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            As we are sure you can tell from many of our posts – we are television junkies (well, most of us).  We watch it all – comedies, dramas, news, sports, movies, documentaries, and yes, we’ll even admit to some knowledge of reality TV.  And while we are sitting on the couch taking in all that our high definition television can throw at us, we are at fairly low risk of injury – carpal tunnel remote control syndrome?  But, once we stand up and start moving around, all of that changes.  There is a risk we’ll stub our toe on the coffee table as we head to the kitchen to refill the popcorn bowl.  There is a risk of getting into a car accident driving to the movie theater (to again sit and become lost in another visual story).  There is a risk of choking on our hamburger at dinner following the movie.   
            Sometimes, like the examples above, the risks are things we just inherently know exist.  Other times, we need some additional warning.  Like the sign on our ride to work that warns of fog ahead or caution tape around a broken sidewalk.  How about a food label that says the product contains nuts – a warning to someone with a peanut allergy to avoid that food.    Bottom line — we are surrounded by risks.  And in our everyday lives, we make decisions about how risk averse we want to be.  Will we walk around the broken sidewalk or jump over the caution tape?  But, if we decide to walk through rather than around, maybe because going around requires us to step into the street, presenting its own risks, we have to accept the fact that we might trip and fall on the broken concrete. 
            The same is every bit as true in the context of prescription drugs.  We don’t need to belabor the point that all prescription drugs contain risks.  All prescription drugs have side effects, that’s why they require a doctor’s prescription in the first place.  Where we rely on our own knowledge and experience in deciding whether the broken sidewalk or the street present the greater risk of injury, with prescription drugs we rely on our physicians.  When the drug label warns of a risk and the doctors are aware of the risk but decide that it is in the patient’s best interest to administer the drug in light of the risk and then the patient develops the very risk warned about – it is unfortunate but it is not a basis for liability against the drug manufacturer.
            So said the Connecticut Superior Court in Zelle v. Bayer Healthcare, LLC, 2012 Conn. Super. LEXIS 481 (Feb. 16, 2012).  Plaintiff was admitted to the hospital with symptoms that caused doctors to believe she was having a stroke.  The doctors ordered two MRIs, one with and one without contrast agent.  The contrast agent contains a known and warned of risk of anaphylactoid allergic reaction.  After administration of the agent, plaintiff did exhibit signs of an allergic reaction including respiratory arrest and hypotensive shock.  Plaintiff was treated for this reaction and released from the hospital.  Id. at *2-3.  Plaintiff alleged both failure to warn and design defect under the Connecticut Product Liability Statute and both claims were dismissed on summary judgment.
            First, failure to warn fell based on the learned intermediary doctrine.  The evidence of warning in this case was abundant.  It was documented in the label under the warnings, precautions and adverse reaction sections.  Id. at *13 n.4.  It was well-known by the doctors and nurses:

     The deposition testimony of each of the physicians and the MRI technician leave no doubt that they were well aware of the possibility of adverse effects as noted in the FDA approved warnings and had for years been well aware of the specific risk of an anaphylactic reaction to the contrast agent. Each confirmed that they had considered the risks versus the necessity to diagnose and treat a possible stroke and determined that the MRI with the contrast agent should be ordered.

Id. at *15.  In other words, the doctors decided to walk through the broken concrete (use contrast agent) because the risk of stepping into a busy street (the stroke) was greater.  Indeed, precisely due to this potentially fatal risk with the contrast agent, the doctors at the facility kept a “crash cart” in the MRI room.  Id. at *22.   
          The court also found that the “plaintiff [did] not present evidence or testimony that contradicts the adequacy of the warning, the nature of the warning, the approval by the FDA or the knowledge and understanding of the warnings by the treating physicians.”  Id. at *15-16.  In fact, apparently, plaintiff’s only “proof” was an unsigned consent form which the court found not only irrelevant, but detrimental to plaintiff’s argument:

the [learned intermediary] doctrine is applicable to the warnings being provided to the physicians and health care professionals and it is not relevant for purposes of this action whether the defendants provided specific warnings directly to the plaintiff.  What the testimony and existence of the Consent Form does confirm is that the health care professionals had specific information concerning the adverse reactions as evidenced by the inclusion of these reactions within a form created by the hospital. Therefore, the plaintiff’s reliance upon the unsigned form to create a genuine issue of facts is misplaced. 

Id. at *12-13. 
            The court then turned to the design defect claim.  In dismissing the claim, the court made two good points.  First, plaintiff needed an expert to establish both the alleged design defect and proximate causation: 

     In an action involving the complications of prescription medication . . . where the claims are either scientific or medical, an expert opinion is required to discuss the development, manufacture, testing, handling and marketing of the product alleged to be defective.  Id. at *19-20.

. . . .

A finding of a defect in the drug is not within the common knowledge of an ordinary person. Without an expert as to the allegations that the product was in some manner defective causing serious unexpected and unforeseen physical injuries, the plaintiff has not been able to forge a sufficient link in the causal chain that would assist a jury in reaching an educated finding that the injuries were caused by a defect in the [drug] which was administered to her.  Id. at *23.

That was enough to grant the defendants’ motion for summary judgment.  But the court also had this to say about design defect in the context of a warned about risk:

[T]he plaintiff’s allegations about the adverse effect of the drug which is noted in the product labeling information approved by the FDA does not, by itself, rise to the level of a defective product. Many courts have recognized that prescription drugs can cause adverse effects but do not create liability in every instance where there is an adverse effect. This is especially relevant for an action in which the plaintiff alleges she has suffered the adverse effects noted in the product labeling. This recognition impacts the plaintiff’s obligation to prove not only that there are adverse impacts but that the plaintiff suffered because the drug was defective and the defect caused other adverse impacts or heightened in some manner the adverse impacts already recognized and addressed through precautions or warnings.

Id. at *21-22 (emphasis added).  Suffering from a warned about risk isn’t enough.  Even if the allergic reaction was connected to the injection of the contrast agent, that by itself does not create a defect.  Id. at *22.  As the court noted, “the product labeling . . . recognized the possibility of this exact reaction from a non-defective drug.”  Id. at *24.  Therefore, without expert testimony of a particular defect in the product, all plaintiff has proven is that she suffered from one of the potential, known, warned about side effects of the drug.  She tripped on the broken concrete.  Unfortunate, yes. A basis for liability, no. 

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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