For anyone wondering how big the fallout is becoming from the explosive story details that are emerging in the case of a former medical technician who infected patients with hepatitis C in a New Hampshire hospital, the answer is becoming manifestly and quickly clear.
Patients injured by fake surgical mesh; litigation commenced
A recent case involving a medical malpractice product liability class action complaint filed by a number of plaintiffs injured by counterfeit surgical mesh illustrates the growing problem that counterfeits pose for the health care industry and medical products suppliers.
Fears and concerns follow med tech's arrest in hepatitis C case
A medical technician arrested last week in New Hampshire allegedly stole powerful drugs from the cardiac catheterization lab in which he worked, injected himself and contaminated syringes in the process that were subsequently used by other patients who contracted hepatitis C.
Drug labeling and medication errors: Researchers recommend changes
Anyone seeking evidence that many Americans are highly medicated need look no further than a recent Michigan State University (MSU) study, in which researchers say that more than 30 percent of all people in the country aged 65 and older take, on average, 10 medications each day.
Study authors say Merck lied about substantial Vioxx risks
It is often pointed out that pharmacies and pharmacists can be just as responsible for medication errors as are physicians and hospitals.
FDA rejects experts' advice on painkillers, doctors' training
A recent article in the New York Times notes that, over the past decade, "overdose deaths related to the abuse and misuse of long-acting narcotics have reached epidemic proportions."
Roche continues to lose Accutane bowel-disease cases
Issues relating to medical malpractice are most frequently focused upon individual doctors and hospitals.
Government says 79 practices bought drugs from unlicensed foreign suppliers
The CBS Evening News (7/3, story 5, 4:45, Pelley) reported that "it turns out many patients" with cancer "are being injected with dubious concoctions no better than water." Although "the Food and Drug Administration approves drugs sold in the United States...some clinics are buying drugs from outside the country not approved by the FDA." CBS News chief investigative correspondent Armen Keteyian said that "we've learned the Federal government has now identified at least 79 US medical practices that purchased drugs from foreign or unlicensed suppliers."
DaVita settles whistleblower suit for $55 million
The Denver Post (7/5, Booth, Osher) reports that kidney dialysis firm DaVita Inc. has settled a whistleblower suit over allegations of drug overuse. DaVita will pay $55 million to settle fraud claims in a Texas suit that challenged the chain's use of the anemia drug Epogen.
Diabetes patient gets Israel's highest-ever award in Avandia class-action
Israeli newspaper Ha'aretz (7/2, Ben) reported that, "The highest-ever award in an Israeli class-action suit against a drug manufacturer - NIS 12.1 million - was recently made under a compromise agreement reached between a diabetes patient and GlaxoSmithKline, the maker of Avandia. The suit had been filed by a diabetic who claimed that GSK had concealed data from the public that showed the drug, which is used to treat people with type-2 diabetes, increased the risk of dying from a heart attack."
Dr. Drew allegedly was paid to promote antidepressant
The New York Daily News (7/4, Goldwert) reported, "Dr. Drew Pinsky may have had a vested interest in seeing that patients took their meds. The media star doctor is facing allegations that he accepted $275,000 to talk up the drug Wellbutrin SR while hosting his radio and television show Loveline. The revelations emerged during the government's case against drug company GlaxoSmithKline, which has agreed to plead guilty to misdemeanor criminal charges and pay $3 billion for committing healthcare fraud, the largest such case in US history."
FDA announces new medical device patient-safety plan
The Wall Street Journal (7/4, Burton, Subscription Publication) reported that on July 3, the Food and Drug Administration announced a new patient-safety plan in which certain medical devices of a high-risk nature are to bear unique identification numbers.
Judge approves GlaxoSmithKline's $3 billion settlement with DOJ
In continuing coverage, the AP (7/6) reports from Boston, "A federal judge on Thursday approved an agreement by British drugmaker GlaxoSmithKline to pay $3 billion for criminal and civil violations involving 10 drugs, the largest health care fraud settlement in US history." The AP adds, "The amount of money involved led US District Judge Rya Zobel to remark in court that she was having trouble keeping track of the numbers. GlaxoSmithKline pleaded guilty to promoting the popular antidepressants Paxil and Wellbutrin for unapproved uses."
Poll: fewer Americans getting health insurance through employers
Politico (7/5, Mak) reported, "Fewer Americans are getting health insurance from their employer, a continuation of a trend that started in 2008, according to a Gallup Poll out Thursday." Just "55.9 percent of adults aged 26 to 64 received employer-provided health insurance in 2012, down from 61.6 percent in 2008." What's more, "dependence on government health insurance -- Medicare, Medicaid and military/veteran's benefits -- is much higher than it was in 2008 and 2009, covering 25.7 percent of the public during the second quarter of 2012." The survey of 87,521 adults was conducted during the second quarter of this year.
CalPERS considers way to lower healthcare costs
Forbes (7/6, Chase) reports that California Public Employees' Retirement System (CalPERS), the third largest insurance buyer, is considering "scrapping health plans to lower its medical tab," especially costs surrounding chronic conditions. "Perhaps the boldest move under consideration for 2014 would be to bypass insurers altogether in some areas of the state and begin contracting for medical services directly with large physician groups," which "could put large medical groups in direct competition with their contracted insurers."
Law seeks to incentivize development of drugs for childhood cancers
The Houston Chronicle (7/6, Powell) reports, "Legislation by Texas Rep. Michael McCaul, soon to be signed by President Barack Obama, will offer drug companies multimillion-dollar incentives to pioneer medications for rare childhood diseases that afflict too few kids to make a profit." The bill "is meant to remedy a chronic mismatch in which the FDA has approved dozens of new drugs to combat adult cancers since 1980 - and only one for the treatment of childhood cancer." According to the Chronicle, "In return for developing drugs for the small and unprofitable market of rare childhood diseases, cooperating pharmaceutical manufacturers could earn vouchers for faster Food and Drug Administration approval of new and potentially more profitable drugs."
Government announces "unprecedented" Glaxo fraud settlement
GlaxoSmithKline (GSK) -- a London-based titan in the pharmaceutical industry that has a strong Pennsylvania nexus, with a large office and plant facilities in the state -- is nearing the end of its long-term investigatory and legal woes stemming from a veritable litany of transgressions committed by the company over a decade-plus period.
Appeals court ruling deflates anti-malpractice tort reform language
Strong advocates of state tort reform, such as doctors and medical facilities seeking to shut the courthouse door as much as possible on would-be litigants with medical malpractice claims, aren't going to like a recent appellate ruling in Maryland.
FDA censures Covidien on thoracic surgery devices
Reuters (6/27, Kuber) reports the US Food and Drug Administration has criticized Covidien Plc for not responding promptly to three deaths and 13 serious injuries related to its thoracic surgery devices. The FDA said that despite receiving several complaints about the devices since May 2009, Covidien did not recall the devices until regulators initiated an investigation into the complaints on January 19 of this year. "Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice," the FDA said in its letter to Covidien, dated June 14.
Watchdog group warns of heart valve risk related to diet pill
Reuters (6/26, Kelly) reports that as regulators prepare to rule on whether to approve Arena Pharmaceuticals' diet pill lorcaserin on Wednesday, watchdog group Public Citizen has asked the US Food and Drug Administration to reject the experimental drug, citing concerns that it could pose a risk to heart valves. The group noted that doctors at an FDA advisory meeting last month said evidence from clinical trials showed an increased heart valve disease risk in patients who used lorcaserin. The panel still voted to recommend the drug for approval by a vote of 18 to 4.
U-T San Diego (6/27) reports the FDA "could delay its decision and require Arena to file more information about Lorcaserin, which could become the first new weight loss drug of its kind approved in the US in more than a decade. The agency is expected to review a possible competing drug -- Vivus' Anexa, on July 17."
FDA bill would increase nanotechnology research in Arkansas
The Arkansas News (6/28, Urban) reports, "President Barack Obama will likely sign into law a bill that could provide more work to the National Center for Toxicological Research in Jefferson," AR. "The Food and Drug Administration Safety and Innovation Act cleared the Senate, 92-4, on Tuesday and now heads to the President for his consideration. Within that bill is a provision that Sen. Mark Pryor, D-Ark., sponsored to authorize $25 million annually for FDA to assess nanomaterials used in drugs and other products."
FDA soon will have new nanotechnology safety program
The New Haven (CT) Independent (6/28, Shaw) reports, "The US Food and Drug Administration will soon have a new nanotechnology safety program, thanks to language tucked into a massive legislative package that's on its way to President Obama." A proposal added to the FDA user fee bill that passed the Senate earlier this week "creates a 'Nanotechnology Regulatory Science Program' within the FDA charged with scrutinizing the safety and efficacy of drugs, medical devices, cosmetics and other products that contain super-small particles. The legislation directs the FDA to both review ongoing academic research on health and safety issues, as well as conduct its own studies and work with other agencies."
