1-800 bad drug.
Article Type: Editorial
Subject: Pharmaceutical industry (Marketing)
Pharmaceutical industry (Cases)
Products liability (Cases)
Patient advocacy (Economic aspects)
Author: Gaby, Alan R.
Pub Date: 07/01/2012
Publication: Name: Townsend Letter Publisher: The Townsend Letter Group Audience: General; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2012 The Townsend Letter Group ISSN: 1940-5464
Issue: Date: July, 2012 Source Volume: 348
Topic: Event Code: 240 Marketing procedures; 980 Legal issues & crime Advertising Code: 94 Legal/Government Regulation Computer Subject: Company marketing practices; Company legal issue
Product: Product Code: 2834000 Pharmaceutical Preparations; 9914450 Product Liability NAICS Code: 325412 Pharmaceutical Preparation Manufacturing SIC Code: 2833 Medicinals and botanicals; 2834 Pharmaceutical preparations
Geographic: Geographic Scope: United States Geographic Code: 1USA United States
Accession Number: 297056603
Full Text: Anyone who watches television these days has seen the seemingly endless barrage of advertisements from law firms encouraging people who believe that they have been harmed by certain medications or medical devices to sue the manufacturers of these products. People who are being urged to file lawsuits include those who took Avandia (a diabetes drug) and later suffered a heart attack, patients who took Actos (another diabetes drug) and then suffered bladder cancer, people who took Pradaxa (a blood thinner) and later had a serious bleeding episode, individuals who took a bisphosphonate (a class of osteoporosis drugs) and subsequently experienced an atypical fracture of the femoral shaft, and women who suffered complications from the implantation of a vaginal mesh (used to treat stress incontinence and uterine prolapse). It now seems that the number of ads encouraging us to seek financial compensation for our medical mishaps is almost as great as the number of ads enticing us to take various dangerous medications. The irony is probably lost on most people that, in order to win the medico-legal lottery, one first has to lose a game of medical Russian roulette.

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Some of the class-action lawsuits being promoted by the 1-800-BAD-DRUG lawyers are no doubt meritorious. There have been instances, for example, in which pharmaceutical companies apparently knew about certain risks associated with a particular medication, but withheld that information from the public. In those instances, patients who were injured seem entitled to both compensatory and punitive damages. However, it appears that many of invitations to sue amount to little more than a shakedown of the pharmaceutical industry by the trial lawyers.

Consider, for example, the bisphosphonate drugs. According to one study, the use of a bisphosphonate was associated with 47-fold increase in the risk of experiencing an atypical fracture of the femoral shaft, although the absolute risk was small (5 cases per 10,000 patient-years of treatment). While bisphosphonates might eventually be proved to cause this type of hip fracture, the available evidence to date has been obtained from observational studies, and therefore cannot prove causality. Moreover, I know of no evidence that pharmaceutical companies were aware of this potential adverse effect and withheld it from the public.

I am not a fan of the pharmaceutical industry have repeatedly chastised it for selectively presenting and interpreting medical research in order to cast natural medicine in a bad light, for ignoring or suppressing potentially valuable treatments that are not highly profitable because they are not patentable, for paying generic-drug companies to delay the introduction of cheaper versions of drugs for which patents have expired, for exerting excessive influence over medical education, and for showering doctors with gifts and other thinly veiled bribes. It is tempting to want to bask in a feeling of vengeance as the trial lawyers hand the drug companies their comeuppance.

However, the situation is not as simple as that. No medication is entirely safe, and some drugs are more dangerous than others. Everyone is aware of that fact, or at least everyone should be aware of it. Except when drug companies purposely withhold information, the known risks and side effects of prescription medications are clearly spelled out in the Physicians' Desk Reference and other publications. There are many safe options for osteoporosis treatment, including nutritional supplements, bioidentical hormones, weight-bearing exercise, and strontium therapy. If people expect to be compensated financially every time that there is a bad outcome, they might fail to exert due diligence regarding their personal decisions, which would include seeking the safest options that are appropriate for their particular situation.

I am not suggesting that tragedies do not occur; nor am I arguing that people who suffer injuries as a result of trusting their doctor's advice "got what they deserved." Rather, I am suggesting that the current system with respect to medical-product liability may not serve the interests of the public. In this system, trial lawyers and a small group of lucky/unlucky patients siphon off large numbers of health-care dollars, patients are not properly incentivized to investigate the risks associated with their treatments, the pharmaceutical industry factors in product liability as a cost of doing business and jacks up drug prices accordingly, and health insurance premiums rise as a result.

The "safety net" that the current tort system purports to provide is largely an illusion, since in the aggregate it makes us less safe. A series of "safety nets" that are piled one on top of another can eventually morph into an impenetrable web that threatens to trap us. I would gladly give up my right to seek compensation for bad outcomes (other than those resulting from fraud or obscenely gross negligence) in exchange for a modest reduction in the cost of health insurance.

Alan R. Gaby, MD
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