"one of the worst offenders" orthopedic surgery overuse . . .

Orthopedists' Financial Conflicts Can Hurt Patients, Surgeon Says

Cheryl Clark, for HealthLeaders Media , March 17, 2015  FiDA highlight added

It is financially compelling for many doctors to do things that aren't really going to help their patients, says an orthopedist who is leading a campaign against surgical overuse.

Financial conflicts of interest often drive physicians to perform worthless surgeries, but the field of orthopedics "is one of the worst offenders," says an Indiana orthopedist who has launched a "moral persuasion" campaign to persuade his colleagues to stop.

"It's really hard for doctors to acknowledge this and change their ways," says James Rickert, MD, who years ago founded the Society for Patient Centered Orthopedic Surgery to address the problem.

It's especially tough for doctors who own related businesses that depend on surgical volume, which puts even more pressure on them to "be more like businessmen instead of doctors," he says.

A lot of orthopedic surgeons "own part of the distributorships that sell the total hip or knee implants to the hospital, and they'll make a ton of money on that. Or they own the imaging center they send their patients to. They own a piece of the surgical center. They know if they're not doing a lot of surgery, they may lose money on their overhead," Rickert says.

A series of four reports from the Government Accountability Office documents greater numbers of procedures referred by physicians who own providing businesses, compared to referrals from non-owners.

"That makes it really compelling for doctors to do things that aren't really going to help their patients. They become more like salesmen, saying things like, 'Well, it might help.' Or, 'We don't have much to lose, let's try it,' knowing full well the data shows there's very little chance the procedure will help and some evidence the patient could be hurt."

Rickert has long been aware of surgical overuse, including his own. But he didn't work hard to stop it until he himself got sick. He was diagnosed with non-Hodgkin Lymphoma at age 42, underwent chemotherapy, bone marrow, and stem cell transplants, recurrences, and foul-ups in his care. Now 54, he's been cancer free for five years. 

"I was accessing the system every day for months as a very sick person, having a lot of problems. I started to think about patient-centered care expectations and how different that is from reality."

As he got better and returned to his Bloomington practice, he founded the society to appeal to surgeons' consciences. So far, 14 fellow orthopedists have joined his effort.

Performing unnecessary surgeries, he says, "is not [necessarily] below the standard of care. For example, the doctor can usually say, 'Hey, he had a torn medial meniscus and here's an MRI that proves it,' even though it was not the right thing for a severely arthritic patient."

"I certainly have a lot of patients referred to me from nearby. And when I look at the surgery and pathology they had, I just know that there was no way that doctor really thought that was going to help them."

At the Lown Institute conference in San Diego last week Rickert described one of many sad cases. Two decades after performing a successful knee scope on a patient, the now severely arthritic patient returned, seeking another scope. Rickert advised that it would not help and could cause problems.

The patient went to another orthopedist and had the procedure. This surgeon thought the worst that would happen would be the patient wouldn't be any better, but would at least be satisfied that the doctor had tried to help. "Instead, the patient gets a deep vein thrombosis that turns into a pulmonary embolism, and two days later he's dead," Rickert says.   

For doctors, it's like an inside secret, he says. "We know about these risks, but the patients don't."

Rickert and some of his colleagues also criticize the American Academy of Orthopedic Surgeons' Choosing Wisely list of five procedures doctors and patients should avoid. None on the academy's current list is especially common or very important, Rickert says. 

Kevin Bozic, MD, chair of the AAOS Council on Research and Quality, said via email that the Choosing Wisely list was created from systematic reviews of the literature and is limited to available evidence that various treatment options for musculoskeletal conditions are effective, "which we are seeking to improve." AAOS is working to define appropriateness criteria incorporating patient preferences and values into medical decision-making, he said. Since it submitted its list of five practice guidelines in 2012, AAOS has published four more to be reviewed for possible inclusion in a second Choosing Wisely list.

At the conference, Rickert and Rob Rutherford, MD, an orthopedic surgeon from Coeur d'Alene, ID, presented what they say is a more relevant list of procedures that are frequently performed, usually unnecessary, high cost, and sometimes harmful:

1. Vertebroplasty
Cost: $10,000 

The percutaneous injection of cement into a fractured vertebra. The procedure, done in about 100,000 patients a year, is falsely marketed as relieving pain quickly. But in clinical trials, pain relief was similar to that seen in patients who underwent sham surgery. The procedure's risks include compression fractures in adjacent vertebrae, dural tears, infections, cement migration, and nerve pain that requires subsequent surgery.

2. Rotator Cuff Repairs in Elderly Patients

Cost: $15,000

About 600,000 such surgeries are performed in the U.S. each year. The number of surgeries increased by 141% between 1996 and 2006. This surgery is vastly overused on patients who are asymptomatic. Complications include infection, bleeding, re-rupture of the rotator cuff, nerve damage, blood clots, and the need for repeat surgery to correct the first procedure.

3. Clavicle fracture repair or "plating" in adolescents
Cost: $13,000
This procedure is performed in a small percentage of adolescents each year to improve function. "I don't know of any good indication, especially with conservative care being so successful" and rarely does the surgery benefit, Rickert says.  

Regardless of patient age, type of sport, and final clavicle shortening, there's no differences in pain, strength, or range of motion. But there is a risk of deep infections, pneumothorax, and other complications. 

4. Anterior Cruciate Ligament Tear Repair in Low-Risk individuals
Cost: $10,000
ACL surgeries are performed in 100,000 patients a year and carry high risks but demonstrate no difference in rates of return to pivoting-activity sports one year later than conservative rehabilitation and activity modification. Complications include infection, instability, stiffness, pain, patellar fracture and growth plate injury in children.

5. Surgical Removal of Part of a Torn Meniscus 

Cost: $6,000
Annually, this surgery is performed in 700,000 patients with knee arthritis and no mechanical symptoms. But it does not provide significant benefit compared with sham surgery in patients with degenerative meniscal tears. There's equal pain relief and functional status.

Rickert, who is on the faculty of the Indiana University School of Medicine, emphasizes that IU Health has a policy forbidding its doctors from accepting money or gifts from the pharmaceutical or medical device industries.

He says his specific orthopedic group does not own an MRI or an orthopedic surgery center. And he acknowledges that he gets "e-mails and grouchy comments from doctors [at other organizations] who want me to not do this [campaign]."  

"There's still a lot of resistance from entrenched interests. But we have to show doctors the data, studies that show this doesn't work, and then ask, 'why are we still doing this?' We have to confront them with the data."

Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists. 

http://www.healthleadersmedia.com/print/QUA-314383/Orthopedists-Financial-Conflicts-Can-Hurt-Patients-Surgeon-Says

Criminal?: Scottish Surgical Mesh Scandal

Revealed: Two doctors on mesh safetyreview team linked to makers of controversial devices

         Oct 05, 2014 13:53

         By Marion Scott  Daily Record (UK)  FiDA highlight

HEALTH Secretary Alex Neil under fire after victims claim the government probe into mesh implants is being rigged to give operations the all-clear.

Health Secretary Alex Neil

TWO doctors on the government team reviewing the safety of mesh implants have links to the makers of devices used in the controversial surgery.

The appointments have fuelled concern of campaigners that the review has been weighted to support the continued use of the procedures, which have left women around the world crippled and led to multi-million-pound compensation payments.

Ash Monga and Karen Guerrero have been paid by Ethicon, the makers of a mesh product called Gynecare.

Dr Monga described himself as a “consultant for Gynecare” in a 2009 medical research paper.

Dr Guerrero, a surgeon at Glasgow’s Victoria Infirmary, received “educational sponsorships” – including payments and travel costs – from Ethicon and another major mesh manufacturer called Bard.

Dr Karen Guerrero

Both were appointed to a 22-strong safety review commission investigating mesh products launched by Health Secretary Alex Neil.

He won plaudits in June after apparently suspending mesh procedures when Hear Our Voice campaigners, supported by the Sunday Mail, gave evidence to reveal how they have been left in crippling agony by mesh, used to treat prolapse and bladder problems.

At the time, Neil said: “I’m proud Scotland has taken this stance and I believe we are leading the way on what is a significant global problem.”

But we revealed the anger of campaigners last week after discovering government medical advisers wrote to hospitals within weeks of Neil’s announcement to say the suspension was voluntary and encouraged them to use mesh on patients as part of clinical trials.

Yesterday, politicians and campaigners raised new concerns about the appointments to the review body to establish if there are any conflicts of interest.

Scottish Labour’s shadow health secretary Neil Findlay said: “It is outrageous that, after taking over a year to reach a decision on mesh implants, the Health Secretary has appointed doctors to the review who might appear to have a vested interest.

“Those affected have been through far too much in the past few years and this latest development is simply inexcusable.”

Mesh product

Olive McIlroy, of Scottish Mesh Survivors, said: “We are dismayed that people appointed to carry out this vital review have such links to the manufacturers who profit from the use of these devices.

“Alex Neil promised victims would be at the very heart of the independent review but it feels very much like we are lone voices pitted against the country’s most powerful mesh supporters.”

Ethicon, a subsidiary of Johnson & Johnson, have twice had their TVT-O device declared as “defective” by a US court.

It has also emerged that Gibraltar-born Guerrero was among 23 signatories backing an objection to Neil’s suspension of mesh use in the NHS in June.

Dr Guerrero backed the call made by Aberdeen-based urology consultant Mohamed Abdel-Fattah asking for mesh trials to be exempted.

Abdel-Fattah, who has also received “travel sponsorship” from Ethicon, was supported by two other members of the review group, Professor Charis Glazener and consultant urologist Voula Granitsiotis.

Read about US mesh victim Martha Salazar who won a £60m payout.

Ethicon’s Lucinda Macari said: “Ethicon, in conjunction with the Association of British Healthcare Industries, are supporting efforts by the Scottish Independent Review to gather full and accurate information about pelvic mesh products.”

The Scottish Government said: “This must be an entirely independent review and will be completed as such.”

          

Mesh scandal: Another boost forScottish campaigners as US victim wins £60m payout

         Sep 14, 2014 14:11

         By Marion Scott  Daily Record (UK)

MARTHA Salazar's case in Dallas, Texas – the second major victory for mesh victims in America within days – prompts new calls for criminal inquiry in Scotland.

Campaigner Elaine Holmes in the Scottish Parliament.

AN American mesh patient has been awarded £60million compensation by a US court.

Martha Salazar won the huge payout after the court in Dallas, Texas, heard that the Obtryx implant made by Boston Scientific was defective.

They jury was also told that the manufacturers had failed to properly test the device on humans.

It was the second major victory for mesh victims in the States within days.

Earlier this month, Jo Huskey was awarded damages totalling £3million by a West Virginia court for pain and suffering caused by a TVT-O mesh 
implant made by Johnson & Johnson firm Ethicon.

Both these mesh devices were given to Scottish women on the NHS before the procedures were suspended pending safety reviews after an outcry by mesh victims.

The US payouts have led to politicians and victims calling for the Scottish Government to sue manufacturers and launch a criminal probe.

Labour’s shadow health secretary Neil Findlay said: “These cases are proof, if any further evidence is needed given the hundreds of women injured here, that the mesh scandal is shaping up to be a very big issue for Scotland’s NHS.

“It’s high time the Scottish Government challenged the manufacturers over the catastrophic health problems these devices have inflicted on so many women.

“If there’s evidence of clinic data and trial evidence being deliberately withheld, criminal action should be considered.”

Elaine Holmes, of Scottish Mesh Survivors, added: “A car manufacturer who did this would face a criminal investigation and lengthy jail sentences. It should be the same for mesh manufacturers.”

Lawyer Cameron Fyfe, who is acting for over 400 women involved in the biggest-ever medical legal action in Scotland, said: “Potential damages in 
Scotland would be a fraction of those in the US but we expect to have similar success.”

Gareth Easton

Scottish Health Secretary Alex Neil

Health Secretary Alex Neil suspended mesh operations in March pending an independent safety review.

It followed a Sunday Mail campaign which exposed the hidden agony of hundreds of women given mesh implants to treat incontinence and bladder problems.

Surgical Mesh: Scandal Deepens in Scotland

Mesh surgeryscandal: Doctor hired to lead mesh probe used to work for manufacturers

         Jun 15, 2014 12:33

         By Marion Scott  Daily Record  FiDA highlight

        

MESH victims have become concerned over the news that Dr Fred Milani, who worked for one of the mesh manufacturers will be investigating safety issues.

A doctor who was once a consultant to one of the world’s biggest mesh manufacturers has been appointed by the European Commission to investigate safety issues.

The appointment of Dutch urogynaecologist Dr Fred Milani has sparked concern among mesh victims, who say they would have preferred someone with no ties to the industry that they blame for their injuries.

We can reveal that, less than two years ago, Dr Milani stated in medical papers that he had a “consultancy agreement” with Ethicon, the Johnson & Johnson company who produce mesh implants to treat pelvic organ prolapse and bladder problems.

The firm also manufactured the TVT-O mesh implant device which was ruled as defective in a US court of law two months ago.

Milani co-authored a number of medical studies and papers with some of Ethicon’s high-profile management team including Dr Piet Hinoul, former medical director of Ethicon’s Gynecare women’s health and urology.

He has also written medical papers with Ethicon’s clinical director in Scotland, Judi Gauld, and Vanja Sikirica, another ex-associate director at Ethicon.

And in his report to Holland’s Health Care Inspectorate into mesh complications last year, it was noted Milani’s research was partially financed by Ethicon.

Campaigner Olive McIlroy, 57, of Scottish Mesh Survivors, said: “This investigation will have a huge influence across European countries in how they deal with the emerging mesh injury crisis.

“We already feel let down by doctors because so very few of them bothered reporting adverse incidents, allowing the mesh industry and medical watchdogs to continue saying the benefits outweigh the risks. It is vital that the victims have complete confidence in what happens from now on.”

Despite 328 women having repeat surgeries to correct damage, just 12 cases were reported by Scottish doctors.

Dutch health experts have delivered new guidelines on mesh surgery but said a ban on products was not in the best interests of patients.

However, mesh will only be used in patients where traditional methods fail.

A spokeswoman for European Commissioner for Health Tonio Borg said: “Strict rules are in place to assure an independent, excellent and transparent 

$10M Settlements to whistleblowers do not prevent patient harm: they protect the perpetrators!

UC OKs paying surgeon $10 million inwhistleblower-retaliation case

The settlement ends a case brought by the ex-head of UCLA's orthopedic surgery department, who says the medical school allowed doctors to take industry payments that may have compromised patient care.

By Chad Terhune          Los Angeles Times     FiDA highlight

April 22, 2014, 8:27 p.m.

University of California regents agreed to pay $10 million to the former chairman of UCLA's orthopedic surgery department, who had alleged that the well-known medical school allowed doctors to take industry payments that may have compromised patient care.

The settlement reached Tuesday in Los Angeles County Superior Court came just before closing arguments were due to begin in a whistleblower-retaliation case brought by Dr. Robert Pedowitz, 54, a surgeon who was recruited to UCLA in 2009 to run the orthopedic surgery department.

In 2012, the surgeon sued UCLA, the UC regents, fellow surgeons and senior university officials, alleging they failed to act on his complaints about widespread conflicts of interest and later retaliated against him for speaking up.

UCLA denied Pedowitz's allegations, and officials said they found no wrongdoing by faculty and no evidence that patient care was jeopardized. But the UC system paid him anyway, saying it wanted to avoid the "substantial expense and inconvenience" of further litigation.

As department chairman, Pedowitz testified, he became concerned about colleagues who had financial ties to medical-device makers or other companies that could unduly influence their care of patients or taint important medical research.

He also alleged that UCLA looked the other way because the university stood to benefit financially from the success of medical products or drugs developed by its doctors.

One of the orthopedic surgeons that Pedowitz complained about testified at trial about receiving $250,000 in consulting fees in 2008 from device maker Medtronic. In memos to university officials, Pedowitz raised concerns about the financial dealings of other doctors as well.

Inside the courtroom Tuesday, Pedowitz sat in the front row with his wife and daughter as the judge told jurors that a settlement had been reached. He said he felt vindicated by the outcome.

"These are serious issues that patients should be worried about," Pedowitz said in an interview. "These problems exist in the broader medical system and they are not restricted to UCLA."

The seven-week trial in downtown Los Angeles offered a rare glimpse into those potential conflicts at a time when there is growing government scrutiny of industry payments to doctors.

Starting this fall, the federal Physician Payments Sunshine Act, part of President Obama's healthcare law, requires public disclosure of financial relationships between healthcare companies and physicians.

Many doctors and universities defend long-standing industry arrangements as essential for carrying out cutting-edge research and top-flight medical education.

In a statement Tuesday, the UC regents said they "resolved this lawsuit to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement."

The statement added that "multiple investigations by university officials and independent investigators concluded that conduct by faculty members was lawful. Patient care was not compromised."

This latest settlement eclipses a $4.5-million payout the UC regents made last year to resolve a racial discrimination lawsuit filed by another UCLA surgeon.

Pedowitz, as part of his settlement, left the UCLA faculty, effective Tuesday. He had agreed to step down as department chairman in 2010 after initially voicing his concerns to top UCLA officials. He filed a whistleblower retaliation complaint in March 2011.

Experts in medical ethics say the UCLA case shows much more needs to be done within academia and by government regulators to address potential conflicts of interest in medicine.

Susan Chimonas, associate director of research at Columbia University's Center on Medicine as a Profession, said some medical schools are still reluctant to take on specialists who bring in considerable money from patients, medical research and patents on breakthrough products.

"Institutions can be dependent on the money these big-earning specialties like orthopedic surgery bring in," Chimonas said. "They are the cash cows and they can set their terms. This is not the first time I've heard of medical schools having policies that are not well enforced."

In an interview last week, the chief compliance officer at the UCLA Health System flatly rejected the notion that the university didn't enforce its policies or look fully into Pedowitz's allegations. She also said industry ties are unavoidable at a big medical school and rules are in place to prevent conflicts.

"We have processes in place to identify those relationships in a transparent fashion and ensure they don't have any inappropriate influence on the actions of the university," said Marti Arvin, chief compliance officer. "In order to meet our mission, it is important we have both the brilliant minds we have at UCLA and collaboration with industry."

Arvin said the university "thoroughly and objectively investigated those allegations of noncompliance raised by Dr. Pedowitz. We were able to determine the vast majority were unsubstantiated."

She said two doctors fell short of university expectations in their handling of outside income, but there was no violation of law or university policy in either instance.

Arvin cited the case of Dr. Nick Shamie, the orthopedic surgeon who testified at trial about receiving $250,000 from Medtronic for consulting work. She said department policy at the time didn't require Shamie to send that outside income through UCLA's faculty compensation plan.

At trial, Pedowitz said he was deeply troubled by the large amount of money Shamie was paid. He testified that he was particularly concerned that Shamie was trying to enroll patients in a research study involving Medtronic at the time.

"I saw this as an obvious problem," Pedowitz testified.

In court, Shamie said he abided by university policy and didn't pursue the study further because finding patients was too difficult. He couldn't be reached for additional comment.

The other physician cited by Arvin for a potential shortcoming was Dr. David McAllister, vice chairman of clinical operations for the orthopedic surgery department.

He didn't report payments from the Musculoskeletal Transplant Foundation, a nonprofit tissue bank that does business with UCLA, because he didn't think disclosure was required in that instance because it didn't involve a for-profit entity, Arvin said.

McAllister also declined to comment, referring a call to UCLA.

Shortly before Pedowitz joined UCLA in 2009, the university was already facing criticism from Congress over the failure of a top spine surgeon to report nearly $460,000 in payments he received from Medtronic and other medical companies while researching their products' use in patients, government records show.

Dr. Jeffrey Wang, who left for USC Spine Center last fall, stepped down as head of UCLA's spine program in 2009 after U.S. Sen. Charles Grassley (R-Iowa) publicized his lapse in disclosure as part of a larger investigation into medical conflicts of interest.

Several patients are now suing Wang and UCLA in state court for negligence, fraud and malpractice in connection with surgeries involving Medtronic's controversial Infuse bone graft. UCLA said it doesn't comment on pending litigation. Wang couldn't be reached for comment.

Shortly after raising his concerns, Pedowitz said, he was pressured to step down as department chairman in 2010. Pedowitz said he was further retaliated against by being denied patient referrals and prevented from participating in grants and other activities.

Before UCLA, Pedowitz worked at UC San Diego and as chairman of orthopedics and sports medicine at the University of South Florida.

Mark Quigley, an attorney representing Pedowitz, said the case could have been avoided if the UC system enforced the policies it already has in place.

"What good are all the policies if they protect the wrongdoers and fail to protect the actual whistleblower?" Quigley said. "The university wanted to cover it all up."

chad.terhune@latimes.com

Twitter: @chadterhune

Toxic medical device cartel penetrates government at the highest levels.

 May 13, 2013 by Brian Johnson

J.C. Scott, SVP, government affairs for AdvaMed is named one of the top lobbyists in theBeltway by CEO Update, a publication covering trade councils

AdvaMed's government affairs guru J.C. Scott has been named a "top lobbyist" by CEO Update, a publication that covers the trade association industry.

Scott received praised by the publication for his work on efforts to repeal the medical device tax,. He was one of only two healthcare related lobbyists on the list.

"[Scott] built bipartisan support for repealing the medical device tax, resulting in a nonbinding 79-20 Senate vote,"the publication wrote. "Helped lead Hill efforts to reauthorize user fees, and then to allow FDA to spend the full amount collected."

AdvaMed hired Scott away from the American Council of Life Insurers 2 years ago. He is a Capitol Hill veteran, having cut his teeth on the Hill as deputy director for policy at the House Republican Conference and in a number of capacities for Rep. Deborah Pryce (R-Ohio) before spending seven years at ACLI.

His predecessor, Brett Loper, left Advamed in early 2011 to become the policy director for House Speaker John Boehner (R-Ohio).

Dirty Secret of (some) Orthopedic Surgeons via Reader's Digest

"Some orthopedic surgeons make millions in soft consulting agreements with device manufacturers."

"Sometimes the same doctors have performed a record number of implants for that company.”—Marty Makary, MD

Where are consumer protections? Not FDA!

http://mobile.reuters.com/article/idUSBRE8AK0T520121121?irpc=932

REUTERS

FDA took 684 days to warn meningitis-linkedfirm: files

Wed, Nov 21 14:28 PM EST   FiDA highlight

By Tim McLaughlin

BOSTON (Reuters) - The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering infractions that could potentially harm patients at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents show.

The New England Compounding Center (NECC) chastised the FDA in a letter dated January 5, 2007, telling the agency its response time was nearly 18 months longer than the FDA's average response, according to letters released under an open records request.

"We believe that FDA's nearly two year delay in issuing the Warning Letter contradicts FDA's rhetoric regarding the asserted risks associated with our compounded products," NECC co-owner and chief pharmacist Barry Cadden said in the letter, released by the FDA under an open records request.

The FDA acknowledged in a letter to Cadden dated October 31, 2008, that there had been a "significant delay" in its response but insisted that the delay "in no way diminishes our serious concerns about your firm's operations."

On Wednesday, a spokeswoman for the FDA, Erica Jefferson, said the delay in issuing the warning letter was due to the agency's limited, unclear and contested authority.

"During the time between the inspection of NECC and the issuance of the warning letter, there was ongoing litigation pertaining to pharmacy compounding and significant internal discussion about how to regulate compounders, all of which delayed FDA," she said.

The FDA has asked lawmakers to clarify its authority to oversee large-scale drug compounders such as NECC. But several Republicans have argued that the agency already had the authority that could have prevented the outbreak.

And on November 19, a congressional panel investigating the outbreak told the FDA not to expect new authority until it releases documents about its role.

According to the Centers for Disease Control and Prevention, 34 people have died and 490 have been injured after Framingham, Massachusetts-based NECC shipped a tainted steroid, methylprednisolone acetate, to medical facilities throughout the United States. The steroid is typically used to ease back pain.

On Tuesday, defense lawyers for NECC's owners told a U.S. District Judge in Boston there was nothing to show they had a direct hand in the cause of the meningitis outbreak.

INDIGNANT AND UNCOOPERATIVE

NECC has consistently pushed back against attempts by regulators to discipline it, despite a series of violations dating back to 1999.

And the pharmacy's principals have sometimes shown little respect for the FDA or its inspectors.

During a re-inspection of the pharmacy in 2004 following up on certain marketing and packaging violations, Cadden and his brother-in-law, Gregory Conigliaro, a co-owner of NECC, became indignant, according to a 2005 memorandum from the FDA inspector. Cadden declined to cooperate without speaking to a lawyer first and at one point instructed his brother-in-law not to answer any more questions.

Conigliaro said he had "a lot of things to finish and just did not have the time to sit with us to answer our questions," the inspector said in his memo.

The FDA's eventual warning letter to NECC in December 2006 was based on an inspection that began in September 2004 and ended on January 19, 2005, according to the documents.

(Reporting by Tim McLaughlin; Editing by Jeffrey Benkoe and Andre Grenon)