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.