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Summary: Viewpoints on the Nuances of IVC Filter Usage

Posted in Devices, IVC Filters

Endovascular Today published an article in July 2014 in which three doctors well-versed in dealing with inferior vena cava (IVC) filters were interviewed for their opinions on indications, patient follow-up & retrieval rates and the prophylactic use of the devices. The three interviewees were:
•    Dr. William T. Kuo, MD, FSIR, FCCP FCIRSE; Director, Interventional Radiology at Stanford University Medical Center, Stanford, California
•    Dr. Gerard Goh, MD, EBIR; Consultant Interventional & Diagnostic Radiologist at The Alfred Hospital in Melbourne, Australia
•    Dr. Frank Arko, MD; Vascular and Endovascular Surgery at Sanger Heart and Vascular Institute in Charlotte, North Carolina

Guidelines for using IVC Filters
The interviewees were questioned as to what guidelines they and their respective facilities followed re: implanting IVC filters. Their answers point to a problem in the field: namely, that there isn’t one uniform set of guidelines for IVC filter use and that they differ across the board.

Dr. Goh employs his facility’s local guidelines. These are based upon the Cardiovascular and Interventional Radiological Society of Europe’s (CIRSE) “quality improvement guidelines” for IVC filter use. These guidelines essentially indicate IVC use is proper in patients with:
•    Pulmonary embolism (PE), a dangerous condition involving a blood clot that could reach the lungs, potentially causing death
•    Deep-vein thrombosis (DVT), another dangerous condition in which the clots form in the deep veins, typically in the legs
•    History of complications from anticoagulant (blood thinning) therapy or in whom such therapies are either ineffective or contraindicated
•    Severe trauma
•    Poor patient compliance with anticoagulant therapy
•    Free-floating iliofemoral or IVC clots.

Dr. Arko follows different guidelines based upon those of the Society of Interventional Radiology (SIR). His facility only implants IVC filters when there are contraindications to blood thinning therapies or such therapies cause complications or simply don’t work. Dr. Arko’s facility doesn’t use IVC filters in trauma patients, however he knows of prophylactic use in severe trauma cases, such as closed head injuries, spinal cord injuries and long bone or pelvic fractures.

Dr. Kuo and his facility are perhaps the most cautious in their use of IVC filters. He cites various published guidelines, such as those from the American College of Chest Physicians (ACCP), the American Heart Association (AHA), the Eastern Association for the Surgery of Trauma (EAST) and SIR. Dr. Kuo said the most recent and often updated guidelines come from the ACCP. However, the most important factor for Dr. Kuo in deciding to use an IVC filter is based on the PREPIC study.

Follow-up & Removal
IVC filters were not intended to be permanent implants. However, at least in the U.S., there is a huge percentage of patients (66% in 2014) who still have their IVC filters long after the risk of PE has passed. The FDA has issued two safety alerts recommending that IVC filters be removed once the risk of PE has passed.

According to Dr. Kuo, the medical literature as well as the FDA’s MAUDE database for adverse event reporting clearly shows that the longer an IVC filter remains in place after the risk of PE has passed, the greater the risk for serious, potentially fatal, complications. In fact, Dr. Kuo and Stanford developed a follow-up protocol for those patients who only need the temporary type of IVC filter device.

Their patients are automatically scheduled for a return visit for removal “within a few months after successful therapeutic anticoagulation has been achieved and once the risk of PE has diminished.” If the IVC filter is still necessary following that appointment, the clinic closely monitors patients and brings them in for removal once the conditions are met. This is accomplished via the clinic’s in-house FILTER registry.

Dr. Kuo has become the “go-to” surgeon for removal of IVC filters that have been left in too long. He and his team have set up the Stanford IVC Filter Clinic, the purpose of which is to help patients who are not necessarily Stanford Medical Center patients, but who have developed complications with their filters that make standard retrieval almost impossible. The Clinic receives referrals from across the country.

Likewise, Dr. Goh’s facility uses an in-house registry, recording all IVC filter implants and projected dates for removal. A removal appointment is typically set for six weeks post-implant and most of their patients undergo removal surgery at that appointment or a later rescheduled time. The clinic also calls patients who don’t keep their removal appointments and focuses on educating them about the need for prompt removal.

Dr. Arko’s removal protocol has patients return four weeks post-implant for a removal assessment. He said their follow-up is very good “due to the fact that we really do not have any trauma patients in our practice.”

Prophylactic Use of IVC Filters
There is a trend in the U.S. to implant IVC filters in certain patient populations as a prophylactic or preventative measure, even when there is no history of PE or DVT. Such populations typically include those undergoing high-risk surgery like spinal or bariatric procedures. None of the doctors felt that enough evidence existed to support such widespread prophylactic use of the devices.

In fact, Dr. Arko said, “I personally try to limit the use of prophylactic filters.” Dr. Goh is of the opinion that, while such use lowers the occurrence of PE, it increases the risk of DVT and, as such, may not be the best choice.

Dr. Kuo agreed. His practice doesn’t typically implant prophylactic IVC filters in trauma patients without a history of venous thromboembolism (VTE), a condition involving both DVT and PE. He said that most trauma patients don’t get the high level of follow-up necessary to ensure prompt removal, which opens them to greater complications in the future. He currently cooperates with Stanford’s bariatric surgery department if they request the implantation of a prophylactic IVC filter. However, he is considering stopping the practice as data showed “little benefit and perhaps significant risks associated with prophylactic IVC filters among bariatric surgery patients.”

The bottom line is that prolonged use of IVC filters presents the majority of patients with an increased risk of serious, potentially life-threatening complications. There are few, if any, long-term use benefits, especially when compared to these risks, which include:
•    Migration of the IVC filter, including to another blood vessel (called embolization)
•    Fracture of the filter
•    Penetration of the inferior vena cava by the filter
•    IVC perforation of the inferior vena cava
•    IVC thrombosis (a clot forming around the filter)

Summary: Inferior Vena Cava Filters in the United States: Less is More

Posted in Devices, IVC Filters

In an article published in the International Journal of Cardiology in 2014, Drs. Mohamad Alkhouli and Riyaz Bashir question the efficacy of the inferior vena cava (IVC) filter as a device for routine use and raise cautions about the apparent lack of retrieval of these temporary filters, particularly in U.S. patients. There is little doubt that in some cases, the IVC filter is a necessary device; however, the article’s authors expressed concern over “prophylactic” use of IVC filters in certain patient populations.

The IVC filter is a device designed to reduce the possibility of recurrent pulmonary embolism or PE, (blood clots reaching the heart and lungs) as well as fatalities caused by PE. The filters are manufactured by eleven companies and, when called for, are implanted in the inferior vena cava, the largest vein in the human body. The article’s authors state there is “only one randomized-controlled trial” that examined the efficacy of the IVC filter in accomplishing its primary purpose. This study, called PREPIC (Prevention du Risque d’Embolie Pulmonaire par Interruption Cave), showed that, while there was a reduction in PE occurrence, there was no impact on short- or long-term mortality. Worse, PREPIC showed a significant increase in the occurrence of deep-vein thrombosis (DVT). DVT is a condition in which a blood clot (thrombus) forms in one of the deeper veins, typically in the legs. If DVT occurs and the clot breaks loose, PE is a likely result and can be fatal.

Though there is a definite lack of data strongly supporting IVC filter use, Drs. Alkhouli and Bashir found that the use of IVC filters in the U.S. is on the rise. At the time of their writing, IVC filters were being used in 12% – 17% of patients with venous thromboembolism (VTE), a condition involving both DVT and PE, but used in over 40% of patients with a high risk of bleeding. One of the items the doctors found most intriguing was the fact that the implantation rates in patients with a high risk of bleeding was 25 times greater in the U.S. than in Europe. This is likely due to a lack of commonality among guidelines for IVC filter use.

The indications (or conditions calling for use) for IVC filters vary widely, even in the U.S. There are two types of indications: therapeutic and prophylactic. The most common indications are therapeutic and include:

  • DVT or PE and contraindication of anticoagulation therapies (reasons blood thinners should not be used)
  • Anticoagulation therapy failure
  • Massive PE
  • Severe cardiopulmonary (heart and lung) disease complicated by DVT.

Among the more controversial prophylactic uses of IVC filters are:

  • Preventing PE in patients having high-risk surgeries, such as bariatric or spinal procedures
  • Trauma victims without VTE

The problem, according to the authors, is that over half of IVC filter placements fall into the prophylactic category, despite one population-based study of 213 IVC filter patients. That study, conducted by a panel of thrombosis experts, showed that only 51% of those studied actually needed the IVC filter. The other 49% didn’t meet the requisite indications for such therapy. Further, there is a marked lack of agreed-upon definition of “contraindication to anticoagulation” therapy, as well as evidence that several patients who were implanted with an IVC filter due to contraindication to anticoagulation were, in face, on anticoagulation protocols.

One paper, referencing the RIETE registry (registry of patients with venous thromboembolism), stated that 60% of patients studied who were implanted with an IVC filter due to “relative or absolute contraindication to anticoagulation” were on some form of anticoagulant therapy. This further underscores the question of “true contraindications to anticoagulation.”

Perhaps the worst issue with IVC filters is the possibility of serious short- and long-term health complications due to their use. Such complications include:

Migration of the IVC filter, including to another blood vessel (called embolization)

Fracture of the filter

Penetration of the inferior vena cava by the filter

IVC perforation of the inferior vena cava

IVC thrombosis (a clot forming around the filter)

The main reason for these complications is late retrieval of the IVC filters. These devices were not meant to be permanent; rather, they are intended for use only until the risk of PE passes and then they are supposed to be removed. Drs. Alkhouli and Bashir cite research that shows “late filter-related thrombosis” occurred in 8% – 30% of cases studied.

The major problem with IVC filters in the U.S. is the poor rates of retrieval. At the time the authors wrote their article, the highest removal rate reported in the U.S. was 34%, compared to 81% in U.K. They found that some IVC filters aren’t removed for good reasons, such as a tilted filter or a trapped clot.

However, the most common reason they found for lack of removal was poor follow-up by implanting doctors. In the meantime, the IVC filters that remain in the body longer than recommended continue to put patients at risk of very serious health complications. This, even after the FDA issued two safety warnings (2010 & 2014) stating that implanting doctors should remove the IVC filters as soon as the risk of PE has passed.

Beginning of the End for Monsanto?

Posted in Lawsuits, Politics, Public Health

A former farm worker named Enrique Rubio may just be the right “David” to take down “Goliath” chemical company Monsanto. Rubio filed suit against the manufacturer of Roundup® early last week, claiming that the company’s infamous herbicide is the cause of his bone cancer and inability to work.

Roundup’s® safety has been hotly debated for years among scientists, environmental activists and those concerned with human health. Rubio’s suit, if successful, may put an end to that debate once and for all by forcing Monsanto to provide proof that it knowingly withheld data on the true dangers of its flagship product.

The active ingredient in Roundup®, a nasty chemical called glyphosate, was discovered in 1970. Rubio’s suit states that [g”]lyphosate is a broad-spectrum, non-selective herbicide used in a wide variety of herbicidal products around the world. Plants treated with glyphosate translocate the systemic herbicide to their roots, shoot regions and fruit, where it interferes with the plant’s ability to form aromatic amino acids necessary for protein synthesis. Treated plants generally die within two to three days. Because plants absorb glyphosate, it cannot be completely removed by washing or peeling produce or by milling, baking, or brewing grains.

Monsanto claimed glyphosate was “a technological breakthrough: it could kill almost every weed without causing harm either to people or to the environment.” However, that doesn’t seem to be the case. The World Health Organization (WHO) asserts that glyphosate is “a probable cause of cancer.”

Why would Monsanto take such a big risk? Money. The company needed a win in the industry in order to continue its “reputation and dominance in the marketplace. Largely due to the success of Roundup® sales, Monsanto’s agriculture division was out-performing its chemicals division’s operating income, and that gap increased yearly.” So, rather than go with a less toxic product, Monsanto sold humanity and the planet for its own bottom line.

Wait, a less toxic product? Is that possible? Indeed, it is possible and was possible from Day One. “The harm caused by [Monsanto’s] Roundup® products far outweighed their benefit. …Roundup® products were and are more dangerous than alternative products and {the company] could have designed its Roundup® products to make them less dangerous. Indeed, at the time that [Monsanto] designed its Roundup® products, the stat of the industry’s scientific knowledge was such that a less risky design or formulation was attainable.

So basically, Monsanto decided it was better (for it) to release a carcinogenic product that it was to spend a bit more money taking the time to research a less harmful alternative. The sad thing is, knowing that its product was dangerous, Monsanto had to pull some serious strings to get it approved.

The EPA originally classified glyphosate as “possibly carcinogenic to humans” in 1985. However, “after pressure from Monsanto, including contrary studies it provided to the EPA, the EPA changed its classification to evidence of non-carcinogenicity in humans in 1991.”

The “contrary studies” involved two “independent” labs that willfully committed scientific fraud. The FDA inspected one lab, Industrial Bio-Test Laboratories (IBT), in 1976. That inspection uncovered “discrepancies between the raw data and the final report relating to the toxicological impacts of glyphosate.”

This prompted the EPA to do its own audit. The EPA found the same results. Moreover, one EPA reviewer said that, “after finding ‘routine falsification of data’ at IBT, that it was ‘hard to believe the scientific integrity of the studies when they said they took specimens of the uterus from male rabbits.’” Unsurprisingly, three of IBT’s top executives were convicted of fraud in 1983.

The other lab, Craven Laboratories, was hired by Monsanto to perform additional tests on glyphosate in 1991. “In that same year, the owner of Craven Laboratories and three of its employees were indicted, and later convicted, of fraudulent laboratory practices in the testing of pesticides and herbicides.”

According to Rubio’s complaint, “Despite the falsity of the tests that underlie its registration, within a few years of its launch, Monsanto was marketing Roundup® in 115 countries.” Nowadays, Monsanto’s glyphosate products can be found in 130 countries and are approved for use on over 100 different crops. If you think that you’re safe, think again.

“[Glyphosate products] are ubiquitous in the environment. Numerous studies confirm that glyphosate is found in rivers, streams, and groundwater in agricultural areas where Roundup® is used. It has been found in food, in the urine of agricultural workers, and even in the urine of urban dwellers who are not in direct contact with glyphosate.”

The New York Attorney General sued Monsanto in 1996 claiming its Roundup® advertising was “false and misleading.” The suit specifically challenged “Monsanto’s general representations that its spray-on glyphosate-based herbicides, including Roundup®, were ‘safer than table salt’ and ‘practically non-toxic’ to mammals, birds, and fish.”

Monsanto agreed, in 1996, to “cease and desist from publishing or broadcasting any advertisements [in New York].”

Various other governments have either severely restricted or outright banned the sale of Roundup®, including the Netherlands, Brazil, France, Bermuda, Sri Lanka and Columbia.

Indeed, this may be the beginning of the end for Monsanto and Roundup®. One can only hope that justice will prevail in Rubio’s case and the chemical giant will be forced to tell the truth and face the consequences.

FDA Issued Serious Warning to C. R. Bard, Inc. Due to Multiple Violations

Posted in Uncategorized

[By Staff Writer Jay Belle Isle]

In a letter dated July 13, the FDA issued serious warning to C. R. Bard Inc. due to multiple violations. The company has been given fifteen business days to respond to the letter or else it may face “seizure, injunction and civil money penalties.” The warning is based on inspections of Bard’s Queensbury, NY and Tempe, AZ manufacturing facilities and is focused on Bard’s Recovery Cone Removal System, Models RC-15 and FBRC.

The FDA has several concerns with these devices, including that they are:

…adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).

… misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

market[ed] … without marketing clearance or approval. Percutaneous retrieval systems, such as the Recovery Cone Removal System, Model RC-15, are regulated as manual surgical instruments intended for specialized use within a specific medical specialty, and thus require marketing authorization in order to be legally marketed in the United States.

Further, the inspection revealed issues with Quality Control of Bard’s IVC filters:

Specifically, IVC filter cleaning, to include removal of chemical processing contaminants, has not been validated for IVC Filters to include Simon Nitinol Filters, Eclipse Filters and Denali Filters. For example, production of Denali Filters requires the use of several processing agents, including, but not limited to the following: nitric acid, methanol, sulfamic acid solution, thermo quench salt, glycolic acid, citric acid, and/or hydrofluric acid. The cleaning processes for IVC filters are not validated or otherwise verified to demonstrate that the above substances are reduced to acceptable levels during routine processing under worst case conditions. Therefore, your manufacturing process was not validated with a high degree of assurance and approved according to established procedures, nor were the process results fully verified by subsequent inspection and test, as 21 CFR 820.75(a) requires.  

As if that wasn’t enough, Bard’s system for reporting and investigating product complaints was found to by woefully inadequate.

The company also incorrectly filed or failed to file adverse event reports. One of these reportable instances involved a death potentially due to a Bard device malfunction. Misreporting of 10 cases as Medical Device Reports (MDR) instead of serious injury events was also noted.

The FDA found Bard’s previous answers to the results of the inspections to be insufficient. The company has until August 3 to report satisfactory resolution of the issues or plans to do so.

Postponement of Daubert Hearing in Zoloft Birth Defects Case

Posted in Uncategorized

U.S. District Judge Cynthia Rufe or the Eastern District of Pennsylvania made the only call she could on Tuesday: the postponement of Daubert hearing in Zoloft birth defects case until September. The multidistrict litigation (MDL) against Pfizer, claiming its popular antidepressant, Zoloft causes birth defects, came to a halt as the plaintiffs’ expert was disqualified due to errors in the article upon which he was basing his argument in the plaintiffs’ favor.

The postponement came during the Daubert hearing – one that allows parties to challenge each other’s expert testimony pre-trial to save time later – when defendant Pfizer revealed a report from its own medical expert, Dr. Stephen E. Kimmel. After reviewing Dr. Nicholas Jewell’s article in the New England Journal of Medicine, Dr. Kimmel noted some data errors. Dr. Jewell’s article provided plaintiffs’ needed support in their argument that Zoloft causes congenital heart defects when used by pregnant women.

Dr. Kimmel’s report states that he contacted Dr. Jewell and told him of the errors, at which point Dr. Jewell confirmed the mistakes. Dr. Jewell then contacted the Journal to request corrections. Based on this finding, Dr. Kimmel gave the opinion that Dr. Jewell’s article could no longer be used.

Judge Rufe had no other course of action but to agree with Dr. Kimmel and decided that the rest of the Daubert hearing would have to wait until the fall so the plaintiffs could conduct further discovery and depositions. Jared: Do we want to link to the CDC piece here as a suggestion?

According to Judge Rufe, plaintiffs’ legal team has “a lot of people to talk to, we have to give them some time. I do see an advocate’s responsibility to try to determine how this change occurred.”

This isn’t the first blow plaintiffs have received in terms of experts. Anick Bérard, the first expert, was removed following a weeklong Daubert hearing in 2014. Contrary to common practice, the judge allowed a second expert. It’s unclear if the plaintiffs will get a third. That isn’t the extent of the expert epic, though.

Judge Rufe ruled in favor of Pfizer in a motion to produce a report by plaintiffs’ expert Dr. Jewell from similar litigation involving Prozac. She ordered plaintiffs to turn over both the report and the testimony from Dr. Jewell.

According to Pfizer, “Dr. Jewell and plaintiffs’ counsel, who are also counsel in the Prozac litigation, insist that the entirety of Dr. Jewell’s expert report and deposition are confidential and thus subject to a protective order. That blanket assertion is highly suspect and implausible. Dr. Jewell is a general causation expert who presents a statistical analysis of data. He typically does not review or discuss plaintiff-specific information or medical records and has not done so in this matter. His opinions in the Prozac litigation, as they are in this litigation, are presumably based primarily upon publicly available, peer-reviewed literature.”

As stated, the plaintiffs were ordered to release the report. Despite Pfizer’s assertions, there were parts that Eli Lilly had identified as confidential redacted. There were also parts that contained personal health information normally protected by HIPAA.

Pfizer’s motion further stated, “In making a blanket assertion of confidentiality over the entire deposition and report, plaintiffs’ and Dr. Jewell’s motives are transparent: They do not want the defendants or the court to ascertain and explore whether there are any inconsistencies in his methodologies in the different SSRI litigations.”

To date, Pfizer has won two of the Zoloft birth defects cases out of the approximately 550 total cases.

 

Source:

Pa. Federal Judge Postpones ‘Daubert’ Hearing in Zoloft MDL

 

Drugs Disapproved by the FDA Deserve Attention

Posted in Drug Studies, FDA Regulation, Public Health

Recently, Reuters reported that “Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness”.

Reporter Lisa Rapaport quotes Dr. Peter Lurie, FDA associate commissioner for public health strategy and analysis, saying “‘Only a minority of the press releases clearly stated that receipt of a complete response letter meant that marketing could not commence, and most findings associating the drug with a higher mortality rate went unmentioned.’” (emphasis added)

In her report, Rapaport notes that Dr. Lurie reviewed announcements by pharmaceutical companies following FDA disapproval released between 2008 and 2013 and found that “About half of the time, the complete response letters cited shortcomings in both safety and effectiveness. Out of 191 concerns about effectiveness raised in the letters, drugmakers disclosed a total of 30 in press releases, while companies shared 22 of 150 safety concerns.

Roughly half of the letters asked for new clinical trials to study safety or effectiveness; and in 59 percent of these cases companies disclosed this in a press release.”

This practice makes intuitive sense for drug companies, however cynical it is to admit. Why would pharma companies want to disclose precisely how a proposed product failed to meet FDA safety and efficacy requirements?

This actually raises an important issue for the FDA: should all proposed pharmaceutical products, not only approved drugs and devices, be a part of public knowledge?  Companies whose stock is traded on the open market are already required to detail drug rejections (as is noted in the aforementioned Reuters piece), but not all drug companies are publicly held.  Privately-held pharmaceutical corporations will argue that disapproved compounds consist in proprietary knowledge, and they may be right, public health concerns aside.

It nonetheless still is important to consider drugs that “may have been,” (or rather, drugs that failed to surmount the ever-weakening FDA approval process).  Many drugs sold in America are disapproved upon initial FDA review, and following simple adjustments to study design, methodology, or statistical rigour are approved without meaningful changes to drug design.  That is, the method used to test a drug’s effectiveness or safety can be adjusted, and a disapproved drug is made legal, without change to a drug’s chemical design.

With attention paid to disapproved drugs through open communication between pharmaceutical companies, the FDA, and the American public, consumers can understand more completely whether substantive changes were made to a drug’s design between initial disapproval and subsequent approval.

By no means would I suggest it is necessary, or would even be helpful, that the American populous attempt a measure of biochemical or pharmacological scrutiny when reviewing the FDA’s news ticker.  That is the task of science journalists and healthcare analysts.  As long is information regarding drug disapproval is available in full, dissemination to the public is possible, and that is a good thing.

Fifth Circuit Releases Reglan Manufacturers from Birth Defect Liability

Posted in Reglan / Metoclopramide

In an unpublished opinion file on April 9, the Court of Appeals for the 5th Circuit affirmed a previous decision in one of the Reglan generics cases, Whitener v. Pliva, Inc. This ruling upholds the district court’s grant of summary judgment in favor of the defendant drug companies on the grounds that the defendants performed no off-label promotional activities.

Lindsey and Joshua Whitener’s son was born prematurely and with severe birth defects after Mrs. Whitener used metoclopramide, a generic form of the heartburn drug Reglan. Mrs. Whitener was suffering nausea and morning sickness and her doctor, Dr. John McCrossen, prescribed metoclopramide as an off-label treatment due to previous successes he’d had with the drug.

The FDA-approved label did not mention any warnings regarding used during pregnancy nor did it recommend metoclopramide as a treatment for pregnancy-related nausea. The Whiteners filed suit in 2010 alleging that the drug’s manufacturers failed to warn them of the danger of using their product during pregnancy and also that the manufacturers had engaged in a “complex scheme” of promotion of the off-label use.

Of the six defendants, three were manufacturers of brand name Reglan (Alaven Pharmaceutical L.L.C., Meda Pharmaceuticals, Inc. and Schwarz Pharma, Inc.), which Mrs. Whitener did not use. The other three (PLIVA, Inc., Barr Laboratories, Inc. and Teva Pharmaceutical Industries, Ltd.) made generic metoclopramide, which Mrs. Whitener did use.

A 2011 U.S. Supreme Court ruling in PLIVA, Inc. v. Mensing, held that state law inadequate warning claims against generic drug manufacturers were preempted, as federal law required the generic labels to be the same as the brand name labels. The 5th Circuit granted defendants’ motions for judgment on the pleadings in the matter of the inadequate warnings. However, it allowed the claim of promotion of off-label use to proceed.

Teva was released from the case due to a jurisdictional issue. The remaining defendants moved for summary judgment on the grounds that the Whiteners could not prove that the premature birth and birth defects were directly caused by any off-label promotion in which they may have engaged. The Whitener’s own doctor, Dr. McCrossen, provided the testimony the court needed to support the motion for summary judgment.

In Dr. McCrossen’s testimony, he stated unequivocally that the decision to prescribe metoclopramide was mad based on his “clinical experience” that the drug “works good to control nausea and vomiting associated with pregnancy.” He further testified that he had never spoken to a representative of the defendants regarding the drug, nor had he been given samples. To the best of his knowledge, no one in his practice had had contact with the defendants either.

Under the court’s Rule 47.5.4, this unpublished opinion is not precedent “except under the doctrine of res judicata…, etc. An unpublished opinion may be cited pursuant to Fed. R. App. P. 32.1(a).” This does not bode well for other plaintiffs with similar claims.

Sources:

Whitener v. Pliva, Inc.

Citing Unpublished Federal Appellate Opinions Issued Before 2007

FDA: AndroGel, Low-T Drugs Must Warn for Heart Attack

Posted in Androgel

On Tuesday March 3rd, the United States Food and Drug Administration required that manufacturers of testosterone supplements (or, Low-T drugs)  include warnings on packaging for the increased risk for heart attack and stroke linked to these drugs.

In years past, a great many peer-reviewed scientific studies had demonstrated that men using Low-T drugs were at dramatically higher risk for heart attack and stroke.  Finally, this work has led the FDA to require a warning label update.

Further, labels for Low-T drugs are now required to include warnings that the medication is approved only for men with specific medical ailments.  The popularity of Low-T drugs has soared in recent years, and many men never actually have testosterone levels checked before getting a prescription.  In this way, huge numbers of men use Low-T drugs to treat “symptoms” of normal aging, placing themselves at high risk for cardiac event without informed consent.

Reuters reported yesterday that “The number of men being prescribed testosterone jumped more than 75 percent, to 2.3 million, between 2009 and 2013” and “About 70 percent of these patients were between the ages of 40 and 64, the FDA said.”

Importantly, that report noted this FDA ruling about Low-T drugs “restricts companies from marketing or promoting their products for age-related low testosterone.”

Annual sales for Low-T drugs topped $2 billion last year, and AndroGel – a popular testosterone-infused gel by Abbvie and Abbott Laboratories – took in over $900 million in sales.

For more information on Low-T drugs and their link to both heart attack and stroke, click here.

Because many men used these drugs unaware of the risks associated, many Low-T lawsuits are currently being filed.  If you or a loved one used a Low-T drug and suffered an adverse cardiac event, you may be entitled to significant financial compensation.  For a free consultation, contact our team of testosterone lawyers today.  Or, find information on Low-T lawsuits here.

(855) 452-5529

justinian@dangerousdrugs.us

 

Here is the FDA Drug Safety Communication for Low-T:

“[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.]

[Posted 03/03/2015]

AUDIENCE: Health Professional, Endocrinology, Urology, Family Practice, Patient

ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.

Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. See the Data Summary section of the FDA Drug Safety Communication for additional details.

BACKGROUND: Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, orbrain that cause hypogonadism. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.

RECOMMENDATION: Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of the possible increased cardiovascular risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/03/2015 – Drug Safety Communication – FDA]”

Previous MedWatch Alert:

[01/31/2014 – Drug Safety Communication – FDA]

Actos Manufacturer to Pay Millions in Cancer Lawsuit Settlement

Posted in Actos & Bladder Cancer

Last week, the pharmaceutical company, Takeda, was ordered to pay $1.3 million in punitive damages to a former Philadelphia schoolteacher who “argued the drugmaker’s Actos diabetes medicine caused his bladder cancer”, Japan Times writes.

Only a few days earlier, that man was awarded over $2.3 million in compensatory damages.

According to that Japan Times article, this was the “fifth Actos patient to convince a jury that Takeda’s former top-selling drug causes bladder cancer. Last year, a federal jury in Louisiana ordered Takeda and Eli Lilly & Co., which at one time sold Actos in the U.S., to pay $9 billion in punitive damages to a shopkeeper who blamed his cancer on the drug. That award was cut to $36.8 million.”

So far, over 8,000 Actos lawsuits have been filed in the United States over the drug’s alleged undisclosed connection with increased risk for bladder cancer, and many of those cases have been consolidated before federal courts.

JT: “Takeda argued in court filings the company properly vetted the drug and included all required warnings on its safety label. It has battled former users’ claims in trials across the country starting in 2013.”

Bloomberg News explains that the Philadelphia schoolteacher was compensated $300,000 for medical expenses and $2 million for pain and suffering after Takeda “failed to properly warn [his] doctors about Actos’s cancer risks.”

Of course, this is still a relatively insignificant company for the largest drug company in Asia, generating $16 billion in revenue since the 1999 Actos release.

Bloomberg: “The Pennsylvania case is Kristufek v. Takeda Pharmaceuticals America Inc., Philadelphia Court of Common Pleas. The consolidated Actos case in Louisiana is In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette).”

2012 – 50% of IVC Filters Fail

Posted in IVC Filters

In 2012 the Journal of the American Medical Association published an article titled “Frequent Fracture of TrapEase Inferior Vena Cava Filters,” providing further insight into one serious side effect related to the use of IVC filters. Inferior vena cava (IVC) filters are small metal filters placed within the vena cava vein used to trap blood clots, stopping them from reaching the lungs, where potentially fatal pulmonary embolism may result.

Dr. Masaki Sano led a team of researchers from the Hamamatsu School of Medicine (Hamamatsu, Japan) and studied 20 IVC filter patients, following up with x-ray imaging periodically in the months following emplacement.

“Among the 20 patients (20 TrapEase IVCFs), 10 TrapEase IVCFs (50%) were fractured. Remarkably, 9 of the 14 filters (64%) that had been inserted for longer than 4 years revealed fractures”, researchers remarked. (emphasis added)

“Thrombus inside the filter was detected in 2 cases. None of the patients presented filter-related life-threatening adverse events such as cardiac tamponade or retroperitoneal hematoma.”

Due to the fact that many IVC filter manufacturers repeatedly failed to warn users of these and other risk linked to IVC filters, IVC filter lawsuits have recently been filed in great number.

If you or a loved one used an IVC filter in the treatment of deep vein thrombosis and suffered an IVC filter fracture or perforation, IVC migration, or another IVC filter side effect, you may be entitled to significant financial compensation through an IVC filter lawsuit.

For a free, no-obligation case consultation, contact our team of IVC filter lawyers at Justinian PLLC.  We have the compassion, experience, and resources required to win the compensation you deserve.  Call today and find out how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

If you have any questions or would like more information, see our IVC Filter Lawsuit Information Page, or give us a call.