Medical research plays a critical role in the development of new treatment protocols. Many people here in Illinois receive medical care based on the latest studies and findings. However, much of this research may be questionable. One study published in the Journal of the American Medical Association found that up to half of the most respected findings published over a 13-year period were exaggerated or incorrect. This unreliable research can leave patients at risk for incorrect treatment and adverse outcomes. Examples of inaccurate medical research are numerous. In 1998, a well-known study incorrectly linked autism to certain childhood vaccinations. According to Bloomberg, a later study concluded the vaccination study was fraudulent. More recently, a Harvard biologist authored a fake study, which found that participants who ate chocolate daily were more likely to lose weight. According to The Chicago Tribune, multiple online journals accepted the study, and numerous news sources presented it as reliable. These inaccurate studies can have severe consequences. For example, after research erroneously suggested bone marrow transplants could treat breast cancer, 40,000 women underwent this procedure. In addition to missing out on more effective treatments, these women were exposed unnecessarily to serious potential complications. As Johns Hopkins School of Medicine explains, bone marrow transplants can cause infections, graft failure and graft-versus host disease. These complications can lead to respiratory issues, organ damage and even death. Inaccurate medical research isn’t always a product of innocent errors. According to The Chicago Tribune, one study reviewed 2,000 retractions of papers published in prominent medical journals and concluded two-thirds involved fraud. Frequently, this fraud may occur due to conflicts of interest. Pharmaceutical companies or government entities fund most medical research, introducing a potential for bias. As The Atlantic explains, researchers also must produce findings worthy of publication in leading journals to secure funding or advance their careers. Therefore, some researchers may exaggerate, misrepresent or invent results. The peer review process doesn’t always succeed in catching these lapses. The Chicago Tribune notes that the professionals conducting the reviews often have their own biases or conflicts of interest. Some studies also don’t receive adequate professional review. When these studies are published in mainstream media, journalists may fail to critically assess the research and conclusions. Fraudulent medical research may represent a growing issue. Since 1975, the number of studies retracted based on fraud has grown tenfold, according to The Chicago Tribune. Widespread changes might be[READ MORE…]
When a US District Court judge fined Boehringer Ingelheim almost $1 million at the end of last year for failure to preserve documents regarding the blood thinner Pradaxa, the decision served as a precursor to a similar position taken by the Court in regards to the Actos portfolio. The Actos manufacturer, Takeda Pharmaceuticals, was cited for failure to preserve documents deemed important to legal proceedings. It seems this was the case for Pradaxa lawsuits as well. Pradaxa is a new-age blood thinner approved by the US Food and Drug Administration (FDA); it was hailed as a safe and effective alternative to a product that had been on the market for nearly 60 years, a blood thinner that required rigorous and regular monitoring. Pradaxa was seen to effectively prevent blood clotting – an important attribute for patients at risk for stroke. However, a problem with Pradaxa bleeding, characterized by uncontrollable bleed-outs that could not be stopped, quickly put Pradaxa under a cloud. Unlike the older drug Coumadin, where the side effects of bleeding could be reversed with the intervention of Vitamin K and plasma, there is no known or effective reversal protocol for Pradaxa. When Pradaxa bleeding occurs, from a simple cut or bruise, there is no antidote. More than 500 Pradaxa deaths were attributed to the new-age blood thinner over a two-year period, according to various reports. Plaintiffs in Pradaxa lawsuits, which numbered about 1,700 according to a report in Bloomberg News (12/10/13), but is now thought to be closer to 2,000 – allege that dabigatran Pradaxa manufacturer Boehringer knew about the potential bleeding profile of Pradaxa, but withheld their concern from doctors and patients. Pradaxa (generic dabigatran) is a relatively new blood thinner that was introduced as a replacement for warfarin in the prevention of strokes among individuals suffering from atrial fibrillation. However, the potential risk of Pradaxa bleeding side effects has caused serious concern surrounding the drug. Symptoms of Pradaxa internal bleeding may include: Unusual Bruising or Bleeding Pink or Brown Urine (which may be a sign of blood in the urine) Red or Black Tarry Stool (which may be a sign of blood in the stool) Coughing up Blood (which may include vomit resembling coffee grounds) Headaches, Dizziness or Lethargy Bleeding from the Gums or Frequent Nose Bleeds Weakness and Swelling of the Arms, Hands, Feet, Ankles or Lower Legs Side Effects of Pradaxa Pradaxa is part[READ MORE…]
According to the American Society for Reproductive Medicine In 2010, 61,000 babies were born through assisted reproductive technology; a few State higher courts have addressed what happens to the frozen embryos once a couple separates. The Illinois court has ruled on an embryo case but the ruling still allows many of the issues to remain unresolved because Justice Patrick J. Quinn wrote that the trial court judge should have sought arguments and rendered an opinion on the validity of the first and second contracts rather than ruling on the arguments about the parties’ rights to become a parent. The circumstances began in March 2010 when Karla Dunston was diagnosed with non-Hodgkin lymphoma and was told that treatment would likely leave her infertile. With her then boyfriend, Jacob Szafranski, they decided to attempt in vitro fertilization. Szafranski donated sperm samples and Dunston donated eggs on April 6, all of which were fertilized before the couple ended their relationship in May 2010. Both signed an agreement stating that, “[n]o use can be made of these embryos without the consent of both partners (if applicable).” A second agreement was drawn up several days later stating that Dunston would have sole control of the eggs and pre-embryos in case the two split up, and that Szafranski “agrees to undertake all legal, custodial, and other obligations to the [c]hild regardless of any change of circumstance between the [p]arties.” This second contract was never signed. In 2011, Szafranski tried to stop Dunston from using the pre-embryos, arguing that he had a constitutional right not to father a child against his will. Dunston argued that her ex-boyfriend was bound agreement terms because he had donated sperm, thereby performing his obligation and making her believe he was committed to the undertaking. She also argued that Szafranski had intended to sign the second contract giving her control of the pre-embryos but Szafranski disagreed with that, as well as the idea that his sperm donations made the agreement legitimate. A Cook County trial court awarded the rights to the embryos to Dunston but Szafranski appealed. A higher court sent the case back, explaining that the case focuses on prior agreements rather than the interests of either party. The case now concerns whether the pact occurred when Szafranski gave the sample or when they signed the medical consent form requiring joint consent for the use of the embryos. A New York[READ MORE…]
A recent headline announced that Abbott Laboratories must pay over $1.6 million for misbranding the prescription drug Depakote. The total included a criminal fine and civil settlements with the states and federal government. In addition, Abbott has agreed to pay 45 states in order to resolve liability under state consumer-protection laws. Acting Associate Attorney General Tony West stated that Abbott put “profits ahead of patients.” This article coincided with a recent expose from ProPublica about an apparent lack of oversight by the FDA of medical devices including artificial hip replacements and pacemakers. According to the May 3rd report, the FDA primarily depends upon voluntary reporting from manufacturers, hospitals, doctors, and patients for notification of problems with devices already on the market. If manufacturers are notified by a doctor or hospital about a death or injury resulting from the use of their product, they have a legal obligation to investigate as well as notify the FDA. A report published last year by members of the Institute of Medicine suggested that only a small number of doctors actually contact manufacturers and that even when incidents are reported to the FDA it may be months before devices are recalled. While the FDA does have a website area devoted to recalled medical devices http://1.usa.gov/Vqkk1 the site is confusing for consumers, as well as medical providers, to navigate. According to the ProPublica article, the FDA does maintain adverse event reports in a searchable database but does not have system for systematically or analytically reviewing reports. The FDA is working on the Sentinel Initiative, a national electronic system for tracking drugs and medical devices, but it has been in development and testing stages since 2008. In March of 2012 bill S.2193 – Ensuring Safe Medical Devices for Patients was introduced in the Senate which would, among other items, expedite the implementation of the unique device identification system for medical devices. While manufacturers and the FDA claim that every medical device carries a potential risk, but the vast majority of devices perform well and improve patient health, as a patient you should be able to rely upon the safety of all medical devices used by your physician. If you believe you have been injured because of a faulty medical device please contact Ankin Law Office. We have experience in both medical malpractice as well as class action suits.
Oftentimes, physicians are employed by more than one medical institution. This can make it difficult establish liability for negligent treatment in medical malpractice cases, since it is sometimes difficult to prove which hospitals employed a physician for the purposes of the negligent conduct at issue. This was the very issue presented in Turner v. U.S., No. 09 C 4606, where the plaintiff was permanently injured during an operation performed on him at Edward J. Hines Jr. Veterans Administration Hospital (VA) in Chicago, Illinois. The brother and guardian of the injured patient, John Johnson, claimed oh his brother’s behalf that the anesthesiologist who allegedly caused the injury was employed by both the VA and Loyola University Medical Center (Loyola), and thus both institutions were responsible for her medical malpractice. In support of the claim that the physician was acting as an agent of Loyola at the time the surgery occurred, the plaintiff offered payroll forms and correspondence between Loyola and the physician indicating she was employed by both Loyola and the VA, evidence that the hospitals are “affiliated institutions” and provide each other with their respective “call schedules,” evidence that the physician’s employment with Loyola requires her to obtain Loyola’s approval before engaging in certain activities, such as clinical research, that both institutions sponsored the research study in which Mr. Johnson agreed to participate, and the physician’s acknowledgment that she “sometimes” wore her Loyola lab coat while working at the VA. The Court found that the evidence was insufficient to support the conclusion that the physician was an agent of Loyola’s at the time of the surgery: “Even if (the plaintiff’s) evidence were not stacked against undisputed, affirmative evidence that Dr. Hanna performed work on Mr. Johnson’s case exclusively as an agent of Hines, not of Loyola,FN6 plaintiff’s cited evidence is not of the sort that could lead a reasonable jury to conclude that Loyola controlled Dr. Hanna’s “manner of doing the work” she performed during Mr. Johnson’s surgery.” The lesson to be learned is that before filing a medical malpractice lawsuit, it is important to carefully research the relationships of the doctors that you believe are at fault and the nature of their relationships with the institutions for whom they work. Sometimes liability and responsibility for negligent conduct may not always be as clear cut as it first seemed. The Ankin Law Office LLC (www.ankinlaw.com) handles workers’ compensation and personal injury cases. You can reach the firm by calling (312)[READ MORE…]
In an attempt to protect consumers from the dangers of defective medical devices, the U.S. Senate recently proposed draft legislation that would require manufacturers to conduct ongoing safety studies of medical devices even after the device has obtained the approval of the U.S. Food and Drug Administration (FDA).Â The legislation was drafted, in part, as a response to the increasing number of lawsuits that have been filed against the manufacturers of defective medical devices, particularly vaginal mesh implants. Currently, the FDA permits certain medical devices to be approved under its 510(k) system, which requires only that manufacturers demonstrate that their product is substantially similar to one already on the market.Â The Senate pointed to the 2010 recall of the DePuy ASR hip implant system, which was approved under 510(k) procedures, as evidence that the current guidelines are ineffective in protecting the public from dangerous and defective medical devices. With respect to the specific dangers associated with transvaginal mesh implants, the FDA has also requested that manufacturers of vaginal mesh implants, such as Bard and Johnson & Johnson, provide additional information regarding the companiesâ€™ safety inspections and recall procedures. Since 2008, the FDA has warned consumers and health practitioners since 2008 about serious complications associated with vaginal mesh implants that are used to treat pelvic organ prolapse and stress urinary incontinence.Â According to the FDA, more than 1,000 reports from nine surgical mesh manufacturers, including American Medical Systems, Bard, Boston Scientific, Caldera, Ethicon, Gynecare, Johnson and Johnson, Mentor and Sofradim, have been filed with the FDAâ€™s adverse events reporting database.Â The American of Obstetricians and Gynecologists and the American Urogynecologic Society issued a joint statement last November recommending that the use of transvaginal mesh be limited.Â Although the FDA is continuing its safety review of vaginal mesh implants, there are currently no plans to issue a recall of these products. Hundreds of lawsuits have been filed against the manufactures of transvaginal mesh implants, as well.Â C.R. Bard and Johnson & Johnson face hundreds of lawsuits from women claiming that their transvaginal mesh implants caused scarring, pain, bleeding, blood vessel damage and other complications. If you have been injured by a medical device, such as transvaginal mesh or a hip replacement system, you may wish to consult with an experienced product liability attorney.Â At Ankin Law Offices, LLC, our knowledgeable Chicago product liability attorneys focus on protecting the victims of dangerous and[READ MORE…]
Nearly 30 states currently limit the amount of damages that can be received in a medical malpractice lawsuit, according to the American Medical Association.Â States with damage caps vary wildly in their limitations and the types of damages that are limited.Â For instance, California limits non-compensatory damages at $250,000, while Nebraska limits total damages at $1.75 million. In 2005, an Illinois law invoked limitations on non-economic damages at $500,000 in lawsuits alleging medical malpractice, including wrongful death, against a physician, and $1 million in lawsuits against a hospital.Â In 2010, however, the Illinois Supreme Court deemed the damage cap to be unconstitutional because it interfered with the authority of judges and juries to reduce verdicts. Similarly, a wrongful death lawsuit filed in Indiana as a result of a catastrophic stage collapse that killed seven people challenges the constitutionality of the Indiana damage cap.Â The plaintiffsâ€™ lawsuit argues that Indianaâ€™s damage cap of $5 million violates the Constitutionâ€™s due process and equal protection clauses, as well as the Indiana Constitution. Some state legislatures have recently proposed tort reform initiatives that would invoke damage caps.Â For instance, earlier this year, the Tennessee legislature approved comprehensive medical malpractice tort reform that limits non-economic damages, such as pain and suffering, to $750,000 in most cases; caps punitive damages at two times compensatory damage or $500,000, whichever is greater; and prohibits punitive damages in most products liability lawsuits.Â Similarly, the North Carolina Senate approved a tort reform bill that would cap non-economic damages at $500,000. On the other hand, Virginia proposed legislation to raise the cap on damages in medical malpractice cases from $2 million to $3 million and would increase the amount by $50,000 every year until 2031, but the bill was ultimately vetoed by the governor on March 31, 2011.Â Â Given the overwhelming support for the Virginia bill, however, it remains uncertain whether the veto will stand or whether the bill will pass. Medical malpractice damage caps undoubtedly hurt patients and the general public by failing to hold doctors, hospitals and other medical professionals financially responsible for their injuries or deaths that they have caused.Â The Chicago medical malpractice attorneys at Ankin Law Offices, LLC are committed to protecting the rights of victims of medical malpractice and their families. Howard Ankin of Ankin Law Office LLC (www.ankinlaw.com) handles workersâ€™ compensation and personal injury cases. Mr. Ankin can be reached at (312) 346-8780 and[READ MORE…]
Last year, Illinois lawmakers passed a comprehensive medical care reform bill that imposed a cap in medical malpractice cases. As explained at the PopTort, when that law was overturned as unconstitutional, a number of other beneficial medical malpractice regulatory laws that were included as part of the reform were scrapped as well due to a non-severability clause included in the original law: (The lawmakers) added a â€œnon-severabilityâ€ clause to the law, so that if the cap were struck down (virtually certain as the Illinois Supreme Court had previously struck down two similar â€œcapsâ€), all of those great medical malpractice insurance regulatory laws would be thrown out the window, leaving Illinois medical malpractice insurers virtually free to once again charge doctors excessive rates. Recently, however, Illinois lawmakers reinstituted a helpful section of the law that will prove to be of great benefit to Illinois residents: an online physician database for medical consumers. In a Chicago Tribune article, this new database was described and its utility to consumers was explained: Illinois patients can now research their doctors using an online database the state launched Wednesday…The database can be accessed through the Department of Financial and Professional Regulation’s website at idfpr.com under the “physician profile” link on the left side. There, patients can learn about a doctor’s educational background and training, determine what type of insurance they accept and find out what languages are spoken in the office. Also included is information about criminal convictions, disciplinary action against the doctor by regulators in Illinois and other states, and whether hospital privileges have been revoked. No doubt this new database is good news for Illinois residents. Now Illinoisans have a useful resource at their disposal that will help them make informed decisions when choosing a physician. And when it comes to making important medical decisions, it never hurts to have as much information as possible available for your consideration. Howard Ankin of Ankin Law Office LLC (www.ankinlaw.com) handlesÂ workersâ€™ compensation and personal injury cases. Mr. Ankin can be reached at (312) 346-8780 and email@example.com.
The Day on Torts blog reports of an interesting lawsuit filed by Massachusetts attorney Kenneth Levine. In the lawsuit,Â Gorbey v. American Journal of Obstetrics & Gynecology, No. 1:11-CV- 11259-NMG (pending in the U. S. District Court for the District of Massachusetts), Levine alleges that the authors of a medical article about brachial plexus injuries that was published in the OB-GYN Journal knowingly relied on a false case report as the basis for the article. Brachial plexus injuries are described at the National Institute of Health’s website as follows: The brachial plexus is a network of nerves that conducts signals from the spine to the shoulder, arm, and hand. Brachial plexus injuries are caused by damage to those nerves. Symptoms may include a limp or paralyzed arm; lack of muscle control in the arm, hand, or wrist; and a lack of feeling or sensation in the arm or hand…In infants, brachial plexus injuries may happen during birth if the babyâ€™s shoulder is stretched during passage in the birth canal… This lawsuit is significant because the article in question is being used to support the claim that this type of injury can occur without any action on the part of a physician. In the article, the authors conclude that a brachial plexus injury can occur in the absence of physician interference, basing their conclusions on what they purport is the “firstÂ unambiguous Â case of a baby born vaginally Â without Â physician traction, and even withoutÂ the occurrence of shoulder dystocia, that resulted in a permanent brachial Â plexus Â injury.” However, as explained above, Levine alleges in the lawsuit that this claim is based on a case report regarding a birth that the authors of the article knew contained false information. Specifically, it is alleged that one author of the article, who was actually involved in the birth upon which the case report was based, later admitted during a deposition that she did in fact use downward traction during the delivery described in the case report and the labor and delivery notes of that birth also indicate that shoulder dystocia was present as well. Furthermore, it is claimed that the other co-author admitted while testifying during an Illinois medical malpractice lawsuit that he did not read the labor and delivery notes before authoring the case report. In the lawsuit, Levine claims that the corporate defendants, including the magazine’s publisher, were made aware of the inaccuracies in[READ MORE…]
Popular wisdom is an interesting thing–it tends to be based on observation rather than scientific testing. But, interestingly, in many cases, once experiments are run to test the truth of a particular hypothesis, it turns out to be true. Such is the case with the longstanding, but unsubstantiated belief that medical errors increase in July. This theory is based in large part on the influx of new medical residents, fresh out of medical school. And, it makes sense, since residents are doctors in training and first year residents have minimal experience handling their own cases. It takes time–and experience–to become a good doctor. It stands to reason that inexperienced doctors are more likely to make mistakes and first year residents are the most inexperienced doctors out there. Until recently, the belief that medical errors spiked mid-summer occurred was simply a theory. However, as recently reported in a New York Times article, a new study substantiates what is commonly referred to as the “July effect.” As explained in the article, the study confirms the long held belief that July isn’t exactly the best month to be hospitalized: The paper, published Tuesday in Annals of Internal Medicine, is believed to be the first systematic review of the data from previous studies. While the analysis found inconsistencies among nearly 40 studies examined, the data produced by the largest and best-designed ones indicated that patient death rates in teaching hospitals increase by 8 percent in July. Those studies also reported longer hospital stays, more drawn-out procedures and higher hospital charges in July, when 20 to 30 percent of the more experienced doctors-in-training leave and a class of newly minted doctors starts working at teaching hospitals, said Dr. John Q. Young, the paperâ€™s lead author… Medical errors happen–and it’s now confirmed that they happen more frequently each year in July.Â That errors occur is unfortunate and inevitable. Physicians are only human. But, the lesson to be learned it that it would be wise to avoid summer hospitalizations, if at all possible. Doing so will arguably reduce the potential for medical errors and the possibility of having toÂ file a medical malpractice lawsuit. Howard Ankin of Ankin Law Office LLC (www.ankinlaw.com) handlesÂ workersâ€™ compensation and personal injury cases. Mr. Ankin can be reached at (312) 346-8780 and firstname.lastname@example.org.
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