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Free & Goss Attorneys

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The Senate Finance Committee, led by Chairman Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) recently released the results of a 16-month long investigation involving Medtronic and its spinal fusion device InFUSE.  The results are as shocking as they are disappointing for the state and health of scientific research.

Major findings of the investigation include:

  • Medtronic was involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic.  The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles.  Medical journals should ensure any industry role in drafting articles or  contributions to authors be fully disclosed.
  • Medtronic paid a total of approximately $210 million to physician authors of Medtronic-sponsored studies from November 1996 through December 2010 for consulting, royalty and other arrangements.
  • An e-mail exchange shows that a Medtronic employee recommended against publishing a complete list of adverse events, or side effects, possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.
  • Medtronic officials inserted language into studies that promoted InFuse as a better technique than an alternative by emphasizing the pain associated with the alternative.
  • Documents indicate that Medtronic prepared one expert’s remarks to the FDA advisory panel meeting prior to InFuse being approved.  At the time, the expert was a private physician but was later hired to be a vice president at Medtronic in 2007.

 

The Committee also concluded that “Medtronic’s actions violate the trust patients have in their medical care.  Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has,” Senator Baucus said.  “Patients everywhere will be better served by a more open, honest system without this kind of collusion.”

The full report can be accessed and read here: http://www.finance.senate.gov/newsroom/chairman/release/?id=b1d112cb-230f-4c2e-ae55-13550074fe86

Johnson and Johnson’s Ethicon unit announced they will stop selling four of their transvaginal mesh kits, three for treating pelvic organ prolapse, and one for treating stress urinary incontinence.  The announcement came yesterday in a letter from J&J to U.S. District Court Judge Joseph Goodwin, the Federal Judge in West Virginia overseeing the consolidated litigation.  The halted sales will take place worldwide.

The recall comes on the heels of an FDA statement slamming J&J for selling its Prolift device for three years without FDA clearance, a recent demand by the FDA for J&J to conduct postmarketing study on organ damage and other serious injuries, and the threat of dealing with tens of thousands of lawsuits related to the product.

Though not certain, there remains a strong possibility the catalyst for the recall was the FDA demand for safety and effectiveness data, and the assumption that none of the recalled devices would prove to be safe or effective enough to remain on the market after FDA review.  Unfortunately, this is just another example of too little too late, as the safety review should have been conducted at market entry.

J&J has asked the FDA for 120 days to end sales in order to “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients.”  In addition J&J “will also discontinue or revise as appropriate, all marketing materials during this time.”

Recalled devices include:

  • Gynecare TVT Secur System
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare Prolift Pelvic Floor Repair System
  • Gynecare Prolift+M Pelvic Floor Repair System

Law.com and ALM publications recently released the 2012 edition of Texas’ Top Rated Lawyers, and we’re proud to announce that Freese & Goss has been recognized as one of the best law firms in Texas.  In particular, the article recognizes both Tim Goss and Rich Freese for their extensive work over the past 25 years representing plaintiffs against major drug and device manufacturers, as well as handling high-profile individual cases.  With offices in three states, Freese & Goss has litigated some of the most significant mass-tort pharmaceutical, environmental, and class action cases in the country.  Impressively, the article highlights their work in mass torts and class action litigation which, over the past three years alone, has resulted in over $100 million recovered for victims.  In addition to founding a top rated law firm in Texas, both Tim and Rich earned the AV Preeminent rating by Martindale-Hubbell, indicating extraordinary professionalism and client satisfaction.

The FDA has taken an unprecedented step to further evaluate vaginal mesh, requiring manufacturers to conduct postmarketing studies designed to gather more data on the safety and efficacy of vaginal mesh products for the next three years.  In all, 33 manufacturers of meshes for pelvic organ prolapse (POP) and seven manufacturers who make second-generation ‘mini-slings’ for stress urinary incontinence (SUI), are affected.  The mandate, however, does not include every type of vaginal mesh, most notably the traditional slings used for SUI.

Relevant to the issue is the fact the FDA never required manufacturers to conduct studies evaluating safety and efficacy prior to approval.  Instead, these devices were approved through the FDA’s 510(k) approval process, which only requires showing ‘substantial equivalence’ to devices already on the market.  One could argue these actions are long overdue considering approval was, and still is, based on mesh used for abdominal hernias, as well as the hundreds of thousands of patients who have had these procedures.  In the meantime, pro-consumer groups, such as Public Citizen, continue to call for a full recall of devices used for POP.

Additional information can be found here:

http://professional.wsj.com/article/SB10001424052970203513604577141080774088846.html?mg=reno64-wsj

http://www.bloomberg.com/news/2012-01-04/fda-orders-safety-studies-for-vaginal-implants-made-by-j-j-and-c-r-bard.html

On September 8-9, the FDA’s Obstetrics & Gynecology Devices Panel will meet to address concerns related to the safety and efficacy of transvaginal mesh.  Today, the panel released both discussion questions and the agenda for the conference, shedding light on FDA concerns, as well as potential future directions the agency may take.

The FDA has broken the discussion into two major divisions: vaginal placement of surgical mesh for pelvic organ prolapse (POP), and abdominal placement of the device.  With regards to vaginal placement, the FDA appears ready to reclassify the device from class II to class III, placing the device in the most tightly regulated classification, ending the ability for future transvaginal mesh devices to gain FDA clearance via the traditional 510(k) ‘substantial similarity’ process.  Instead, as a class III device, new transvaginal mesh products would be required to submit to the premarket approval (PMA) process, which in turn necessitates safety and effectiveness testing prior to FDA approval.

The FDA is also asking physicians and other concerned parties whether the list of potential risks should be expanded.  Currently, the FDA has identified the following risks via literature review and adverse event reports submitted to the MAUDE database.  These include:

Peri-Operative Risks

  • Organ perforation
  • Bleeding (including hemorrhage/hematoma)

Long Term Risks

  • Vaginal Mesh Exposure.  Clinical sequelae include pelvic pain, infection, dyspareunia (painful sex for patient or partner), vaginal bleeding, vaginal discharge, and the need for additional corrective surgeries.
  • Mesh erosion into the bladder or rectum.  Clinical sequelae include pelvic pain, infection, dyspareunia, fistula formation and the need for additional corrective surgeries (possibly including suprapubic catheter, diverting colostomy).
  • Other risks that can occur without mesh erosion.  These risks include pelvic pain, infection, dyspareunia, urinary problems, vaginal scarring/shrinkage, recurrent prolapse, neuro-muscular problems.

The FDA is also looking for additional information to support or refute its conclusion that scientific evidence does not demonstrate that vaginal mesh used for POP repair provides any clinical benefit compared to surgical repair of POP without mesh.  On this issue, they have asked for further input on such issues as whether the pelvic compartment for repair alters the safety or effectiveness of the device (e.g. anterior, posterior), whether the type of mesh used affects outcome (e.g. synthetic vs biologically derived grafts), and whether certain sub-populations would benefit from the mesh.

Finally, the FDA is asking respondents to answer whether clinical studies should be performed, either prior to approval, or in the context of postmarketing surveillance.  In addition, there are questions regarding how these studies should be conducted, with an emphasis on study design and the role and make-up of control groups.

The FDA does not seem as concerned with abdominal placement of these devices, stating their belief that abdominal placement of surgical mesh for POP repair is a well-established clinical practice.  On this subject, the FDA is asking concerned parties to state whether they agree with this assertion, and if not, whether premarket clinical data should be required and how it should be reported.  As with vaginal placement, they are also asking whether postmarketing surveillance should be required, and if so, how these clinical studies should be conducted, and which outcome measures and controls should be selected.

We will continue to monitor the FDA’s progress as they examine the current transvaginal mesh regulatory environment, and will report any major developments as they appear.

The New York Times has published an article following their own investigation into serious problems attributed to metal-on-metal hip replacement devices.  Perhaps the most striking aspect of the article is the overwhelming increase in the number of adverse events reported to the FDA since January of this year.  Specifically, over 5,000 adverse event reports were submitted, more than the agency had received in the previous four years combined.

The article also describes what we’ve discussed previously, namely that these devices were designed and marketed as lasting at least 15 years.  The devices are falling far short of this estimate according to both published research and the Times, typically only lasting a few years before requiring replacement or revision surgery.

In addition to shortcomings in durability, the article also touches on one of the more controversial defects associated with the device, the tendency of these devices to release small particles of cobalt and chromium into the bloodstream and surrounding tissues during normal day-to-day activities.  While the effects of this defect aren’t fully understood, it appears that over time these particles can increase in concentration and availability in the body, resulting in inflammation and crippling injury.

Finally, there is mention of the controversial FDA clearance process known as 510(k) approval.  In short, this route of clearance allows manufacturers to point to a ‘substantially similar’ device to claim that their device is safe and effective without having to conduct safety trials.  The unfortunate result of this process is exemplified by these devices, namely that when problems eventually do arise, the amount of existing research is usually insufficient to fully grasp the nature and extent of the defect and/or injury.  With regard to these hip replacement devices, the FDA and manufacturers are scrambling to design and employ studies intended to answer these questions.  Probably not by coincidence, these studies were not initiated by the manufacturers on their own accord, but instead were requested by the FDA following the consistent rise in adverse event reports.  Serious doubt remains as to whether these studies will even produce any worthwhile information, primarily because the results won’t be gathered and published for years.

Over the next few weeks, we will be discussing various topics surrounding the new transvaginal mesh (TVM) FDA warnings.  Rather than posting a single, overwhelming discussion on this topic, we’ll instead narrow our focus to different, distinctive aspects of the device, what is known and unknown, and what exactly it is the FDA is now so concerned about.  Our hope is to relay to the reader why this is quickly becoming  a contentious issue for consumers, attorneys, government officials at the FDA, and device manufacturers.  To start, we’ll be discussing a general overview of the device, as well as its approval history, since this is where the controversy starts.  For reference, there is an excellent publication in Female Patient by Dr. Littman which can be accessed here.  In it, you will notice that he’s developed a very informative ‘family tree’ of TVM devices in figure 1.  Furthermore, table 3 nicely illustrates what will be discussed below, namely the rationales used by TVM device manufacturers to have their products approved.

While the FDA deserves praise for issuing a recent warning concerning the safety and effectiveness of transvaginal mesh devices, there are two major criticisms.  First, the warning is coming far too late.  Hundreds of thousands of these devices have been installed in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  Furthermore, some wonder whether these devices should have been approved in the first place, pointing to the void in understanding the long-term outcomes in terms of the safety and effectiveness of the device.  Second, many believe defects associated with the device, both known and unknown, are serious enough that the FDA should consider an immediate recall, or at least strengthen and continue to disseminate the warnings given the magnitude of the problems.

TVM devices have a strange but not necessarily uncommon approval history.  The FDA approves new devices through one of two routes, either based on pre-market approval (PMA), or a finding of substantial similarity to previously approved devices (called the 510(k) process).  The PMA process is intensive, involves extensive testing by the manufacturer, and requires the FDA to spend on average around 1,200 hours reviewing each application.  Conversely, the 510(k) process is far less rigorous, requiring little to no manufacturer testing, and only requiring on average 20 hours of review time by the FDA.  It should be noted, however, that this is a somewhat simplified overview of the process, and there are exceptions as is the case with devices posing a high potential risk (e.g. pacemakers, coronary stents).  While there are benefits to PMA approval, namely pre-emption (in a sense, a bar) to medical device lawsuits, the 510(k) process is simply put quick and easy.  For example, TVM was approved based on the manufacturer’s argument that the device was substantially similar to mesh used in abdominal hernia surgery.  Each subsequent TVM manufacturer could then point to the previously approved TVM device, claim substantial similarity, and walk away with the right to market a ‘new’ device.

A major problem with this simplified approval process, and is evident with TVM devices, is that it often comes with uncertainty regarding long-term consequences, and in a manner of speaking is no better than crossing ones fingers and hoping for the best.  In the TVM scenario, these assumptions have proved devastating in areas such as mechanics, bioactivity, placement, and surgical skill.  These defects, and the untoward adverse effects arising from them, will be discussed in detail in the next installment.  What is of primary importance to this discussion however, is the fact that TVM devices were approved using a loose connection to hernia mesh products.  Thus, the argument over whether hernia and vaginal meshes can actually be considered substantially similar, is an area of major disagreement, and is in part responsible for the FDA’s current review of the 510(k) process.  To illustrate this point, some argue that on its face, abdominal surgery and vaginal surgery are vastly different.  Fundamentally, the abdomen is mechanically and structurally distinct from the vagina.  For instance, the thick muscular structure of the abdomen makes it far more amenable to mesh insertion and acceptance.  The vaginal area and pelvis however, lack many of these supporting aspects, and instead rely in many cases on placement using hooking mechanisms inserted into the surrounding anatomy to anchor and support a TVM device.

On top of differences in anatomy, TVM and abdominal mesh also differ in terms of the structure of the material, the shape and size of the devices, the method of placement, and the manner of surgery (i.e. placement through the abdomen vs intravaginally).  These differences readily apparent just by looking at images of one type of mesh compared to another.

The TVM saga also highlights the dangers of approving subsequent lines of me-too devices.  What often happens, and is the case here, is the success of an initial manufacturer’s device leads to development of equivalent devices by secondary manufacturers.  The same ‘me-too’ phenomenon is seen with pharmaceuticals as well.  Unlike pharmaceuticals however, follow-on manufacturers can simply point to the initial device and claim substantial similarity, thereby reducing the time it takes to market the device, as well as maximizing the window of profitability before the device is rendered obsolete by future technology.  In one sense, this is why the 510(k) process was developed.  However, when the initial device is defective, poorly understood, or never intended for the use the follow-on product claims, problems arise.  Some of the transvaginal mesh devices were approved following this chain of action, and bring us to where we are today, only with a greater concern over the viability of the 510(k) process.

FDA Strengthens Warning Label for Topamax

[ Thursday, March 24, 2011 ]

The FDA has indicated that changes will be made to the warning label of the anti-epileptic drug Topamax® in response to new data linking the drug with the development of birth defects.

The data, collected and presented by the North American Antiepileptic Drug Pregnancy Registry at MassGeneral in Boston, outlines the risk for developmental irregularities in children maternally exposed to the drug during pregnancy.  Researchers found that exposure to Topamax® during pregnancy raises the prevalence of major malformations from about 1.3% to 3.8%.  Furthermore, these newborns were more likely to develop cleft lip and exhibit abnormally low birth weight when compared to similar anti-epileptic drugs, as well as control groups.

In response to these data, the FDA will rescheduled Topamax® from pregnancy category C, to class D, representing the newly acknowledged risk for birth defects if taken during pregnancy.

Scientists from the UK and USA recently reported in the British Medical Journal data providing new insight into the adverse cardiac effects produced by Avandia®.  The study analyzed the medical outcomes of over 810,000 patients by combining previously reported data sets, each set involving patients taking thiazolidinediones.

Results indicated that Avandia® increases the risk of myocardial infarction by 16%, the risk of congestive heart failure by 23%, and death by 14% when compared to similar other drugs.  These results add to the growing body of literature implicating Avandia® as a drug with an unacceptable risk profile, especially when one factors in reports suggesting Avandia® precipitates the development of bone fractures and bladder cancer.

While the European Medicines Agency (the functional equivalent to the US FDA)  has recommended suspending the market authorization of the drug, the FDA continues to weigh its options, most recently voting to add marketing restrictions.  Given the reported 3.8 million Avandia® prescriptions dispensed annually, the potential harm suffered by the public may ultimately be more than expected.  Regardless, GlaxoSmithKline continues to market the drug, even while they face hundreds of lawsuits.

DePuy Failure Rate may be Higher than Expected

[ Thursday, March 17, 2011 ]

A recent press release by the British Hip Society reported both higher than expected failure rates for the DePuy ASR XL® device, as well as other serious health concerns associated with the metal-on-metal hip replacement.  These results come on the heels of the annual British Hip Society Conference, and was co-authored by the presidents of the British Hip Society, British Orthopaedic Association, and the chair of the Expert Advisory Group on Metal Bearing Hips.

The release centers on the the excessive failure rate of the DePuy Device, previously reported by the FDA, the British MHRA, and the Australian Joint Registry.  While previous failure rates ranged from 10-40%, this new report puts the failure rate at 49% after six years, an unacceptable number by any standard.  While uncertainty remains whether the failures are a result of wear or corrosion, multiple aspects of the device may fail, including the bearing surface, stem, and the ‘Morse’ taper connecting head and stem.  Finally, the report touches on the growing concern over the potential for heavy metal poisoning, noting that oftentimes patients show elevated levels of blood cobalt and chromium.

DePuy recalled the device in July of 2010, and is facing thousands of lawsuits seeking compensation for damages ranging from heavy metal poisoning, to the mental, physical, and financial costs of revision surgery.  In anticipation of litigation and settlement, Johnson and Johnson has set aside almost $1 billion, and is currently looking for a new CEO to run DePuy.

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