Articles Posted in Patient Safety

Following up a story I wrote about earlier this week, today’s New York Times reports that a Los Angeles jury has “ordered Johnson & Johnson to pay more than $8.3 million in damages… in the first of more than 10,000 lawsuits pending against the medical products maker” and its subsidiary, DePuy Orthopedics.

The lawsuits stem from allegations that DePuy knew of problems with its all-metal Articular Surface Replacement (ASR) hip implant long before the product was formally recalled in 2010, yet failed to act.

Of key interest for unsafe medical product victims here in Oregon or elsewhere are some of the legal technicalities of the jury verdict. According to the Times the jury award, which was announced Friday, does not include punitive damages because the jury found that DePuy “did not act with fraud or malice.” As the paper goes on to explain, however, it is not immediately clear how this will impact the thousands of other ASR-related legal actions. Though the article does not say so, this is partly because today’s case was decided by a state court in California. Different courts in other cities or states may view the matter differently, and state laws on medical product liability also vary from place to place. Another ASR-focused trial is scheduled to begin next week in Illinois. All that said, it is important for anyone suffering from what they believe to be an ASR-related injury to understand the details of the California jury’s award. According to the Times the jury ordered Johnson & Johnson to pay the plaintiff, a former prison guard from Montana, “$338,000 to cover his medical expenses. It also ordered him to be paid $8 million to cover his pain and emotional suffering.”

An editorial published last month by the New York Times raises important questions about the legal and moral responsibility medical device manufacturers have, or ought to have, concerning their products.

The newspaper focused on all-metal hip implants in general and the actions of DePuy Orthopaedics in particular. DePuy is a division of pharmaceutical and medical supply giant Johnson and Johnson. The paper writes that “about 93,000 patients around the world” received DePuy’s all-metal Articular Surface Replacement (ASR) model hip implant until it was recalled in 2010. However, the paper notes, “documents show that as early as 2008 DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed.” The article goes on to note: “That was never disclosed to doctors who were putting the device into patients, nor were other unfavorable internal studies.”

In response DePuy’s president wrote to the Times this week to take issue with the editorial, noting that the ASR had been approved by federal regulatory authorities and that when data indicated that numerous patients were requiring early replacement of their implants the company “recalled the product and immediately supported patients with a reimbursement program for their medical costs.”

An article published yesterday in the New York Times raises serious questions about product safety issues concerning bed rails, and is worth our notice here in Oregon. The paper’s reporting is built around the shocking revelation that the Consumer Product Safety Commission and the Food and Drug Administration have both “known for more than a decade about deaths from bed rails but had done little to crack down on the companies that make them.”

Even the fact that two government agencies had so much evidence raising questions about these dangerous products came to light only after a woman whose mother died in a bed rail accident launched a persistent letter-writing campaign. The woman became concerned about safety issues after her 81-year old mother died when she was “apparently strangled after getting her neck caught in side rails used to prevent her from rolling out of bed” at the nursing home where she lived.

The newspaper reports that data compiled by the CPSC documented 150 adult deaths, mainly among senior citizens, as a result of bed rails between 2003 and mid-2012. “Over the same time period, 36,000 mostly older adults – about 4,000 a year – were treated in emergency rooms with bed rail injuries,” the Times adds.

An opinion piece published earlier this month in the Wall Street Journal is an impassioned plea for greater accountability among physicians and greater engagement by patients all in the name of dramatically improving medical care and patient safety.

The piece by Dr. Marty Makary, a surgeon at Johns Hopkins, begins with a striking assertion: “medical mistakes kill enough people each week to fill four jumbo jets,” he writes. “But these mistakes go largely unnoticed by the world at large, and the medical community rarely learns from them.”

Makary’s solution? Better professional practice combined with a more attentive and engaged public.

The shocking case of a Portland doctor who, according to The Oregonian, faces “manslaughter and reckless endangerment charges in connection with two after-hours tummy-tuck operations she gave to employees in 2010” is a reminder that all of us need to keep Oregon patient safety in our thoughts when considering medical procedures.

According to the newspaper the doctor, whose medical license has now been suspended, allegedly performed solo surgery on two of her employees in a back room at her office after the day’s work was done. One of the two employees subsequently died from complications stemming from the tummy-tuck while the other “complained of dizziness and a rapid heartbeat afterward.”

All of us place great faith in doctors and we have the right to expect, in return, that our doctors will perform their duties in a manner that keeps patients’ well-being first and foremost in their minds. Of course, this is exactly what the vast majority of doctors do every day.

Earlier this month news broke of a head-spinningly large fraud settlement involving the pharmaceutical giant GlaxoSmithKline. According to ABC News the company “agreed to an unprecedented $3 billion settlement with the US government over allegations that the company advertised drugs for uses not approved by the Food and Drug Administration.”

Over the years we have all become a bit numb to horror stories about the health care industry. One of the few things both sides in the debate surrounding the Affordable Care Act appear to agree on is that the US healthcare system is in need of significant reform (exactly what sort of reform is a subject of far more debate).

Cases like this are the sort of thing that not only give an entire industry a bad name, but make reasonable people wonder how much deeper, and broader, corporate fraud is in the health care and pharmaceutical industry. To what extent are other companies putting their own profits ahead of patient and consumer safety?

The small-town pharmacist who knows all of his or her customers is a staple of TV and the movies. That fictional pharmacist has plenty of time to triple check medications and their dosage and to discuss things in detail with patients, most of whom have been his friends for years.

It ought to come as no surprise in 2012 that reality does not measure up to Hollywood’s fantasies. According to The Oregonian, “a recent survey by the Oregon Board of Pharmacy reported that more than 350 chain pharmacists – more than half of those responding – said their working conditions don’t promote safe and effective care.”

Perhaps most shockingly, only one-quarter of the 1300 pharmacists responding to the state’s survey “agreed working conditions promoted safe and effective patient care.” The article goes on to note that “many complained of having more prescriptions to fill each day with fewer staff; of 12-hour shifts with scant breaks; and constant distractions, such as administering immunization shots to augment profits.”

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