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Promoting Drugs and Medical Devices for Unapproved Uses

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Medical Devices for Unapproved Uses For several decades, Parker Waichman LLP has successfully represented clients in product liability lawsuits for injuries related to defective drugs and medical devices. Our personal injury attorneys have a vast knowledge of drug and medical device injury litigation issues, including off-label … [Read more...] about Promoting Drugs and Medical Devices for Unapproved Uses

Stockert 3T in Heater-Cooler Infection Risk

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Heater-cooler devices are designed for use during surgery to maintain a patient's body temperature. The device is used in surgeries where the heart and blood flow is stopped, such as heart transplant surgeries and cardiac bypass surgeries. The device contains a closed water circuit, which does not contact the patient. However, … [Read more...] about Stockert 3T in Heater-Cooler Infection Risk

Heater-Cooler Devices Deadly Bacterial Infections Risk

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What is an HCD? Specifically, the Stöckert LivaNova 3T heater-cooler unit is an HCD used in approximately 60 percent of the heart-bypass procedures conducted annually in the United States and has been associated with mounting injury and death reports and lawsuits. HCDs are used in approximately 250,000 surgeries annually in the … [Read more...] about Heater-Cooler Devices Deadly Bacterial Infections Risk

Heater-Cooler Devices Heart Surgery Infections Risk

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Contaminated Heater-cooler Devices Creates More Troubles. Contaminated Heater-Cooler Devices Linked To A Serious Infections. Contaminated heater-cooler devices manufactured by LivaNova, formerly known as Sorin Group S.p.A., have been linked to serious infections in patients undergoing open heart surgery since 2012. During surgery, … [Read more...] about Heater-Cooler Devices Heart Surgery Infections Risk

First Xarelto Bleeding Cases Scheduled for Trial in Early 2017

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Xarelto Bleeding Cases Scheduled For Trial. Thousands of personal injury and wrongful death lawsuits before Judge Eldon Fallon in the Eastern District of Louisiana claim that the blood-thinning drug Xarelto caused severe and often fatal bleeding side effects. The first xarelto bleeding cases, known as bellwether trials, in the … [Read more...] about First Xarelto Bleeding Cases Scheduled for Trial in Early 2017

Heater-Cooler Devices Linked to Bacterial Infections

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Heater-Cooler Devices Have Been Linked to 8 Bacterial Infections. Heater-cooler devices, which are used to maintain a patient's blood temperature during heart surgery, have been linked to 8 bacterial infections at WellSpan York Hospital in Pennsylvania Of the 8 patients infected, four have died. It is unclear whether the deaths were … [Read more...] about Heater-Cooler Devices Linked to Bacterial Infections

Sham Medical Device Surgery Costly, Dangerous, Controversial

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Some medical device testing appears to be using human beings as placebos. Some medical device testing appears to be using human beings as placebos in which people undergo bogus surgeries to determine a potential device’s efficacy. In drug trials, some participants are given placebo drugs, while others are given a real drug so that … [Read more...] about Sham Medical Device Surgery Costly, Dangerous, Controversial

Swedish Woman Dies after six Tysabri Infusion Treatments for Multiple Sclerosis

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Woman Dies Of Tysabri Infusion Treatments. Physicians in Sweden have reported that a multiple sclerosis patient they were treating with the drug Tysabri has died. According to a MedPageToday.com report this week, physicians at Umeå University say the woman suffering from MS died seven months after beginning her Tysabri treatment … [Read more...] about Swedish Woman Dies after six Tysabri Infusion Treatments for Multiple Sclerosis

PW Attorney Named to Biomet M2a Magnum MDL

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Parker Waichman Tapped To protect patients harmed by Biomet M2a Magnum hip implant. The national law firm of Parker Waichman LLP has again been tapped for a leading role in protecting the rights of people injured by defective medical devices, this time those harmed by the Biomet M2a Magnum™ hip implant. Attorney Daniel C. Burke … [Read more...] about PW Attorney Named to Biomet M2a Magnum MDL

Staph infection reported among cardiac patients at LA’s Cedars-Sinai

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Five heart patients at LA's Cedars-Sinai Medical Center contracted staph infections. Staph infection Reported Among Cardiac Patients at LA's Cedars-Sinai. Five heart patients at Los Angeles' Cedars Sinai Medical Center contracted staph infections last summer after one surgeon implanted them with a new heart valve. According to an … [Read more...] about Staph infection reported among cardiac patients at LA’s Cedars-Sinai

Acetaminophen Overdose A Risk For Infants, Children

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  Acetaminophen Overdose Alert On. Acetaminophen overdose, long known to be a risk for adults, is a risk for infants, as well. Acetaminophen is the active ingredient in Tylenol and, because of the drug’s popularity, many consumers are unaware that ‘acetaminophen’ carries risks for very serious health affects. According to … [Read more...] about Acetaminophen Overdose A Risk For Infants, Children

70,000 Children Per Year Injured by Medical Devices

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Injured by Medical Devices. Medical devices send tens of thousands of children and teens to the ER every year, according to researchers at the U.S. Food & Drug Administration (FDA). Their study appears online in the journal Pediatrics. To reach their conclusions, researchers from the FDA’s Center for Devices and Radiological … [Read more...] about 70,000 Children Per Year Injured by Medical Devices

Lawsuit Claims Defective NobelDirect Dental Implants by Dentist

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NobelDirect Dental Implants. A California dentist is suing the maker of the NobelDirect dental implant, claiming the device is faulty. The lawsuit, which was filed late last month in U.S. District Court for the Central District of California, seeks class action status on behalf of thousands of other U.S. dentists. The NobelDirect … [Read more...] about Lawsuit Claims Defective NobelDirect Dental Implants by Dentist

Byetta More Safety Studies

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Agency wants the studies to asses the drug’s risk of inflammation of the pancreas, acute renal failure and thyroid neoplasms. The Food & Drug Administration (FDA) is requiring Amylin Pharmaceuticals to conduct more safety studies of its type 2 diabetes drug, Byetta.  The agency wants the studies to asses the drug's risk of  … [Read more...] about Byetta More Safety Studies

NIH To Propose Rules Banning Ghostwriting, Require More Disclosure From Researchers

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NIH could require medical researchers to disclose their financial relationships with drug and device makers. New ethics rules to be proposed by the National Institutes of Health (NIH) next month could require medical researchers to disclose their financial relationships with drug and device makers if they receive funding from the … [Read more...] about NIH To Propose Rules Banning Ghostwriting, Require More Disclosure From Researchers

Warning: Choking Hazard for Philips Lifeline Personal Help Buttons

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  Philips Lifeline Personal Help Buttons Warning. U.S. Health Regulators warned today that Philips Lifeline Personal Help Buttons can pose a choking hazard. According to a notice posted on the Food & Drug Administration (FDA) website, there have been at least six reports between 1998 and 2009 of serious injury or death, … [Read more...] about Warning: Choking Hazard for Philips Lifeline Personal Help Buttons

Cardiologist Reports on Medical Device Payments

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Unreported Medical Device Payments. A prominent cardiologist with ties to Columbia University is facing questions regarding his ties to medical devices makers, the New York Times is reporting. According to the Times report, two U.S. Senators are concerned that Dr. Martin B. Leon may not have reported all payments he received from … [Read more...] about Cardiologist Reports on Medical Device Payments

Evenflo Didn’t Investigate Breast Pump Complaints, Warning Letter Says

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The Evenflo Co. did not properly investigate reports that its "Comfort Select" breast pumps caused some women to suffer electric shocks. In a warning letter dated  August 25, the Food & Drug Administration (FDA) also said that during inspections earlier this year, several manufacturing violations were found at two Ohio plants … [Read more...] about Evenflo Didn’t Investigate Breast Pump Complaints, Warning Letter Says

Synthes Execs Plead Guilty in Norian XR Illegal Testing Case

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SYNTHES EXECS in "hot water. " Two Synthes Inc. executives have pleaded guilty to participating in illegal clinical trials of the company's Norian XR bone cement, according to a New York Times report. Norian XR bone cement was approved by the Food & Drug Administration (FDA) in 2002 for use in the arm, but not the spine. As we … [Read more...] about Synthes Execs Plead Guilty in Norian XR Illegal Testing Case

No Justice for Plaintiffs in Little Noticed Supreme Court Decision

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Supreme Court Issued Implication For Plaintiffs. A Supreme Court decision issued in May is proving to have dangerous implications for plaintiffs in civil lawsuits.  According to a New York Times article, the decision in  Ashcroft vs. Iqbal has made it far easier - in fact, too easy - for  federal judges to dismiss civil lawsuits long … [Read more...] about No Justice for Plaintiffs in Little Noticed Supreme Court Decision

Institute of Medicine Urges Reform on Medical Conflicts-of-Interest

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  Institute of Medicine calls for reforms. A new report from the Institute of Medicine calls for significant reforms to prevent financial conflicts-of-interests in medicine from hindering patient care or the advancement of medical knowledge. We have long reported on the way the financial arrangements between the medical … [Read more...] about Institute of Medicine Urges Reform on Medical Conflicts-of-Interest

Johns Hopkins Institutes Ban on Industry Gifts to Doctors

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Johns Hopkins University has implemented a new policy to prevent conflicts-of -interest problems. Johns Hopkins University has implemented a new policy to prevent conflicts-of -interest problems between its doctors and the drug and medical device industries.  According to The Wall Street Journal, the policy bans free drug samples and … [Read more...] about Johns Hopkins Institutes Ban on Industry Gifts to Doctors

Older Medical Devices To Get Safety Reviews

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U.S. regulators are finally going to review 25 types of medical devices that were marketed prior to 1976. U.S. regulators are finally going to review 25 types of medical devices that were marketed prior to 1976.  According to a statement from the Food & Drug Administration (FDA), all of the medical devices slated for review were … [Read more...] about Older Medical Devices To Get Safety Reviews

Kickback Charges Against Orthopedic Device Makers Dropped

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Charges Against Orthopedic Device Makers Were Dropped. Criminal charges were dismissed yesterday against several orthopedic device makers because they have fulfilled the terms of deferred prosecution agreements they reached with U.S. prosecutors a year and half ago. According to Dow Jones News Wire, Zimmer Holdings Inc., Johnson … [Read more...] about Kickback Charges Against Orthopedic Device Makers Dropped

GAO Sting Raises Questions About Medical Trial Oversight

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GAO registered a fictitious institutional review board. A sting operation that allowed investigators to gain approval to test a fake medical device is raising serious questions about the oversight of medical trials. According to the Associated Press, as part of the sting, the Government Accountability Office (GAO) was also able to … [Read more...] about GAO Sting Raises Questions About Medical Trial Oversight

Risks of BPA in Medical Devices to Be Investigated

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Risks of BPA Awaits Probe. Medical Devices To Be Investigated. The Food & Drug Administration (FDA) has launched two studies to determine if bisphenol-A (BPA) in some medical devices is exposing patients to health risks.  According to the Website medpagetoday.com, the two medical device studies will focus on whether BPA in … [Read more...] about Risks of BPA in Medical Devices to Be Investigated

Stimulus Has Funds for Comparing Medical Treatments

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Measure allows for medical treatment efficacy comparison. The U.S. economic stimulus plan just approved by Congress has within it a provision to fund a measure that allows for medical treatment efficacy comparison, reported UPI.  President Barack Obama is expected to sign the legislation into law tomorrow. As part of the plan, … [Read more...] about Stimulus Has Funds for Comparing Medical Treatments

Top Hospital Medical Device Hazards For 2008 Revealed

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List of Top 10 Hospital Medical Device Hazards Released. The ECRI Institute just released its annual list of top ten hospital medical device hazards for this year. The Institute is a nonprofit organization that “researches the best approaches to improving patient care” and is a designated Collaborating Center of the World Health … [Read more...] about Top Hospital Medical Device Hazards For 2008 Revealed

Edwards Lifesciences Face Congressional Probe of Myxo Ring Device

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Device that repairs faulty heart valves has problems. Edwards Lifesciences' experimental Myxo ETlogix 5100 Ring device is at the center of an investigation being conducted by Sen. Charles Grassley (R-Iowa). The Senator is concerned that the Myxo Ring is being used in patients even though it has not yet been approved by the Food & … [Read more...] about Edwards Lifesciences Face Congressional Probe of Myxo Ring Device

Cleveland Clinic Discloses Industry Ties

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Ensure it is not involved in any medical conflicts of interest. Ohio’s Cleveland Clinic is making public any industry ties its physicians, scientists, and physician/scientists have with drug companies and device makers. The Associated Press noted that the move by the Cleveland Clinic was made to ensure it is not involved in any … [Read more...] about Cleveland Clinic Discloses Industry Ties

Patient Alleges Heart Surgeon Implantation of Experimental Device Without Consent

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Heart Surgeon Unauthorized Implantation. The Associated Press (AP) is reporting on a prominent Chicago surgeon earning royalties on a new heart device he implanted in a 41-year-old woman without her consent; this, according to a lawsuit filed by patient Toni Vlahoulis. Dr. Patrick McCarthy claims he donates the royalties to … [Read more...] about Patient Alleges Heart Surgeon Implantation of Experimental Device Without Consent

Important Test Often Skipped by Doctors Before Cardiac Surgery

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Studies focused on how to treat patients with clogged arteries. Two new studies report that cardiac patients may fare better by receiving fewer artery-opening stents and that stents tend to be used arbitrarily.  Both studies focused on how to treat patients with clogged arteries, a condition known as ischemia, in which patients … [Read more...] about Important Test Often Skipped by Doctors Before Cardiac Surgery

Illegal Sales of LabCorp Ovarian Cancer Test

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Violation of the law by selling an ovarian cancer screening test without regulatory approval. Laboratory Corp of America (LabCorp) is in violation of the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said yesterday.  LabCorp’s OvaSure test does not fall in a category in which it … [Read more...] about Illegal Sales of LabCorp Ovarian Cancer Test

Efforts Underway to Reduce Industry Influence in Medicine

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  Industry Influence in Medicine. One of the most frequent critics of these unseemly financial ties has been Sen. Charles Grassley (R-Iowa). Earlier this week, Grassley criticized a University of Texas researcher who worked on a National Institutes of Health study involving the GlaxoSmithKline antidepressant Paxil. The … [Read more...] about Efforts Underway to Reduce Industry Influence in Medicine

Safety Notice says Liko Universal SlingBar Poses Fall Risk

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Various models of the Liko Universal SlingBar could place patients at risk. A safety notice for the Liko Universal SlingBar was issued by Liko AB this past June.  According to the notice, various models of the Liko Universal SlingBar could become detached from the mobile lift, putting patients at risk of falling. The products … [Read more...] about Safety Notice says Liko Universal SlingBar Poses Fall Risk

Mass Governor Enacts Health Bill with Gifts-to-Doctors Rules

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  Bill With Gifts-to-Doctors Strong Rules. According to a recent Associated Press report, Massachusetts Governor Deval Patrick just signed a bill created, in part, to help reduce that state’s increasing health care costs. The bill will require “hospitals and doctors to adopt a statewide electronic records-keeping system by … [Read more...] about Mass Governor Enacts Health Bill with Gifts-to-Doctors Rules

Anika Therapeutics Warned for Conditions at Massachusetts Medical Device Plant

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Anika Therapeutics Manufacturing Problems Uncovered. Anika Therapeutics, the maker of medical devices used to promote the protection and healing of bone, cartilage and soft tissue, has received a Food & Drug Administration (FDA) warning letter about manufacturing problems uncovered during a March inspection of its plant in … [Read more...] about Anika Therapeutics Warned for Conditions at Massachusetts Medical Device Plant

Pediatric Medical Devices Puts Children at Risk

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  Pediatric Medical Devices are Not Approved. According to Ziyad Hijazi, chief of pediatric cardiology at Rush University Medical Center, and other doctors, children receive worse treatment in the United States, and have even died, because pediatricmedical devices are not approved. Hijazi travels annually with two or three … [Read more...] about Pediatric Medical Devices Puts Children at Risk

BPA in Medical Devices Concerns Lawmaker

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Rep Rosa DeLauro urges the US FDA Science Board follow Health Canada’s lead and expand its inquiry. Representative Rosa DeLauro (Democrat-Conneticut) is urging the US Food and Drug Administration’s (FDA) Science Board follow Health Canada’s lead and expand its inquiry of bisphenol A (BPA) by identifying all medical devices containing … [Read more...] about BPA in Medical Devices Concerns Lawmaker

OraQuick Rapid HIV Test Hundreds of False Positives

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OraQuick Rapid HIV Test False Positive Results. The OraQuick Advance Rapid HIV-1/2 Antibody Test has been discontinued in New York City as a means of HIV testing there. The faulty test has been delivering unusually high false positive results and the US Centers for Disease Control and Prevention (CDC) have now become involved. In … [Read more...] about OraQuick Rapid HIV Test Hundreds of False Positives

Replacement Hormone Therapy Can Double Clot Risk

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Menopausal Women Who Take Hormone Therapy. A French review of a variety of studies just revealed that menopausal women who take hormone-replacement therapy (HRT) pills more than double their risk of developing a potentially fatal blood clot.  The review of 17 studies suggested that the risk was also significantly higher during the … [Read more...] about Replacement Hormone Therapy Can Double Clot Risk

Despite Tainted Heparin, US Drug, Medical Device Companies Still Like China

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  Adverse Reaction Linked To Tainted Heparin. Pharmaceutical companies and medical device makers are in no mood to break their China habit, as several life sciences companies are planning on expanding manufacturing operations in that country. That, despite 21 deaths and a staggering number—over 700—of reported adverse … [Read more...] about Despite Tainted Heparin, US Drug, Medical Device Companies Still Like China

Tonsillectomy Patients Often Burned by Defective Cauterizing Devices

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  Concerns Over Defective Cauterizing Devices Growing. Defective cauterizing devices used during tonsillectomy often burn areas around the lips and mouth. As it turns out, these cauterizing device burns are an underreported complication of tonsillectomy that can result in long-term problems, according to a study reported in … [Read more...] about Tonsillectomy Patients Often Burned by Defective Cauterizing Devices

Biliary Stents Off-Label Use May be Putting Patients at Risk

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  Patients are at Risk with Biliary Stents Off-label Use. Biliary Stents, used off-label to prop open clogged arteries in the legs and torso, could be injuring thousands of patients each year. Biliary Stents, approved by the Food & Drug Administration (FDA) to help drain digestive fluids from the bile ducts of cancer … [Read more...] about Biliary Stents Off-Label Use May be Putting Patients at Risk

RF Ablation Device Warning Sparked by Deaths when used to Remove Lung Tumors

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RF Ablation Device Warning Due To Alleged Deaths. A medical device being used to remove lung tumors has been implicated in the deaths of several patients. According to a Food & Drug Administration (FDA) warning, these Radio Frequency (RF) Ablaton Devices have not been approved to remove lung tumors. RF Ablation Devices use … [Read more...] about RF Ablation Device Warning Sparked by Deaths when used to Remove Lung Tumors

Ortho Evra Birth Control Patch Lawsuit Settled

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  Defective Ortho Evra Birth Control Patch. Ortho Evra manufacturer, Johnson & Johnson, recently settled a lawsuit with the family of a 14-year-old girl killed by the defective birth control patch. The case is just one of many Ortho Evra lawsuits settled by Johnson & Johnson prior to going trial. It likely hints at … [Read more...] about Ortho Evra Birth Control Patch Lawsuit Settled

Heart Stents No Better Than Treating Stable Heart Patients With Medication

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Heart Stents No Better Than Treating Stable Heart Patients. The study of more than 2,000 patients found that those who underwent the expensive procedure, known as angioplasty, in non-emergency situations were no less likely to suffer a heart attack or die than those who only took aspirin and other medicines to thin their blood and … [Read more...] about Heart Stents No Better Than Treating Stable Heart Patients With Medication

Interpol expose SA body brokers

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Probe on human tissue exports. An international investigation into human-tissue exports is under way in South Africa. The Interpol probe into the country’s multimillion-rand tissue industry – which turns donated bones, skin and tendons into end products began this week. It was a request requested by US health watchdog, the Food … [Read more...] about Interpol expose SA body brokers

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Johns Hopkins Uncovers Serious Safety Problem with New Medical Device

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Sudden and unexplained increases in bloodstream infections. Sudden and unexplained increases in bloodstream infections at the Johns Hopkins Hospital led to the discovery of a completely unintended and unforeseen health and safety hazard with a new catheter device that was actually supposed to make patient care easier and … [Read more...] about Johns Hopkins Uncovers Serious Safety Problem with New Medical Device

FDA Panel Says ‘No’ to Silicone Implants

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  Silicone Implants Health Effects. A Food and Drug Administration advisory panel recommended today against allowing silicone breast implants back on the market, citing concerns about possible health effects and design problems that cause some to break prematurely. The vote to disapprove the application by Inamed Corp. of … [Read more...] about FDA Panel Says ‘No’ to Silicone Implants

Study: Pacemakers Can Cause Heart Failure

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People with the most common pacemaker types are more likely than similar people without pacemakers to die from or be hospitalized for gradual heart failure, sometimes within six months, according to a large study confirming doctors' belief the life-saving devices actually harm some patients. Experts say the tens of thousands of … [Read more...] about Study: Pacemakers Can Cause Heart Failure

Unomedical Airway Adapters Recalled

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Unomedical Airway Adapters Are Being Recalled. Unomedical Inc. issued a recall Thursday on airway adapters distributed in the United States and Europe, saying several have been blocked and could cause serious or life-threatening injury to patients. One serious injury has been reported. The adapters are used as accessories in a … [Read more...] about Unomedical Airway Adapters Recalled

Call For Increased Warning

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  Increased Warning For Ortho-Evra Users. Hopes vanished when the 18-year-old college student collapsed and later died. Zakiya Kennedy had big dreams of becoming a model or designer. But in April, those hopes vanished when the 18-year-old college student collapsed while waiting for the subway in New York City. She died on the … [Read more...] about Call For Increased Warning

Guidant Settles Lawsuits

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Dozens of deaths has reached an out-of-court settlement of nine lawsuits. The owner of a Menlo Park company that made a medical device linked to dozens of deaths has reached an out-of-court settlement of nine lawsuits that claimed malfunctions of the product. The lawsuits had been filed over the past two years against EndoVascular … [Read more...] about Guidant Settles Lawsuits

Mechanical Heart Valve Patients Try For Class Action Status

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Mechanical Heart Valve Patients. When 59-year-old Sharon Frost received her mechanical heart valves in 1998, she believed it would help her heart condition. Now five years later she finds it difficult to breathe, walk and spend time with her grandchildren. "It's frustrating. I can't even go up the stairs and carry a glass of water … [Read more...] about Mechanical Heart Valve Patients Try For Class Action Status

Red Cross May Have Released Unsafe Blood

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More than 200 violations of federal blood safety rules. The American Red Cross may have released tainted blood to hospitals, the government said Friday, reporting more than 200 violations of federal blood safety rules in its battle to get the Red Cross to improve the quality of its blood operation. The Food and Drug Administration … [Read more...] about Red Cross May Have Released Unsafe Blood

Outcomes Following PolyPropylene Mesh PuboVaginal Slings For Stress Urinary Incontinence

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PolyPropylene Mesh PuboVaginal Slings Placement Inuries. 56 consecutive women underwent a ProteGen sling placement in a community hospital. Methods Between 5/97 and 3/98, 56 consecutive women underwent a ProteGen sling placement in a community hospital setting by a single surgeon using a standard technique. Chart review and … [Read more...] about Outcomes Following PolyPropylene Mesh PuboVaginal Slings For Stress Urinary Incontinence

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