“The story you are about to hear is true; the names have been changed to protect the innocent.”  Well, not exactly, we don’t change the names but we try to give you the facts.  Just like Sgt. Joe Friday, we seek facts (note that our title is the phrase actually used by Jack Webb in the series Dragnet, whereas the more well known “just the facts, ma’am” was popularized by a spoof performed on Ed Sullivan’s Talk of the Town).  As defense lawyers, we immerse ourselves in facts.  We learn all the details of the plaintiff’s medical history, employment history, education.  We learn all the details of the alleged injury or disease – we know the risk factors, other potential causes, treatments and projections.  We particularly like it when courts are as interested in the facts as we are.  As were the courts in two cases decided last week; one on a motion to dismiss and the other on a motion for summary judgment.  But, both centered on design defect and so we thought we’d look at them together.
            First up is Tilden v. General Electric Company, 2012 U.S. Dist. LEXIS 40773 (E.D. Tenn. Mar. 26, 2012) which involved an allegedly defective MRI machine.  According to the complaint, while undergoing an MRI, a piece of the machine broke and fractured the plaintiff’s arm which had to be surgically repaired.  Plaintiff died approximately two months later allegedly as a result of “illness and the fracture to his forearm.”  Id. at *2-3.  All of plaintiff’s product liability claims were subsumed under the Tennessee Products Liability Act which requires that plaintiff prove that the “product was defective and unreasonably dangerous at the time the product left the control of the manufacturer.”  Id. at *8 (citation omitted).  And, of course, plaintiff bears the burden on proximate cause too.
            At the motion to dismiss phase, the court wasn’t looking to see if plaintiff had proven his case, but rather whether the plaintiff had alleged sufficient facts for the court to infer the existence of a defect and proximate cause.  Id. at *10.  Plaintiff’s facts were – the machine broke and plaintiff was injured.  Not nearly enough.  Even Sgt. Friday couldn’t build a case with that little to go on.  As the court found:  “[E]ven if a plaintiff allegedly suffered an injury from a product, it does not necessarily follow that the product was defective.”  Id. at *13.  Nor does it follow that because an injury was sustained, it was caused by the alleged defect.  Plaintiff’s allegations must trace the alleged injury to the specific defect, not just the product as a whole. 

While plaintiff alleges that the MRI machine caused [his] injury . . . and expedited his death, plaintiff has not alleged any facts indicating how the alleged defect–whether it was in the design or in the manufacturing of the MRI machine–caused [his] injuries. . . . [t]he relevant question is not whether the [the product] caused [the plaintiff] pain; the issue is whether the alleged defective design or manufacturing of the [the product] caused [the plaintiff] pain. . . . Plaintiff’s complaint contains no factual allegations regarding this issue of causation.

Id. at *15-16 (citation and quotation marks omitted).  Without the facts, the court’s decision was clear – conclusory allegations and legal conclusions don’t satisfy the requirements of Twiqbal – case dismissed. 
            The second case is Sosnowski v. Wright Medical Technology, Inc., 2012 U.S. Dist. LEXIS 41303 (N.D. Ill. Mar. 27, 2012).  Being at the summary judgment stage, this case was much farther along than Tilden and therefore, the court was looking at many more facts. But, the facts stacked heavily in favor of defendant.  The product was a hip prosthesis.  Plaintiff, who then weighed 340 pounds, underwent hip replacement surgery in 2006.  At that time, plaintiff signed an informed consent form that included the risk of device failure.  Six weeks after surgery, plaintiff reported being pain-free and for about one year in 2007-2008 he was able to work as a school custodian.  Then, in 2010, the hip prosthesis fractured due to fretting and fatigue.  At that time, plaintiff weighed 438 pounds.  Id. at *1-2. 
            So, in summary – plaintiff had his hip replaced; the surgery was a success to the point of plaintiff being able to work in a physically demanding job.  Then, four years later, plaintiff, already obese, gained another 100 pounds and the implant fractured.  Dum-de-dum-dum.  It doesn’t take a detective to figure out what happened here.
But, let’s look at the court’s analysis anyway.  It applied the risk-utility test to determine whether plaintiff had met his burden on design defect.    First, utility.  No question that hip implants are useful to the population as a whole and clearly, this one was useful to plaintiff for at least four years.  Id. at *6.  Based on the facts, utility goes to the defendant.  Second, likelihood of injury.  Here, the facts were that after 10 years on the market, the highest fracture rate reported for this device was 0.36% — similar or lower than most reported in the medical literature.  Id. at *8-9.  Advantage defendant. 
Next, compliance with industry standards.   Defendant’s facts were that it had complied with ISO standards and that the fatigue testing it provided to the FDA as part of the 510(k) clearance process was “consistent with normal industry practices.”  Id. at *9-10.  Plaintiff pointed to data in the medical literature regarding how much weight the prostheses are subject to.  To which the court responded:

Nor does plaintiff offer evidence that the medical literature he cites represented an industry standard, an authoritative voluntary organization’s design guidelines, or design criteria set by legislation or governmental regulation.

Id. at *10.  Moving on to warnings, the device contained a warning regarding the exact risk at issue:  “An overweight or obese patient can produce high loads on the prosthesis which can lead to failure of the prosthesis.”  Id. at *11.   Two more for the defendant’s column.
            The court next had to consider the availability and feasibility of an alternative design.  The prosthesis at issue was made of titanium.  Plaintiff argued that it could have been made of cobalt chromium, a stronger alloy.  Plaintiff’s expert stated that cobalt chromium “appears to be a valid substitution.”  Id. at *11-12.  Plaintiff’s expert, however, failed to address the down sides of using cobalt chromium.  Facts pointed out by defendant’s experts — such as, increased stiffness, less biocompatibility, and allergenic/carcinogenic properties.  Id. at *12-13.  Therefore, the court concluded:

that plaintiff has not shown that a prosthesis made from cobalt chromium is a better alternative to titanium. It is not sufficient that the alternative design would have reduced or prevented the harm suffered by the plaintiff if it would also introduce into the product other dangers of equal or greater magnitude.

Id. at *13-14 (citation and quotation marks omitted). 
            Finally, the court considered the consumer’s expectations.  Here, the facts are that everyone was aware of the potential for product failure, but “[w]hile the risk of plaintiff’s type of injury was foreseeable, . . . plaintiff has not offered evidence showing that these risks outweighed the benefits.”  Id. at *15.  Putting all of the facts together, the court found:

Because plaintiff has not offered evidence that the risks of defendant’s prosthesis outweighed its benefits, the court concludes that no reasonable jury could find in plaintiff’s favor on his strict products liability claim based on a design defect theory.

Id. at *16.  For all the same reasons, the court also dismissed plaintiff’s negligent design claim.  And, because the defendant “warned of the precise risk that plaintiff now complains of” and that warning was not inaccurate or misleading, plaintiff’s failure to warn claim also failed.  Id. at *18-20.
            So, those are the facts.  You’ve got to plead facts to start a case and you’ve got to prove facts to get to a jury.  Without that, plaintiff’s claims are more likely to get caught in a dragnet than see the inside of a courtroom.