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.

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.

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.

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.

U.S. SUPREME COURT RULES IN FAVOR OF GENERIC DRUG MANUFACTURERS

A landmark Supreme Court ruling limiting liability for generic drug makers will have a significant negative impact on litigation brought against makers of generic drugs.

In June, the U.S. Supreme Court struck down the lawsuit of Gladys Mensing, who sued a manufacturer of generic Reglan (metoclopramide) after developing a severe and permanent neurological side effect. The court ruled that the defendant Pliva Inc., was not responsible for her health problems because the company accurately reproduced the warning label distributed by the brand name manufacturer – the party liable under federal law for previously undisclosed side effects.

In a 5-4 decision, The Court reasoned that state law failure-to-warn claims against generic drug manufacturers would require greater warnings than those approved by the Food & Drug Administration (“FDA”) for the brand name version of the drug and are preempted by the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (the “FDCA”), which require that the generic drug’s label warnings must be the same as those of the originally approved branded drug. The Court specifically found implied conflict preemption here because “[i]f the [defendants] had independently changed their labels to satisfy their state-law duty,” according to the Court, “they would have violated federal law.”

In the wake of Pliva, Inc. v. Mensing, it may be that generic manufacturers are free from liability when it comes to “side effects” litigation. Millions of Americans take advantage of generic drugs because generic manufacturers produce drugs that are almost always considerably cheaper, but just as effective as the brand name equivalent. One of the reasons for low costs is that generic drug makers are free from research and development costs. The Supreme Court ruling may serve to continue that trend.

This decision means that generic drug manufacturers can rely on a federal preemption defense to defeat state law failure-to-warn claims so long as the generic drug label at issue has met the federal requirement of being identical to the corresponding brand-name drug label.

Justice Sotomayer dissented and stated that, "As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: This out-come 'makes little sense.'"

Pfizer Spend $3.8 Million Lobbying in First Quarter

In our globalised world, there are few industries that come close to the pharmaceutical industry in the reach and the impact it has on the lives of ordinary citizens. Economic heavyweights can easily get their voices heard within political arenas, because economic and political interests are always intertwined. Pfizer is said to be the most powerful political lobbyist of the pharmaceutical industry, and the drug giant is constantly using this power to influence regulations, laws and policies that suit its own interest. Pfizer Inc. spent $3.79 million in the first fiscal quarter this year lobbying the federal government on issues from drug pricing and patents to tax rates and aspects of the 2010 healthcare overhaul, according to a quarterly disclosure report.

Pfizer, the world's biggest drugmaker by revenue, lobbied on Medicare prescription drug coverage and rebates paid for drugs bought through Medicaid, reform of patent laws and handling of patent disputes, and implementation of the health care overhaul. It also lobbied on extending and improving the federal tax credit for research and development spending, taxes on repatriation of income earned overseas and deferral of taxes on some earnings.

Pfizer lobbied on free-trade agreements with Korea, and on market access and regulatory issues involving the E.U., Japan, India and other countries. It also lobbied on the fees the government charges to review and approve experimental drugs, rules for producing generic versions of biologic drugs, and on research required under the health overhaul to compare effectiveness of drugs and other treatments.

Pfizer also sought to influence legislation concerning ways to fight the growing problem of microbes becoming resistant to drug treatment, and on rules restricting sales of cough medicines containing the ingredient dextromethorphan, which is included in over-the-counter medicines such as Robitussin.

Pfizer has not only been lobbying Congress and the White House, but other government agencies whose list reads like an alphabet soup. Pfizer lobbied the Food and Drug Administration, the Patent & Trademark Office, the Centers for Medicare and Medicaid Services and the Departments of Commerce, State and Health & Human Services, according to a disclosure report filed April 20 with the House clerk's office.

A federal law enacted in 1995 requires lobbyists to disclose activities that could influence members of the executive and legislative branches.

NEW WARNING LABEL FOR FOSAMAX

As a result of ongoing investigations regarding Fosamax and use of bisphosphonates (BPs) to treat osteoporosis, the FDA has announced that the risk of atypical fractures of the thigh will be added to the Warnings and Precautions section of all labels of BP drugs.[1] Specifically, these atypical fractures are known as subtrochanteric and diaphyseal femur fractures. Recent studies strongly suggest there is a causal link between people who take BPs and the increased risk of these atypical fractures.[2] Furthermore, not only are people who take BPs put in greater risk of fracture, these particular types of fracture are especially more dangerous than more common femur fractures.[3] Additionally, the use of BPs results in longer and more complicated healing of the bone.[4]

What is a subtrochanteric and diaphyseal femur fracture?

Aytpical subtrochanteric femur fracture is a fracture occurring on the shaft of a femur immediately below the lesser trochanter. That is, right below the hip joint. These fractures are not common, rather they account for about only 7% to 10% of all “hip/femoral diaphyseal fractures.”[5]  Furthermore, given the unique nature of this fracture, special implants are required in order for the fracture to heal, and they are also more susceptible to malunion or nonunion. Additionally, those affected are liable to suffer long term effects. One study indicated that after 2 years, about 50% of persons who suffered a subtrochanteric fracture did not recuperate their pre-fracture walking abilities and faced difficulties performing routine activities.[6] A total of 71% could not live in the same conditions as they lived previously. [7]

A diaphyseal fracture on the other hand, is a fracture that occurs on the main or midsection of the femur. These of course are one of the more common fractures. What is significant however is that these fractures are more typically associated with high trauma incidents, whereas people taking BPs have incurred these fractures as a result of little to no trauma.[8]

In general there are also other features seen in people taking BPs that make these particular subtrochanteric and diaphyseal fractures atypical. First, the fractures are transverse, that is a straight break perpendicular to the shaft of the femur, or it is a straight angled break.  Second, the breaks are clean, in that the bones are not crushed or splintered as you would expect from high trauma breaks. Third, incomplete fractures tend to occur on the lateral side of the femur. Finally, more minor features include patients whose bones show evidence of an increase in the thickness of the femurs wall, delayed healing, and patients also report that weeks prior to the fracture they experienced symptoms such as dullness and aching in their groin or thigh. 

What’s the cause?

While it remains unclear whether BPs are the cause of the unusual femur fractures, the evidence has certainly convinced the FDA to prompt these new warning label requirements. What studies show is that BPs do increase bone density and strength, that is after all exactly what they prescribed to do. That increased strength and density however is achieve by reducing bone turnover. That means essentially instead of  the “out with the old, in with the new,” as is the case for normal bone “remodeling,” it is more like, “keeping the old, and piling on the new.” The problem however is that bones naturally incur cracks and micro damage, which is in turn naturally repaired by the body through the process of remodeling. Absent remodeling which is suppressed by the BPs, micro damage begins to accumulate. Over time, the end result is a thicker, much denser bone, albeit one that is less structurally sound, thus the increased risk in these atypical fractures.

In the short run, it may be that using BPs to combat osteoporosis is an effective treatment. However, for those patients unaware of the risks associated with BPs, like those who have been affected by Fosamax, evidence indicates that whether a person should undergo long term treatment requires a careful assessment of the risks versus its benefits. For this reason the FDA specifically recommends that health care professionals reevaluate a patients need to continue BP therapy, especially in those when have been treated with BPs over five years.

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 toll free at 1-866-515-8880 or at booths@pittmandutton.com.

---

[1] US Food and Drug Admin. FDA Drug Safety Commc’n: Safety Update for Osteoporosis Drugs, Bisphosphonates, and Atypical Fractures (2010).

[2] Shane E, Burr D. Ebeling PR, et al. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Report of a Task Force of the American Society for Bone and Mineral Research. 25 J. Bone Miner. Res. 2267 (2010).

[3] Id. at 2272.

[4] Id. at 2271.

[5] Id. at 2272.

[6] Id.

[7] Id.

[8] Id. at 2268.