How would you feel if you were harmed by a medicine you took as prescribed and then learned that the drug company wasn’t liable — even though it knew about the risk and didn’t tell you or your doctor?

This is exactly what has happened in the case of Fosamax (alendronate), a drug used to treat bone-thinning osteoporosis and osteopenia. After it was approved by the Food and Drug Administration and women across the country began taking the drug, the FDA and its maker, Merck, started receiving reports about spontaneous fractures of the thigh bone among women taking the drug.

These fractures, dubbed “Fosamax fractures,” happen with no warning and usually require surgery. Although they are a rare side effect of the drug, millions of women have taken the drug. While the true number of Fosamax fractures isn’t known, about 500 women have sued Merck for failing to warn them about the risk of this painful and possibly debilitating side effect. These lawsuits are at the heart of a case, Merck, Sharp & Dohme Corp. v. Doris Albrecht, et al., that will be argued before the U.S. Supreme Court on Jan. 7, 2019.

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MedShadow Foundation, the nonprofit organization I founded in 2012 to inform the public about the side effects of medicines, along with three former FDA officials, filed an amicus curiae brief in support of Albrecht, the defendant in the case. Such “friend of the court” briefs are filed by individuals or organizations that aren’t parties in a case.

Merck acknowledges that Fosamax caused these fractures and that the company knew about them. In 2008, Merck started the process to get the FDA’s permission to put a warning on the drug label — the inserts that come with all medicines, providing information such as instructions on how to take a drug, what it can be used for, and warnings. The FDA reviews and must approve any information on drug labels for accuracy. These labels are generally considered fair warning to users about possible side effects or adverse events and, in that way, provides legal protection for drug companies from being sued for causing them.

The FDA relies on manufacturers to update and make changes to drug labels throughout the lives of their drugs. That’s because approvals for new drugs are often based on small clinical trials of 1,000 or fewer people that normally last less than a year. Unusual or rare side effects and can’t be detected in such small, short-term trials. Once a drug is approved and thousands or millions of people are taking it, new side effects and adverse events can emerge.

The spontaneous fractures caused by Fosamax didn’t begin appearing until the drug had been on the market for five years. And these fractures aren’t the only significant bone problems linked to the drug. Cases of osteonecrosis (literally “bone death”) of the jaw, a painful condition where jaw bones become exposed, were reported by people taking Fosamax. In 2013, Merck agreed to pay $27.7 million to settle 1,140 lawsuits from individuals who alleged that Fosamax caused them to develop this condition.

Pharmaceutical companies have the best access to reports of adverse events, and they pay attention to updating drug labels as an important patient-protection safeguard.

When Merck applied to the FDA for a label change to reflect these fractures, the FDA rejected its request. Why? Because Merck described them as stress fractures, which are minor and quite different from far more serious spontaneous fractures. A stress fracture is an incomplete bone break that is generally treated by rest and inactivity. A spontaneous fracture is a complete break that occurs in a seemingly normal bone without any trauma and must often be repaired with surgery.

Although drug companies are responsible for updating labels, the FDA can require updates. In 2010, the FDA convened a panel to review the increasing number of reports of Fosamax-related spontaneous fractures. After reviewing the research, the panel found a clear connection between Fosamax and spontaneous thigh bone fractures. The FDA then ordered Merck to change the label.

The women suing Merck claim that the company failed to warn them about a known adverse event. Merck is claiming that the FDA did not allow the company to change the label, making it impossible for Merck to warn women or their doctors.

If Merck prevails, the disingenuous tactic it used for Fosamax could be replicated by other pharmaceutical companies and have far-reaching effects.

Suppose a pharmaceutical company discovers that one of its drugs causes a serious adverse event. The company files an application for a change to the drug label, but knowingly designs the change so the FDA won’t accept it — either by minimizing the risk of the adverse event or by not accurately reflecting the risk. The drug company could then claim it isn’t liable for not warning consumers about that adverse event because the FDA denied the label change.

If the Supreme Court allows drug companies to circumvent the law this way — which is what Merck is attempting to do in this case — it would remove the motivation for pharmaceutical companies to provide the FDA with timely and transparent information.

MedShadow Foundation is a small nonprofit with limited resources. Yet we have taken on the costly and time-consuming process of filing an amicus brief because we believe that pharmaceutical companies cannot be allowed to obscure the risks, side effects, and adverse events of drugs — or exaggerate their benefits.

The foundation’s mission is to protect quality of life by ensuring that people have all the known information about side effects before deciding to take a prescription or over-the-counter drug. Today, pharmaceutical companies are motivated to reveal previously unknown risks and warn the medical community so they can’t be sued for damages. The FDA and the law must maintain that obligation to protect people from unnecessary harm.

There will always be some risk with medicines, but consumers have the right to all the information about benefits and risks of drugs — whenever that information is discovered — so they can make informed decisions about their health and well-being.

Suzanne Robotti is the founder and president of MedShadow Foundation and the executive director of DES Action USA. She is also the consumer representative on the FDA’s Drug Safety and Risk Management Advisory Committee. MedShadow Foundation does not accept funding from pharmaceutical or medical device companies.

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  • I am crying as I read Vicki’s comments. I am caring for my mom who has now suffered her third break. And yes, this one is the hip/femur area just like Vicki’s.
    First the ankle, second the sacrum and now the spontaneous fracture in the hip requiring a rod down the femur to “nail” the hip. I am telling every woman I know DO NOT take these drugs. The side effects are not worth it! As a caregiver I can attest to the pain and debilitating fractures that are caused by this drug. Eat healthy, eliminate processed foods, and exercise. But my Mom did all these things and still fractures, I am a firmly convinced caused by these drugs. Please tell everyone!

    • Hello Diane, I am so sorry about your mom. There is nothing like the pain one suffers with one of the spontaneous fractures such as this. I am part of an online support group for those that have already suffered the femur fractures such as your mom (It is not a “hip” fracture most likely, but sadly many hospitals use the wrong code and wording when they see a gray-haired person present with a fracture–they assume!!) The support group was begun by a female doctor who had suffered from Fosamax, the first Bisphosphonate drug on the market. I know she would be able to answer any questions you may have. Her contact is: jennifer@jenniferschneider.com and tell her how you found out about her. She is amazing and the support group (for only those who have already suffered the fractures) has been my lifeline in this decade long journey of pain and lost quality of life.

  • I am interested in any follow up of this case regarding fosamax, or any of the other biphosphonate drugs used to treat osteoporosis. I have taken them in the past. Now I am on prolia. I have recently read of similar reactions regarding this drug. I want to stop it, but read warnings about stopping it without starting something else. My doctor told me prolia was not in the same class of drugs, but I believe it has the same long term side effects- regarding femur fractures and jaw bone death. I am having joint pain which I’ not sure is related to this drug. If you have any current information on Prolia, I would like to read about it. I perform dexa scans at my job. Thank you.

    • Prolia is not the same class, but the side effects are the same!! Why don’t doctors understand that?? I have to give the Amgen credit because they do prominently state in the patient insert and their ad that femur fractures happen. Those of us who suffered–and I do mean suffered–traumatic, spontaneous snapped femurs (as well as other bones) have used Forteo. It is not for everyone, but it does create new bone. It is limited to a 2-year Rx and is a daily injection you give yourself. Depending on your other health issues or history, it may not be for you, but it is worth the conversation. I warn people as often as I can because so many lives were destroyed by these drugs. I know they have helped people, but the long-term prescription (and with what I know even though they say 5 years is OK, we have people in our support group who fractured just shy of taking the drugs for 4 years) should never, ever happen and NEVER for “osteopenia!” This is a list of some side effects, but of course there are others. (https://www.rxlist.com/prolia-side-effects-drug-center.htm) If you are having thigh/leg/foot pain, get an MRI (not x-ray) ASAP as this pain is usually caused by the sneaky stress fractures that are lurking and could snap at any given moment. Stress fractures are missed a lot on regular x-ray. I hope this helps and I hope your future is not diminished in any way. Do not put off taking care of this issue. The only advocate for any patient is the patient.

    • Prolia is as bad if not worse because you can sustain a femur fracture even quicker if you do stop it. Adding more Bisphosphonate drugs after it will do multiple layers of damage. Forteo may be your only option and since you are experiencing pain in the thigh area you need an MRI to determine if you have a stress fracture already. Stress fractures sometimes do not show up at all on regular x-rays. You are indeed in a precarious situation as your doctor has done you no favors . I am part of an online support group for those that have already suffered the femur fractures. The was begun by a female doctor who had suffered from Fosamax, the first Bisphosphonate drug on the market. I know she would be able to answer any questions you may have. Her contact is: jennifer@jenniferschneider.com and tell her how you found out about her. She is amazing and the support group (for only those who have already had the fractures) has been my lifeline in this decade long journey of pain and lost quality of life.

  • My Dr. had me on Alendronate sodium Tabs- 70 mg for many years. Within the last 1 1/2 years, I had 3 compressure fractures in my back. I’m still having pain & can’t do much work.

  • I had two spontaneous, complete, traumatic femur fractures in 2009, which occurred within a three-month time span. In between those fractures for which I had surgery to insert rods, spend weeks in rehab and lost a lot of blood to the point of needing a transfusion, a vertebral disk fractured. 17 months later, with non-healing of the femur, I had to have the left femur re-rodded. Finally, it healed 10 months later. Then, I began having mid-foot metatarsal fractures a total of 5. Taking more than 26 months to heal!

    My bones have been destroyed–I never had Osteoporosis, and there is no such disease as Osteopenia, but doctors scared women into taking the drug to “save their life and not get old!

    My life has been altered beyond belief. Our savings was used for deductibles, co-pays and I had to retire early from a job I loved. My husband has been wonderful through all this, but this is not the life we planned.

    Now I have daily pain with Fibromyalgia, most likely brought on by the trauma and stress, and have bursitis in both hips constantly due to the top screws of the rods rubbing the trochanteric bursa with every movement. Isuffer from neuropathy in both legs and feet that the neurologist found comes from the leg surgeries and not from the spine.

    Those of us who have gone through this–and thousands more did not join the mass torte suits, but have been dropped because even though they were never warned and were on the long drug before the warning label appeared in Oct. 2010 their fractures happened after that date.

    We were used as guinea pigs and will die earlier than we might have due to our current health and the need to medicate with other drugs to have any quality of life.

    We will not win. The Supreme Court will vote for corporate America and leave us to suffer further. We want the healines about what they did more than the money. This is big news, but it doesn’t get heard.

    Thank you for what you do.

    • Vicki, I am so sorry to learn of what you have been through. Capitalism hurts people in so many, many ways and this is one horrific example.

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