Ennis & Ennis, P.A. Blog

A Conflicted FDA Panel, Bayer & Birth Control Pills

J Murawski — 2012-01-12T01:17:07Z

- Pharmalot

01/11/2012 - Last month, an FDA advisory committee voted 15-to-11 that the benefits of the Yaz and Yasmin birth control pills outweigh the risks, and so the drugs should remain on the market, albeit with added information about the risk of blood clots. The decision followed a long-running controversy - studies by Bayer, which sells the pills, found there is no risk, while other studies say the risk is evident.

However, four of the panel members held ties to Bayer - either as paid consultants or in the form of research funding - but the FDA did not disclose those conflicts. Attorneys for women who are suing Bayer had attempted to publicize the connections last fall, but were prevented from doing so because the information was contained in documents that were deemed to be confidential .

The episode underscores ongoing concern over agency handling of advisory panels and conflicted members. As noted in The Washington Monthly, which writes about the Yaz and Yasmin panel conflicts in great detail, a similar controversy occurred in 2004 when conflicted FDA panel members were more likely than those without conflicts to vote that the Vioxx painkiller was safe and should remain on the market.

In recent months, agency officials - including FDA commish Margaret Hamburg - have complained about a paucity of qualified experts to serve on panels who do not hold some type of conflict in a bid to loosen regulations. Meanwhile, though, panel vacancy rates have remained low and conflict of interest waivers granted have remained below target, suggesting the agency has not having as much difficulty finding qualified experts as officials maintain.

Ironically, the FDA did yank Sid Wolfe of Public Citizen Health Research Group from its Risk Management Advisory Committee - one of two advisory panels that were convened last month to review the Bayer pills - over an alleged ‘intellectual conflict of interest.’ Specifically, the agency cited a newsletter called ‘Worst Pills, Best Pills News’ and the WorstPills web site, in which the group has labeled both pills as ‘do not use’.

At the same time, the FDA did not provide the panel with a report by former FDA commish David Kessler - and who now serves as an expert witness for plaintiffs in the sprawling Yaz and Yasmin litigation - in which he offered a scathing expert opinion that the drugmaker wrongfully withheld safety information from the FDA after reviewing internal Bayer documents (you can read his report here). The report was unsealed prior to the advisory committee meeting last month, but became available after the deadline for submitting documents to the agency for use at the meeting, according to the FDA.

The lawsuits allege that Yaz and Yasmin have risks beyond those of traditional birth control pills and Bayer too aggressively promoted the pills without disclosing those higher risks. Earlier this year, a pair of studies found that women taking birth control pills containing drospirenone are more likely to develop blood clots than those who take an older oral contraceptive .

The FDA panel last month voted 21-to-5 to change the labeling on the pills to warn that drospirenone can cause blood clots. But as The Washington Monthly notes, “the panel stopped short of recommending that the labels should warn the pills are more likely than other contraceptive pills to cause blood clots. Instead, the panel suggested the labels say the evidence about blood clots is conflicting.”

So who were the conflicted panelists? Here is what the magazine writes: The acting chair, Julia Johnson, a professor of obstetrics and gynecology at the University of Massachusetts Medical School, conducted four clinical trials - including one of drospirenone as hormone replacement - for Bayer (look here). In an e-mail to the magazine, she wrote “the FDA is very vigilant on examining potential conflicts of interest and was aware of all my research,” but would not say anything else. “The US FDA states that I cannot speak about the meeting.”

Then there was Paula Hillard, a professor of obstetrics and gynecology at Stanford School of Medicine who has served as a paid consultant to Bayer Schering (see this). She tells the magazine she complied with all FDA disclosures, but referred questions to the FDA, which declined to respond by citing the confidentiality clause of the Ethics in Government Act.

There was also Elizabeth Raymond, a senior medical associate at Gynuity Health Projects in New York, who conducted studies funded by Barr, which has a licensing agreement with Bayer for generic versions of Yaz (look here). She tells the mag the the FDA was “fully aware of all of my relevant current and past activities.”

And Anne Burke, an assistant professor of gynecology and obstetrics at Johns Hopkins University in Baltimore, has received research funding from Bayer-Berlex and Duramed, which has a licensing agreement with Bayer for generic Yaz and Yasmin (take a peek). She also maintained that she fully disclosed this to the agency. However, when asked if the FDA was aware of the conflicts, an agency spokeswoman would only tell the magazine that no waivers were issued.

Another panel member confirmed to the magazine that he received consulting fees from a law firm representing Bayer in 2006, but did not disclose the information to the FDA because the FDA “did not require information for that time frame for consulting unrelated to the meeting topic,” the magazine writes.

“The Yaz case puts FDA’s feckless ethics policy into stark relief. It also reveals the human impact of conflicts of interest and why we need an FDA that shuns even the appearance of such conflicts,” Danielle Brian, executive director of the Project On Government Oversight, tells the mag. “Right now, the bar for considering whether an advisor has a conflict is too high.”

The litigation, which was to have begun this month, was postponed by a federal judge in favor of mediation

Yaz Birth Control Pill Lawsuit Information::

If you or a loved one have suffered serious yaz side effects, injury or death while using Yaz you may be entitled to compensation. Contact the yaz side effects lawyers of Ennis & Ennis, P.A. today for a free nationwide case evaluation. Our experienced Yaz attorneys can answer any questions you may have about Yaz side effects or a potential Yaz lawsuit. Fill out the case evaluation form at ennislaw.com or call toll free: 1.800.856.6405.

Under no circumstances should you discontinue taking any medication, including Yaz or one the generic versions, without first consulting with your doctor.

Propecia - Finastride Side Effects - Sexual Dysfunction Lawsuit News: Hair-Loss Drugs Blamed for Multiple Problems

J Murawski — 2012-01-12T01:12:48Z

- Courthouse News Service

01/11/2012 - A man who took the male pattern baldness drug Propecia for four years claims it gave him "severe sexual dysfunction and cognitive impairment."
Jason McCord sued Merck & Co. in Federal Court.

Merck has been sued at least 15 times in the past two years for similar claims, according to the Courthouse News database.

McCord says he was 36 when he was prescribed Propecia, in 2006, and he took it for four years. He says the trade-off wasn't worth it.

"Male pattern hair loss affects 30 percent of men by the age of 30 years and 50 percent of men by the age of 50 years. Men who suffer from hair loss may be perceived as older and less physically and socially attractive," according to the complaint.

"Male pattern hair loss is a common condition thought to be caused by a combination of genetic factors and a hormone called dihydrotestosterone ('DHT').

"DHT is a substance in the body that can shrink hair follicles until a person no longer has hair on top of his head.

"Finasteride is a 5-alpha reductase inhibitor that decreases the conversion of testosterone to DHT, therefore, preventing hair loss.

"Propecia, or finasteride, may produce undesirable side effects to patients who use the prescription drug, including but not limited to, sexual dysfunction and cognitive impairment.

"The rates of the sexual dysfunction as a result of finasteride are reported to be as high as 39 percent in published clinical studies. In addition, it has been reported in 2003 that only 50 percent of patients experience resolution of their sexual function adverse events after discontinuation of finasteride."

The U.S. FDA approved Propecia for hair loss in 1997 and more than one million people have taken it by prescription, McCord says.

Before he took the drug, McCord says, he "did not suffer from sexual dysfunctions or cognitive impairment. However, while consuming Propecia, plaintiff began to suffer severe sexual dysfunction and cognitive impairment. Plaintiff's adverse effects continued after Plaintiff discontinued using Propecia."

He claims: "Defendants knew or should have known that Propecia, when taken as prescribed and intended, causes and contributes to an increased risk of persistent and/or permanent serious and dangerous side effects including, without limitation, cognitive impairment, development of depression, and various forms of sexual dysfunction such as erectile dysfunction, reduced ejaculate volume, diminished or reduced libido, reduced sexual sensation and/or infertility ('sexual dysfunction') even after discontinuation of use."

Defendants Merck & Co. and Merck Sharpe & Dohme sell their 1-milligram tablet of finasteride as Propecia.

Finasteride was first approved by the FDA in 1992, for treatment of benign prostatic hyperplasia, or enlarged prostate, according to the complaint. It was marketed then as Proscar.

In 2009, Swedish researchers concluded that Propecia could cause permanent erectile dysfunction, McCord says. That led to warnings on Propecia labels in several European countries, including the United Kingdom and Italy.

"According to the FDA's website, defendants have updated the Propecia label in the United States nine times since introducing the drug into the market, and none of the label revisions have included a warning regarding persistent and/or permanent sexual dysfunction in patients that discontinued use of the prescription drug," the complaint states.

"In April of 2011, defendants updated its 'Patient Information about Propecia' insert to indicate patients have reported 'difficulty in achieving an erection that continued after stopping the medication.' Upon information and belief, defendants' updated insert is the first warning it gave to patients in the U.S. regarding persistent and/or permanent sexual dysfunction after discontinuation of use.

"Upon information and belief, the Propecia label distributed in the United States continues to fail to warn users of persistent and/or permanent sexual dysfunction and cognitive impairment after discontinuation of use."

McCord says he has "suffered significant pain and suffering, and his quality of life has severely diminished."

He seeks damages for strict liability, negligence, breach of implied warranties, breach of express warranty, fraudulent concealment, unfair and deceptive trade, and negligent infliction of emotional distress.

Neither the law firm nor Merck immediately responded to requests for comment.

Propecia Sexual Side Effects Lawsuit

If you or a loved one have experienced Propecia sexual side effects such as low libido, erectile dysfunction or decreased sexual arousal you may be entitled to compensation. Our Propecia Erectile Dysfunction Lawyers are currently accepting Propecia Sexual Side Effects cases nationwide. For more information about the Propecia side effects lawsuit or to file your Propecia Sexual Dysfunction Lawsuit fill out the free case evaluation form at ennislaw.com or call our Propecia Attorneys toll-free at: 1.800.856.6405 for a free Propecia Sexual Dysfunction Lawsuit evaluation.

Scripps doctors defend Plavix test for coronary stent patients

J Murawski — 2012-01-12T01:04:40Z

- North County Times

01/11/2012 - There's no need to perform a certain genetic test before deciding whether to prescribe the anti-clotting drug clopidogrel (Plavix), according to a new study published in the Journal of the American Medical Association.

However, doctors at Scripps Health who have pioneered the use of this test say Plavix testing is indeed helpful in preventing heart attacks and deaths in coronary stent patients, and that the JAMA study is flawed.

Who's right is a matter of extreme interest to the estimated 1 million patients who get coronary stents each year in the United States, including this reporter, who got five of them in August 2010. But for patients, there's no obvious answer, in part because the answer hinges on what question you ask. Is the Plavix test useful for all heart patients, or just for those getting coronary stents? That's something you and your doctor will need to decide.

Plavix inhibits the clumping of platelets, blood-cell fragments that start the clotting process. The Plavix test screens patients for a gene variant, or genotype, called CYP2C19. This genotype is known to be less responsive to Plavix's anti-clotting effect.

Patients with this genotype are at higher risk of stent thrombosis, the formation of a blood clot in their stent, said cardiologist Matthew Price, director of the Cardiac Catheterization Laboratory at Scripps Green Hospital.

Since stent thrombosis is extremely serious, Scripps tests patients for this genotype before coronary stents, which hold blood vessels open, are implanted. Patients with the genotype can be placed on a stronger antiplatelet drug, Price said.

The JAMA article said the study found no "clinically significant" relationship between the genotype, Plavix therapy and cardiovascular problems.

That study included an analysis of other studies, or a meta-analysis, which the authors said provided firm evidence that there was no need for routine testing. The potential association with stent thrombosis was found in studies with small numbers of patients and may have been subject to biases, the JAMA article stated.

An accompanying editorial in the magazine suggested that the genotype test was an example of "irrational exuberance" for genetically personalized medicine. The editorial recommended trying a larger-scale study of the genotype test for coronary stent patients to see whether the weak association detected was real or coincidence.

"In the absence of such a study, physicians should use CYP2C19 or platelet reactivity testing rarely, if ever, and interpret the results with caution," stated the editorial by Steven E. Nissen, a cardiologist with the Cleveland Clinic Foundation. "It is still likely that pharmacogenomics has a bright future in cardiovascular medicine, but the pharmacogenomics approach to drug therapy must undergo the same rigorous testing for efficacy and cost-effectiveness that is required for other therapies. Overzealous adoption based on limited biochemical data does not serve the public interest."

Scripps's Price said the study cast too wide a net by considering all cardiovascular disease, losing focus on the proven association between the genotype and coronary stenting. Since stent-associated clots are so serious, he said, even a small increase in them should be avoided.

"The analysis includes a large number of patients from trials that had nothing to do with coronary stenting," wrote Price and Scripps cardiologist colleagues Eric Topol and Paul Teirstein, along with other doctors, in a response to the JAMA study.

A more formal response to be published in JAMA is in the works, Price said.

The study itself showed that among patients receiving coronary stents, there was an extra 14 per 1,000 increase in stent thrombosis among those with the genotype, compared with those who didn't have it, the Scripps doctors' response stated. "With over 1 million patients undergoing coronary stenting per year in the United States, this extrapolates to over 14,000 stent thrombosis events per year."

Clotting from a stent "is almost a purely platelet-driven issue," Price said. So it makes sense that patients receiving coronary stents would be the most at risk of a stent clot associated with a reduced response to Plavix. Studies that examined outcomes of patients in whom Plavix was used in other conditions, such as atrial fibrillation, wouldn't be pertinent to this issue, he said.

Preventing stent thrombosis is extremely important because the event is so serious, Price said.

"It is an important public health problem," Price said. "It shows up either as a big heart attack or you drop dead."

Plavix Side Effects Lawsuit::

Plavix Attorney Taking Plavix Side Effects Cases

If you or a loved one have experienced Plavix Side Effects you may be entitled to compensation. Contact the Plavix attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Plavix side effects, a possible Plavix class action lawsuit, or any other type of Plavix litigation. Call us toll-free at: 1.800.856.6405 or fill out the free case evaluation form at ennislaw.com

FDA Requires Transvaginal Mesh Makers to Study Risks: Ennis & Ennis, P.A. explains the FDA’s Order to manufacturers of transvaginal mesh devices requiring safety studies to be conducted on the devices used to treat pelvic organ prolapse and stress urina

J Murawski — 2012-01-10T23:58:50Z

- Ennis & Ennis

01/09/2012 - On January 3, 2012, the U.S. Food and Drug Administration (FDA) mandated postmarket surveillance studies be performed by manufacturers of urogynecologic surgical mesh devices. The FDA issued 88 postmarket study orders to 33 manufacturers of transvaginal mesh for pelvic organ prolapse (POP) and 11 postmarket study orders to seven manufacturers of mesh mini-slings for stress urinary incontinence (SUI). “These are studies that should have been conducted before the devices were approved by the FDA,” commented attorney Holly Ennis of Ennis & Ennis, P.A.

The manufacturers, which include American Medical Systems, Inc., C.R. Bard, and Johnson & Johnson, are required to submit study plans to the FDA that address specific safety and effectiveness concerns related to the surgical mesh devices. Data from the studies will enable the FDA to better understand the safety and effectiveness profiles of these devices.

This Order follows years of reports of serious injuries associated with the devices such as vaginal mesh erosion, pain, painful sexual intercourse, infection, urinary problems, bleeding, organ perforation, recurrent prolapse, neuro-muscular problems and vaginal scarring. Additionally, an FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products.

In 2010, about 185,000 women underwent procedures in which mesh was implanted vaginally to treat urinary incontinence, according to The New York Times. That same year, researchers reported in a medical journal that about 15 percent of the women treated with vaginal mesh experienced potential complications. The study, which appeared in the journal Obstetrics and Gynecology, also concluded that mesh did not provide greater benefits than the traditional surgical treatment in which a patient’s own ligaments are used to strengthen the vaginal wall.

According to a Safety Communication dated July 13, 2011, the FDA has already identified surgical mesh placed transvaginally for POP repair as an “area of continuing serious concern,” as it is unclear that “transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

The FDA approved of these devices under the controversial 510(k) approval process, which allows devices to be cleared for market, without any studies performed on patients, as long as they are “substantially equivalent” to existing products.

On November 21, 2011, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) issued a Joint Committee Opinion opining that due to the concerns about the safety and efficacy of the use of transvaginal mesh to treat pelvic organ prolapse (POP), it should be reserved for high-risk women for whom the benefit may justify the risk.

In September 2011, an advisory panel recommended the FDA reclassify the mesh as “high-risk” devices that require human testing. Despite this request and study findings, the FDA has yet to make that decision.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Remember the law limits the time in which a claim can be filed, so don't wait.

Vaginal Mesh Implant Lawsuit

If you or a loved one have suffered or been injured from a defective transvaginal mesh sling you may be entitled to compensation. Contact the vaginal mesh sling attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding your transvaginal mesh sling injury a possible class action lawsuit, or any other type of vaginal mesh litigation. Call us toll-free at: 1.800.856.6405 or fill out the free case evaluation form on this page.

Bard Avaulta Transvaginal Mesh Implant Lawsuit Information::

Gynecare Prolift Pelvic Floor Repair System Lawsuit Information::

Ennis & Ennis, P.A. is also investigating cases involving: Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, Yaz, Yasmin and Ocella Birth Control Pills.

Health warning: Women's pelvic mesh linked to infection

J Murawski — 2012-01-07T03:27:53Z

- Digital Journal

01/06/2012 - The FDA has issued a warning, on Jan 5, about post-surgical health risks for women who receive a type of surgical mesh, in relation to pelvic problems. The meshes are produced by many leading medical device manufacturers.

The U.S. Food and Drug Administration (FDA) have instructed medical device manufacturers to examine safety complications in relation to a type of surgical mesh which is widely used to repair women's pelvic problems. According to Reuters the FDA received over 1,500 reports of complications related to the use of such meshes between 2008 to 2010, and that the level of complaints has risen throughout 2011. Although surgical meshes have been used for many years for different types of surgery, the application of meshes for pelvic operations is relatively new.

Due to a series of concerns the FDA has instructed some thirty-three manufacturers of medical meshes to undertake retrospective safety studies and for these reports to be submitted back to the FDA for evaluation. The manufacturers required to undertake further analysis include Johnson & Johnson, Boston Scientific Corporation, and CR Bard Inc.

The surgical meshes are manufactured from either synthetic or biological materials. The meshes are implanted in women to repair weakened or damaged tissue as an alternative to conventional stitches. Surgical pelvic mesh products provide support for a woman’s organs in the pelvis, which may drop, fall, or protrude (prolapse) due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. The devices also support the woman’s body in cases of pelvic organ prolapse and stress urinary incontinence as part of urogynecologic procedures.

The latest FDA request follows a previous inquiry by the agency. This study, from 2011, revealed that women who have had a type of surgical mesh implanted to support their reproductive organs are actually at an enhanced risk of pain, bleeding and infection compared to women who have undergone traditional surgery with stitches.

Star Tribune Business stated that the consequence of the FDA action is that the mesh may be reclassified as a high-risk device. The change in classification would require manufacturers to perform a comprehensive product safety test before release. This will take time and cost the manufacturers far more in development and manufacturing expenses.

The Boston Globe speculates that the FDA notification will lead to a flurry of lawsuits, especially if it is proven that adequate safety tests were not carried out.

Vaginal Mesh Implant Lawsuit

Bard Avaulta Transvaginal Mesh Implant Lawsuit Information::

Gynecare Prolift Pelvic Floor Repair System Lawsuit Information::

Yaz Birth Control Case Ordered to Mediation

J Murawski — 2012-01-07T03:24:43Z

- Ennis & Ennis

01/06/2012 - The first Yaz pulmonary embolism lawsuit that was scheduled to begin trial January 9, 2012 will not begin as planned. The Honorable David Herndon, who is the presiding judge on many Bayer birth control pill lawsuits, ordered the case to mediation. http://www.ilsd.uscourts.gov/Documents/mdl2100/Order53.pdf. “This is a good sign for both parties to begin the process of a global resolution to the litigation,” commented attorney Holly Ennis of Ennis & Ennis, P.A.

Currently there are thousands of lawsuits wherein women allege that Bayer failed to warn of increased risk of blood clots with birth control pills Yaz, Yasmin and Ocella. These lawsuits also allege that Bayer company officials wrongfully touted Yaz to be just a safe as other birth control pills and promoted the drug for uses not approved by the U.S. Food and Drug Administration (FDA). http://www.ilsd.uscourts.gov/mdl/mdl2100.aspx

A large number of these Yaz claims are filed in a federal multidistrict litigation (MDL) in the Southern District of Illinois wherein Judge Herndon hears all of the claims. This allows attorneys to gather necessary evidence for multiple cases simultaneously and avoids document duplications and inconsistent rulings. From these cases, one case in particular, Kerry Sims v. Bayer, was scheduled to begin trial, but will be mediated instead.

Judge Herndon appointed a Special Master, Stephen Saltzburg, a George Washington law professor, to mediate the Sims case. The Order states, “…the interests of this litigation, plaintiffs and defendants, will be better served by an alternative plan.” http://www.ilsd.uscourts.gov/Documents/mdl2100/Order53.pdf.

Attorney Holly Ennis recommends that women who have taken Yaz or Yasmin and experienced blood clots, pulmonary embolisms, deep vein thrombosis, stroke or gallbladder disease should fill out a MedWatch Form at www.fda.gov and obtain the opinion of an experienced Yaz lawyer to explore their legal rights. Ennis & Ennis, P.A. has been investigating Yaz and Yasmin side effect cases since 2009.

Ennis & Ennis P.A. continues to offer free, nationwide, confidential consultations for women who have suffered Yaz and Yasmin side effects by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving: Accutane, Actos, Avandia, Fosamax, Plavix, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Wright Conserve Hips, Wright Profemur Hips, Depakote, Reglan, SJS/Dilantin, Transvaginal Mesh Devices, Yaz, Yasmin and Ocella Birth Control Pills.

Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights.

Yaz / Yasmin / Ocella Lawsuit News Archive::

Under no circumstances should you discontinue taking any medication, including Yaz or one the generic versions, without first consulting with your doctor.

The FDA orders Johnson & Johnson, C.R. Bard and 31 other companies to take another look at complication rates associated with their transvaginal mesh implants.

J Murawski — 2012-01-07T03:20:00Z

FDA probes JNJ, Bard and others on transvaginal mesh risks

- Mass Device

01/06/2012 - As public pressure mounts over the potential harm caused by transvaginal mesh implants the FDA ordered device makers, including Johnson & Johnson and C.R. Bard , to take another look at complication rates associated with their devices.

The watchdog agency asked a total of 33 companies to conduct 3 years of safety and effectiveness trials under growing concerns after deaths and injuries linked to the products spiked in recent years.

The moves follow citizens' petitions, multi-district lawsuits and FDA panel meetings surrounding the implants, which were catalyzed by warnings issued in July, that the surgical mesh may pose unnecessary risk to women without adding clinical benefit.

During the Sept. 2010 FDA panel meetings, mesh makers including Johnson & Johnson and Endo Pharmaceuticals Holdings Inc. (NSDQ:ENDP), agreed that more safety studies and labeling changes might help warn patients and doctors of potential risks. The watchdog agency asked Endo to conduct new studies for its vaginal mesh products.

The FDA is now asking manufacturers to collect and review all existing data on the safety and efficacy of the devices, and the agency mandated 88 postmarket surveillance studies between the 33 companies, according to an FDA update.

The watchdog agency added that it's still considering bumping the mesh from a Class II to a the higher-risk Class III device category, a move that was also discussed in the Sept. meeting.

Late last month 3 U.S. Senators probed Bard on its management of the clamor surrounding its transvaginal mesh devices as part of a larger investigation into medical device recalls, including for Medtronic's 2007 Sprint Fidelis recall and Zimmer Holdings for its NexGen knee implant.

Transvaginal mesh is used to treat pelvic organ prolapse, which occurs when internal support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagina.

"There are clear risks associated with the transvaginal placement of mesh to treat POP," said Dr. William Maisel, deputy director and chief scientist of the FDA's Center for Devices & Radiological Health, in an agency release in July. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant – complete removal may not be possible and may not result in complete resolution of complications."

From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, 5 times as many as the agency received from 2005 to 2007, according to the release.

In the mean time, lawsuits have piled up against multiple mesh makers, and patient advocacy groups have called for a mandated recall after an internal FDA research group recommended that additional clinical testing be required for new transvaginal mesh products.

The FDA isn't likely to enforce a recall, Maisel told Bloomberg.

"There's strong support in the clinical community that mesh serves a role for certain patients," Maisel said. "Our goal is not to completely remove these products from the market."

Wall Street didn't seem to pay much notice, with share prices for JNJ, BCR and fellow mesh-maker Boston Scientific each losing less than 1% in value since the watchdog agency released its mandate yesterday.

Representatives for Johnson & Johnson subsidiary Ethicon Endosurgery and C.R. Bard did not return requests for comment.

Vaginal Mesh Implant Lawsuit

Bard Avaulta Transvaginal Mesh Implant Lawsuit Information::

Gynecare Prolift Pelvic Floor Repair System Lawsuit Information::

Federal Actos Lawsuits Consolidated to Single Judge in Louisiana

J Murawski — 2012-01-05T01:57:03Z

- Ennis & Ennis

01/04/2012 - On December 28, 2011, the U.S. District Court for the Western District of Louisiana consented to the assignment of all federal Actos cases to Honorable Rebecca F. Doherty. As a result, more than 100 cases will be transferred to the Western District of Louisiana at this time. “I have no doubt this number will increase significantly because consumers are still learning of the link between Actos and bladder cancer,” commented attorney David Ennis of Ennis & Ennis, P.A.

In August, Plaintiffs with pending lawsuits against Japanese company Takeda Pharmaceuticals America Inc. (Takeda), the manufacturer of Actos, filed a motion to transfer 11 pending actions, and all subsequent Actos injury actions, to a single judge for pretrial proceedings. The consolidation avoids document duplications and inconsistent rulings, while also potentially saving on expert testimony.

Actos, with pioglitazone as its sole ingredient, has been linked to increased risk of bladder cancer. In June the U.S. Food and Drug Administration (FDA) required added warnings on the Actos label indicating that the medication may increase the risk of bladder cancer (bladder tumors) when taken for more than a year. Additionally, the newly updated drug label also recommends that healthcare providers should not use pioglitazone in patients with active bladder cancer and should use pioglitazone with caution in patients with a prior history of bladder cancer. (http://www.fda.gov/Drugs/DrugSafety/ucm266555.htm)

Takeda and Eli Lilly & Company jointly promoted Actos in the United States since its launch in 1999; however as of 2006, Takeda solely assumed all marketing and sales responsibilities for Actos. “In 2008, with the knowledge of the risk associated with developing bladder cancer while using Actos long term, Takeda achieved its marketing goal by making Actos the tenth best-selling medication in the U.S., all while placing American citizens utilizing Actos at risk of developing bladder cancer,” the lawsuits allege. Furthermore, in the fiscal year ending March 31, 2010, Actos had sales of $4.6 billion, making it Takeda’s best selling drug, according to Business Week.

For those who take Actos, bladder cancer symptoms may include: blood in urine, painful urination, frequent small amounts of urination, frequent urinary tract infections, lower back pain, and abdominal back pain.

If you or a loved one has suffered from bladder cancer or bladder tumors after taking Actos, complete a MedWatch Form at www.fda.gov so that the FDA is aware of the adverse event. Then seek the opinion of an experienced lawyer to explore your legal rights.

Ennis & Ennis P.A. is offering free nationwide confidential consultations for patients who are taking or have taken Actos, Actoplus or Duetact and suffer these symptoms by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Avandia, Fosamax, Transvaginal Mesh Devices, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills.

Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights.

More Actos Bladder Cancer Lawsuit News::

If you have taken Actos and experienced serious Actos side effects such as Actos Bladder Cancer call our Actos lawyer today to find out about an Actos lawsuit. With offices in Washington D.C. and throughout Florida we are ready to help Actos side effects victims nationwide. Let our Actos Attorneys evaluate your case for free today. Fill out our online case evaluation form at ennislaw.com or call us toll free at: 1.800.856.6405 for your free, confidential case evaluation.

Under no circumstances should you discontinue taking any medication, including Actos or Pioglitazone, without first consulting with your doctor.

Actos Bladder Cancer Side Effects Lawsuit Information::

Plavix Study Halted by Higher Rate of Bleeding and Death

J Murawski — 2012-01-05T01:53:30Z

- Ennis & Ennis

01/04/2012 - A recent study conducted by the National Institute of Neurological Disorders (NINDS) to determine if Plavix-aspirin therapy could prevent recurring strokes in people who had recently suffered subcortical strokes was halted after patients on Plavix-aspirin therapy suffered a higher-than-expected number of bleeding events compared to subjects taking aspirin alone. The Plavix-Aspirin arm involved 3,000 patients.

The Wall Street Journal stated that patients in the study treated with the Plavix-aspirin combo also suffered a higher death rate compared to those on aspirin only.

According to the Journal, 6.5% of patients on Plavix-aspirin therapy combination experienced a bleeding event, versus 3.3% of those on aspirin alone. The death rate among people in the combo therapy group was 5.8% versus 4.1% in the aspirin-only group.

In addition to the higher bleeding and death rates, the Plavix-aspirin arm of the study was unable to demonstrate that combo therapy provided any additional benefit in preventing strokes.

According to the Journal, the arm of the SPS3 study testing whether blood-pressure medications can prevent strokes and cognitive decline will continue.

Plavix Side Effects Lawsuit::

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Plavix Attorney Taking Plavix Side Effects Cases

"Vaginal Mesh Surgery Poses Greater Risks than Benefits", Warns FDA

J Murawski — 2012-01-05T01:48:39Z

- Brunei FM!

01/04/2012 - Adult women all over the world are familiar with vaginal mesh implantation for the repair of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). Originally, it was considered as the best treatment for these conditions. But recently, vaginal mesh lawsuits have multiplied all over the United States after complaints of deadly complications brought by the implantation of vaginal mesh started to appear and increase at a fast pace.

In 2010, there were over 100,000 procedures involving surgical mesh, and75 percent of these were implanted vaginally.

On October 20, 2008 the U.S. Food and Drug Administration (FDA) first issued safety information on vaginal mesh because of the many adverse effects related to it. 1500 cases of adverse events caused by vaginal mesh were reported to the FDA in a span of two years from 2008 to 2010, five times greater than in 2005 to 2007.

The mostly reported complications related to vaginal mesh surgery include mesh erosion, development of infections, bleeding, recurrence of prolapse, pelvic organ perforation, and voiding difficulties. Out of these, the most common is mesh erosion, and has the tendency to prompt the development of other complications. A study on October 2010 was discontinued since 15 percent of its participants developed mesh erosions during the study. Moreover, mesh erosion is the most difficult to deal with since it requires multiple operations to repair; and most often, mesh erosions are impossible to correct.

According to the FDA, vaginal mesh procedures expose patients to deadly complications. In comparison to other non-mesh procedures, the benefits of vaginal mesh are not well-defined. The agency also asks gynecologists and urologists to consider non-mesh procedures to treat POP and SUI patients, and only administering vaginal mesh procedures to patients who will gain more benefit from it than complications.
The FDA further proposed that special training on vaginal mesh placement should be completed by surgeons, symptoms on possible complications during and after the procedure should be watched carefully, and patients should be well-informed on the potential risks of this procedure.

The number of vaginal-mesh-related complications continue to grow despite the fact that vaginal mesh FDA warning was first announced in 2008. This may be related to the continuous availability of these products in health care facilities; as there are still many manufacturers producing them making more and more physicians use their products and continue practicing vaginal mesh surgeries in hospitals or their own clinics. While it is the doctors’ responsibility to keep their patients safe, it is also important for the patients to make themselves aware about the safety and efficacy of the use of vaginal mesh.

Bard Avaulta Transvaginal Mesh Implant Lawsuit Information::

Gynecare Prolift Pelvic Floor Repair System Lawsuit Information::

FDA Orders Studies for J&J Vaginal Mesh Implants

J Murawski — 2012-01-05T01:45:48Z

- Bloomberg

01/04/2012 - U.S. regulators ordered Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) to study rates of organ damage, infection and painful sex linked to vaginal mesh implants, reacting to doctors and patients who say the devices have harmed women.

The Food and Drug Administration wrote J&J, C.R. Bard and 31 other manufacturers yesterday, asking them to collect as much as three years of data on the safety and effectiveness of the implants, the agency’s William Maisel said today in a telephone interview. That followed an FDA report in July that found a fivefold jump in deaths, injuries or malfunctions linked to some of the products.

Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates. The devices’ alleged failures have spurred more than 650 lawsuits against manufacturers, as well as heightened scrutiny of the FDA program that cleared meshes for sale without human testing.

“We believe there are certain uses of mesh where we need additional data to help guide the clinical community,” said Maisel, deputy director of science for the FDA’s device-approval center. “Our goal is to make sure the right women use it at the right time.”
J&J, the biggest maker of vaginal mesh, fell (JNJ) less than 1 percent to $65.48 at the close in New York. C.R. Bard also declined (BCR) less than 1 percent to $86.08. J&J is based in New Brunswick, New Jersey, and Bard in Murray Hill, New Jersey.

Threaded in Place

The letters ask each manufacturer to collect data on the results of transvaginal procedures, in which the hammock-like meshes are threaded in place through an incision in the vagina. The FDA said in July that it wasn’t clear from available studies whether the devices provided any benefit over older methods in many cases.

The requests also went to companies including Endo Pharmaceuticals Holding Inc. (ENDP) of Chadds Ford, Pennsylvania, and Boston Scientific Corp. (BSX), based in Natick, Massachusetts. The companies have 30 days to respond.

The meshes were approved through the FDA’s 510(k) system, which allows products to reach the market without human testing if the agency decides they’re similar to devices already for sale. In October, Bloomberg News reported many implants can trace their approvals back to a Boston Scientific mesh recalled for safety problems in 1999.

Patient Advocate

“Now these companies are going to have to tell the truth,” said Lana Keeton, the Austin, Texas, founder of Truth In Medicine, an advocacy group for mesh patients. Keeton sued J&J over injuries she blamed on a 2001 implant. The case was dismissed by a federal judge in 2007.

While companies say the devices are safe, “up until now, there’s been no data, there’s no denominator to glean that from,” said Keeton, who has also worked as a paid consultant for attorneys suing mesh makers. “It’s just been marketing.”

Matthew Johnson, a spokesman for J&J’s Ethicon unit that makes the devices, said the company was reviewing the correspondence from the FDA.

“Ethicon’s transvaginal mesh devices are already among the most studied devices on the market, and we will continue to support their use in surgical repair with clinical evidence, through investigator-initiated and company-sponsored trials,” he said in an e-mail.

Kevin Wiggins from Endo Pharmaceuticals and Eric Olson from Boston Scientific didn’t immediately return phone calls seeking comment. Messages also weren’t immediately returned by Scott Lowry, a Bard spokesman.

Advisory Panel

The edges of mesh fibers can constrict or cut into internal organs after they’ve been implanted, studies have found. The procedure is also prone to infection because the vagina through which the devices are inserted isn’t a sterile environment, said Clifford Wheeless, an emeritus associate gynecology professor at Johns Hopkins University School of Medicine, in a telephone interview last year.

In September, an advisory panel recommended the FDA reclassify mesh used for pelvic organ prolapse, a condition in which weakened muscles fail to support internal organs, as “high-risk” devices that require human testing. The FDA hasn’t made a decision yet, Maisel said today. He said the agency also isn’t likely to heed the call of some patient advocates for a complete recall.

“There’s strong support in the clinical community that mesh serves a role for certain patients,” he said. “Our goal is not to completely remove these products from the market.”
Manufacturers sell about $175 million worth of prolapse mesh worldwide, Bard estimated on a conference call in 2010.

Vaginal Mesh Implant Lawsuit

Bard Avaulta Transvaginal Mesh Implant Lawsuit Information::

Gynecare Prolift Pelvic Floor Repair System Lawsuit Information::

Judge calls off Yaz trial, orders suits into mediation

J Murawski — 2012-01-05T01:40:47Z

- FiercePharma

01/04/2012 - The first Yaz trial won't open as scheduled. A federal judge delayed the bellwether patient lawsuit, set for trial next week, and appointed a special master to mediate instead. And this special master is well versed in pharma liability litigation: It's George Washington law professor Stephen Saltzburg, who handled mediation in 26,000 Seroquel lawsuits.

Judge David Herndon, who's overseeing litigation over Bayer's birth control pills, had promised in the fall to press for settlements after the bellwether trials wrapped up. But in an order filed Dec. 31, Herndon abandoned his previous plan in favor of mediation, saying this alternative will "better serve" plaintiffs and defendants in these cases. Herndon ordered both sides to meet with Saltzburg "without delay" and negotiate in good faith.

The order not only put the first Yaz trial—Kerry Sims v. Bayer—on hold, but also put the rest of the bellwether trials in limbo. Herndon is presiding over thousands of suits claiming Bayer contraceptives Yaz and Yasmin caused dangerous blood clots, and the drugmaker didn't adequately warn patients of the risks. Bayer maintains the pills are safe and effective when used as directed.

Lawyers aren't the only ones debating the drugs' safety. A range of studies have turned in conflicting results on their safety risks, with some highlighting substantial increase in clotting risks and others finding no increase. In December, an FDA advisory panel reviewed the data, and the group recommended labeling changes to clarify the potential risk of blood clots. The committee backed the drugs' risk-benefit profile, however, with a 15-11 vote

- Read Judge Herndon's order (PDF)::

Yaz / Yasmin / Ocella Lawsuit News Archive::

Under no circumstances should you discontinue taking any medication, including Yaz or one the generic versions, without first consulting with your doctor.

Yaz - Yasmin Birth Control Lawsuit Test Trials Scheduled to Begin Next Year

J Murawski — 2012-01-03T03:08:08Z

- Ennis & Ennis

01/02/2012 - Bayer is facing more than 7000 lawsuits over its popular birth control pills Yaz and Yasmin over serious side effects such as blood clots, deep vein thrombosis (DVT), gallbladder disease, and other cardiovascular complications. Many of the lawsuits allege that Bayer failed to adequately warn about these risks.

With so many lawsuits pending with common claims, Judge Herndon will conduct three "test trials" or "bellwether trials" to evaluate how juries are likely to respond to evidence and testimony common to all of the cases. The test trials are also meant to inspire settlements throughout the country. According to motions asking the court to consolidate several other individual lawsuits into single trials, Bayer has resisted any type of settlement thus far.

Last month, attorneys representing plaintiffs in thousands of Yaz, Yasmin and Ocella lawsuits released an expert witness report written by former FDA Commissioner David Kessler, in which Kessler asserted that Bayer AG had hidden a higher blood clot risk associated with Yasmin, the precursor to both Yaz and Ocella.

According to Kessler, Bayer had documented that Yasmin was 10 times more likely to cause serious side effects, including a dangerous type of blood clot called deep vein thrombosis (DVT), in the draft of an August 2004 white paper produced by its employees.

But when the paper was submitted to the FDA, the statement mentioning the increased DVT risk was omitted. Also omitted was an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives, Kessler said. “Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin’s NDA (new drug application) could be made,”

The test trials are scheduled to begin next year.

Yaz / Yasmin / Ocella Lawsuit News Archive::

Under no circumstances should you discontinue taking any medication, including Yaz or one the generic versions, without first consulting with your doctor.

Takeda Actos Suits Combined in Louisiana Court, Panel Rules

J Murawski — 2012-01-03T03:05:09Z

- Bloomberg

01/02/2012 - Lawsuits against Takeda Pharmaceutical Co., Asia’s biggest drugmaker, claiming its Actos diabetes drug causes bladder cancer will be consolidated before one judge in federal court in Louisiana, a judicial panel said.

The federal Judicial Panel on Multidistrict Litigation sent the lawsuits to the Western District of Louisiana, in Lafayette, to be overseen by U.S. District Judge Rebecca Doherty. Doherty will coordinate pretrial proceedings, including evidence- gathering.

“Centralization in the Western District of Louisiana will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation,” the panel ruled yesterday. It will also allow “the panel to assign the litigation to an experienced judge who sits in a district in which no other multidistrict litigation is pending.”

The lawsuits claim that patients who use Actos, a prescription drug approved for the use in treating type 2 diabetes, increases the risk of bladder cancer. The plaintiffs also claim that Takeda and co-defendant Indianapolis-based Eli Lilly & Co. withheld information about the risk and failed to provide adequate warnings.

Sara Gourley, an attorney for Osaka, Japan-based Takeda, didn’t immediately return a call for comment.

The company said in a September filing that 54 federal lawsuits had been filed by then. Dozens more suits have been added in federal court since, according to court records.

More Patients

Several thousand patients have contacted plaintiffs lawyers about filing such suits, Paul J. Pennock, a New York-based lawyer representing former users of the drug, said in an interview last month.

U.S. regulators found in June that an analysis of a Takeda- sponsored study showed some users of Actos, the world’s best- selling diabetes medication, faced an increased risk of developing the potentially fatal disease. The federal lawsuits were all filed in July or later, the federal panel said in yesterday’s ruling.

Takeda officials this year pulled Actos, its top-selling drug, off the market in Germany and France after it was linked to an increased cancer risk.

Takeda had asked the panel to consolidate the cases in the Northern District of Illinois in Chicago, near the headquarters of five of the company’s units, or the Louisiana court as an alternative. Lawyers for plaintiffs disagreed on the choice of venue, proposing six other courts as well as those in Chicago and Lafayette.

The lawsuits are consolidated in In Re: Actos Products Liability Litigation, MDL 2299, U.S. District Court, Western District of Louisiana (Lafayette).

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If you have taken Actos and experienced serious Actos side effects such as Actos Bladder Cancer call our Actos lawyers today to find out about an Actos lawsuit. With offices in Washington D.C. and throughout Florida we are ready to help Actos side effects victims nationwide. Let our Actos Attorneys evaluate your case for free today. Fill out our online case evaluation form at ennislaw.com or call us toll free at: 1.800.856.6405 for your free, confidential case evaluation.

Under no circumstances should you discontinue taking any medication, including Actos or Pioglitazone, without first consulting with your doctor.

Actos Bladder Cancer Side Effects Lawsuit Information::

The Cost of Healthcare Continues to Increase with Failing Hip Implants: Ennis and Ennis, P.A. Explains the Drastic Costs Associated with Metal-on-Metal Hip Implants

J Murawski — 2011-12-30T01:05:12Z

- Ennis & Ennis

12/29/2011 - Medical and legal experts estimate that failed metal-on-metal hip implants may cost taxpayers, insurers, employers and others billions of dollars, contributing to the soaring cost of healthcare according to a recent New York Times article. The drastically high rate of all-metal hip implant revisions is now the most widespread medical implant failure in decades. ‘This is not new information to me because for quite some time now, I have received a high volume of complaints from potential clients who are devastated because their metal-on-metal implant only lasted several years when they are supposed to last approximately 15 years,” reports attorney David Ennis of Ennis & Ennis, P.A.

The primary culprit of the hip failure is metal wear. The wear of metal parts against each other generates debris that is damaging tissue and, in some cases, crippling patients.
All-metal implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States, according to an August 2011 New York Times article. According to one estimate, some 500,000 patients have already received an all-metal replacement hip.

Manufacturers of metal-on-metal hips include DePuy Orthopaedics, Stryker, Zimmer, Biomet and Wright Medical Technology. So the financial fallout is expected to be usually large and complex because the issues involve a class of products, not a single device or just one company.

In September 2011, the U.S. Food and Drug Administration (FDA) received more than 5,000 adverse events reports in the first six months of 2011 regarding all-metal hips, which was more than the agency had received in the prior four years combined. Then a study in England revealed that all-metal hips were failing at nearly three times the rate of hips made from metal-and-plastic components, which can last 15 years or more.

The United States does not have a formal tracking system for the outcome of orthopedic procedures. However based upon a National Joint Registry for England and Wales, which reports an ever-increasing metal-on-metal failure rate, it is anticipated that additional tens of thousand of patients in the US will have to undergo revision surgery, according to Dr. Art Sedrakyan, a researcher at Weill Cornell Medical College of Cornell University.

“Even when I was involved with the Sulzer Orthopedics settlement about 10 years ago, the number of affected patients was not nearly as high as it is now with all of the metal-on-metal hip claims,” commented Ennis. “This is just a travesty for thousands of patients.”
Ennis & Ennis, P.A. recommends that anyone with a metal-on-metal hip implant system, who is experiencing pain in the groin, hip or leg, swelling at or near the hip joint, or a limp/change in walking ability, first seek medical attention. Then file an adverse event report with the FDA at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Lastly, consult with an experienced attorney.

Ennis & Ennis is offering free, nationwide, confidential consultations to anyone who has a metal-on-metal hip replacement system by calling toll free 1-800-856-6405 or by going to http://www.ennislaw.com and completing an online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Wright Conserve Hips, Wright Profemur Hips, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills.

Defective DePuy Metal on Metal Hip Implant Lawsuit

If you or a loved one have been injured as a result of a defective hip replacement you may be entitled to compensation. Our experienced Hip Replacement Side Effects Lawsuit Attorneys are here to answer any questions you may have about a hip replacement lawsuit or a possible hip replacement class action lawsuit. Fill out the free hip replacement lawsuit case evalution form or contact our DePuy ASR Hip Replacement Recall Lawsuit Lawyers directly by calling toll-free: 1.800.856.6405.

Will Flawed All-Metal Hip Replacements Cost J&J and Zimmer $5 Billion?

J Murawski — 2011-12-29T03:09:38Z

- Forbes

12/28/2011 - If you have an all-metal hip replacement, you may be among the lucky ones who can walk. Or you may be worse off than you would have been without the allegedly flawed device. One thing’s for sure: Those flaws are going to cost Johnson & Johnson (JNJ) and Zimmer Holdings (ZMH) plenty in legal fees and possible settlement costs. How much? Maybe $5 billion.

One thing is for sure: there are people out there suffering tremendously due to the flaws in all-metal hip replacements. As the New York Times reports, the friction of metal parts — the ball and joint — rubbing against each other create splinters that can cause infections and other damage to the people who host these devices.

One of them, a 55-year-old worker at Caterpillar (CAT), Thomas Dougherty, has incurred “$400,776 in charges related to hospitalizations, and $28,081 in doctors’ bills,” according to the Times.

Numbers on how much these flaws will cost the manufacturers are hard to come by. But there are estimates of how many people may have received the all-metal implants. The Times reports that about 33% of the 250,000 hip replacement patients per year received the all-metal version. That percentage has fallen sharply and the Times estimates that 500,000 patients have the all-metal implants.

And those all-metal implants do not have a great track record. The Times cites a study finding that over a five year period, none of the all-metal implants outlasted the older versions and 30% were worse.

The two biggest all-metal hip replacement makers are feeling the pain. J&J’s DePuy division has recalled 40,000 of its all-metal implants and as of October 2011, 9% or 3,500 patients had filed suit against J&J, according to the Times. Meanwhile, the Times said that Zimmer Holdings claims that “its all-metal implants are safe,” and has settled “hundreds of patient claims.”

Neither the U.S. government, nor the industry tracks how many of these hip replacement operations fail. However, there are two data points that could help in making an estimate of how much these allegedly flawed all-metal hip replacements will cost their manufacturers.

First, there is precedent in the form of a 2001 settlement made to patients who received contaminated hip and knee replacements. Back then, Sulzer Orthopedics paid “a record $1 billion to settle claims by 6,800 patients” whose artificial hips and knees from the company were “contaminated with industrial oil during the manufacturing process.” And the Times quotes a former Sulzer lawyer as estimating that the cost of settling the problems with all-metal hips will be much higher.

Second, the Times interviewed Dr. Art Sedrakyan, a researcher at Weill Cornell Medical College who combined an extrapolation from non-U.S. data on hip replacement performance with estimates of U.S. metal hip use to conclude that the number of patients by 2021 who will need to get their all-metal hips replaced could total in the ”tens of thousands.”

My conclusion is that this problem could cost J&J, Zimmer, and other metal-hip replacement providers about $5 billion. I based this estimate on two key assumptions. First, the average cost to settle each all-metal hip replacement claim will be $169,000 — 15% more than in the $147,000 average in the 2001 Sulzer settlement. Second, that the manufacturers will end up settling 30,000 claims.

While these assumptions may be wrong, there is no doubt that they do not factor in the reputational damage that these allegedly flawed devices have caused the industry. Nor do they reflect the cost to whoever ends up paying the hospital bills to treat the patients who host these all-metal hip replacements.

Defective DePuy ASR Hip Implant Recall Lawsuit

If you or a loved one have been injured as a result of a defective hip replacement you may be entitled to compensation. Our experienced Hip Replacement Side Effects Lawsuit Attorneys are here to answer any questions you may have about a hip replacement lawsuit or a possible hip replacement class action lawsuit. Fill out the free hip replacement lawsuit case evalution form at ennislaw.com or contact our DePuy ASR Hip Replacement Recall Lawsuit Lawyers directly by calling toll-free: 1.800.856.6405.

Patients, insurers feeling fallout of metal hip failures

J Murawski — 2011-12-29T03:06:55Z

- New York Times

12/28/2011 - The most widespread medical implant failure in decades - involving thousands of all-metal artificial hips that need to be replaced prematurely - has entered a new phase, the money one.

Medical and legal experts estimate the hip failures could cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. The financial fallout is expected to be unusually large and complex because the episode involves a class of products, not a single device or just one company.

The case of Thomas Dougherty represents one particularly costly example. He spent five months this year without a left hip, largely stuck on a recliner watching his medical bills soar.

In August, Dougherty underwent an operation to replace a failed artificial hip, but his pelvis fractured soon afterward. The replacement hip was abandoned and then a serious infection set in. Some of the bills: $400,776 in charges related to hospitalizations, $28,081 in doctors' bills, $5,823 for laboratory tests and $2,995 in home nursing visits.

"I'm sitting here on a La-Z-Boy meant for someone who is 80 and I'm 55," said Dougherty, who lives in Groveland, Ill., outside Peoria, and works at Caterpillar, the heavy-equipment manufacturer.

His bills are "five times as much" as he paid for his home.

The so-called metal-on-metal hips like Dougherty's, ones in which the ball and joint of a device are both made of metal,

within a few years of implant instead of lasting 15 years or more, as artificial joints normally do. The wear of metal parts against each other is generating debris that is damaging tissue and, in some cases, crippling patients.

The incidents' soaring costs have set off a financial scramble. Recently, lawsuits and complaints against makers of all-metal replacement hips passed the 5,000 mark. Insurers are alerting patients that they plan to recover their expenses from any settlement money patients receive. Medicare is also expected to try to recover its costs.

Some patients like Dougherty are doing their part, too. While his insurer has covered his bills so far, Dougherty said he was preparing to sue his surgeon and Johnson & Johnson, which produced his artificial hip, to help recoup some of the insurer's money.

"All these payers want to be paid back," said Matt Garretson, the founding partner of the Garretson Resolution Group, a firm in Cincinnati that manages product liability cases.

Until a recent sharp decline, all-metal implants accounted for nearly one-third of the estimated 250,000 hip replacements performed each year in the United States. Some 500,000 patients have received an all-metal replacement hip, according to one estimate. A new study found that not a single new artificial hip or knee introduced during a recent five-year period, implants that included the all-metal hips, performed better in terms of durability than older devices, and 30 percent of them were worse.

One troubled all-metal model, implanted in 40,000 U.S. patients, was recalled last year by the DePuy division of Johnson & Johnson. As of October, some 3,500 patients had filed a lawsuit involving that device, which is expected to fail in thousands of more patients in coming years.

Device producers have taken differing stances to covering patient expenses. Zimmer Holdings, which says its all-metal implants are safe, has quietly settled hundreds of patient claims, lawyers involved in those cases say. Also, DePuy has agreed to cover costs related to the device it recalled last year, a hip known as the ASR, or Articular Surface Replacement.

DePuy would not comment on how much it had paid in recall-related costs. But a spokeswoman, Mindy Tinsley, said in a statement that DePuy was working closely with patients and insurers.

Things have not gone smoothly for everyone who has taken DePuy's payment offer. One patient, Paula Laverty, received a hospital bill for $41,578 and a call from the facility warning her that the bill would be turned over soon to a collection agency if not paid.

Laverty, of Cape Elizabeth, Maine, said she spent weeks calling the firm handling claims related to DePuy's ASR. She said she eventually learned that the implant maker had paid the hospital $18,000 for her replacement procedure and that the $41,578 represented the remaining charges.

This month, after being contacted by the New York Times, DePuy made an additional payment to the hospital, according to Tinsley, the company spokeswoman.

Along with ASR-related cases, DePuy also faces more than 560 lawsuits in connection with the all-metal version of another hip model, called the Pinnacle, the device that Dougherty received. Because the company says that the all-metal Pinnacle is performing well, costs related to its replacement are being borne by Medicare, insurers or patients themselves.

To recoup their expenses, insurers typically notify patients through lawyers that they expect to be reimbursed from any settlement money patients receive, rather than pursue their own lawsuits with the device makers. Also, Medicare is expected to start enforcing new laws next year that will make it easier for the agency to recover taxpayer dollars spent treating patients injured by problem drugs and medical devices, legal experts said.

Still, some patients are weathering some of the financial effects on their own. While Charmin McCune, a teacher in Wylie, Texas, is recuperating well from a recent replacement operation, she said that she and her husband, who is also a teacher, have had more than $12,000 in expenses related to lost workdays and child care that have not been covered by insurance.

Dougherty, the Illinois patient, underwent a procedure this month to get a new hip implant, an operation that will add tens of thousands of dollars to his medical bills. All went well, he said, so he hopes to spend next year back on his feet and at work, rather than in a chair.

"You can't do anything," he said of his current situation. "You see your wife doing everything for you. It is just not right."

Defective DePuy ASR Hip Implant Recall Lawsuit

If you or a loved one have been injured as a result of a defective hip replacement you may be entitled to compensation. Our experienced Hip Replacement Side Effects Lawsuit Attorneys are here to answer any questions you may have about a hip replacement lawsuit or a possible hip replacement class action lawsuit. Fill out the free hip replacement lawsuit case evalution form at ennislaw.com or contact our DePuy ASR Hip Replacement Recall Lawsuit Lawyers directly by calling toll-free: 1.800.856.6405.

New Models of Implants Not Better, Study Finds

J Murawski — 2011-12-29T03:04:00Z

- New York Times

12/28/2011 - A new study suggests that the recent technology for artificial hips and knees did not perform any better than older, less expensive designs.

The study, which draws on data from Australia’s orthopedic registry, covered implants introduced from 2003 to 2007 and was published this week. The findings are significant for patients in the United States because many of the new designs, like so-called metal-on-metal hips, are widely used here. Those implants, which have both a ball and cup made of metal, are expected to fail prematurely in tens of thousands of patients rather than lasting 15 years or more as artificial joints are supposed to do.

The Australian study showed that not a single new artificial hip or knee introduced over a recent five-year period was any more durable than older ones. In fact, 30 percent of them fared worse.

The Australian study concluded that both patients and taxpayer-financed health care programs were paying a high cost because surgeons were using newly designed implants, introduced with little test data, over existing designs that had track records.

“Not only has the introduction of this technology been potentially detrimental to patient care, but the current approach may be an important driver of increased health care costs,” the review concluded.

Dr. Stephen E. Graves, the director of the Australian registry and a co-author of the study, said he believed that surgeons, hospitals and regulators should closely look at the review’s results. In the case of the all-metal hips, some experts say they believe that replacing them may cost companies, insurers and taxpayers billions of dollars.

“There needs to be a careful re-evaluation of current deficiencies in regulation,” Dr. Graves said in a recent e-mail.

The Australian review is part of a special issue of a medical journal, The Journal of Bone and Joint Surgery, devoted to studies that examine the benefits and the limitations of orthopedic registries. While America does not have a registry, the Food and Drug Administration is financing efforts to see whether data from sources like overseas databases and registries run by hospitals here can be used to better monitor device performance.

Many experts argue that such efforts are essential because 700,000 Americans undergo hip or knee replacement every year, and that number is expected to increase sharply as the population ages.

In a registry, information about a patient is entered into a database when he or she receives an implant. Then, when that patient undergoes surgery again to replace that device, more data is added. By looking at large numbers of patients followed in a registry, researchers can tell whether certain device models are failing prematurely at significantly higher rates.

But researchers in England, which has a registry, pointed out in another article in the same medical journal that a product-related disaster had likely already occurred before it was detected in a such a database. As a result, some experts say they believe that there must be greater scrutiny of implants either before or after they go on the market to detect problems earlier.

Another review in the same issue found that the results of published studies that accompany the introduction of new implants could bear little resemblance to registry findings about a device’s success once it went into broader use.

That review, by researchers in Austria, found that surgeons involved in the original published reports are often involved in its development and may have a financial stake in them. In addition, such reviews tend to be short term.

Some surgeons say they believe that one type of all-metal implant known as a resurfacing device is permitting some patients to remain more active. However, data indicates that such benefits are limited to one group of patients, namely larger, middle-aged men.

This month, bipartisan legislation was introduced in the Senate that could force manufacturers to track the performance of implants like artificial hips after they have been approved for sale. Proponents of the bill acknowledge that the measure faces an uphill fight.

Both device producers and their allies in Congress have maintained that any additional F.D.A. regulations would slow the development and marketing of innovative products that benefit patients. For his part, Dr. Graves, the Australian official, said he believed that such arguments were misleading.

“The purpose of regulation is not to impede innovation but to ensure safety and effectiveness of medical devices,” he stated. “This protects patients, but it also protects companies.”

Defective DePuy ASR Hip Implant Recall Lawsuit

If you or a loved one have been injured as a result of a defective hip replacement you may be entitled to compensation. Our experienced Hip Replacement Side Effects Lawsuit Attorneys are here to answer any questions you may have about a hip replacement lawsuit or a possible hip replacement class action lawsuit. Fill out the free hip replacement lawsuit case evalution form at ennislaw.com or contact our DePuy ASR Hip Replacement Recall Lawsuit Lawyers directly by calling toll-free: 1.800.856.6405.

Updated Guidance for Use of Vaginal Mesh for POP

J Murawski — 2011-12-27T00:12:21Z

- OBGYN.net

12/26/2011 - In further response to the Safety Communication issued by the FDA in July 2011 regarding the use of vaginal mesh, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) jointly state that the use of vaginal placement of synthetic mesh for the treatment of pelvic organ prolapse (POP) should be reserved for high-risk women for whom the benefits may outweigh the risks. The College and the AUGS also state that there is an urgent need for development of a national registry to track outcomes for all current and future patients who receive vaginal mesh implants.

The specific recommendations of The College and AUGS for use of vaginal mesh include the following:

• Continued audit and review of outcomes and the creation of a surveillance registry for all current and future vaginal mesh implants.

• Outcome reporting for prolapsed surgical techniques defining success, complications, and total reoperation rates.

• Surgeon training for vaginal mesh placement specific to each device, including surgical experience with reconstructive surgery and thorough understanding of pelvic anatomy

• Rigorous comparative effectiveness trials of synthetic mesh and native tissue repair and long-term follow-up.

•Patient counseling about alternative native tissue repairs and the permanent nature of synthetic mesh, as well as discussion of the risks, benefits, and alternatives to the procedure.

• Limiting use of POP vaginal mesh repair to high-risk women for whom the benefit may justify the risk.

• Adoption of new mesh products and devices only with clinical long-term data demonstrating equal or improved safety and efficacy compared with existing products and devices.

Vaginal Mesh Lawsuit

If you or a loved one have suffered or been injured from a defective transvaginal mesh sling you may be entitled to compensation. Contact the vaginal mesh sling attorneys of Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding your transvaginal mesh sling injury a possible class action lawsuit, or any other type of vaginal mesh litigation. Call us toll-free at: 1.800.856.6405 or fill out the free case evaluation form on this page.

Bard Avaulta Transvaginal Mesh Implant Lawsuit Information::

Gynecare Prolift Pelvic Floor Repair System Lawsuit Information::

Do the Osteoporosis Medicine Fosamax and Dental Work Mix?

J Murawski — 2011-12-27T00:09:52Z

- The Huffington Post

12/26/2011 - Today's topic is a bit on the "dire" side... Not that I like alarming anyone, but if I come across something that I deem important, I want to share it. So for this post, I would like to discuss Fosamax (aka alendronate) and dentistry, because there is a definitive risk factor involved.

To start, let's go over what Fosamax is, and what it's used for. Fosamax is the trade name for Alendronate, which is a drug used to prevent/combat osteoporosis. Osteoporosis is a condition generally associated with age in where your bones become more brittle and more likely to break. Although men can (and do) suffer from it, it's generally associated with post-menopausal women.

Fosamax is a drug that is taken to prevent/combat osteoporosis. It's really that simple -- the medication is meant to slow bone loss. But it's also one of those drugs that you see advertised on TV that has a list of side effects longer than the list of benefits. (Just watch this ad to see what I mean). I almost don't understand that trend -- what is up with these drugs with side effects that are worse than the symptoms you are treating? I've even seen some that talk about possible DEATH as a side effect (like this ad for Abilify, a depression drug). I don't know about you, but when they mention "coma" or "death" in the ad, I personally can do without the drug.

But ok, let's get back to Fosamax and its side effects (which, to alleviate any confusion, do NOT include coma or death). However, one thing the commercial doesn't tell you is how it can affect any dental work you get done, or how it can affect your jaw. There has been clinical proof that raises a cause for concern here.

In the simplest terms, Fosamax seems to work on other bones, but strangely, not the jawbone. In fact, the drug seems to increase the possibility of developing osteonecrosis of the jaw, which is the "death of bone" in your jaw. (I'm not being dramatic here -- this is what the Mayo Clinic calls it.)

In addition, on pretty much every website I looked at Fosamax on (including the Mayo Clinic, drugs.com and Web MD) all seem to have pretty strong warnings regarding Fosamax and dental work. And I can tell you that as a NYC Cosmetic Dentist I have personally seen cases where a tooth extraction did not heal correctly because the patient was on Fosamax (I was the second dentist in this incident -- I always ask patients what drugs they are taking precisely for instances like this).

One of the issues that I have with this drug is the fact that dental problems are so common. You have to look hard to find someone that won't need any dental work over, say, the next five years. So saying something akin to "If you are going to have dental work done, it may be a problem" (I'm paraphrasing) is certainly not helpful. Dental work is just too common for me to be comfortable with this side effect. You may as well say "Hey, if you drink a caffeinated beverage, this might be a cause for concern." I'm not against the long list of side effects, mind you, but when it's something as common as dental work, well yeah, that's a problem for the patient. I mean, how many of you out there can honestly say that you won't get any cavities (or need any other dental work) for the rest of your life? Likely not too many of you -- that's just a fact of life -- cavities and dental work happen. It's common -- common enough that caution should be taken when looking at this particular drug. (Well, I would say caution should be taken before taking ANY drug -- especially those "death and coma as a possible side effect" ones I mentioned earlier!)

In looking a little further at Fosamax, I came across this ABC News report regarding a woman who fractured her thigh bone while on the drug, and the growing evidence of femur-related issues (which the company has addressed in a small insert into the side effects). Now in all fairness, this could come from doctors prescribing this a little early (to people who "might" develop osteoporosis), but it's worth including in the discussion -- after all, if the drug is supposed to make your bones stronger, then why the jawbone issues? And taking that one step further, what other bones might be harmed instead of helped? It's a fair point.

In the end, like I mentioned earlier, caution is warranted for any drug. But in this case, I wanted to bring it to light because it affects something near and dear to me -- my patient's oral health.

Until next time, keep smiling.

Fosamax News Archive::

Fosamax Side Effects Lawsuit

If you or a loved one have taken Fosamax and have been injured as a result of Fosamax side effects such as osteonecrosis of the jaw or low energy femur fracture, contact the Fosamax lawyer of Ennis & Ennis, P.A. today. The Fosamax lawyers of Ennis & Ennis specialize in Fosamax lawsuits resulting from Fosamax side effects injuries. Ennis & Ennis, P.A. is a national mass tort litigation / drug litigation law firm with offices in Washington DC and throughout Florida. Call us today or fill out our free online case evaluation form at ennislaw.com.

Under no circumstances should you discontinue taking any medication, including Fosamax, without first consulting with your doctor.