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.

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[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.