The Injury Board Commentary - Medical Devices & Implants

Survey Reveals that Some Doctors Mislead and Hide Information from Patients

Jim Lewis — Sun, 12 Feb 2012 19:32:08 GMT

In a nationwide survey of nearly 2,000 physicians, close to 20 percent of physicians disagreed with the notion that they should "never tell a patient something that is not true." Basically, this means roughly 20 percent of doctors are comfortable with not telling the truth to their patients. If that wasn’t bad enough, 11 percent of the physicians surveyed admitted that they told a patient "something that was not true" in the past year, according to sacbee.com.

Many doctors disagreed with the notion of revealing all of their financial ties to companies that make drugs and medical devices. In the survey, 35 percent of physicians did not agree with the notion that these ties should always be fully disclosed to patients. This is troubling since some patients may not be comfortable having a certain procedure done or taking a particular medication if they were told that their doctor was being funded by the company making that drug or something affiliated with a particular procedure.

Take, for example, the DePuy hip replacement recall. After the recall was announced, it was discovered that DePuy paid 200 doctors close to $80 million for “consulting” work. Some surgeons were paid over $1 million each. Some people have suggested that getting paid large amounts of money by a manufacturer influences what the doctor suggests to their patients.

But the most disturbing revelation from the survey was related to doctors actually being comfortable hiding medical mistakes. The survey revealed that 34 percent of physicians did not completely agree that "all significant medical errors" should be disclosed to patients. Furthermore, 20 percent of physicians said they had actually withheld information about medical mistakes from their patients in the past year. This behavior is totally unacceptable. It’s one thing to not want to tell a patient about a medical error, but it’s totally different to consciously withhold that information. Innocent patients have suffered serious injuries, or had their injuries exacerbated, by medical errors that were not disclosed to them. For example, our firm represented a client who suffered serious injuries after it was discovered that a surgical sponge was left inside her body from a surgery. As a result of this blatant medical error, the patient had to undergo a bowel resection surgery.

If you or a loved one is undergoing a procedure, know that your doctor has no right to withhold important information regarding your condition and medical procedures. Such behavior is wrong and grounds for legal action.

About the Editors: The Shapiro, Lewis & Appleton personal injury law firm, which has offices in Virginia (VA) and North Carolina (NC), edits the injury law blogs Virginia Beach Injuryboard, Norfolk Injuryboard and Northeast North Carolina Injuryboard as pro bono services.

Originally posted at InjuryBoard by Jim Lewis

Mesh Implant Update: FDA Requires More Studies and Information From Manufacturers

M. Brandon Smith — Sun, 12 Feb 2012 11:10:51 GMT

Following up on previous warnings about the safety of transvaginal mesh implants to treat pelvic organ prolapse, the FDA is now enlisting the research power of the manufacturers of these devices. On January 3, the FDA sent letters to 35 manufacturers of surgical mesh implants, mandating them to conduct a total of nearly 100 post-market studies. These studies are to address specific safety and effectiveness concerns related to surgical mesh devices used in POP treatment. Unfortunately requesting these studies comes a little too late. The products originally got approval without clinical testing and the results for many women have been disastrous.

Concerns about the use of transvaginal mesh to treat POP hit the news in July of last year, when the FDA issued a safety communication calling attention to the hundreds of reports of adverse outcomes that it had received. In just the two-year time span between 2008-2010, the FDA received 1,500 reports of complications related to mesh treatment procedures. Based on those reports and additional study, the FDA found that serious complications from the use of surgical mesh to treat POP “are not rare,” and that the use of mesh is not clearly more effective than other surgical procedures even though it may expose patients to greater risk. Since issuing that safety communication, the FDA has continued its review of the safety of transvaginal mesh implants.

Depending on the results of the review, the FDA is apparently considering reclassifying mesh implants as a riskier device than originally believed. As reported by Reuters, surgical mesh has been used since the 1950s to treat abdominal hernias, which meant that the manufacturers of transvaginal mesh implants originally got product approval without the need for doing clinical trials. But the use of those mesh implants for POP treatment only started in the 1990s and the flood of adverse reports now calls into serious question its safety. A reclassification of the device would mean manufacturers need to do clinical trials.

What does all of this mean for patients? The fact is that thousands of women—nearly 75,000 in 2010 alone—received a medical treatment that had never undergone significant safety testing. Many of them are now suffering because that treatment was unsafe and are seeking legal recourse to hold these manufacturers accountable for putting an un-tested and un-proven product on the market.

Originally posted at InjuryBoard by M. Brandon Smith

FDA warns dentists and vets that hand-held dental X-ray units may harm patients

Paul Napoli — Sun, 12 Feb 2012 10:55:40 GMT

Government regulators are warning dentists and veterinarians not to use unapproved hand-held dental X-ray devices imported from outside the United States.

Hand-held dental X-ray units, which are small, portable devices that use a form of radiation to create a picture of teeth, bones and soft tissue of the mouth, must comply with the U.S. Food and Drug Administration’s (FDA) radiation safety and medical device requirements, and receive FDA clearance before sale in this country. To ensure the radiation safety of their patients and staff, dentists and veterinarians should only be using hand-held dental X-ray units cleared by the FDA that carry a permanent certification label, ID tag and warning label.

The FDA said yesterday that the agency is aware of unapproved, illegal hand-held dental X-ray devices sold on the internet then shipped directly to customers in the U.S. and that these devices could potentially expose the user and patient to unnecessary and potentially harmful X-rays.

“Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA’s standards,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.

To ensure this, users should:

Verify the presence of required labels on the device.
Ask vendors whether the device has been reviewed and cleared by the FDA.
Access the FDA Medical Device Approvals and Clearances searchable database to verify that the X-ray unit has been cleared by the FDA.
Contact their state regulatory agency if they become aware of a device that may be hazardous or does not meet the FDA’s requirements.

The FDA is also notifying state regulatory veterinary and dental organizations and health organizations to be aware of the illegal hand-held X-ray units and their risks.

There have been no reports of injury or adverse effects at this time.

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Originally posted at InjuryBoard by Paul Napoli

Pelvic Mesh Implant Lawsuits Move Forward in Courts

Joe Saunders — Wed, 08 Feb 2012 21:28:37 GMT

Products liability lawsuits against three different manufacturers of transvaginal surgical mesh devices were assigned to a single federal judge in a multidistrict litigation proceeding this week. The February 7, 2012 Order by the Panel on Multidistrict Litigation assigned lawsuits from all over the United States to the federal Court in Charleston West Virginia. A prior multidistrict litigation proceeding involving the C.R. Bard Avaulta vaginal surgical mesh has been pending in the Charleston Court for several years.

The panel of judges making this assignment reasoned that the reported defects in all of these mesh products were similar and that Judge Godwin in Charleston who has been handling the C.R. Bard Avaulta pelvic mesh litigation could use his experience to expedite the litigation involving the other manufacturers.

A multidistrict litigation is not a class action. Each woman will continue to have her own individual case and if the case does not get settled the case will be remanded to her home town for an individual trial. Each woman will have the right to make her own individual decision on whether to settle or take her case to trial.

Multidistrict litigation is frequently used in mass disasters such as an aircraft crash or a major hotel fire or collapse. It is expected that there will be thousands of women who will eventually file lawsuits. The widespread marketing of transvaginal surgical mesh to women in the United States is, in my opinion, a mass health disaster.

The lawsuits allege that the manufacturers of these products recklessly and negligently marketed these mesh products for surgical treatment of pelvic organ prolapse and stress urinary incontinence and put the companies’ interest in making profits ahead of the safety of women. Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) can be treated surgically in most cases using a women’s native tissue without implantation of surgical mesh. The risks of complications are much lower if the mesh is not used.

In many cases with mesh implantation the mesh causes inflammation and infection. The implanted mesh also can shrink and cause chronic pain. Frequently, the mesh will start to extrude through the vaginal wall causing bleeding and pain. Many women have had multiple surgeries to try to trim the extruding mesh or cut deeper to try to remove parts of the mesh. It is practically impossible to remove the mesh because it is implanted deeply through the pelvis with strips or arms extending deep into the pelvis and towards the abdomen. Consequently, there may be no cure for some of these women. I have one client that has had 8 surgeries and is still in pain every day.

It appears that the manufacturers mislead the womens’ doctors by promoting the mesh kits and being safe and effective for treating POP and SUI. The medical studies that the manufacturers used to promote these products describe the anatomical benefits of using the mesh to restore the vaginal vault but the studies did not look at the outcomes on the women who had the implants in the months and years after implant. The U.S. Food and Drug Administration has recently become concerned about the high rate of adverse outcomes after these implants and is conducting data collection to decide whether to order a recall to prevent future implant surgeries on such a broad scale. Many medical specialists believe that is a few limited cases a mesh implant might be warranted if the woman is fully and properly advised of the risks of bad side effects but that the wholesale promotion of these mesh products to all women with POP or SUI is dangerous and wrong.

These mesh kits probably cost less than $100 to manufacture but they are sold to hospitals for over $2,000. This high profit margin provides an inventive for the manufacturers to sell as many of these kits as they can. It will be interesting to see what juries think of this motive to oversell these devices. Many of the lawsuits ask for punitive damages against the manufacturers on this basis.

The three new manufacturers added to the multidistrict proceeding procedure are American Medical Systems, Inc., (AMS); Boston Scientific Corp.; and Ethicon, Inc. which is a Johnson & Johnson company. Each of these manufacturers makes a number of different transvaginal surgical mesh products in different sizes and designs but it appears that they all have unacceptably high rate of side effects and complications.

The coordination of these cases for pretrial management will help to define the scope of this national health disaster and provide a forum for the women and their lawyers to find out the truth about what these companies knew and why they chose to expose women to these horrible health complications.

Originally posted at InjuryBoard by Joe Saunders

Metal-on-Metal Hip Replacements Cancer Risk

Shezad Malik MD JD — Wed, 08 Feb 2012 09:51:48 GMT

A medical study underway is expected to reveal that side effects of metal-on-metal hip replacements can cause genetic damage, which could lead to an increased risk of cancer.

According to the U.K.’s Telegraph newspaper, a study to be presented next month at the British Hip Society conference will include findings that suggest the metal particles released by the grinding of metal-on-metal hip replacements could cause chromosomal changes, which may lead to kidney cancer and bladder cancer.

The findings are the latest nails in the coffin over the safety of the once-popular hip implant designs. These hips have been the subject of massive recalls and product liability lawsuits filed by individuals who allege that they are subject to failure within a few years after surgery.

The most likely cause of the genetic damage is metal debris made up of cobalt and chromium, which is released into the body when metal hip implant parts grind against each other. The particles have been linked to tissue damage, tumors, high metal ion blood counts and metal blood poisoning, known as metallosis.

DePuy Orthopaedics, a division of Johnson & Johnson, already faces a massive number of metal hip implant lawsuits. In August 2010, a DePuy ASR metal hip implant recall affected 93,000 implants worldwide and about 40,000 sold in the United States.

Approximately 3,500, of those victims who received the implant in the U.S. have already filed a DePuy ASR hip lawsuit. As more hip implants fail over time, the number of people filing product liability claims against manufacturers is bound to increase.

Recent data from the National Joint Registry for England and Wales indicates that nearly a third of patients will experience problems within six years and other estimates suggest that as many as half of all individuals who received the recalled hip system may eventually experience loosening or failure of their implant.

In May 2011, the FDA asked device manufacturers to obtain more information about the level at which the metal particles released by hip replacements becomes dangerous, how much metal they actually release and what the potential side effects of metallosis are.

Read more here and visit my website for further information.

Originally posted at InjuryBoard by Shezad Malik MD JD

Allergan Stops Sales of Lapband to 1-800-Get-Thin Bariatric Surgery Centers

David Mittleman — Sun, 05 Feb 2012 11:52:23 GMT

In Southern California, the 1-800-Get-Thin advertisements can be seen on billboards promising weight loss up to 130 pounds. However, the maker of the lapband device, Allergan, recently announced that it will stop selling the product to 1-800-Get-Thin over concerns of the company's poor safety record.

Back in December, the FDA warned 1-800-Get-Thin that their ads were misleading because they fail to spell out the risks associated with the surgery. In addition, the Los Angeles Times also reported at least 5 deaths of individuals that underwent surgery at one of the 1-800-Get-Thin affiliated surgical centers. The 1-800-Get-Thin marketing firm and individuals who own affiliated surgical centers have been hit with two wrongful death suits and a whistleblower suit filed by ex-employees and patients who are concerned over the safety of the centers, billing fraud, and the cover-up of a death of at least 1 patient.

Allergan says that it has no ties to 1-800-Get-Thin and that it has no control over how its buyers market the product. On February 2, the company said that is stopped selling the device to 1-800-Get-Thin. The California Department of Insurance is also investigating the claims of billing fraud and the Los Angeles County Board of Supervisors is seeking legislation to regulate bariatric treatment centers more tightly.

Originally posted at InjuryBoard by David Mittleman

Biomet Hip Replacement Lawsuit

Shezad Malik MD JD — Sat, 04 Feb 2012 11:24:00 GMT

A Texas plaintiff has filed a federal complaint against Biomet Orthopedics over problems with their M2A Magnum metal-on-metal hip replacement system, which she says failed shortly after being implanted.

The complaint was filed by Carol St. Cyr in January, alleging that the Biomet M2A Magnum hip replacement she received was defectively designed and manufactured.

According to allegations raised in the product liability lawsuit, the metal head and acetabular cup of the Biomet hip replacement grindr against each other, causing premature failure and leading to metal blood poisoning from cobalt and chromium fragments; a condition known as metallosis.

St. Cyr, 69, received the Biomet M2A Magnum hip replacement in May 2009. Shortly afterwards, she began to suffer groin and hip pain, problems walking, sitting and standing, inflammation and other complications.

According to experts, as the metal hip replacement parts rub against each other, microscopic particles of cobalt and chromium may be shed into the body, which can result in metal poisoning. This may result in soft tissue damage, inflammatory reactions, bone loss, asceptic fibrosis, local necrosis and other problems that may lead to the need for a risky hip revision surgery.

Concerns about the safety of all-metal implants increased in 2010, after a DePuy ASR metal hip recall was issued due to higher-than-expected failure rates. More than 90,000 of the recalled implants were sold worldwide before the problems were acknowledged by the manufacturer, and hundreds of individuals in the United States have filed a DePuy ASR hip lawsuitafter experiencing complications with the implant.

In addition to DePuy and Biomet, a number of other artificial hip manufacturers also make all-metal implants, which have also been the subject of similar product liability lawsuits.

In May 2011, the FDA asked device manufacturers to obtain more information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are.

Originally posted at InjuryBoard by Shezad Malik MD JD

Public Citizen Chides FDA for Failing to Recall Stryker Stent

Greg Webb — Mon, 30 Jan 2012 08:00:00 GMT

According to a recent Bloomberg Businessweek article (Jan. 12) by Michelle Fay Cortez, Michael Carome, deputy director of Public Citizen’s Health Research Group and author of a petition to recall the Stryker Corporation’s Wingspan stent, boldly criticized the U.S. Food and Drug Administration (FDA) for not recalling the medical device due to evidence of increased possibility of stroke in certain patients when the Wingspan stent was used.

Following a review last year by an independent panel which stopped a definitive scientific trial of the device due to safety risks, Public Citizen requested FDA pull the stent from the marketplace. Carome said, “Given the evidence of significant harm with no evidence of any benefit, there is no justification for any additional patients to be treated with this dangerous device.” Carome also said, “To allow any further implantation of this device would be highly unethical, as well as a violation of FDA laws and regulations.”

Michelle Bolek, FDA spokesperson, says the FDA plans to review an addendum to Public Citizen’s original petition and respond directly to Public Citizen. Stryker continues to advocate the use of their Wingspan stent to enlarge narrowed arteries in the brain after drug therapy to do so has proved ineffective.

Stryker Corp. is based in Kalamazoo, Michigan, and reported sales of $366.1 million from their neurovascular products during the first three quarters of 2011. Stryker purchased Boston Scientific Corporation’s neurovascular segment in 2010 and acquired the Wingspan Stent System at that time.

Originally posted at InjuryBoard by Greg Webb

Transvaginal Mesh Lawsuits Move Forward

Joe Saunders — Sun, 29 Jan 2012 10:55:43 GMT

Thousands of women who have had surgical mesh implanted to treat pelvic organ prolapse and stress urinary incontinence are suffering from serious complications that are very difficult or impossible to cure. Many women have had multiple surgeries to try to have the mesh removed or trimmed after suffering continued pain, bleeding, pain with intercourse and other symptoms. Hundreds of lawsuits are being filed around the country against the manufacturers of these mesh products.

Manufacturers such as Bard, Johnson & Johnson, Boston Scientific, and AMS have made huge profits selling surgical kits to doctors and hospitals and aggressively promoting the use of vaginally implanted surgical mesh to reinforce the vaginal vault and hold organs in place. Previously, surgeons primarily stitched a women’s natural tissue to remedy pelvic organ prolapse and stress urinary incontinence. It appears that in most cases use of this prior procedure using the natural tissue was substantially effective without the risks of complications inherent in implanting a polypropylene mesh through the vaginal canal. It appears that the manufacturers of the mesh have mislead the obstetricians and gynecologists about the relative safety of the use of the transvaginal mesh procedures in order to increase the manufacturer’s profits from the sales of these kits. The pelvic organ prolapse surgical kits that are being promoted by the manufacturers probably cost less than $100 to manufacture but they are sold to the hospitals for over $2,000.

In 2011, the United States Food and Drug Administration (FDA) ordered all manufacturers to report adverse events of all of these products and study the increasing reports of these serious complications. In 2008, the FDA had believed that these complications from the transvaginal mesh implants were rare. However, now the FDA has seen so many adverse events that they have revised their statement to now conclude that complications are not uncommon.

Federal lawsuits involving the Bard Avaulta mesh product have been coordinated before a United States District Judge in West Virginia. A panel of federal judges sitting in Miami last week considered a petition to have theWest Virginia judge assigned to preside over the pretrial management of federal lawsuits against Johnson & Johnson, Boston Scientific, and AMS as well. There are an increasing number of lawsuits pending in state courts primarily in New Jersey, California, Minnesota, and Massachusetts.

I expect that the lawsuits involving the transvaginal mesh products will number in the thousands because so many women are suffering serious and long term complications without any cure and they are only starting to realize that they have been victim to the over marketing of a dangerous product that had not been properly tested.

One Ob/Gyn physician that I have spoken to believes that the use of the transvaginal mesh may be appropriate in a very few difficult cases when implanted by a specialist but that the wholesale implantation of these mesh products on a regular basis as a routine treatment for pelvic organ prolapse or stress urinary incontinence is not safe. Certainly, clients of our firm with whom I have spoken would never have agreed to the implant if they had any idea of the suffering that they would endure.

Originally posted at InjuryBoard by Joe Saunders

DePuy Defective Hip Problems Biting into Johnson & Johnson

Shezad Malik MD JD — Sat, 28 Jan 2012 11:14:40 GMT

Defective design problems with recalled DePuy hip ASR replacements are beginning to bite into Johnson and Johnson quarterly profits.

Recently, the medical product company reported only $218 million in net earnings for the last quarter of 2011.

The reduced earnings was attributed to a $2.9 billion charge, which included expenses from DePuy ASR hip lawsuits, among other charges.

J&J set aside $1B

This charge follows a nearly $1 billion set aside in the fourth-quarter 2010 for costs associated with DePuy hip problems, including funds for potential DePuy ASR settlements and costs associated with the recall program.

Litigation and Settlement charges could exceed $5B

According to experts, DePuy and other manufacturers of similar metal on metal implants could ultimately face $5 billion in legal costs and settlement fees associated with problems from metal-on-metal hip replacements.

In August 2010, a DePuy ASR recall was issued after the system was linked to a higher-than-expected failure rate. By the time the DePuy hip implant was removed from the market, about 37,000 of the devices had already been used in the United States.

At the time of the recall, Johnson & Johnson indicated that the DePuy ASR failure rate was about 12%.

According to some experts the actual percentage of people who are likely to experience problems with their implant, including loosening, metal poisoning and possible revision surgery, is going to be higher with time.

Federal MDL Consolidation in Ohio

Since the recall, a growing tsunami of lawsuits over the DePuy ASR hip have been filed against Johnson & Johnson in courts throughout the United States.

The federal DePuy ASR litigation has been consolidated for pretrial proceedings in the U.S. District Court for the Northern District of Ohio as part of an MDL, or multidistrict litigation. About 3,500 DePuy ASR metal hip recipients have sued the company so far.

Originally posted at InjuryBoard by Shezad Malik MD JD