Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Twitter: @JjrkCh

Monday, November 13, 2017

Verdict $247M : J&J DePuy Pinnacle Ultamet 4th Bellwether Trial
Watch this video!

Dallas Morning News

Johnson & Johnson was ordered Thursday by a Dallas jury to pay $247 million to half a dozen patients who claimed the company hid defects in its Pinnacle artificial hips, its third big-dollar loss over the products.
Officials of the company's DePuy unit, which makes the hips, knew the devices were defective but failed to properly warn doctors and patients about the risk that they would prematurely fail, the jury ruled. The panel awarded a total of $79 million in actual damages and $168 million in punitive damages to a group of six New York residents whose hips had to be surgically removed.
The number of lawsuits accusing J&J and DePuy of mishandling the metal-on-metal hips has grown by more than 13 percent over the past year, to 9,900, according to a regulatory filing. J&J stopped selling the devices in 2013 after the U.S. Food and Drug Administration toughened artificial-hip regulations.

"These companies' behaviors were so reprehensive that it demands repeated punishment," Mark Lanier, a lawyer for the hip recipients, said after the verdict. Lanier won the previous two verdicts against J&J and DePuy.
J&J officials said Thursday in an emailed statement they acted "appropriately and responsibly" in the development and marketing of the Pinnacle hips. "We will immediately begin the appeal process and remain committed to the long-term defense of the allegations in these lawsuits,'' Stella Meirelles, a spokeswoman for DePuy, said in the release.
Johnson & Johnson won the first Pinnacle hip case to go to trial in October 2014 after a federal court jury in Dallas rejected a Montana woman's claims that the devices were defective and gave her metal poisoning.
Another Dallas jury ordered J&J last year to pay $502 million to a group of five patients who accused the company of hiding defects in the hips. A judge cut that verdict in July to about $150 million.
Earlier this year, a third Dallas jury ordered J&J and DePuy to pay more than $1 billion to six California residents whose hips had to be removed after failing. That award was later slashed by nearly half.

The Pinnacle devices weren't covered by New Brunswick, N.J.-based J&J's $2.5 billion settlement of claims over its ASR line of artificial hips. J&J recalled 93,000 of those implants worldwide in August 2010, saying 12 percent failed within five years.

The Pinnacle cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas for pretrial information exchanges and test trials. Kinkeade agreed to combine the six cases in the most recent trial.
The six New York plaintiffs in the current case are Uriel Brazel, an 88-year-old physician; Karen Kirschner, a 67-year-old elementary school teacher; Ramon Alicea, 61, a chauffeur; Hazel Miura, 60, a housing official; Eugene Stevens, 53, a health-care aide; and Michael Stevens, 52, a financial analyst.
The hip recipients argued DePuy officials rushed the Pinnacle hips to market with little testing and misled doctors about the device's safety profile, assuring them there was little risk of metal poisoning and tissue damage from the metal-on-metal product.
"They ran a grand seduction,'' Lanier, the group's lead lawyer, told jurors in closing arguments Nov. 14 "Surgeons were seduced into using metal-on-metal'' by DePuy executives' false assurances the company had "solved the metal-on-metal problem,'' the plaintiffs' lawyer added.
J&J's lawyers countered that the devices failed because of routine wear-and-tear rather than a flawed design and the company properly marketed the product.
"Not a single surgeon'' said they picked the Pinnacle hip "because of advertising or a brochure or any marketing,'' Steven Quattlebaum, J&J's lawyer, told jurors in his closing statement. "They had good experience with it before they implanted it in any of these patients.''
In their ruling, jurors found J&J DePuy relied on "intentional misrepresentations" about the hips' safety profile to bolster sales and engaged in "deceptive business practices" in their marketing of the devices, according to a verdict form.
Jef Feeley and Tom Korosec, Bloomberg

#HEALTH NEWSNOVEMBER 16, 2017 / 12:05 PM / 
Johnson & Johnson hit with $247 million verdict in hip implant trial

NEW YORK (Reuters) - A federal jury in Dallas on Thursday ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay $247 million to six patients who said they were injured by defective Pinnacle hip implants.

The jury found that the metal-on-metal hip implants were defectively designed and that the companies failed to warn consumers about the risks.
Six New York residents implanted with the hip devices said they experienced tissue death, bone erosion and other injuries they claimed were caused by the implants’ design flaws.

Law360, Dallas (November 16, 2017, 12:34 PM EST) -- A Texas federal jury on Thursday hit Johnson & Johnson and its DePuy Orthopaedics Inc. unit with a combined $247 million verdict in a bellwether trial over DePuy’s Pinnacle line of metal-on-metal hip implants, delivering the third consecutive nine-figure verdict in the multidistrict litigation.

The unanimous jury found J&J and DePuy liable for a series of design and manufacturing defects, fraud and deceptive business practices, and found the companies had acted with wanton, reckless or malicious conduct. They awarded $90 million in punitive damages against J&J and $78

For the six individual plaintiffs, each of whom is from New York, the jury awarded more than $77 million in past and future medical expenses and pain and suffering, including each plaintiffs’ actual past medical expenses, the amounts of which were stipulated to by the parties. Four of the plaintiffs’ spouses were awarded loss of consortium damages totaling $1.7 million.

"I'm stunned the amount was that high," Mark Lanier of The Lanier Law Firm, an attorney for the plaintiffs, said after the verdict. "I'm overjoyed for the clients."

Lanier said the verdict is notable because U.S. District Judge Ed Kinkeade excluded from evidence a number of inflammatory documents and emails that J&J has said shouldn't have been admitted in previous bellwether trials, and the jury still awarded nearly a quarter-billion dollars in damages.

“He kept out every piece of reprehensible evidence that he could, and I was scared to death we’d walk away with nothing," Lanier said.

Lanier said he looks forward to taking the full record of the case to the Fifth Circuit and believes the win would be upheld.

Yet J&J's lawyers said an August 31 ruling from a Fifth Circuit panel renders the verdict a "phyrric victory" for the plaintiffs. In that decision, a majority of the panel said Judge Kinkeade reached a “patently erroneous” result and clearly abused his discretion by holding J&J and DePuy had waived their right to object to his court in Texas conducting trials for plaintiffs from other states.

"This nine-week trial was a disservice to everyone involved because the verdict will do nothing to advance the ultimate resolution of this six-year old litigation," John Beisner of Skadden Arps Slate Meagher & Flom LLP said in astatement. "We will continue to seek further appellate guidance that will finally allow the fair, meaningful adjudication of these claims.”

The verdict followed a two-month trial, the fourth bellwether in multidistrict litigation that includes more than 9,000 cases alleging design defects in DePuy’s Pinnacle Ultamet line of metal-on-metal hip implants. In 2016, Texas juries found in favor of two groups of plaintiffs from Texas and California, awarding them $502 million and more than $1 billion in damages, respectively, though those verdicts were later reduced to $150 million and $543 million. In the first bellwether trial involving the Pinnacle Ultamet, a jury sided with J&J against a sole plaintiff from Montana.

The jury specifically found J&J and DePuy liable for design defect, negligent design, inadequate warning, manufacturing defect, negligent manufacture, negligent misrepresentation, intentional misrepresentation to the surgeons who performed the initial hip implant surgeries on the plaintiffs, fraudulent concealment from the plaintiffs and from the surgeons and deceptive business practices as to the plaintiffs and the surgeons. The jury also found J&J liable for negligent undertaking of a duty to provide services to DePuy and for aiding and abetting DePuy in its tortious conduct. The jury did not find J&J or DePuy liable for intentional misrepresentation to the plaintiffs.

A spokeswoman for DePuy, Stela Meirelles, said in a statement that the company acted appropriate and responsibly in developing the metal-on-metal hip implant.

“We have no greater responsibility than to the patients who use our products," Meirelles said. "We will immediately begin the appeal process and remain committed to the long-term defense of the allegations in these lawsuits.”

During the trial, the six plaintiffs told jurors they’d suffered a range of injuries, including severe tissue damage that caused permanent muscle loss, intense pain, loss of hip movement and walking with a permanent limp. They say the Pinnacle product shed microscopic metal ions into their bodies, causing side effects that J&J and DePuy didn’t warn surgeons about and that could have been avoided with a safer design.

The plaintiffs alleged J&J and DePuy valued marketing above research and development and rushed the Pinnacle product into production without any testing in humans out of a desire to capture a greater market share. They claimed the companies pushed the Pinnacle product with an incorrect statistic that it was 99 percent successful; that they’d used cheaper, less safe alternatives in the manufacturing process to keep costs down; and that the alleged defects in the product turned people’s hips into “ticking time bombs.”

In his closing statement, plaintiffs' counsel Mark Lanier of The Lanier Law Firm asked the jury to punish J&J "for being indifferent to our health” through a large punitive damages award that would capture the attention of company executives who didn’t attend the trial.

J&J and DePuy made the case during the trial that metal-on-metal was a viable, reasonable option for hip implants and that its Pinnacle Ultamet product was offered to help doctors choose the device that best fit their patients. The companies said the metal-on-metal implant was developed to solve a bone degradation problem with an existing polyethylene hip implant on the market and denied putting profits above patient safety and long-term results.

In a closing statement, defense counsel Steve Quattlebaum of Quattlebaum Grooms & Tull PLLC said the plaintiffs had made an emotional appeal and told a good story but that their allegations were not backed up by evidence or science. Quattlebaum said there’s no evidence the surgeons who treated the six plaintiffs relied on or even saw the 99 percent statistic when choosing which kind of implant to use and said there’s no evidence the plaintiffs’ injuries were caused by the product specifications the plaintiffs had complained about during the trial.

The plaintiffs are represented by Mark Lanier of The Lanier Law Firm, Jayne Conroy of Simmons Hanly Conroy, Richard Arsenault of Neblett Beard & Arsenault and Wayne Fisher of Fisher Boyd Johnson & Huguenard LLP

The defendants are represented by John H. Beisner, Stephen J. Harburg and Jessica Davidson Miller of Skadden Arps Slate Meagher & Flom LLP, Steven W. Quattlebaum of Quattlebaum Grooms & Tull PLLC and Tracie J. Renfroe of King & Spalding LLP.

The consolidated cases are Alicea et al. v. DePuy Orthopaedics Inc. et al., case number 3:15-cv-03489; Barzel v. DePuy et al., case number 3:16-cv-01245; Kirschner v. DePuy et al., case number 3:16-cv-01526; Miura v. DePuy et al., case number 3:13-cv-04119; Stevens v. DePuy et al., case number 3:14-cv-01776; and Stevens v. DePuy et al., case number 3:14-cv-02341, in the U.S. District Court for the Northern District of Texas.

--Editing by Rebecca Flanagan.

Update: This story has been updated with comment from representatives for the parties.

Frances Scott discusses one significant day in the jury trial that ends tomorrow.

I will post the verdict here.  The closing arguments are happening tomorrow and the charges have already been read to the jury.  

With another potentially $1 billion verdict on the line, two heavyweight lawyers—plaintiffs' counsel W. Mark Lanier and defense lawyer John Beisner—are trading ever-escalating accusations and barbs in court papers in a high-stakes DePuy hip implant trial.
By Amanda Bronstad | October 18, 2017

With another potentially $1 billion verdict on the line, two heavyweight lawyers—plaintiffs’ counsel W. Mark Lanier and defense lawyer John Beisner—are trading ever-escalating accusations and barbs in court papers in a high-stakes DePuy hip implant trial.
Lanier and his team are complaining of improper conduct and frivolous objections, and lawyers for hip implant maker Johnson & Johnson’s DePuy Orthopaedics Inc. have accused plaintiffs’ attorneys of misleading the jurors and springing new evidence on them in a “trial by ambush.”
To be sure, it’s no surprise that lawyers in the fourth bellwether trial over Pinnacle hip implants are fighting tooth and nail. Two previous trials landed $502 million and $1.04 billion verdicts. And as in those trials, Johnson & Johnson faces consolidated claims made by multiple plaintiffs at the same time—six New York plaintiffs to be exact.

It’s also not the first time that Lanier and Beisner have traded barbs in the litigation, which involves more than 9,000 cases. Earlier this year, Beisner, of Skadden, Arps, Slate, Meagher & Flom in Washington, D.C., accused Lanier, of The Lanier Law Firm in Houston, of failing to disclose payments he made to two expert witnesses in the second bellwether trial.
But the accusations in the latest trial, which began on Sept. 19 in Dallas, have been excessively contentious. In the latest spat, Lanier raised questions about potential tampering with one of his witnesses—a revelation that U.S. District Judge Ed Kinkeade of the Northern District of Texas on Monday said could end up involving federal prosecutors and the FBI.
Lawyers on both sides already have slung more than a dozen motions and trial briefs at one another. Neither Lanier nor Beisner responded to calls seeking comment on this story.
Kinkeade has yet to rule on the series of motions. Here’s what’s been filed:
Plaintiffs’ lawyers have filed:
  • A Sept. 27 trial brief to stop defense lawyers from making “repetitive and meritless objections” during trial. “Defendants’ tactics are nothing more than improper attempts to delay and obfuscate the trial,” the brief says. Johnson & Johnson’s lawyers responded on Sept. 29 with: “The fundamental premise of plaintiffs’ brief is that defendants should only be allowed to make objections at trial if plaintiffs deem those objections to have merit. This proposal is as preposterous as it sounds.”
  • Trial briefs filed on Sept. 21 and Oct. 3 accuse Johnson & Johnson’s lawyers of improper conduct – in particular, telling the jury about the worldwide popularity of Pinnacle hip implants knowing that plaintiffs’ attorneys were barred from bringing up previous deferred prosecution agreements involving bribes to foreign government officials and payments to doctors. Johnson & Johnson’s lawyers, in a Sept. 26 response, accused plaintiffs’ attorneys of mischaracterizing those agreements.
  • At a hearing on Monday, Kinkeade heard arguments about the statements of doctor that a DePuy sales representative told him “there could be ramifications” for his medical practice in connection with his upcoming testimony for the plaintiff. “He said the lawyers were ‘on him like crazy,’” according to an Oct. 15 affidavit filed by Dr. David Shein. Kinkeade called the developments “certainly disturbing and disconcerting to me.” He said he wanted the U.S. Attorney’s Office and the FBI to interview the sale rep and any lawyers who contacted him.
Johnson & Johnson’s lawyers have filed:
  • An Oct. 11 motion for mistrial based on Lanier’s references during witness questioning to prior cases involving DePuy hip implants. The motion notes that Lanier has done this before. “As demonstrated by the last MDL trial—where similar improper questioning and testimony culminated in gargantuan verdicts—improper references to ‘hundreds of other lawsuits’ are uniquely prejudicial because they tend to inflate any damages award.” The motion claims Lanier’s references violate a motion in limine order and, although some of the defense’s objections were sustained, “the horse was already out of the barn and the damage had been done.” On Oct. 15, Lanier denied any violations of court orders and insisted that the references are necessary to show witness bias and establish claims for punitive damages.
  • An Oct. 9 motion to exclude or limit the testimony of Dr. Bernard Morrey—one of the experts whose payments Beisner accused Lanier of failing to disclose in an earlier trial. In a Sept. 18 order, Kinkeade allowed Morrey to testify as long as he provided a written report to Johnson & Johnson three days prior to testimony. The motion, which is Johnson & Johnson’s second in this case, says the report “essentially reprinted Dr. Morrey’s testimony” from an earlier trial “in bullet-point format.” If he testifies, the motion cautions, Morrey should not be permitted to mention his own patient experiences without medical records nor give opinions that are not in his report—as happened in previous trials. Lanier countered in an Oct. 10 response: “Defendants are fully aware of the testimony Dr. Morrey intends to offer at trial—and they have known it for a very long time.”
  • An Oct. 15 motion for a jury instruction on the duty to warn to “correct plaintiffs’ counsel’s misrepresentation.” Specifically, the motion accuses Lanier of “insinuating to the jury several times” that Johnson & Johnson had a duty to warn patients when, under New York law, that duty was to surgeons.
  • An Oct. 15 motion for a jury instruction to “disregard plaintiffs’ counsel’s misleading questioning” of a defense witness regarding assets he held in a nonprofit foundation. Plaintiffs’ attorneys, in an Oct. 17 response, insist that an instruction isn’t necessary.
  • A Sept. 19 motion to reconsider consolidation of the six plaintiffs into a single trial. The motion is sealed, but Johnson & Johnson has repeatedly fought consolidated trials as leading to larger verdicts and prejudicing defendants. In an Oct. 10 response, plaintiffs’ attorneys called consolidated trials “standard operating procedure” in mass torts.
It’s unclear how Kinkeade could approach the motions and trial briefs. In the last trial, Johnson & Johnson’s lawyers filed a trial brief complaining that the plaintiffs would end up with more time than they would. But according to a Nov. 17 transcript, Kinkeade criticized defense counsel for causing its own delays by asking witnesses multiple questions just “to get to the point.”

“It’s just every time you file one of those, if it’s deserved I’ll take it, and I think I’ve done that in this trial,” he said, referring to trial briefs and motions. “You’ve got a very clean trial, regardless of the fact y’all have filed two motions for mistrial. So be it.” 

In addition to Beisner, Johnson & Johnson’s team on the court papers includes Skadden’s Stephen Harburg, another Washington partner; Steven Quattlebaum of Quattlebaum, Grooms & Tull in Little Rock, Arkansas; and Tracie Renfroe, a Houston partner at King & Spalding.
On the plaintiffs’ team, Lanier is joined by Wayne Fisher of Fisher, Boyd, Johnson & Huguenard in Houston; Richard Arsenault of Neblett, Beard & Arsenault in Alexandria, Louisiana; and Jayne Conroy of Simmons Hanly Conroy in New York.

Amanda Bronstad

Amanda Bronstad is the ALM staff reporter covering class actions and mass torts nationwide. She is based in Los Angeles.

Thursday, November 9, 2017

All the Patient Outcome Information the Hip Surgeons Want You to Know . . . M/M failures mentioned???

Written by  Laura Dyrda | Friday, 03 November 2017 17:06

The American Joint Replacement Registry released its 2017 Annual Report, outlining data on hip and knee replacements.
The report, released at the 2017 American Association of Hip and Knee Surgeons Annual Meeting in Dallas, Nov. 2 to Nov. 5, includes data from 654 institutions and 4,755 surgeons who performed 860,080 hip and knee replacements.

"The AJRR has seen significant growth since the previous report; this year's report has a 101 percent increase in procedures, a 57 percent increase in reporting institutions and a 50 percent increase in surgeons," said AJRR Board of Directors Chairman Daniel Berry, MD. The data includes primarily procedures performed in the hospital, although eight ASCs reported data for 1,020 procedures.

Key highlights from the report include:

1. Hip revision surgery burden: 8.6 percent (down from 14.6 percent in 2012)

2. Knee revision burden: 5.1 percent (down from 6.2 percent in 2012)

3. Primary knee implant design:

• Posterior stabilized: 48.5 percent
• Cruciate retaining: 35.3 percent
• Ultracongruent: 5.6 percent
• Other: 8 percent

4. Unicompartmental knee replacements: 3.2 percent of all primary knee replacements

5. Surgeons performing unicompartmental knee replacement: 24.3 percent

6. Surgeons performing patellofemoral arthroplasty: 4.7 percent

7. Average length of stay for primary hip replacements: 3.5 days

8. Average length of stay for primary knee replacements: 2.9 days

Tuesday, November 7, 2017

Pseudotumor and Johnson & Johnson DePuy Pinnacle Hips

November 6, 2017
DALLAS — Pseudotumor formation occurred in 52% of patients who underwent metal-on-metal total hip arthroplasty performed with two different designs of prostheses and later underwent metal artifact reduction sequence MRI or MARS MRI of the hip, a presenter said at the American Association of Hip and Knee Surgeons Annual Meeting

“So overall prevalence and severity, over half of our patients had a pseudotumor and nearly 40% either had a type 2 or type 3 lesion,” Daniel E. Goltz, BS, said.

The 207 hips that underwent MARS MRI received an ASR THA prosthesis or a Pinnacle prosthesis with Ultamet liner (both DePuy) metal-on-metal (MoM) hip implant. The patients represented just the patients who had MARS MRI and had any pseudotumors graded among 178 patients with ASR prostheses and 788 patients with Pinnacle prostheses who were operated on between 2002 and 2013 and had a minimum 2-year follow-up and average 8-year follow-up.
Goltz and colleagues analyzed the factors associated with a pseudotumor and found those patients were significantly more likely to have higher cobalt levels, a higher cobalt-chrome ratio, a high-offset femoral stem and a larger size acetabular cup.
“Patients with thick-walled cystic or solid masses were more likely to be revised than those with thin-walled cystic masses (P < .001),” the investigators wrote in the study abstract.
In his presentation, Goltz said, “Interestingly, we found that symptoms may not be the best reliable indicator of whether or not a patient has a pseudotumor or its severity.”
The study definition of being symptomatic after MoM THA was pain, weakness or a limp, he noted.
“Sixty percent of our cohort actually ended up having symptoms,” Goltz said. However, among the asymptomatic patients, 47% had a pseudotumor, he said.
“It is our hope that this work will be able to guide all of you as clinicians as you make what may come to be a challenging decision in terms of which patients to revise and the timing for that revision,” Goltz said. – by Susan M. Rapp

Kleeman L, et al. Paper #39. Presented at: American Association of Hip and Knee Surgeons Annual Meeting; Nov. 2-5, 2017; Dallas.

Disclosure: Goltz reports no relevant financial disclosures.

Tuesday, October 31, 2017

If Cars Were Sold Like Healthcare . . .

In all reproductions and shares of this piece, please attribute it to the author,  Patient Advocate & harmed patient, Kerry O'Connell.  

If cars were sold like Healthcare.

  1. They would never disclose the price
  2. There would be no finance packages
  3. Months after you drove off you would get a very big bill from the dealer
  4. Then you would get a separate bill for the salesmen’s time talking you into it
  5. Six months later you would start getting separate bills from every supplier who provided parts
  6. You would get bills for the gas, and the oil, and the air in the tires
  7. There would be absolutely no owner’s manual of any kind
  8. There would be absolutely no warranty of any kind

When you brought it in for service

  1. They would give you no cost estimate or repair time
  2. You would sign a release stating that they might fix your car, they might not be able to fix your car, in the process of trying to fix your car it might burn to the ground and in any of these cases you are still responsible  for every cost that they incurred while your car was there.
  3. If they happened to leave any tools in your car  you would be charged extra
  4. If any work performed caused rust, smells, or cosmetic concerns you should be happy  it runs.
  5. If the problem  reoccurs you get to come back and pay again

No matter what you felt about the above experiences you would be prohibited from telling anyone under threat of lawsuit.

Tuesday, October 24, 2017

Catastrophic FAIL: Easier to Recall Spinach Than Medical Implants

By Joe Carlson OCTOBER 21, 2017 — 2:00PM
Fictitious medical device label is shown for unique device identifier information.

In March 2015, Target Corp. alerted customers to throw out certain 10-ounce bags of organic chopped spinach because they were potentially contaminated with listeria bacteria, which can cause serious health problems.
The recall notice, filed with the U.S. Food and Drug Administration, urged people who bought the spinach to check UPC codes and a special nine-digit tracking code called the DPCI that Target includes on its sales receipts. The recall was routine, and no illnesses were publicly linked to the incident.
No such system exists for medical device consumers, however.
In fact, proposals to give insurers and patients access to the serial numbers on their implanted medical devices remain controversial.
Manufacturers say it would cost additional time and money with no guarantee of benefit to put the device serial numbers into insurance claim forms. Consumer safety officials and auditors argue the move would improve patient safety and enhance accountability.
To patient advocates like Lisa McGiffert, director of the Consumers Union's Safe Patient Project, omitting device serial numbers from an insurance claim would be like buying a car without getting its VIN number.


Doesn’t Add up: The medical industry is divided over adding a unique device identifier (UDI) to devices, which would make it easier to locate a device but at a higher cost for companies.
"We don't even have the make and the model" in insurance claims, McGiffert said. "We can put it on a car — why shouldn't we have it on a hip that you're putting in my body?"
Thousands of medical devices are recalled each year, but it can be hard to track them. In 2005, former Minnesota device maker Guidant Corp., now part of Boston Scientific, urgently recalled thousands of pacemakers because excess moisture could seep inside the life-preserving devices and ruin them.
A handful of patients with the devices went into cardiac arrest or experienced heart failure, and one death may have been linked to a pacemaker failure. Yet the Government Accountability Office (GAO) reported in 2011 that 1,732 of these recalled pacemakers were never recovered because there was "no implant record available."
Medicare, which pays hospitals to implant such devices in patients aged 65 and older, had no direct way of tracking down which of its patients may have gotten those 1,732 leaky Guidant pacemakers — nor, for that matter, any of the hundreds of thousands of other heart devices that have been recalled by the medical device industry in the years since then, critics inside and outside the government say.
Congress mandated a system of serial numbers to track medical devices known as UDIs, or unique device identifiers, back in 2007, and the Food and Drug Administration has been rolling out rules for how and when to use them ever since.
The med-tech industry and some doctors have fought hard to keep them out of Medicare claims and private insurance bills.
A two-year investigation by Medicare's inspector general office recently concluded that the publicly funded health insurer spent an estimated $1.5 billion over 10 years on surgeries and follow-up care for patients who had one of seven specific heart devices made by Minnesota manufacturers. The review did not include the Guidant pacemakers mentioned by the GAO and didn't examine other widely recalled types of devices, like metal-on-metal hip implants.
John Boujoulian, senior auditor on the Medicare inspector general investigation, said the lack of UDI numbers in Medicare claims makes it harder to locate patients affected by medical device recalls. But as it stands, Medicare would have to do a detailed review of medical records to find the UDIs to track down devices that it pays to have implanted or replaced.
"We had to go through all the medical records to find out," Boujoulian said in an interview about the audit. Using subpoenas to the device makers, "we had lists of all the people who had the medical devices implanted and the specific models, and we had to go through them all to see which ones had issues."
But going through the detailed medical records of patients is exactly what the medical device industry advocates.
"We support the collection of the UDI in the electronic health record, where it can actually be used to really help track patient outcomes and be used in a more proactive way around postmarket surveillance," said Don May, executive vice president for the Washington-based medical device manufacturer trade group AdvaMed. "If we are really concerned about patient safety, then let's go to the tool that makes the most sense."
Industry officials say the codes are too long and varied to put into insurance claims. AdvaMed says hospitals would have to invest in new bar code scanners and come up with ways to accurately transmit the data to payers. The American Medical Association says reporting UDIs in insurance claims would be cost prohibitive and insufficient for detecting widespread problems.
Organizations including Centers for Medicare and Medicaid Services and the Medicare Payment Advisory Commission have supported adding a short section of the UDI known as the "device identifier," or DI, to Medicare claims forms.
The full UDI, however, can run to 75 characters and comes in three different formats used by three different standards organizations. The full code contains not just model numbers, but batch and lot numbers, dates of manufacture and other information that would identify which specific devices are affected by problems.
AdvaMed Associate Vice President Zach Rothstein, who advocates on medical device regulation involving the FDA, said researchers who use just snippets of the UDI codes may draw inaccurate conclusions about devices that could negatively affect both medical device makers and patients.
"Think about all the food recalls where you go to your freezer and say, 'Well, was this done in that time frame and in that plant?' And the news gives you the code. It's not just this was Tyson chicken," he said. "Without [the full serial number], you just don't know."
Advocates say patient safety would benefit from the added transparency, dismissing arguments that it's too difficult or expensive. Ben Moscovitch, manager, health information technology at Pew Charitable Trusts, noted that the FDA's Sentinel program to root out problems with prescription drugs is based largely on claims data, which incorporates 10-digit National Drug Codes.
"Many of the safety challenges that occur with devices occur across the entire product line," Moscovitch said, "and to evaluate the safety of products in that capacity requires only the brand and model of the device, and not the production information that is included in the [full UDI]."
The three companies that made the recalled or defective heart devices that led to $1.5 billion in Medicare spending documented in the inspector general's report — Boston Scientific, Medtronic and St. Jude Medical owner Abbott Laboratories — all declined to comment for this story.
Asked whether the medical device companies' opposition to including UDIs in Medicare-claims forms was related to financial concerns like lost sales or increased litigation, May noted that product recalls are already costly.
"From a litigation perspective, I think malpractice attorneys are very aggressive in a lot of ways, and this just becomes one additional data source," May said. "But if you've got a product that is recalled, my guess is the company is already feeling a financial impact because it's a product that they've had to recall."

Tuesday, October 3, 2017

Could One Company Be . . . Medtronic? St. Jude?

By FRED SCHULTE and CHRISTINA JEWETT   OCT. 2, 2017  The New York Times
WASHINGTON — Medicare paid at least $1.5 billion over a decade to replace seven types of defective heart devices, a government watchdog says. The devices apparently failed for thousands of patients.
A report released on Monday by the inspector general’s office for Health and Human Services said officials needed to do a better job tracking these costly product failures to protect patients from harm. More detailed reporting could lead to earlier recognition of serious problems with medical devices and faster recalls of all types of “poorly performing” ones, the inspector general’s office said.
The report marks the first effort by anyone in government to assess the losses to taxpayers and patients 65 and older from medical gear that proves faulty.
Officials said the $1.5 billion lost from the seven devices from 2005 through 2014 was a “conservative estimate.” Patients also paid $140 million in out-of-pocket costs for this care, the report noted.
The report found that nearly 73,000 people on Medicare had one of the seven devices replaced because of recalls, premature failures, medically necessary upgrades or infections. It did not outline specific injuries that patients suffered as a result.

The inspector general did not identify the manufacturers of the seven devices, but officials said they included implanted cardio defibrillators and a pacemaker that had either been recalled because of flaws or had “prematurely failed.” Pacemakers and implantable defibrillators are small devices placed under the skin to help treat irregular heartbeats.
How best to identify these defects and cut Medicare spending associated with fixing them has been under consideration at various times since 2007, according to the report. But it remains a contentious issue.
The inspector general recommended that hospitals and doctors be required to submit detailed information identifying failed devices, like serial and batch numbers, during the billing process.
“This could help reduce Medicare costs by identifying poorly performing devices more quickly, which could also protect beneficiaries from unnecessary costs and improve their chances of receiving appropriate follow-up care more quickly,” the report said.
David Lamir, an official in the inspector general’s Boston office, said the $1.5 billion figure represented a “drop in the bucket” of the true costs to Medicare from medical products that malfunction. He said device failures not only waste money, but also can expose patients to a “high risk of illness,” including needless surgeries.

The report said that medical device recalls nearly doubled from 2003 through 2012 and noted that they have probably cost Medicare billions of dollars. In the past five to six years, more than 200 cardiac devices have been recalled, according to the inspector general’s office. In most cases, manufacturers withdrew their products voluntarily after reports surfaced of injuries or malfunctions. Device makers are required to report problems they learn of, often from doctors and hospitals, to a database run by the Food and Drug Administration.
Diana Zuckerman, president of the National Center for Health Research who has testified before Congress on device safety, said her organization supports making hospitals report malfunctioning devices when they seek Medicare payments to cover an implant surgery. She said the change would help officials pinpoint faulty devices before issuing a recall for tens of thousands of products in patients.
“It would be much more obvious much more quickly which implanted devices were causing problems,” she said.
Ms. Zuckerman noted that the report did not touch on other high-profile device failures, like metal-on-metal hip implants or vaginal mesh.
Medical device companies and some doctors have opposed tighter reporting, arguing that it would be costly and difficult to integrate with existing payment claim forms and might not yield useful information.
“It is abundantly clear that data collected in electronic health records is a far superior and more cost-effective method for monitoring the performance of medical devices,” said Mark Leahey, who heads the Medical Device Manufacturers Association. The trade group represents nearly 300 device companies.
Mr. Leahey said that the electronic health record “captures the full clinical history of the patient, their changing health status and detailed information on their medical treatments,” including any surgically implanted devices.
A spokesman for the Centers for Medicare and Medicaid Services said the agency had not seen the report and would have no comment.
But in written remarks included in the report, Seema Verma, the agency’s administrator, said the tighter reporting requirement was “under consideration” and that the agency would “carefully evaluate the potential that this policy would impose a burden on physicians unnecessarily.”
This article was produced in collaboration with Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.