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.