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The CMG Voice

Why Most Firms Do Not Handle Medical Products Or Drug Litigation

Posted Monday, February 27, 2017 by Gene Moen

Like most medical malpractice firms, we get occasional referrals of cases involving drugs or medical devices that have caused harm in a medical setting. And like most firms, we ordinarily do not handle them. The reasons are simple: in mass tort cases (i.e., case in which there are many claimants around the country) a firm can only handle such cases if it has a large number of clients and is willing to pay the very large costs associated with the litigation. Representing only a few such clients with regard to a particular drug or device is difficult at best.

When a major drug company or device manufacturer faces many lawsuits around the country, they will spend huge amounts of money to defend the cases that first go to trial. The reason is that the outcome of those trials will impact the settlement value of the other claims. The same goes for the plaintiffs’ firms. If they have a hundred similar cases, they will spend large amounts on the first ones going to trial, because if they prevail the “value” of the other claims will increase dramatically. Thus, a case with a verdict potential of $1,000,000 may justify spending twice that amount because of that impact on the rest of the firm’s similar cases.

When many cases are filed in various federal courts around the country, one specific district court judge will usually be designated to handle the cases. This is done under a statute dealing with “multi-district litigation” (MDL) so that there are not contradictory rulings while the litigation proceeds. That then means that the cases filed around the country are all transferred to the MDL judge.

In MDLs, the court will usually designate a committee made up on the plaintiffs’ attorneys to handle discovery. The drug company or device manufacturer will then be ordered to designate the company representatives to be deposed by a member of the plaintiffs’ committee, or other specific discovery to be conducted. This then avoids the possibility of scores of attorneys all wanting to depose the same company employees about facts relating to the case. Sometimes, too, the MDL judge will order that other attorneys who want access to the depositions or other discovery materials pay some part of the costs of obtaining the evidence, sometimes as a percentage of the fees that are earned in settlement. .

Mass tort cases are usually very complex and difficult, for the reasons set out here. Many firms will advertise nationally for clients so that they have enough claims to justify going forward with claims. If you have a potential claim involving a drug or medical device, if you type in the name of the product and the word “attorney” on a search engine like Google, it is likely you will see many websites of such national firms. You may also see advertisements on TV seeking claimants. Handling such claims is a big business, and many firms that represent individual patient who have been injured because of their health care (medical malpractice cases) will not be able to take on cases involving medical products or unsafe drugs.

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Off-Label Use Of Drugs Can Be Beneficial

Posted Thursday, February 23, 2017 by Gene Moen

Most people don’t realize that, once the FDA approves a drug for a particular use, it can then be prescribed by a physician for an entirely different medical condition. Many of those “off-label” uses start through word-of-mouth information about how a particular drug seemed to help treat different conditions. Sometimes published studies have indicated usefulness of the drug for a condition not studied in the original FDA approval.

Some researchers think there should be a concerted effort to test existing drugs to find those that may help in treating different conditions. As a recent article pointed out, developing new drugs is an expensive and lengthy process, and often the side-effects that are found during the testing will block approval of the drug. But “finding new targets for drugs already in use to treat other disease, in other words repurposing, is an emerging area in developing anti-cancer therapies.” The “old” drugs have already been tested thoroughly for side-effects.

A recent study has found that calcium channel blockers — commonly prescribed for hypertension — can effectively stop cancer metastasis (spread of cancer cells from the original site of the cancer to other tissues or organs). The mechanism by which it does this is related to a very complicated process by which some aggressively spreading cancer cells express a protein called “Myosin-10” which increased the cancer cell motility or movement.

These cancers have a large number of structures that are like sticky “fingers” that allow the cells to sense their environment and to navigate through adjacent tissue. One researcher said it is like a blind spider finding its way through touch. The research found that the calcium channel blockers targeted those “fingers,” making them ineffective and blocking the cell movement.

Much more research is needed to determine which cancers can effectively be treated through using calcium channel blockers. Currently the research is centered on breast and pancreatic cancer. But the findings of the study reaffirm the concept that “repurposing” existing drugs may be a faster and more efficient way of developing new treatments of diseases and conditions.

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Medical Apologies Mean More Than Simply Saying “I’m Sorry”

Posted Monday, February 20, 2017 by Gene Moen

A recent blog post discussed a study that showed that the “apology” statutes did not mean a reduction in malpractice claims. The laws were passed to encourage doctors to disclose errors and apologize for them, by not allowing the apologies to be admissible at trial.

The pioneer in the “apology movement” is Dr. Lucian L. Leape. In an article in Frontiers of Health Services Management in 2013, Dr Leape discussed the concept in detail. He states that simply telling the patient or family that the doctor is “sorry” for a bad outcome is not enough. The apology has to make clear that the health care provider is accepting “ownership” of the mistake and accepts responsibility for the consequences. Following are some of the takeaways from Dr. Leape’s article:

“Apology conveys respect, mutual suffering, and responsibility. Meaningful apology requires that the patient’s physician and the institution both take responsibility, show remorse, and make amends.”

“Restoring the balance — acknowledging “we’re both hurting” — begins to restore the relationship, which is important to both parties.”

“If we are to make progress in preventing errors, it is essential that we learn from our mistakes, analyze the failures, and identify the systems changes that will prevent them in the future.”

“Even if communication is flawless and apologies are forthcoming when indicated, patients often require a long time to recover, lose their fear, and re-establish trust.”

“As custodian of the systems, the hospital has primary responsibility both for the mishap and for preventing it in the future. Hospital leaders must step up and take that responsibility.”

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Maternal Mortality Going Down — Except In The United States

Posted Thursday, February 16, 2017 by Gene Moen

Improvements in medicine and public health around the world have helped to reduce the mortality rate for mothers giving birth. From 2000-2015, the maternal death rate fell by more than a third. The reduction has been consistent over time and covering most underdeveloped countries.

That’s why it is so striking that, in the United States, maternal mortality from pregnancy or childbirth complications has risen almost the same percentage. Among the developed countries, only Mexico has a higher maternal mortality rate. The explanation is multi-factorial: increased maternal age, increase in chronic illness during pregnancy, and substance abuse in many communities are some of the reasons.

In the face of this startling statistic, many efforts are being made to reduce or reverse the trend. On both the national and local level many organizations are dealing with the underlying reasons for maternal mortality: The Council on Patient Safety in Women’s Health Care, the Alliance of Innovation in Maternal health, and “Merck for Mothers” are three of the groups focused on reversing the maternal mortality rate in the U.S.

They are sponsoring technical assistance to local hospitals to address some of the major problems, such as obstetric hemorrhage, severe hypertension, and venous thromboembolism. The Merck for Mothers program funds local groups that use community health workers to improve health care system navigation for low-income pregnant women.

The problems have been most persistent in African-American women, who have a four-fold risk of maternal mortality. So some programs are focused on improving health education and outreach in that particular community.

The goal of these efforts is to bring the American mortality to levels comparable to those in Western Europe. At least, the hope is that the U.S. can no longer be next to last among all developed countries. We have the most expensive health care costs in the developed world, and it seems anachronistic that the quality of that health care is in such dire shape.

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Swedish Medical Center Notifies Patients About Infection Concern From Use Of Cardiovascular Surgery Device

Posted Monday, February 13, 2017 by Gene Moen

Swedish Medical Center recently sent letters to all patients who had undergone cardiovascular surgeries where a particular heater-cooler system had been used. The device, manufactured by LivaNova, a London-based medical device manufacturer, is used to warm and cool patients and had been used in 60% of hospitals. The letter from Swedish said “Upon notification by the FDA and CDC, Swedish Medical Center tested its heating and cooling devices and found NTM bacteria in several of the machines.”

The problem is that bacteria from the devices is believed to be found in aerosolized droplets of water from the heating and cooling loops. Dangerous levels of bacteria — Mycobacterium — were found to have grown in the devices and were being released into the air by the exhaust fan. Once released, the bacteria can settle into the patient’s open chest or infect other equipment used in the surgeries. The result can be a very slow-growing infection that may not be recognized for months or even years after exposure.

The FDA reported 32 cases of patient infections arising from the devices between 2010 and 2015, but acknowledged there may be many more that are unreported. The slow growing nature of the infections makes it difficult for doctors to relate it back to the use of a machine many months earlier.

The infections are difficult to treat, may become chronic, and can lead to death. More than 250,000 patients have had surgeries with this particular device, every year, so the number of infections could be substantial. Some lawsuits have already been filed against the manufacturer and these are likely to increase as more infections are diagnosed.

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