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Defective Medical Products

Defective Medical Products

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Are Boats Required to Have Insurance in California?

  California law does not require boaters to insure their boats. Despite California’s policy on boater’s insurance, it is wise to get coverage to minimize risks to your personal assets. Boating insurance is like car or home insurance; it covers

FDA tells Bayer to undergo study of Essure Birth Control


The Food and Drug Administration (FDA) told Bayer-manufacturers of Essure-they must undergo a new postmarket surveillance study of the permanent birth control that analyzes the heightened risks to patients. “While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications,” the FDA said in a press announcement.

Essure is supposed to create a natural barrier in the fallopian tubes so sperm can’t reach the eggs, preventing pregnancy. A physician implants the device through the vagina and into the fallopian tubes, where it produces an immune response causing tissue build-up in the fallopian tubes. Essure was approved by the FDA via the Premarket Approval (PMA) process and is a class III device, generally the highest risk devices and subject to the highest level of regulatory control. Despite this “high” level of regulatory control, many women are experiencing life-threatening side effects from Essure. Devices with PMA from the FDA are protected from product liability lawsuits brought in state courts. The court found that federal preemption prohibits state law claims that challenge the safety or effectiveness of PMA devices. If the PMA is revoked, individuals may be able to file a lawsuit.

The agency has received over 5,000 adverse event reports from women regarding their Essure device. The complaints include side effects ranging from pregnancy, pelvic pain, cramping, migration, allergic reactions, and perforation of the fallopian tubes and uterus. Many of these women are forced to undergo surgery for removal of their fallopian tubes (Salpingectomy), or removal of their uterus (Hysterectomy). Essure was approved on November 4, 2002. According to the FDA, “From Nov. 4, 2002, Essure’s approval date, through May 31, 2015, the FDA received 5093 medical device reports related to Essure. The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants.” Unfortunately, the FDA still has not selected to revoke the Essure PMA. However, the effort to revoke the PMA application is ongoing.

Instead, the FDA released a statement recommending that sterilization devices, such as Essure, include a Black Box warning label, a label required for devices that potentially cause death or serious injury, explaining the possible side effects.  The agency’s recommendation was published as a draft guidance with labeling recommendations for Essure. The FDA will finalize the guidance information after receiving comments from the public and the industry for two months.

Know Your Rights

In cases where it can be shown that the manufacturer of the medical device lied to the FDA to obtain approval, or failed to report adverse events with the product, a product liability case may be viable. It is important to protect your legal rights and have a case on file. Contact an Essure injury attorney at Kershaw, Cook & Talley for a free case consultation at 888-997-5170, or fill out our confidential online form found on this page.

FDA will require PMA for two types of hip replacements

February 18, 2016- On Thursday, the Food and Drug Administration (FDA) announced a final order which will require manufacturers to submit a premarket approval (PMA) application for two types of metal on metal (MoM) total hip replacement devices:

hip joint metal/metal semi-constrained with a cemented acetabular component

hip joint metal/metal semi-constrained with an uncemented acetabular component

Here is the excerpt from the FDA announcement released today:

Given the known risks, the FDA believes that there is insufficient evidence and information to conclude that general controls in combination with special controls would provide reasonable assurance of the safety and effectiveness of these devices. The agency has determined that these devices should remain Class III (higher risk) devices and PMA applications must be filed with the agency by May 18, 2016 if a manufacturer wants to continue marketing their MoM total hip replacement devices and/or market new MoM total hip replacement devices.

Manufacturers will be required to submit a PMA application that includes: (1) any risks known, or that should be reasonably known, to the applicant; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all nonclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.

Other FDA activities to date include:

DePuy Pinnacle 2016 Trial Update 2

Hi, I am Stuart Talley. I am the partner responsible for the hip litigation. The reason I am doing this video today is to provide an update on the ongoing Pinnacle metal-on-metal hip trial that is currently taking place in Dallas, Texas. This cases involves five separate plaintiffs who allege they were injured as a result of metal debris that was being released from these metal-on-metal hips.

So, the plaintiffs called Andrew Ekdahl, DePuy’s former CEO, to the stand. Mr. Ekdahl has a long history of being in sales and marketing. He eventually worked his way to becoming CEO of this company. There was a big emphasis on the cross-examination of Mr. Ekdahl about his marketing background, and how someone with his background was running the company as opposed to someone with an orthopedic or scientific background.

One of the things that took up a lot of the day was cross-examination concerning memos from 1995. The story that’s being told through this trial is that in 1995 DePuy became aware that other manufacturers of hips were coming out with other bearing surfaces. So, at this point in time, most hips were made out of metal and plastic; plastic liners with the metal ball. There was a push in the industry to come out with metal-on-metal hips.

In 1995, DePuy got its lead scientists together to look at these other bearing surfaces. There is a detailed memo that was prepared by DePuy’s head of science where he describes the different bearing surfaces for the hips. He concludes that metal-on-metal has a history of not being a very good bearing surface. He talks about how in the sixties and seventies manufacturers came out with metal-on-metal hips, and there were lots of problems with metal wear debris.

In this memo, he talks about how the failure rate of these hips was much higher than with metal-on-plastic, how the metal-on-metal hips were leeching cobalt and chromium, and how toxic and poisonous those metals can be compared to hips with plastic.  Hips with plastic debris typically do not cause a lot of problems compared to the metal debris. In the memo, the head scientist at DePuy also says from the standpoint of innovation it makes more sense to come out with a better plastic, and modify the metal-plastic design than it does to go with the metal-on-metal design that has been shown to fail in the past. For some reason, the advice of DePuy’s head of science did not carry the day. DePuy eventually went into the metal-on-metal market with the DePuy Pinnacle, and then eventually the DePuy ASR Hip, which is recalled.

Interestingly, in the cross-examination there was also discussion about a meeting that took place with several doctors hired to come in and talk about these different bearing surfaces. There are minutes of this meeting which occurred back in 1995. The plaintiffs’ attorneys discuss how in 1995 the doctors who were consulting with DePuy indicated that a metal-on-metal design could potentially lead to litigation. So, there was this knowledge back in 1995 that metal-on-metal hips have failed in the past, that their failure rate was bad, that the danger from a metal-on-metal hip in the debris was much different, and more dangerous for the patients than the metal-on-plastic design. For some reason, DePuy chose to ignore all this advice in 1995 and went ahead with the metal-on-metal hip design. Apparently, this decision was based on market share.

There was also discussion at the trial with Mr. Ekdahl about the marketing and the way DePuy marketed its hips. DePuy spent millions of dollars on taking surgeons to dinner, go to conferences to talk about the benefits of metal-on-metal hips. The plaintiffs’ attorney went through some of the financial records in the budgets and it turns out that DePuy was actually spending more money on marketing and advertising than it was on research and development during this time period.  There was a big push to get market share.

The other issue that was mentioned during trial was that the doctors, the ones who were flying all over the country getting paid millions of dollars to talk about how great the metal-on-metal hips were, stopped using those hips almost within a year or two after they started. There were some doctors who only used it for two years. They saw the problems with the hips and they stopped using it. Despite, DePuy continued selling the Pinnacle hips to the public.

At the end, there was also lots of discussion about the way the DePuy Pinnacle was approved by the Food and Drug Administration (FDA). The defendants like to make a big deal of the fact the hips were approved by the FDA, so it must be a good product. During trial, it was stated that the hip was approved through a loophole in the FDA process. It was approved via the 510K process, a process where you can go to the FDA with a product, a product substantially similar to one approved previously but has a minor modification. Essentially, that’s how the hip was approved. DePuy submitted something similar to a hip that was already approved and on the market, and the FDA rubber stamped it. So, there was no testing, no clinical trials and nothing submitted to the FDA to prove that the device was safe and effective. Instead, all DePuy had to prove was that the Pinnacle was substantially similar to something else that was already on the market. The problem is that the device that was substantially similar to the Pinnacle was eventually pulled from the market because it was defective and had problems with metal wear debris. That respective device was also pulled from the market because it was shown to be substantially similar to these hips back in the sixties and seventies that were also pulled from the market.

The plaintiffs’ attorney did a great job demonstrating the “chain of devices” that led to the Pinnacle hip. The demonstration showed all of these devices had failed in the sixties and seventies, they failed in the early two thousands and they failed at the end of 2010. This completed the testimony for the day and it was definitely a good day for the plaintiffs. The defense has yet to go but there are some really damaging documents that were presented. The 1995 memos were very good for the plaintiffs and they support the fact that DePuy really knew there were problems with these metal-on-metal hip designs before they released the device on the market.

FDA Adds Warnings to Invokana Drug Label


On December 4, 2015, the Food and Drug Administration (FDA) released a drug safety communication after a safety review resulted in adding warnings to the labels of a class of Type 2 diabetes drugs called sodium glucose cotransporter-2 inhibitors or SGLT2 inhibitors, like Johnson & Johnson’s Invokana.

The agency revised the labels to include risks of too much acid in the blood and serious urinary tract infections (UTIs). Both conditions may lead to hospitalization. SGLT2 inhibitors release blood sugar via the urine and reduce blood glucose levels. However, this increases the risk of diabetic ketoacidosis (DKA), a life-threatening condition in which the body produces high levels of blood acids called ketones.

DKA occurs when the body cannot break down sugar as an energy source. Instead, the body burns fat for energy, producing ketones. Ketones are waste products and poison the body. DKA can cause diabetic coma, even death. The FDA warns, “Patients should stop taking their SGLT2 inhibitors and seek medical attention immediately if they have any symptoms of ketoacidosis.” Symptoms include nausea, vomiting, trouble breathing, confusion, abdominal pain, and fatigue.  DKA associated with the use of SGLT2 inhibitors can occur with normal blood glucose levels. Consequently, this may delay treatment of the ketoacidosis because the blood glucose levels were below those typically expected for diabetic ketoacidosis.

SGLT2 inhibitors, such as Invokana, may cause urinary tract infections or bladder infections. The signs and symptoms of a UTI include painful urination, burning sensation in the urethra, frequent urination or urge to urinate, blood in the urine, fever, and flank pain (pain in the lower stomach or pelvis). Symptoms in the elderly can be vague or non-specific.

Healthcare professionals should monitor patients taking SGLT2 inhibitors who present with suggestive symptoms for ketoacidosis and urinary tract infections.

If you suffered diabetic ketoacidosis (DKA) or a urinary tract infection (UTI) after taking Invokana, contact an attorney at Kershaw, Cook & Talley for a free case evaluation at 888-997-5170.

FDA, 21st Century Cures Act and Medical Devices, Oh My!

The Food and Drug Administration (FDA) has regulated the approval of medical devices since 1976. And “regulate” is used loosely in this context. In this day and age, advances in medicine are making way for waves of new drugs and medical devices. However, the regulatory oversight for this influx of medical devices is severely lacking.  This is disconcerting considering the multitude of drugs and devices currently on the market. Many of these medical devices on the market underwent only one clinical trial, unlike new drugs which require two clinical trials, a more startling revelation. Rita F. Redberg and Sanket S. Dhruva wrote an op-ed discussing The F.D.A.’s Medical Device Problem in The New York Times:

The F.D.A.’s Medical Device Problem 

By Rita F. Redberg and Sanket S. Dhruva

July 17, 2015

THE Food and Drug Administration has been regulating the approval of medical devices since 1976, but its regulatory oversight has not kept pace with the increasing complexity of this technology. Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials). And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).

As a result, there have been many warnings about, and recalls and withdrawals of, medical devices that were found to be dangerous only after they were on the market. (In 2009, for example, the Sprint Fidelis defibrillator, which by that time had been implanted in hundreds of thousands of heart patients, was recalled because it frequently malfunctioned, harming many patients and leading to numerous deaths.) And because the F.D.A.’s oversight of medical devices once they are on the market is also weak, it is very likely that many malfunctions and other problems remain undetected.

Incredibly, legislation that the House of Representatives passed last week would severely weaken, not strengthen, the F.D.A.’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not.

The legislation, disingenuously titled the 21st Century Cures Act, would make it possible for companies that produce high-risk medical devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories (i.e., the experiences of individual patients). In other words, anecdotal evidence, rather than the scientific studies, could be used to approve devices.

This act would also create a new, faster approval process for “breakthrough technologies” that are believed — but not necessarily proved — to offer significant advantages over existing alternatives. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk. The legislation defines “breakthrough” loosely, creating a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick.

In general, the proposed law is likely to shift the burden of evidence to clinical studies that are conducted only after the devices have been put on the market. Unfortunately, such studies are often delayed months to years after a device is approved. Many are never completed (and even when they are, their findings are often not publicly available). Although the proposed law alludes to “timely postmarket data collection,” that vague directive needs to be clearly defined — and more important, enforced — by the F.D.A. In fact, according to a 2014 journal article co-written by one of us, the F.D.A. has never issued a warning letter or penalty for a postmarket study delay.

Even if a postmarket clinical study deems a medical device dangerous, it still can be difficult to remove it from the marketplace. In 2005, for example, an intracranial stent called the Wingspan was approved on an expedited basis to prevent recurrent strokes. When a high-quality clinical trial was finally completed, in 2011, it found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence, the F.D.A. did not withdraw the device (though it did narrow its recommended uses). The Wingspan continues to be marketed and implanted today, putting patients at unnecessary risk.

Once a medical device is developed and approved, its manufacturer often makes small changes intended as enhancements (such as using a different size wire or new material). Currently, the F.D.A. is the arbiter responsible for ensuring that these changes result in a safe and effective device. But alarmingly, the 21st Century Cures Act would establish a third-party program of nongovernment authorities to assess whether a company is permitted to make such changes. The act would enable the device manufacturer itself to select — and pay — the third party from an approved list. This flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices.

The 21st Century Cures Act would subject millions of Americans to unsafe or untested medical devices. We urge the Senate, as it takes up the bill, to avoid these dangerous provisions. Unlike medical drugs, which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective. Stricter evidence standards and increased federal funding of the F.D.A. are needed to ensure that innovative medical devices lead to better health.

Defective & Dangerous Products

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“Bill and Stu worked expeditiously to get my hip claim resolved.
I couldn’t believe how personable they were and easy to contact.”

-S. Thomas

“Stuart helped me with a case involving a defective hip replacement. He was incredibly responsive to my calls and concerns and really kept me updated on what was going on in the litigation. Even though his office was not in my hometown, he actually flew out to meet with me. He was incredibly knowledgeable about the case and really helped me through a very difficult time.”

-Personal Injury Client, as seen on AVVO

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