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Dangerous Drugs & Medical Devices

News & Commentary on Prescription Drug & Medical Device Lawsuits

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.

IVC Filters: 86% Exhibit Serious Side Effects

Posted in IVC Filters

In 2012, a team of researchers from the Department of Radiology and Biomedical Imaging at the University of California, San Francisco published an article that illustrated some serious risks associated with the use of IVC filters.

Inferior vena cava filters are small metal filters inserted into the inferior vena cava vein, used in patients with deep vein thrombosis (DVT) to mechanically catch blood clots before they can reach the lungs and cause in pulmonary embolism.  Sometimes, these filters are implanted permanently, and sometimes IVC filters are implanted for a limited time, ranging from a few months to a year.

Unfortunately, IVC filters can prove difficult to remove, and research has shown that the longer an IVC filter stays in the inferior vena cava, the more likely it is to fail or cause dangerous side effects.  IVC side effects can include perforation (tearing) of the IVC vein or internal organ, IVC fracture and embolization (wherein the IVC filter breaks and travels through the blood to the heart or lungs, resulting in myriad – potentially deadly – health problems), and both tilting and migration of the device.

The team from UC San Francisco, led by JC Durack, studied 50 IVC filter patients with abdominal CT scans, and presented results of their study titled “Perforation of the IVC: rule rather than exception after longer indwelling times for the Günther Tulip and Celect retrievable filters.” in Cardiovascular and Interventional Radiology.

Durack et al. (2012) found “Perforation of at least one filter component through the IVC was observed in 43 of 50 (86%) filters on CT scans obtained between 1 and 880 days after filter placement.”

“All filters imaged after 71 days showed some degree of vena caval perforation, often as a progressive process. Filter tilt was seen in 20 of 50 (40%) filters, and all tilted filters also demonstrated vena caval perforation.”

As such, researchers concluded that “Longer indwelling times usually result in vena caval perforation by retrievable Günther Tulip and Celect IVC filters” and noted that side effects “from IVC filter components breaching the vena cava can be significant.”

Because of the high rate of IVC complications, the team suggests “filter retrieval as early as clinically indicated and increased attention to the appearance of IVC filters on all follow-up imaging studies.”

Due to the fact that many IVC filter manufacturers have failed time and again to adequately warn users of these risks, many IVC lawsuits are currently being filed, including one multidistrict litigation.

If you or a loved one used an IVC filter and suffered an adverse outcome, you may be entitled to significant financial compensation.  For a free, no-obligation IVC case consultation, contact our team of IVC lawyers at the information provided below.

We have the compassion, experience, and resources to win the compensation you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

If you have any questions about IVC filter lawsuits, see our IVC Filter Lawsuit Information page or give us a call.

Doctors urge blood testing with Xarelto, despite Bayer’s claim it’s unnecessary

Posted in Xarelto

In recent years, a new anticoagulant drug called Xarelto (rivaroxaban) has been found by the FDA to increase the risk for major bleeding events over other drugs in its class.  And unlike other drugs in its class, the manufacturer does not recommend regular blood testing, a simple procedure which can lower the risk for major bleeding events by 40%.  Here, we discuss one piece of research titled “New oral anticoagulants in the treatment of acute venous thromboembolism – a systematic review with indirect comparisons.” on risks associated with Xarelto by an Austrian research team, published in VASA (2014).

The team studied over 27,000 patients using a variety of anticoagulants and measured the risk for stroke and bleeding events, finding that “Regarding occurrence of the composite bleeding endpoint, apixaban performed better than all other NOACs and dabigatran better than rivaroxaban and edoxaban.”

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Xarelto lawsuits cite studies indicating higher risk for bleeding than Bayer reports

Posted in Xarelto

Titled “The potential role of anticoagulant therapy for the secondary prevention of ischemic events post-acute coronary syndrome”, a piece by A.C. Camuglia et al. (published in Current Medical Research and Opinion – August, 2014) from Royal Brisbane and Women’s Hospital and the University of Queensland (Queensland , Australia) reviews the safety of an anticoagulant drug called Xarelto.  Recently, a number of studies have indicated that this blood thinner carries a higher risk for major bleeding events than others in its class.

The team writes, “The use of dual antiplatelet therapy has led to a substantial reduction in ischemic events post-acute coronary syndrome (ACS). Despite this, recurrent event rates remain high. Recent research has combined antiplatelet with anticoagulant therapy to reduce recurrent event rates further”, noting that while “Compared with standard medical therapy, rivaroxaban demonstrated improved efficacy outcomes and significantly reduced mortality after an ACS. Although clear benefits of novel oral anticoagulants post-ACS have been proven, concerns regarding bleeding are still a barrier to widespread use.” (emphasis added)
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Study shows Xarelto carries higher risk for bleeding than industry standard

Posted in Xarelto

Here, we discuss a study titled “Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial.”, published in European Heart Journal this year by G. Breithardt and a team of German researchers.  This study aimed to further evaluate the safety of Xarelto (rivaroxaban), an anticoagulant drug linked to increased risk for major bleeding events.

[Click here to read safety communications regarding Xarelto from the FDA]

The team writes, “Among 14 171 patients, 2003 (14.1%) had [significant vascular disease (SVD)]; they were older and had more comorbidities than patients without SVD,” and “The rate of stroke or systemic embolism with rivaroxaban vs. warfarin was consistent among patients with SVD [2.01 vs. 2.43%; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.55-1.27] and without SVD (1.96 vs. 2.22%; HR 0.89, 95% CI 0.75-1.07; interaction P = 0.76).”

However, Breithardt et al. (2014) also found that “rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD (19.8% rivaroxaban vs. 16.8% warfarin; HR 1.25, 95% CI 1.05-1.49) vs. those without (14.2% rivaroxaban vs. 14.1% warfarin; HR 1.01, 95% CI 0.94-1.10; interaction P = 0.034), even when controlling for risk factors and potential confounders.” (emphasis added)

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2014 – Researchers Cite Xarelto Bleeding Risk

Posted in Xarelto

Recently, studies have shown that the anticoagulant drug Xarelto (rivaroxaban) is linked to a dramatically increased risk for major bleeding events compared to other drugs in its class.  Here, we discuss one such piece of research, titled “New oral anticoagulants in acute coronary syndrome: is there any advantage over existing treatments?”, published in the September, 2014 edition of International Cardiovascular Research Journal by a team of Italian researchers led by A. Messori.

This team states that their study “re-examined the studies published thus far on this topic to evaluate the effectiveness of dual antiplatelet therapy in comparison to some of these new approaches (mainly, ticagrelor + aspirin and dual therapy plus a new oral anticoagulant [NOAC]; i.e., “triple therapy”).”  To perform this study, the team evaluated and analyzed a number of previously-conducted studies with statistics to get a better overall picture of this risks and benefits of anticoagulant use.
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