harrismartin.com/article/19176/calif-ethicon-abbrevo-transvaginal-mesh-trial-ends-in-57-million-verdict-for-plaintiff/
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Local woman wins $5.7 million in lawsuit against Johnson & Johnson
Mar 5, 2015 | The Bakersfield Californian
By Courtenay Edelhart
A jury returned a $5.7 million verdict Thursday in favor of a 50-year-old Tehachapi woman who had sued Johnson & Johnson and a subsidiary over a medical device that has generated a slew of similar lawsuits nationwide.
"I'm super grateful," said Coleen Perry, dabbing tears with a tissue after the verdict was read in Kern County Superior Court. "Of course I'm very happy about it not only for myself, but this is a step in the right direction for all the thousands upon thousands of mesh victims out there who are still waiting for their day in court."SHARE1Print
Johnson & Johnson and wholly owned subsidiary Ethicon, Inc. said they would appeal the jury verdict in the case involving Ethicon's TVT Abbrevo pelvic mesh.
The device is used as a minimally invasive treatment for women suffering from stress urinary incontinence, or SUI.
"We have strong grounds for appeal as we believe the evidence showed the TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development and marketing of the product," said Matthew Johnson, director of communications for Ethicon, in a written statement. "We have always made patient safety a top priority and will continue to do so.
"We empathize with all women suffering from SUI, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events. TVT Abbrevo has been deemed safe and effective by regulators and practitioners alike, and it continues to be an important option for treating physicians to offer to women suffering from SUI."
Perry filed a lawsuit against New Brunswick, N.J.-based Johnson & Johnson and Ethicon in April 2013 over complications from the medical device implanted in her in March 2011 to treat stress-induced incontinence, or brief urination with coughing, sneezing, laughter or other exertion.
Pelvic mesh products have been marketed to treat both stress-induced incontinence and pelvic organ prolaps, or POP. That's when the muscles and ligaments supporting a woman's pelvic organs weaken, which can allow organs to slip out of place. The condition is common among older women and those who have undergone hysterectomies.
There has been a tidal wave of lawsuits over synthetic surgical meshes implanted through the vagina since the U.S. Food and Drug Administration issued a notification in 2008 that it had received high numbers of complaints about them. Three years later, the FDA issued an advisory saying serious complications associated with surgical mesh for transvaginal repair of POP were "not rare."
The devices cannot be removed after implantation because over time they become intertwined with surrounding tissue.
In 2012, a jury awarded Christine Scott of Bakersfield $3.6 million in a similar case against C.R. Bard Inc., which manufactured a device placed in her body to treat POP.
Both women said after the implants, their incontinence did not improve, and they were left with chronic pain that had ruined their ability to have comfortable intercourse.
Both said that their husbands could feel the mesh poking through the vaginal wall during sex. Perry's husband had suffered abrasions to his penis as a result, she and her husband said.
Scott was in court to support Perry Thursday, and the women embraced after the trial concluded.
The jury award consisted of $700,000 in compensatory damages and $5 million in punitive damages.
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**Breaking News* Verdict In! $5.7 Million for Ms. Perry in her Pelvic Mesh Trial
Mar 5, 2015 | Mesh Medical Device News Desk
By Jane Akre
Verdict Day
During its fourth day of deliberations, the jury in the product liability trial of Perry v. Ethicon finally decided for the plaintiff, Coleen Perry and awarded her $5.7 million.
This morning the jury in the Bakersfield, California court was reportedly quiet and did not seek any additional testimony as they had during the three previous days.
Ms. Perry was implanted with an Abbrevo mini-sling in 2011, as a treatment for incontinence. She has since suffered chronic pelvic pain, dyspareunia, mesh erosion, shrinkage of the mesh and scar tissue formation, among other complications.The verdict break down includes:$700,000 in compensatory damages$5,000,000 in punitive damages
The Abbrevo mini-sling, made of polypropylene, was found defective in its design and in its instructions to doctors, the end users.
This is the first punitive damages award against Ethicon/J&J for a case involving a mesh sling (as opposed to mesh for pelvic organ prolapse).
Attorney Peter de la Cerda tells Mesh News Desk, “We couldn’t be happier for Mrs. Perry. The jury’s verdict shows thoughtfulness for the serious and life-altering injuries she sustained from the TVT Abbrevo. The jury’s verdict also sends a clear message to Ethicon, Inc. and Johnson & Johnson – the concerned citizens of California will not stand for these manufacturers’ improper conduct in designing and marketing the TVT Abbrevo.”
Plaintiffs’ attorneys had asked for a minimum of $17.2 million for pain and suffering, future medical expenses and punitive damages.
The Abbrevo mini-sling, made from Ethicon’s Prolene mesh, remains on the market unlike its prolapse mesh, Prolift and the TVT Secur which were quietly removed almost three years ago.
During the trial, Ms. Perry’s attorneys showed jurors how polypropylene mesh degrades over time and erodes into vaginal tissue. Scar tissue shrinks and forms painful bands that lead to chronic pelvic pain and dyspareunia (painful sex). The defense, representing Ethicon, a division of Johnson & Johnson, tried to show how Ms. Perry had an active life with her husband and even went zip-lining with him in Hawaii.
The jury was shown the Material Safety Data Sheet – a label that accompanies raw polypropylene resin, that warns the resin material is not intended to be used in making implantable medical devices. Despite that warning from Sunoco, a petroleum company, the resin was used to make the Abbrevo and other pelvic meshes.
Ethicon’s TVT-O, a transobturator sling, has twice been found defective in jury trials (Huskey, Batiste). The Prolift trial of Linda Gross, conducted in a New Jersey courtroom in February 2013, yielded the highest jury award against J&J to date, $11.1 million, which includes $7.76 in punitive damages. That case is on appeal.
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Scope Blamed for Superbug Infections Not FDA Cleared
Mar 5, 2015 | Medical Device and Diagnostic Industry
By Marie Thibault
The superbug saga continues, with FDA saying this week that the duodenoscope model blamed for sickening patients and contributing to two deaths at a medical center in Los Angeles never received FDA approval. The agency released this information in an update Wednesday to its prior safety communication regarding these devices. It appears that the maker of the scopes initially did not believe FDA review was needed, while the agency took a different view later.
Endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes made by Olympus Corp. of the Americas were used at Ronald Reagan UCLA Medical Center in endoscopic procedures to diagnose and treat diseases of the liver, bile duct, and pancreas between October 3, 2014 and January 28, 2015. Last month, the health system notified 179 patients that they may have been exposed to the carbapenem-resistant enterobacteriaceae (CRE) during the procedures.
Also Wednesday, another Los Angeles-area hospital, Cedars-Sinai Medical Center, reported that they have identified four patients who caught CRE infections related to an ERCP procedure with the Olympus scope.
Now, FDA says that the Olympus TJF-Q180V duodenoscope does not currently have 510(k) clearance, but that physicians should not cancel ERCP procedures. Though Olympus initially determined back in 2010 the scope model did not need FDA review because it was a modified version of an already-cleared duodenoscope, the company filed a 510(k) submission with FDA after the agency requested it.
According to a statement from the company, “Olympus markets the TJF-Q180V duodenoscope in the U.S. based upon applicable 510(k) clearance guidelines. Olympus modified our 510(k)-cleared duodenoscope in 2010 and determined that the resulting TJF-Q180V did not require a new 510(k) application according to the FDA policy on modifications to 510(k)-cleared devices. The FDA subsequently requested a 510(k) notification with information regarding the modified device. Olympus submitted a 510(k) to the FDA, and the company continues to cooperate with the agency.”
In the updated safety communication, FDA said it “is not taking action against Olympus regarding its device during our review of the application, because, based on the information currently available to the Agency, we believe that that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year.”
Additionally, FDA notes that infections have been seen in patients who had procedures with other ERCP duodenoscopes, not just the Olympus model. Three manufacturers sell this type of scope in the United States: FUJIFILM, PENTAX Medical, and Olympus. CRE infection outbreaks related to ERCP duodenoscopes have been seen in hospitals around the country over the past few years, including Virginia Mason Medical Center in Seattle and Advocate Lutheran General Hospital in Illinois.
Because infections aren’t isolated to just Olympus scopes, FDA says it “has no evidence that the lack of a 510(k) clearance was associated with the infections.”
An Olympus spokesperson said in an e-mailed statement, “Olympus does not comment on active legal matters or speculation.”
Some may be surprised to learn that a medical device was used for years without FDA approval, but it’s not the first time in recent history this has happened. In March 2012, Bloomberg News reported that Johnson & Johnson had sold a vaginal mesh implant for three years, between March 2005 and May 2008, without FDA clearance. According to the Bloomberg report, the company thought it didn’t need to seek FDA approval because the vaginal mesh was similar to another approved mesh. The company filed a 510(k) application after being told by FDA that it was necessary, Bloomberg reported. The mesh was cleared by the FDA in May 2008, but later became the target of hundreds of injury lawsuits.
“It’s actually probably more common than you would think that industry and FDA disagree on whether a new 510(k) is needed or not,” says Brad Thompson, a member of Epstein Becker & Green in the healthcare and life sciences practice and a member of MD+DI’s editorial advisory board.
FDA did not respond immediately to a request for comment.
According to FDA regulations, a new 510(k) submission is needed for modifications that“could significantly affect the safety or effectiveness” or are a “major change or modification in intended use.” The onus is on a company to decide if a 510(k) submission is needed, but supporters argue this is necessary because of the sheer number of device modifications each year. Companies use FDA guidance published back in 1997 to decide whether to file a 510(k) application.
“The problem is, over the years, there’s been a fairly significant shift in the way FDA wants to draw that line,” Thompson says, referring to the line determining when a modification necessitates a 510(k) submission.
FDA has tried to update its thinking on the matter. After a controversial 2011 draft guidance was nixed by the passage of the Food and Drug Administration Safety and Innovation Act in 2012, FDA held a public meeting in June 2013 to gather input on the issue. At that meeting, industry argued to keep the 1997 guidance, while others believed FDA, not companies, should determine when a 510(k) application is needed.
The meeting was followed by a January 2014 report to Congress, but new guidance has not yet been published.
So, Thompson says, not only is the test to determine whether a new 510(k) application is needed more subjective than many realize, but FDA and industry are also on different pages during this transition period.
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