Navistar Bus Recall

Navistar, the manufacturer responsible for MaxxForce brand diesel engines, school and commercial buses, trucks, personnel carriers and vehicle parts, has recalled multiple school bus models because of safety defects. Navistar is based in Fort Wayne, Indiana, and manufactures a number of heavy-duty vehicles for everything from construction and farm use to people and cargo conveyance. The BE and CE series buses are built by subsidiary IC Bus.

Navistar plans to initiate a recall for certain models year 2011 and 2012 IC RE school buses manufactured from February 4, 2010 until June 16, 2011 and 2011 and 2012 bus models IC RE made between August 24, 2010 and June 8,2011.  The National Highway Traffic Safety Administration (NHTSA) issued a report that these models have a positive battery cable that might rub against the hydraulic cooler reservoir-mounting bracket. This defect could lead to an electrical short, which in some cases could result in a fire. No information was given as to how many buses may be affected by this defect. The New York Times reported that up to 15,500 buses could be affected by this recall.

Navistar also plans to recall approximately 340 buses with model years 2011 and 2012 CE and RE manufactured from October 8, 2009 until April 14, 2011 because they were made without, or with improperly installed, floor channel reinforcements. This means the buses do not conform with seat back rear force displacements requirements and raise the risk of passenger rearward ejection.

In December of 2011, Navistar recalled certain model year 2012 International Durastar and IC Bus HC Heavy trucks and buses manufactured from February 10, 2011, through February 18, 2011, that were equipped with a Meritor MFS08 Series Non-Drive front steer axle. During the assembly process, the steering attachment bolts may have been insufficiently torqued. Insufficient torque of the steering arm bolts may result in bolt fatigue and fracture and/or arm separation, thereby potentially resulting in loss of steering control and increasing the risk of a crash. No injuries were associated with these recalls. Navistar plans to notify owners soon and work with them to repair the buses free of charge.

Our firm is currently investigating claims for those people who have been by a recalled Navistar bus. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

Knauf CDW Proposed Settlement Agreement

The proposed settlement agreement with Knauf filed with the Court last week is a complicated document and many people are asking a number of questions about it. A majority of the questions I have been asked deal with the so-called “cash out option” from the uncapped fund.

The cash out option will not be determined by dollar-per-square foot. The homeowner will need estimates for remediation of their home. One will be done by Xactimate and the other by another contractor which can be Moss. Xactimate is basically a computer program where the contractor will plug in certain information particular to that home. They will put in bids for the home and the homeowner will be able to view the bids online. The homeowner can take the higher of the two bids or 65% of the Xactimate bid. Typically Xactimate is a much higher bid than the regular bid. The homeowner will get a cash out equivalent to the bid he chooses minus $4.50 per square foot. This subtraction is roughly the difference in the $8.50 per square foot move out lump sum for homeowners in the pilot program because the homeowners who select the "cash out" poption are not moving out to have their home remediated.

There are some requirements for the cash out option. One, there cannot be a mortgage on the home or if there is, the homeowner must provide a release by the mortgagee or lien holder. Second, the homeowner must record the existence of reactive CDW in the local property clerks’ office, if permitted by local law. Third, the homeowner must covenant to inform subsequent purchasers of the home of the presence of KPT drywall. There is specific language in the settlement agreement that they must state under oath. 

As far as an approved remediation plan, that information is located in Exhibit F, starting at page 179 of the agreement, found here: http://www.laed.uscourts.gov/Drywall/12-21-11.kpt.global.settlement.pdf

It is almost exactly the same as the pilot program remediation plan (which is a somewhat different plan than the plan laid out in the Hernandez decision). The main difference between this plan and the pilot program plan is that all appliances in homes under 3500 square feet are automatically replaced. For homes greater than 3500 square feet, appliances are replaced if signs of corrosion are found. The theory is that homes over 3500 square have higher-end appliances such as Vikings, and the cost to replace these items is significant if they are not damaged or appear compromised by CDW. This really comes into effect when getting a bid for the self-remediation aspect of the settlement and does not truly effect the protocol for remediating a home.

It is unclear right now what to do about homes that have KPT drywall on only one floor or in an added bathroom, bedroom, expanded kitchen, etc. That scenario is not clearly addressed by the proposed settlement agreement. I would suspect that the homeowner would have to get a bid to replace only those areas affected by KPT drywall and can get an approved contractor to do the work.

New Medicare and Medicaid Self-Calculated Final Conditional Payment Amount Option

As many of us who practice personal injury law know, the new Medicare and Medicaid laws regarding subrogation interests for a personal injury settlement are time consuming and strenuous to deal with. Many consider these laws draconian in nature because of the harsh penalties that can be handed down on the injured victims and their representatives for even minor mistakes or omissions. In practice, clients want to know why it is taking so long for the release of their settlement funds and become frustrated at us because the government is holding up the process. Even when a case is in an MDL and the attorney has the benefit of a special master and an ombudsman to help, the process is still daunting. However, it looks like there are some new mechanisms on the horizon that will hopefully help alleviate this process for everyone.

The Centers for Medicare & Medicaid Services (CMS) will be implementing an option that will allow certain Medicare beneficiaries to obtain Medicare's final conditional payment amount prior to settlement. This option is scheduled to be available in February 2012, for certain settlements involving physical trauma based injuries where treatment has been completed. Under this option, the beneficiary or his representative will calculate the amount of Medicare's conditional payment amount using information received from the Medicare Secondary Payer Recovery Contractor (MSPRC), the MyMedicare website, or other claims information available to the beneficiary. The MSPRC will review this amount and, if finding the amount accurate, will respond with Medicare's final conditional payment amount within 60 days. To secure the final conditional payment amount, the beneficiary must settle within 60 days after the date of Medicare's response.

In order to use this option, ALL of the following criteria must be met:

1. The liability insurance (including self-insurance) settlement will be for a physical trauma based injury (the settlement does not relate to ingestion, exposure, or medical implant- basically disqualifying this option for almost all mass torts cases);
2. The total liability settlement, judgment, award, or other payment will be $25,000 or less;
3. The Date of Incident occurred at least six months before the beneficiary or his representative submits his proposed conditional payment amount to Medicare;
4. The beneficiary demonstrates that treatment has been completed and no further treatment is expected either through a written physician attestation or by certifying in writing that no medical treatment related to the case has occurred for at least 90 days prior to submitting the proposed conditional payment amount to Medicare

Explicit instructions on how to use this process will be posted on the Medicare Secondary Payer Recovery Contractor's website at www.msprc.info by January 15, 2012. CMS will leverage existing processes to the greatest extent possible. This is an initial step to provide beneficiaries and their representatives with Medicare's conditional payment amount prior to settlement. CMS plans to expand this option as it gains experience with this process. Hopefully, this option will be expanded both in the types of injuries and the amount of settlement.

GLOBAL SETTLEMENT ANNOUNCED FOR CHINESE DRYWALL KNAUF CLAIMS

On Thursday in New Orleans, Judge Fallon announced at the monthly status conference for the Chinese Drywall MDL that a global settlement has been reached with Knauf (KPT).　The settlement will include all plaintiffs who filed claims against KPT prior to December 9, 2011.

The final settlement document is not presently available.　It will be made public and posted on the Court's website December 20, 2011.

The general terms of the settlement were described as follows:

The homeowner will have three (3) options to choose from.

1. The homeowner can participate in a remediation performed by Moss Construction (essentially the same settlement as the pilot remediation program); or,

2. A self-remediation with a "qualified contractor" of the homeowner’s choosing; or,

3. A pure cash-out option. The cash-out option will not include the $8.50 per square foot for move out cost. In addition, the cash-out option will be provided at a $4.00 per square foot discount from the remediation cost.

Finally, the settlement will create a $30 million "other loss," fund. Plaintiffs can make claims against this fund for economic losses caused by Chinese drywall as well as claims for personal injuries. The economic losses envisioned for this fund include those homeowners who have been foreclosed on or were forced into a short-sale because of toxic and corrosive Chinese drywall.

In addition, Knauf has agreed to pay attorneys’ fees and costs up to $160 million. This option will make homeowners whole because attorney’s fees will not be taken out from this option.

There will be no details of the settlement until the settlement documents are released on December 20, 2011. A preliminary settlement approval hearing will be held on January 4, 2012. After that, it is anticipated that a fairness hearing will be held in front of Judge Fallon sometime in either June or July of 2012.

For those homeowners whose claims are already in the pilot remediation program, this settlement should have little effect on that process moving forward.

ACTOS LAWSUIT UPDATE

Actos, a prescription drug designed to help diabetes patients manage their blood sugar levels, is one of the best selling drugs in the United States, bringing in over $2.4 billion dollars in sales. Hundreds of thousands of people worldwide have taken Actos, but many may be unaware of the increased danger of bladder cancer that long-term usages of Actos can bring.

In early testing, Actos was found to provide only a small increase in the chance of contracting Actos bladder cancer while taking the drug. However, in September 2010, the FDA announced that Takeda Pharmaceuticals, the manufacturer of Actos, provided interim data spanning five years that suggests there may be a risk of bladder cancer the longer the medication is used. After 24 months, the rate of exposure and the increased Actos cancer risk reached statistical significance. In June 2011, an Actos recall was issued in France after health authorities ordered doctors to stop prescribing the drug due to the possible risk of bladder cancer.

Germany has also pulled the drug completely off of the market. The sale of Actos is still allowed in the United States at this time, but the FDA has issued a warning about the product and the risk of bladder cancer. The FDA has also ordered the manufacturer to change the wording on the drug’s warning labels. Despite the enhanced warning labels on the drug, this does not mean that patients who have contracted Actos bladder cancer after taking Actos long-term to treat their diabetes cannot file an Actos lawsuit.

Because of these new findings, dozens of Actos lawsuits have been filed by people seeking redress for their injuries. A class action lawsuit has recently been filed in Louisiana against Takeda pharmaceuticals claiming that information about the danger of Actos bladder cancer was suppressed or hidden from the general public. The Actos lawsuit also alleges that the manufacturer had significant financial incentives to try and prevent the spread of the information.  In general, anyone who was prescribed the drug is a potential class member of the Actos lawsuit, even if they did not contract Actos bladder cancer while taking the drug.

A motion was filed by plaintiffs’ lawyers in August to centralize the federal litigation over bladder cancer from Actos into an “MDL”. An “MDL”, or Multi-District Litigation, is a powerful tool useful in mass torts litigation and I have blogged extensively about the benefits of the procedure. Pittman, Dutton & Hellums has represented many injured plaintiffs in a number of MDL’s including In re: Total Body Formula, In Re: Chinese-manufactured Drywall and In re: DePuy Orthopaedics, Inc. ASR Hip Implant.

Although Takeda Pharmaceuticals has indicated they agree the lawsuits should be consolidated for discovery and pretrial proceedings, they disagree about where the cases should be centralized. The U.S. Judicial Panel on Multidistrict Litigation heard oral arguments for a motion for centralization of the Actos lawsuits on December 1, at their hearing session at the Tomochichi United States Courthouse in Savannah, Georgia. All lawsuits allege that defendants, including Takeda Pharmaceuticals, were negligent and failed to warn of the risks associated with the medication. The motion for the MDL was filed on August 31 by plaintiffs Glen and Nina Weant. Our firm filed a brief advocating for the MDL to be located in Birmingham, Alabama.

As a patient who was prescribed Actos, either for diabetes glucose management or any other reason, you need to be aware of the increased risk of Actos bladder cancer that taking Actos brings. If you have Actos bladder cancer, or believe that you may have Actos bladder cancer, please contact me at booths@pittmandutton.com or call toll free 1-866-515-8880.

Latest Alabama Supreme Court Ruling on Experts

On November 18, 2011, the Alabama Supreme Court issued an opinion in Springhill Hospitals, Inc. v. Critopoulos, No. 10909646.  After undergoing a cardiac-artery-bypass graft, Critopoulos was placed in the cardiac-recovery unit, where a nurse noticed that he had developed a decubitus ulcer.  A med-mal lawsuit was brought against several nurses and the hospital.  One contention was that the nurses allowed the development of the ulcer because they did not properly move or rotate him while he was bed-ridden.  The trial court rejected the defendants’ challenges that the plaintiff’s nursing expert was not “similarly situated.”  The jury found for the plaintiff as to all but one nurse and awarded $300,000 in damages.  The Supreme Court found that the expert did not qualify as “similarly situated.”  The expert was amply qualified in the area of wound-care management and pressure-ulcer prevention; she was a “big wig” at Duke Hospital. 

The Supreme Court concentrated on the fact that the care was rendered in a cardiac-recovery unit and involved the concerns and/or risks associated with a fresh post-CABG patient. They also honed in on the point that the expert, “had never seen an immediate post-CABG patient for preventive measures; that she had provided hands-on treatment to fresh postoperative patients only for would care; and that, at Duke, the cardiac-recovery nurses provided pressure-ulcer-prevention care for postoperative patients in the cardiac-recovery unit.”  The expert could not evaluate how unique factors in caring for this type of patient would influence decisions as to moving or rotating a patient.

This opinion demonstrates the need to have your expert look as much like the defendant healthcare provider as possible.  Critopoulos’s expert was clearly tops in the general field of pressure-ulcer prevention; still, the Supreme Court concluded that post-CABG patients are unique enough that the expert should be familiar with caring for such unique patients.  This opinion is consistent with a trend of opinions that hold that a generalist cannot qualify as a “similarly situated” healthcare provider when the defendant was practicing a specialized area of medicine.

Merck Wins Another Bellwether Fosamax Trial

Merck, manufacturer of the drug Fosamax, has declared itself the victor in the fifth bellwether trial concerning the product and a condition known as osteonecrosis of the jaw (“ONJ”). The Whitehouse, N.J., drug maker is facing hundreds of cases in state and federal courts, generally alleging that use of Fosamax can cause a jaw-destroying condition known as ONJ and that Merck failed to properly warn of this risk.

On October 3, Merck issued a press release announcing that “a federal court jury in New York found in its favor in the Secrest v. Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her FOSAMAX use.” Secrest v. Merck (case no. 1:06-cv-06292)—a so-called bellwether lawsuit—is the fifth lawsuit involving claims that Fosamax caused a plaintiff to suffer ONJ to go to trial. Merck, the developer and manufacturer of the brand-name drug, is currently defending thousands of Fosamax cases, including cases alleging that the drug caused users to suffer femur fractures, as well as ONJ cases. The cases involving femur fractures were recently transferred to a separate MDL.

Merck won three of the first four bellwether trials in the ONJ MDL. The first case to be tried to a verdict, Maley v. Merck, resulted in a defense verdict for Merck in May 2010; the second case to be tried to a verdict, Boles v. Merck, initially resulted in a mistrial in September 2009 after the jury was unable to reach a unanimous verdict and a retrial of that case in June 2010 resulted in a plaintiff verdict-which was later reduced by Judge Keenan and which Merck intends to appeal after the damages portion of the case is retried; the third case to be tried to a verdict, Graves v. Merck, resulted in a defense verdict for Merck in November 2010; and the fourth case to go to trial, Rosenberg v. Merck, which was tried in the Superior Court for Atlantic County, New Jersey, resulted in a defense verdict for Merck in February 2011.

The outcome is significant because bellwether trials are used to assist attorneys to evaluate similar cases for determining settlement talks and strategies. As of June 30, 2011, there were about 1,650 lawsuits, including approximately 2,050 plaintiff groups, that have been filed in federal and state courts.

Recent Alabama Opinion Regarding Contributory Negligence

In Lafarge North Am., Inc. v. Nord, No. 109062, six justices found that Nord was contributorily negligent as a matter of law; Malone, Woodall and Main dissented.

The records shows that Nord regularly picked up loads of cement bags at Lafarge’s cement packhouse, which had two loading bays.  Drivers would park their trucks in one of two bays and walk to an office “to receive [a] load assignment.”  A Lafarge employee, using a forklift, would load pallets of bags onto the truck’s flatbed.  Nord had parked his truck in the second bay and walked to the office.  Upon leaving the office and as he was walking across the first bay, the forklift operator backed up and ran over Nord’s foot.  The jury awarded Nord $125,000 in compensatory damages and $75,000 in punitive damages. 

All nine justices agreed that there was not even “substantial” evidence of wantonness.  The six-justice majority relied on the following in finding that Nord was contributorily negligent as a matter of law:  (1) due to his frequently picking loads at this packhouse, Nord was well aware that forklifts operated in the loading zone; (2) Nord knew that forklifts were dangerous machines that could injure a pedestrian; (3) Nord testified that he knew that it was a good safety practice to get the attention of a forklift operator when entering an area where a forklift was in operation before attempting to walk through that area and (4) Nord indicated that he could have taken an alternative route. 

The six-justice majority concluded that, with appreciation of the danger, Nord voluntarily entered into a dangerous situation.  Arguably, the most germane fact was that Nord failed to get the forklift operator’s attention despite Nord’s appreciation that the operator might not have known of Nord’s presence.

I must presume that we will see defendants rely on this opinion in future summary-judgment motions.  There was evidence that the forklift operator was not looking backwards as he was backing up but the majority concentrated on Nord’s failure to get the operator’s attention, as opposed to taking an alternative route.

FDA Actos Warnings

The drug Actos (pioglitazone hydrochloride) is used in the treatment of diabetes. Actos is used to control blood sugar levels in patients with Type 2 diabetes, which keeps the body from producing enough insulin to properly use the sugar in the bloodstream.  Type 2 diabetes can also cause the patient to become resistant to insulin.  Actos remedies this problem by making cells more sensitive to insulin, thereby making it easier for sugar to pass through the body.

The Food and Drug Administration (FDA) mandated a “Black Box” warning be added to Actos packaging in 2007.  A second FDA warning in June 2011 contained specific details of the risk of bladder cancer associated with Actos.

A recent study of 193,099 patients over a five-year period found that people who took Actos for at least 12 months or longer were 40 percent more likely to develop bladder cancer. A subsequent FDA Adverse Event report found that Actos was involved in one-fifth of all reported diagnoses of bladder cancer in diabetes drug users. At this time, however, Actos is still on the market and being prescribed by physicians. 

If you represent a client who has been diagnosed with bladder cancer after using Actos, we would welcome the opportunity to work with you on these cases.  Please contact Booth Samuels at booths@pittmandutton.com or at 1-866-515-8880.

Evaluating a Potential Fosamax Case: Part II

How should you evaluate a potential Fosamax case?

One important tool is determining whether the patient was diagnosed with osteopenia or osteoporosis at the time they were first prescribed Fosamax.

Osteopenia is a condition where bone mineral density is lower than normal. It is considered by many doctors to be a precursor to osteoporosis. However, not every person diagnosed with osteopenia will develop osteoporosis. More specifically, osteopenia is defined as a bone mineral density T-score between -1.0 and -2.5. This score is based on a deviation from the bone mineral density of a healthy 30 year old white woman. Any test result over a -2.5 will result in a diagnosis of osteoporosis.

In reality, osteopenia is an arbitrary diagnosis. It is an invented term to characterize women who may be at risk of osteoporosis and have lost some bone density. There is no real medical basis for developing this term or choosing that number. Many women are told they have osteopenia when they may never develop osteoporosis. The definition or term is controversial among the medical community. The patient’s diagnosis may not always be determined by a test result from a bone scan but from the doctor’s notes/diagnosis. However, if we find the test result fits in that -1.0 to -2.5 reading and the doctor prescribed Fosamax, it is almost a certainty that the doctor diagnosed the patient with osteopenia.

Because of the loose definition of osteopenia, the treatment for the ‘condition’ is even more controversial than the diagnosis. Many women diagnosed with osteopenia are treated with biosphosphates, including Fosamax. It is reported that half of all postmenopausal women are being told they had this "disease"—with the implication that they should begin taking drugs to treat it. These patients probably should not be treated with biosphosphates to begin with and better treatment would consist of monitoring by their doctors.

There are several reasons why the distinction between the two is important in evaluating a potential case. We know that osteoporosis patients are much more at risk for bone fractures, whereas osteopenia patients have almost as much risk for bone fractures than a healthy white woman age 30. An osteoporosis patient is much more likely to have a history of fractures, making the causation connection difficult. Also, an osteoporosis patient is probably on more medication than an osteopenia patient, thus making the causation connection even more difficult.

Our firm is currently investigating claims for those people who have taken Fosamax and have been injured. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or booths@pittmandutton.com.

AUGUST 26TH DEADLINE FOR FILING KNAUF CHINESE DRYWALL CASES

         

            The Plaintiffs Steering Committee has decided to file another Complaint for those homeowners who have drywall manufactured by the Knauf entities. The deadline to be submitted into the Multi-District Litigation out of New Orleans is Friday August 26. This may be the last chance to be included into the MDL. We believe that filing Knauf claims through the MDL is the most practical option for those homeowners affected by toxic and corrosive Chinese drywall.

            Knauf Plasterboard Tianjin is one of the biggest manufacturers of defective Chinese drywall. Most of the defective and toxic drywall was imported into the United States between 2005 and 2007. Due to the large scale rebuilding efforts on the Gulf Coast after Hurricanes Katrina, Rita, Ivan and other storms, builders imported drywall from China because there was not enough domestic drywall for their needs. However, corrosive Chinese drywall is not limited to only the Gulf Coast States, but has been found in places such as Virginia. Unfortunately, most of this Chinese drywall is toxic, corrosive and defective.

            Evidence of homes containing toxic Chinese drywall includes repeated AC coil failures, electrical issues, appliance failures, corroded wiring, tarnished fixtures and sulfur odors. Many toxic Chinese drywall homeowners are also afflicted with respiratory issues, nose bleeds, headaches and/or unexplained rashes. Those homeowners who previously experienced asthma or allergy problems have reported that their symptoms are much worse than before they moved into their Chinese drywall homes.

            To be included in this Complaint, a homeowner must obtain evidence or indicia of Knauf Plasterboard (Tianjin) Co. Ltd. (“KPT”), Knauf Plasterboard, (Wuhu) Co. Ltd. (“Wuhu”), or Guangdong Knauf New Building Materials Products Co., Ltd (“Dongguan”) as the drywall manufacturer (photos, inspection reports, etc.). Typically, these Knauf entities marked their drywall with the words “Knauf” or “Knauf-Tianjin” in dot matrix print markings.

            If you believe you have defective Chinese drywall manufactured by Knauf in your home and you suffer from the above mentioned home and health problems, please contact me immediately. This may be your last chance to be included in the MDL and you must act now. Although the Steering Committee is not filing claims for Taishan manufactured drywall, they are considering doing so in the future.

FOR A FREE CASE EVALUATION, CONTACT BOOTH SAMUELS AT BOOTHS@PITTMANDUTTON.COM OR CALL TOLL FREE 1-866-515-8880

ZIMMER KNEE CASES CONSOLIDATED FOR MDL

The Judicial Panel on Multidistrict Litigation issued a transfer order August 8th for In Re: Zimmer Nexgen Knee Implant Products Liability Litigation MDL No. 2272. There were 28 cases filed so far and the Panel was notified of more than 45 additional related actions. Counsel for Plaintiffs argued for centralization in the Northern District of Illinois, the Eastern District of New York and the Central District of California.

Counsel for Zimmer argued against centralization because the actions before the Panel implicated eight products, six different design teams, six different sets of design history documents and eight different 510(k) applications. Zimmer’s attorneys argued that discovery would not overlap among those actions and that these cases should not be consolidated for MDL purposes. In the alternative, they argued for centralization in the Northern District of Indiana.

The Panel, however, did not agree with Zimmer’s lawyers and ordered all pending actions transferred to the Northern District of Illinois. The Panel was not persuaded by Zimmer’s arguments about the distinctiveness of the various femoral components and ruled that an MDL does not require a complete identity or even a majority of common factual or legal issues as a prerequisite for transfer.

The Panel assigned the MDL to the Honorable Rebecca R. Pallmeyer. Besides citing that Judge Pallmeyer is an experienced and highly-regarded jurist, the Panel concluded that the Northern District of Illinois is an appropriate venue because 10 of the 28 pending actions are in that district and the district is relatively close to Zimmer’s Indiana headquarters.

The MDL will consolidate actions alleging that Zimmer’s “high-flex” femoral components (i.e., the Cruciate Retaining (CR) and Legacy Posterior Stabilised (LPS) components and the “Gender Solutions” versions) and the MIS Tibial components are prone to premature loosening, causing pain and loss of movement leading to revision surgery.

If you suspect that your implant may have loosened, it is important to see your physician. Your doctor will likely perform bone scans and X-rays to determine the viability of your implant. Our firm is currently investigating claims for those people who have Zimmer knee implants and have been injured. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.

Advisory Group Concludes that the FDA 510(k) Fast Track Medical Device Approval Process is “Fatally Flawed”

The Institute of Medicine (IOM) recently completed a yearlong audit of the 510(k) Medical Device Approval Process and reached shocking conclusions.

The 510(K) Approval Process has been around for 35 years and was enacted in 1976 when the FDA was given responsibility for medical devices. This process allows medical devices to enter the market if they are found to be “substantially equivalent” to products already in the market. Essentially, it gives medical device manufactures a means of by passing what would otherwise be a much lengthier and costly approval process. This way medical devices are able to reach the market sooner to the benefit of patients who in some cases, cannot afford to wait. Sooner means roughly a ten month process as opposed to possibly years of a complex testing.

Arguably a lot of patients benefit, however the lax review process does open the door to possible devastating results. For example, the failure the DePuy ASR hip implant which affected over 90,000 recipients of the hip with life altering health problems. There are of course many other examples, and certainly the risk is high for future issues considering the review process accounts for a shocking 90 percent of medical device applications. 

The IOM concluded that the 510(k) approval process is “fatally flawed” and argued replacing the entire process with a new framework. To support its conclusions the IOM claims that the process does not adequately protect patients nor does it promote innovation. Furthermore, it found that medical devices are able to enter the market by establishing substantial equivalency to much older devices that predate any complex FDA review. In other words, medical devices can enter the market by being compared to older devices that have never been tested to be safe. Finally, the IOM further stated that there is no sufficient means of monitoring the approved devices after they have entered the market. Thus, the IOM proposes that the current 501(k) approval process needs to be terminated all together. In its place, a new framework should be developed with a more comprehensive review process and a means of monitoring post-market data.

In response however, the FDA dismissed the IOM’s proposals. Rather the FDA is more focused on improving the current process than scrap it all together. One improvement suggested has been the development of a new category for riskier devices which may demand more heighted scrutiny than “substantial equivalence.” Whatever the outcome, the IOM’s radical report sheds light on the fact that countless consumers will remain vulnerable until something is done.

If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

MEDICAL COMMUNITY SHIFTS ITS STANCE IN RESPONSE TO APPARENT RISKS LINKED TO FOSAMAX

As evidence mounts that atypical femur fractures are linked to long term use of bisphosphonates, such as Fosamax, doctors are beginning advise their patients to discontinue its use after two to three years. Indeed, doctors must not only re think the length of time their patients take Fosamax, but perhaps they should re think to whom they prescribe it to as well.

Drugs like Fosamax were developed to make bones stronger and combat the detrimental effects of osteoporosis. The drugs were so popular that doctors began prescribing them not only to women with osteoporosis, but to those who were osteopenic, in other words those who are at high risk of developing osteoporosis. However, instead of delaying or preventing onset of osteoporosis, long term use of bisphosponates has been seen to make some women’s bones more brittle.

While reports may indicate that the causal link between bisphosphonate use and a-typical femur fractures has not yet been established, interestingly, recent conversations have switched not to whether the causal link exists, but the need to reduce the amount of time patients take the drugs and whether the benefits outweigh the risks. After all, in addition to the apparent risk of a-typical femur fractures, drugs like Fosamax have already been linked to severe musculoskeletal pain and osteonecrosis of the jaw, a condition where bone in the jaw begins to die due to poor blood supply.

Do the benefits outweigh the risks? Or, is the cure worse than the disease? There is no doubt that bisphosphonates increase bone mineral density, at least at the outset. In the early stages, the increased bone density may aid in preventing the more common hip and spine fractures suffered by many women with osteoporosis. Thus it’s not surprising that doctors would rather decrease the amount of time a patient takes a course of bisphosphonates rather than eliminate its use all together.

On the other hand, if one chooses to take bisphosphonates, the possible risks aren’t any better than had you elected to not take the drugs. Much like hip fractures common to those with osteoporosis, femur fractures are very serious. In fact, the femur is the strongest bone in the body, hence the oddity that some bisphosphonate users suffer a femur fracture by merely taking a step forward. Like hip fractures, the mortality rate for femur fractures is substantial. Compared to a mortality rate of 15% to 20% for hip fractures, the mortality rate for femur fractures is reported around 20% to 35%. Coupled with the other side effects liked to bisphosphonate use, it may be in a patients best interest to await more long term studies of the drug’s effects.

Our firm is currently investigating claims for those people who have taken Fosamax and have been injured. I you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

Banner Settles In Chinese Drywall Litigation

Judge Fallon last week gave preliminary approval to a $54.5 million settlement between Banner Supply and thousands of homeowners the company supplied with defective Chinese drywall. Most of the affected properties are located in Southwest Florida. Judge Fallon presides over more than 10,000 drywall cases merged in multidistrict litigation in New Orleans. However, like the Inex “settlement”, the preliminary approval does not mean it is a done deal.

Banner, based in Miami, purchased about 1.4 million sheets of Chinese drywall, but says it didn't know of defects. It is estimated that 3,000 homes in Florida have Chinese drywall supplied by Banner.

Meanwhile, some attorneys believe the settlement as it stands is full of unanswered questions and looks like a raw deal. Unless those questions are answered, they will advise their clients to opt out.

There have been many criticisms of the settlement including:

- An estimated payout of $4,000 to $6,000 per homeowner, way short of the amount of money needed to fix drywall-damaged homes.

Homeowners won't be told what amount they will receive until the deadline passes for them to decide whether to take the settlement. The deadline will be in mid-August.

- The settlement terms allow for attorney fees of as much as 32 percent of the $55 million, and no limit on administrative costs.

- Banner is not required to contribute its corporate assets to the settlement fund. The $55 million would come only from four Banner insurers: Chartis, FCCI Insurance Co., Hanover American Insurance Co. and Maryland Casualty Co.

Attorney fees are actually in the control of Judge Fallon. The amount fluctuates from hourly fees to percentages of 40 percent or more among the law firms involved. What Fallon has indicated is that he will not approve any fee that is more than 32 percent.

As to unanswered questions, Fallon will hold a fairness hearing before the settlement is finalized so anyone with objections can have them addressed.

In a statement provided by a spokesman, Banner attorney Michael Peterson of Miami said that Banner "has been severely harmed by misrepresentations made to it."

The toxic and corrosive drywall, imported mostly between 2005 and 2008, emits sulfur compounds that corrode air conditioning coils, electrical wiring, plumbing fixtures and other metal items in the home. Homeowners complain of health problems from respiratory illness to nosebleeds.

There are some dangerous consequences for those Plaintiffs who opt out of the proposed settlement. The biggest problem would be if Banner filed for bankruptcy and Plaintiffs had to pursue their claims through bankruptcy court, which could take years and yield nothing. Plaintiffs would be left holding the bag if no other defendants settles or if any judgment was uncollectible.The alternative of taking some money, no matter how little, looks like a much better decision than opting out of this settlement.

Venue Selection for Multi-District Litigation

             The use of Multi-District Litigation as an efficient method for handling complex litigation has been around since 1968 and is becoming more and more popular. Everything from the BP oil spill disaster to Chinese drywall to the DePuy hip recall has found its way into a Multi-District Litigation (MDL) setting. 

           

            Congress authorized the formation of an MDL in Title 28 U.S.C. 1407. Subpart (a) states that, “When civil actions involving one or more common questions of fact are pending in different districts, such actions may be transferred to any district for coordinated or consolidated pretrial proceedings.” Typically, litigation that qualifies for an MDL involve complex disputes between many similarly situated plaintiffs located in various districts across the country and common defendants. One of the advantages of an MDL is lower costs for litigation due to the streamlining of discovery and the cutting down of duplicative discovery. Another is that an MDL creates a forum where all parties are under one roof which helps to facilitate settlement. If settlement is not reached by a certain point, the cases filed in the MDL are transferred back to their respective venues for trial.

            An MDL setting is also beneficial to those plaintiffs who have filed similar claims in state court which are not acceptable for transfer to the MDL. Recently, an emphasis has been placed on coordination between the two jurisdictions, allowing for discovery coordination and settlement negotiations. An August 23, 2010 article on www.law.com emphasized this importance by reporting on In re Total Body Formula, an MDL assigned to Judge David Proctor in the Northern District. Judge Wong of DeKalb County Georgia presided over several similar lawsuits which were filed in Georgia state court. Judge Wong noted that District Judge Proctor actively promoted cross-jurisdictional cooperation and invited him to participate in the mass mediation that resulted in a settlement of the cases consolidated in the MDL and some of the cases pending in various state courts. The article noted that the lawyers appreciated the electronic document repository that the federal court created for all pending cases, whether filed in federal court or state court.

            As authorized under Title 28 U.S.C. 1407(d), the MDL panel consists of seven circuit and district judges throughout the country who are appointed by the Chief Justice of the United States Supreme Court. No two judges can be from the same circuit and a concurrence of four members of the panel shall be necessary for any action. Once civil actions are docketed with the MDL panel, the panel is tasked with making the decision of which venue to transfer the MDL. The MDL panel also decides the particular judge who will preside over the MDL in the chosen venue.

            Parties file memorandum briefs with the panel advocating for the transfer of the MDL to certain venues and even certain judges within those venues. Each filing party is also permitted to file a separate statement limited to one page setting forth reasons why oral argument should, or need not, be heard. Requests for hearings are typically granted, but oral argument is brief. A party is generally given no more than two to three minutes to present their oral argument in front of the panel.

            Multiple factors are considered by the panel in deciding which district court to assign an MDL. A list of what appears to be the most important current factors include: (a) significant pretrial progress of an action pending in the transferee district; (b) the docket conditions or resources of the transferee judge or district; (c) the geographic centrality or proximity of the transferee district to the filed actions; (d) the proximity of the transferee forum to relevant documents or potential witnesses; (e) the general experience of the transferee judge; (f) the familiarity of the transferee judge with the factual or legal issues in the MDL due to presiding over a previous action involving similar issues; (g) the accessibility of the transferee district court; and (h) the proximity of the transferee district to the conduct or event at issue.

            The panel has broad discretion in determining the district to which an MDL is transferred. The weight given to each factor depends on the issues and facts of the MDL. However, one of the most important factors appears to be the experience of the transferee judge. In In re Silicone Gel Breast Implants Prods. Liab. Litig., Docket No. MDL-926, the panel transferred pending breast-implant litigation to the Northern District of Alabama and assigned the litigation to Judge Samuel Pointer, a former member of the MDL panel, even though no action was currently pending in that district. The panel stated that they assigned the MDL to Judge Pointer because of his experience and ability to handle such an important and challenging assignment. Another important factor is the docket conditions of the transferee judge and district. In practice, the panel evenly spreads MDL’s throughout the country, thus ensuring that a single district is not strapped unnecessarily with a heavier load of multi-district cases.

            MDL’s can be a great avenue for your client’s case. They can potentially cut down on costs, expenses and time. Although determining where an MDL will be transferred is not an exact science, it is important to understand the factors that go into that decision.

            (portions of this post appeared in an article written by Booth Samuels

             for the Alabama Association for Justice Journal)

Evaluating a Potential Fosamax Case

How should you evaluate a potential Fosamax case? 

The length of time a person took Fosomax is likely the most important factor in determining whether a person has a claim. The magic number is five years. This number comes from an FDA warning issued on October 13, 2010 to patients and health care providers about the possible risk of atypical thighbone (femoral) fracture in patients who take bisphosphonates. According to the FDA warning, the optimal use of bisphosphonates use for osteoporosis is unknown and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years. Furthermore, the FDA recommends that health care providers consider periodic reevaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.

Why five years? While there is no doubt that use of Fosomax increases bone density that however “does not necessarily equate with good bone quality.” The problem is that “turnover is a natural part of maintaining bone health.” The use of Fosomax however reduces osteoclast activity and bone resorption. As a result, bone formation is also reduced, thus over a long period of time microdamage, that naturally occurs in bones, that would otherwise be normally repaired by the body, begins to accumulate.  

What is also significant is that merely ceasing to take Fosomax or its generics, does not remove a person from the adverse effects of Fosomax. To the contrary, biphosphates, such as Fosomax, are stored in a person bones for up to ten years. In effect, early studies indicated that alendronate accumulates in the bone and re-circulates when bone containing the alendronate is remodeled. In fact, this quality was originally touted as one of the possible benefits of alendronate because “many years of treatment may produce self-sustaining concentrations.” (Study funded by Merck). Interestingly, this very same article published in 1998 noted that while the effects of alendronate may continue after a person has stopped treatment, “if alendronate were to cause an adverse effect that has not yet been recognized, endogenous exposure to alendronate would also continue after stopping treatment.” Thus, Merck clearly knew as of 1998 that absent studies of the long term effects of alendronate, Merck would essentially be gambling by continuing to manufacture and distribute Fosomax.

Our firm is currently investigating claims for those people who have taken Fosamax and have been injured. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.