Honolulu Personal Injury Lawyer - Medical Devices & Implants

New Medical Device Allows Immediate Blood Analysis During Surgery

Wayne Parsons — Sat, 29 Aug 2009 13:37:11 GMT

Timing is everything in surgery and blood analysis informs the doctors about the presence of disease. Now a team of British electronic professors and medical doctors has developed a new device to do it on the fly in the operating room. If successful _ and it looks like they are well on the way to mastering the engineering issues _ this will save lives and prevent unavoidable errors.

Science Daily reports on Aug. 29, 2009 about a new hand-held device featuring a microfluidic chip and micro-electrodes, that allow a surgeon to get instant blood cell analysis of the patient's blood. The device is in development at the University of Southampton in the U.K. The work is described in Lab on a Chip.

David Holmes, David Pettigrew, Christian H. Reccius, James D. Gwyer, Cees van Berkel, Judith Holloway, Donna E. Davies and Hywel Morgan. Leukocyte analysis and differentiation using high speed microfluidic single cell impedance cytometry.

Lab on a Chip, 2009; DOI: 10.1039/b910053a

The Southampton team led by Professor Hywel Morgan at the University’s Nano Research Group within the School of Electronics and Computer Science (ECS) in conjunction with Professor Donna Davies and Dr. Judith Holloway at the School of Medicine, has developed a microfluidic single-cell impedance cytometer that performs a white cell differential count. The system was developed in collaboration with Philips Research.

The Abstract:

Miniature high speed label-free cell analysis systems have yet to be developed, but have the potential to deliver fast, inexpensive and simple full blood cell analysis systems that could be used routinely in clinical practice. We demonstrate a microfluidic single cell impedance cytometer that performs a white blood cell differential count. The device consists of a microfluidic chip with micro-electrodes that measure the impedance of single cells at two frequencies. Human blood, treated with saponin/formic acid to lyse erythrocytes, flows through the device and a complete blood count is performed in a few minutes. Verification of cell dielectric parameters was performed by simultaneously measuring fluorescence from CD antibody-conjugated cells. This enabled direct correlation of impedance signals from individual cells with phenotype. Tests with patient samples showed 95% correlation against commercial (optical/Coulter) blood analysis equipment, demonstrating the potential clinical utility of the impedance microcytometer for a point-of-care blood analysis system.

Microfluidics – a set of technologies that control the flow of minute amounts of liquids – are incorporated inside the chip and measure a number of different cells in the blood. Tiny electrodes in a channel measure the electrical properties of each blood cell as the blood cells flow through the device. Each blood cell type is identified and counted. This allows the surgery team to identify and diagnose the presence of various diseases. The system recognizes the three main types of white blood cells: T lymphocytes, monocytes and neutrophils more rapidly and less expensively than other available methods.

‘At the moment if an individual goes to the doctor complaining of feeling unwell, a blood test will be taken which will need to be sent away to the lab while the patient awaits the results,' said Professor Morgan. 'Our new prototype device may allow point of care cell analysis which aids the GP in diagnosing acute diseases while the patient is with the GP, so a treatment strategy may be devised immediately. Our method provides more control and accuracy than that what is currently on the market for GP testing.

Getting the device to do the same with red blood cells and platelet count is next for the research team. The device is targeted to be handheld and cost in the range of $1,500 to $2,000 US. The devices would utilize a disposable chip costing a few dollars each. A new facility called the Southampton Nanofabrication Centre opens on 9 September 2009 to make the devices.

Originally posted at InjuryBoard by Wayne Parsons

Medical Device Safety Act would allow state suits, but some lawmakers oppose it.(2)

Wayne Parsons — Tue, 26 May 2009 08:01:49 GMT

The Greenville News (5/24, Osby) reported that the "Medical Device Safety Act of 2009... would reverse the high court's decision" and would allow patients to sue Medtronic under state law. Don Fernbach, who was one of the patient's shocked by a defective lead said, "As long as victims of defective medical devices can't sue...these companies have no impetus to do the right thing." However, "U.S. Rep. Bob Inglis, R-S.C., said manufacturers should take reasonable steps so their products are safe, but shouldn't have to be 'guarantors' of good outcomes, or product development would be suppressed." Inglis "added that while accountability through litigation is the best argument for the bill, FDA has a 'rigorous' system for approving devices, and it would drive up costs." In addition, "U.S. Sen. Jim DeMint opposes the bill for the same reasons."

Originally posted at InjuryBoard by Wayne Parsons

Medical Device Safety Act would allow state suits, but some lawmakers oppose it.

Wayne Parsons — Tue, 26 May 2009 08:00:59 GMT

Originally posted at InjuryBoard by Wayne Parsons

Obama undoes Bush pre-emption policies.

Wayne Parsons — Thu, 21 May 2009 14:21:50 GMT

The AP (5/21, Yost) reports, "The Obama White House on Wednesday undid a Bush administration policy that used federal regulations to undermine a wide range of state health, safety and environmental laws" many of which "limited the ability of injured consumers to sue companies in state courts." This is the latest move by the Obama administration to undo pre-emption policy. Kenneth Baer, communications director at the White House Office of Management and Budget, said, "When it comes to pre-emption, we're saying no more of their approach." Now, "the Obama administration will ask agencies to go back and find Bush-era regulations that contain pre-emption language in the preambles or in the body of the regulations and that are not justified by law." Les Weisbrod, president of the American Association for Justice, said "the Obama administration has 'overturned actions taken by Bush administration bureaucrats who were influenced by powerful, well-connected corporations.'"

The Wall Street Journal (5/21, Mundy, Kendall) reports, "The memo didn't name specific industries but it could affect a wide range of consumer products subject to both federal and state regulation." The Chamber of Commerce's Bryan Quigley said, "Allowing for more lawsuits will not create more jobs, except maybe for plaintiffs' lawyers." However, a statement by the American Association for Justice said, "The move will buttress 'laws designed to give Americans basic rights to hold wrongdoers accountable.'"

BusinessWeek (5/21, Francis) reports, "Lauded by the plaintiffs' bar and downplayed by some business groups, Obama's decision reverses a highly charged Bush Administration practice and could help rewrite the legal landscape for everything from pharmaceuticals and beauty products to car safety equipment, mattress flammability, and food sweeteners." Les Weisbord, president of AAJ said, "On behalf of the thousands of people whose cases have been affected by complete immunity preemption, we are heartened by the Presidential memo released today." He added, "The Obama memo on regulatory preemption makes clear that the rule of law will once again prevail over the rule of politics."

Originally posted at InjuryBoard by Wayne Parsons

House lawmakers hear debate over medical device preemption.

Wayne Parsons — Thu, 14 May 2009 14:40:16 GMT

CQ HealthBeat (5/14, Kim) reports that the House Energy and Commerce Committee's Health Subcommittee "heard witness testimony on a measure that would allow consumers to sue companies under state law for injuries sustained by sophisticated medical devices" on Tuesday. Supporters of HR 1346, the Medical Device Safety Act of 2009, said "that the bill would ensure product safety and consumer protection, while opponents argued that the bill would stifle life-saving medical innovation and impose unnecessary regulation on medical device companies." The bill is in response "to a Supreme Court ruling issued last year that states that under the Medical Device Amendments of 1976, certain medical devices that must go through Food and Drug Administration (FDA) pre-marketing approval are preempted from being sued for liability under state law." That decision "has already resulted in 1,400 injury cases being thrown out of court, said Committee Chairman Henry A. Waxman (D-CA) [a] co-sponsor of the bill. It's the possibility of litigation that is one of the most powerful incentives to safety, Waxman said."

NPR (5/13, Silberner) reported, "The U.S. Supreme Court ruled in February 2008 that an OK from the Food and Drug Administration for a high-tech medical device is all a manufacturer needs to avoid being sued in state court." Now, "Rep. Frank Pallone (D-NJ) wants to change that." He said, "There are problems with medical devices that arise outside of the FDA approval process because that process is limited. ... And we should not preclude people from suing and recovering damages if something comes up."

Modern Healthcare (5/13, Rhea) reported that House lawmakers "listened to testimony from experts and patients and argued the merits of the Medical Device Safety Act of 2009." The act is "sponsored by Rep. Frank Pallone Jr. (D-N.J.)" and "would negate the Supreme Court's decision in last year's Riegel vs. Medtronic case, which involved a Medtronic-manufactured balloon catheter that ruptured inside the patient during coronary artery surgery."

Originally posted at InjuryBoard by Wayne Parsons

Tort Reform For Victims of Unsafe Medical Devices: Pass The Medical Device Safety Act of 2009

Wayne Parsons — Wed, 13 May 2009 18:23:28 GMT

Hearings began on Tuesday, May 12th before the Subcommittee on Health on H.R. 1346, The Medical Device Safety Act of 2009. I explain it below but before you go any further make sure to read the excellent analysis of Cecelia Prewett: House Energy and Commerce Subcommittee Considers Ability of FDA to Regulate Medical Devices.

Bruce Braley, a Member of this Subcommittee has been aggressively advocating for this hearing, and will be actively participating, in an effort to pass this important piece of legislation. Here is what Congressman Braley from Iowa has to say on the subject:

The Medical Device Safety Act of 2009 is needed to ensure that every American patient has the ability to hold manufacturers of defective medical devices accountable for injuries and deaths caused by unsafe products. It would also prevent these manufacturers from receiving total immunity from any claims simply by virtue of receiving a Food and Drug Administration device approval. This bill clarifies the intention of Congress to keep American patients safe by maintaining complementary systems to protect consumers through the FDA and American courts.

The need for this legislation was made evident in the Supreme Court’s flawed decision in Riegel v. Medtronic, which completely ignored Congressional intent regarding the ability of injured patients to hold medical device manufacturers accountable for their injuries. This bill will restore Congress’ original intent to allow injured patients to recover for their injuries caused by manufacturers of defective and dangerous medical devices.

I hope that everyone will call their represenatives in Congress to support this Bill. The video shows how to call Senator Grassley also of Iowa to get him to support the bill. Here is you can do it easily:

http://www.youtube.com/watch?v=rrQBFW0EfvY

How easy is that? Please use this as a script for yourself on this and other legislation.

What do you think about companies putting dangerous products on the market? Here is an informative video about defibrillators and other medical devices.

http://www.youtube.com/watch?v=Ai_TB6IxZBA

Can you believe it that our Congress has allowed manufactuers to avoid responsibilty in many of these situations. Shame on you Medtronic!

Originally posted at InjuryBoard by Wayne Parsons

Hawaii Swine Flu Update - Tamiflu Stockpiles Vary Widely Throughout World

Wayne Parsons — Sun, 10 May 2009 15:14:14 GMT

Hawaii has a few Swine Flu cases, most recently a student up at UH. Our medical community seems well organized and prepared. The entire country seems to be on top of this situation.

We now know that the current virus H1N1 virus probably doesn't have the teeth that will lead to a large scale pandemic like the 1918 one that killed so many people. But the life cycle of a virus and its propensity to mutate means that in a matter of days a new strain could take wings and cause problems. The fear is that the current virus connects with the avian flu virus from Asia and then becomes significantly more virulent. This little virus looks pretty scary when you see it up close.

The general picture of H1N1 has been widely reported:

Influenza A virus subtype H1N1, also known as A(H1N1), is a subtype of influenzavirus A and the most common cause of influenza (flu) in humans. Some strains of H1N1 are endemic in humans, including the strain(s) responsible for the 1918 flu pandemic which killed 50–100 million people worldwide. Less virulent H1N1 strains still exist in the wild today, worldwide, causing a small fraction of all influenza-like illness and a large fraction of all seasonal influenza. H1N1 strains caused roughly half of all flu infections in 2006.^[1] Other strains of H1N1 are endemic in pigs and in birds.

The question as I see it in Honolulu is how do we deal with the possible infection in the community now, and then how is Hawaii prepared should a more virulent flu emerge?

Looking at the current infection risk, people with flu like symptoms should go to the doctor and not circulate in the community particularly around children and the elderly until they are sure that they don't have H1N1. Get some disinfectant wipes and carry them everywhere. Look for ones that are effective against virus. All soap is not created equal. Wash hands and face frequently. Use a soap that is antibacterial. I do not not about antiviral soaps. I would be interested if any of you know. Don't touch as many things as you used, particularly in public places. Airplane travel? Don't unless you have to.

Now what about masks? That is a controversial subject. Do they stop the H1N1 virus?

The State of Tennessee says that no one knows for sure but that wearing one is okay:

The state said it doesn't want people with influenza symptoms walking around the general public without masks. Jones said he did not recommend that healthy people wear masks if the person is already being careful washing his or her hands on a regular basis.

He said there was not major scientific evidence one way or the other to wearing masks, but the state was not pushing the general public to wear them.

The state said they have a stockpile of about 600-dozen courses of Tamiflu vaccine.

According to the CDC:

Information on the effectiveness of facemasks and respirators for the control of influenza in community settings is extremely limited. Thus, it is difficult to assess their potential effectiveness in controlling swine influenza A (H1N1) virus transmission in these settings. In the absence of clear scientific data, the interim recommendations below have been developed on the basis of public health judgment and the historical use of facemasks and respirators in other settings.

Unless otherwise specified, the term "facemasks" refers to disposable masks cleared by the U.S. Food and Drug Administration (FDA) for use as medical devices. This includes facemasks labeled as surgical, dental, medical procedure, isolation, or laser masks. Such facemasks have several designs. One type is affixed to the head with two ties, conforms to the face with the aid of a flexible adjustment for the nose bridge, and may be flat/pleated or duck-billed in shape. Another type of facemask is pre-molded, adheres to the head with a single elastic band, and has a flexible adjustment for the nose bridge. A third type is flat/pleated and affixes to the head with ear loops. Facemasks cleared by the FDA for use as medical devices have been determined to have specific levels of protection from penetration of blood and body fluids.

When close contact with others cannot be avoided, the use of Facemasks or respirators in areas where transmission of novel influenza A (H1N1) virus has been confirmed should be considered as follows:

Persons who are at high risk of complications from novel influenza A (H1N1) infection (for example, persons with certain chronic medical conditions, children less than 5 years, persons 65 or older, and pregnant women) should consider their risk of exposure to novel influenza if they attend public gatherings in communities where novel influenza A virus is circulating. In communities with several reported cases of novel influenza A (H1N1) virus infection, persons who are at risk of complications from influenza should consider staying away from public gatherings.

Based on currently available information, for non-healthcare settings where frequent exposures to persons with novel influenza A (H1N1) are unlikely, masks and respirators are not recommended.

Persons who are ill with influenza-like symptoms should stay home and limit contact with others as much as possible. When not alone or in a public place, protect others by wearing Facemasks to reduce the number of droplets coughed or sneezed into the air and the time spent in crowded settings should be as short as possible.

Respirators should be considered for use by individuals for whom close contact with an infectious person is unavoidable. This can include selected individuals who must care for a sick person (e.g., family member with a respiratory infection) at home.

These interim recommendations will be revised as new information about the use of Facemasks and respirators in the current setting becomes available.

So do masks work or not? I find it puzzling that scientists and mask manufacturers do not know. The first question is do the masks stop the virus. If so that should be said in simple up front terms. If not then say that also. Are H1N1 virus particles too small for the masks? If the problem is that the masks can leak - which makes perfect sense to me, then that should be said clearly. I just read a bunch stories on masks and Swine Flu and if it was in there I couldn't find it. I just got a lot of words with carefully chosen phrases.

http://gannett.a.mms.mavenapps.net/mms/rt/1/site/gannett-wgrz-3315-pub01-live/current/launch.html?maven_playerId=articleplayer&maven_referralPlaylistId=playlist&maven_referralObject=1110547956

For Hawaii I have decided not to wear a mask for this flu. If I get on an airplane I will probably wear one. We connect with all of Asia and all of the mainland US and European travelers are always on airplanes to and from Hawaii. At worst the mask can't hurt. Which mask? The N-95 seems to be the one of choice. The main thing is to not spread the disease and that requires some decisions if you get sick.

Originally posted at InjuryBoard by Wayne Parsons

Synthes settles investigation into conflicts of interest among physicians researching its products.

Wayne Parsons — Thu, 07 May 2009 15:58:45 GMT

The New York Times (5/7, B4, Abelson) reports,

"The New Jersey attorney general has announced a settlement with a medical device maker accused of failing to disclose financial conflicts of interest among doctors researching its products." Attorney General Anne Milgram added that "her office is investigating other similar conflicts in the device industry," and has "issued subpoenas to five major device makers."

http://www.youtube.com/watch?v=i0_mZDQhKq0

Under the recent settlement,

"Synthes, the maker of the ProDisc artificial spinal disk," is required "to disclose any future payments or investments held by doctors involved in researching its products." In addition, "the company has agreed to make the information publicly available through its website," and to "stop paying doctors who are conducting clinical trials of its products with stock or stock options." Synthes "agreed to pay $236,000 to reimburse the attorney general's office for its investigation."

Milgram sent a letter "Tuesday to the FDA and members of Congress," criticizing regulators "for doing 'nothing to regulate these conflicts,' despite...an obvious lack of disclosure from the researchers."

Originally posted at InjuryBoard by Wayne Parsons

Mentor Corporation Sued for Complications Associated with ObTape.

Wayne Parsons — Tue, 05 May 2009 17:28:28 GMT

The New York Times (5/5, D5, Rabin) reports that "dozens of women" are "suing the maker of [a] vaginal sling, called ObTape" for complications they claim are associated with the product.

The product was used in patients with "stress urinary incontinence" to "plug the leak by inserting a hammock made of a strip of synthetic mesh like material...under [the] urethra." Mentor Corporation "stopped selling ObTape in 2006 but says there is nothing wrong with the product, which was cleared for sale by the Food and Drug Administration.". But injured women have experienced the tape migrating in their body and disintegrating.

http://cbs4.com/video/?id=53869@wfor.dayport.com

However an FDA MedWatch Alert in late 2008 brought this product to public attention:

On October 20, 2008, the United States Food and Drug Administration, which regulates the medical device industry, issued a MedWatch Alert informing healthcare professionals of serious complications associated with surgical mesh vaginal slings, such as the Mentor ObTape. In that Alert, the FDA notes that it has received hundreds of adverse incident reports concerning these devices over the past three years, including complaints of infection, vaginal tissue erosion, perforation, and recurrence of the very problems that the slings were intended to treat. The Alert also contains a list of recommendations for physicians who have implanted these devices in patients, or who may be treating patients who have had these slings implanted, including vigilance for potential adverse effects of the sling, informing patients that complications associated with the slings may require additional surgery that may not correct the problem, and informing patients “about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse [and] scarring…”.

The FDA Alert states:

Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed trans vaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
Recommendations
Physicians should:

Obtain specialized training for each mesh placement technique, and be aware of its risks.

Be vigilant for potential adverse events from the mesh, especially erosion and infection.

Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.

Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.

Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).

Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

Additional patient information can be found on the following FDA Consumer website at http://www.fda.gov/cdrh/consumer/surgic

But, the suits "raise new questions about the process by which the FDA reviews new medical devices." The agency "merely 'clears' medical devices with minimal testing if they are deemed 'substantially equivalent' to devices already in use." And, for ObTape, "the chain of similarity claims can be traced back to an older product that caused so much harm it was taken off the market." Still, the FDA approved the "new generation of vaginal slings whose only claim to safety was their similarity to the flawed device."

This highlights a major consumer battleground over tort reform with drug companies and medical device manufacturers: should FDA approval of a device bar any woman injured from bringing a lawsuit? That is exactly what Big Pharma is pushing on the courts and Congress. As you can see from this story the FDA is not equipped to determine the safety of a product as FDA was stripped of a mandate and funding to carry out meaningful evaluations. Big drug companies and medical product manufacturers put profits ahead of people and these women with ObTape injuries are trying to change that situation.

The Mentor story is covered beautifully by Jane Akre at Injury Board:

Lawsuit: Mentor Mesh For Urinary Incontinence

Other good resorces on medical device regulation failures at the FDA can be found at:

Defective Medical Devices & Implants by Injury Board

FDA Asked to Overhaul its Medical Device Testing System by Carrie Strasser

Embattled FDA Office of Device Evaluation Accused of Acting Illegally by Wayne Parsons

Federal Preemption: Is the FDA testing process fail-safe and protecting you, the patient? by Steve Lombardi

FDA not enforcing medical device safety standards by Jessica Smagacz

FDA Holds Meeting on Medical Device Approval by David Mittleman

What do you think about this? This issue has not happened by accident. Read about the history of tort reform and the conspiracy against people like those women injured by ObTape fueled by corporate greed and political corruption at the top in The History Of Tort Reform - A Story of Corporate Greed And A Conspiracy Against Justice For The People.

I'd like to hear from the Mentor Corporation and the FDA. How about you:?

Originally posted at InjuryBoard by Wayne Parsons

Embattled FDA Office of Device Evaluation Accused of Acting Illegally

Wayne Parsons — Wed, 22 Apr 2009 23:17:13 GMT

The New York Times (4/22, A15, Harris) reports,

"An unusual internal meeting scheduled for Wednesday at the Food and Drug Administration may signal how agency officials intend to handle the many controversies swirling around its embattled device division." According to an email from the director of the agency's office of device evaluation, Dr. Donna-Bea Tillman, the FDA will hold an "all-hands meeting" on April 10 "to discuss the strategic direction of the device center."

In letters to President Obama and members of the administration, "nine dissident scientists" stated that "agency officials had acted illegally and that patients were routinely put at risk by medical devices approved for sale despite significant and often unanimous objections from scientific reviewers." As a result, "a Congressional investigation into the scientists' concerns has been opened."

The subject has been covered brilliantly in an article by one of my favorite consumer advocates, Jane Akre: "Medical Device Division of FDA Broke, Needs Fixing"

In addition, lawmakers are expected to propose legislation this week "that would ask the Institute of Medicine to investigate concerns surrounding the device division."

These matters are crucial to all Americans and every resident of the State of Hawaii. Health and safety in medical treatment is something we all should be able to trust. Doctors and their insurance companies spend most of their time complaining about lawsuits that result from bad doctor's negligence. They should be crusading for a better FDA to protect their patients from unsafe medical devices among other things. In Hawaii it would be refreshing to hear from doctors on a subject like this as opposed to having them seeking special laws to excuse them from negligent injury to their patients.

Originally posted at InjuryBoard by Wayne Parsons