Political Question Doctrine Bars Relief in Products Liability Action

As lawyers practicing in the neat little world of products liability, we sometimes become complacent with our narrow world, which is more often than not populated by familiar concepts like strict liability, state of the art, and warranty disclaimers.  We’re comfortable with these concepts.  We use them every day, and we can recite by name and sometimes even citation the cases that stand for those fabled and familiar principles. But every once in a while, a case comes along that requires us to leave our comfort zone and do what our law school professors challenged us to do: think outside the realm of the class in which we were sitting at that moment, and reach into concepts we (at least arguably) learned from other classes.

This was the situation facing the defense lawyers in the case Armedi v. BAE Sys., Inc., 1:10-CV-01557-JOF, 2011 WL 1707251 (N.D. Ga. Apr. 22, 2011).  The case involved the unfortunate death of Rebar Amedi, a civilian contractor working as a translator for the U.S. Army in Iraq.  Mr. Amedi was killed when the Mine Resistant Ambush Protected (“MRAP”) vehicle called a Caiman in which he was riding was struck by an improvised explosive device, commonly known as an IED.  According to the facts agreed to by the parties:

There were eight occupants in the passenger compartment of the Caiman which was designed to hold only six people. None of the occupants wore a seat belt and the doors to the compartment were not combat locked. The equipment stored in the MRAP was secured only by bungee cords and parachute cord, instead of ratcheting straps. Even though the passenger compartment was intact, the rear doors came off and it appears that Mr. Amedi was thrown from the vehicle and he sustained fatal injuries.

Mr. Armedi’s widow brought suit against BAE Systems, Inc., BAE Systems Land & Armaments L.P.; and BAE Systems Tactical Vehicle Systems LP, on April 16, 2010, in the Superior Court of Fulton County, alleging product defect, negligence, and breach of warranty claims arising out of the death of Mr. Amedi.  The case was removed by the defendants, and they immediately filed a motion to dismiss not based on defenses they learned in products class, but based on the political question doctrine and the combatant activities exception to the Federal Tort Claims Act.

We will spare your digging through your home library for that dusty Con Law book, and remind you about the factors relevant to determining if a dispute raises a “non-justiciable political question.”  If only one of the factors is present, the court dismisses the case.  Those factors are:

1. a textually demonstrable constitutional commitment of the issue to a coordinate political department;
2. a lack of judicially discoverable and manageable standards for resolving it;
3. the impossibility of deciding without an initial policy determination of a kind clearly for nonjudicial discretion;
4. the impossibility of a court’s undertaking independent resolution without expressing lack of the respect due coordinate branches of government;
5. an unusual need for unquestioning adherence to a political decision already made; or
6. the potentiality of embarrassment from multifarious pronouncements by various departments on one question.
Likening the case to a prior 11th Cicuit Court of Appeals case on the same issue, the Court held that because the events which led up to Mr. Armedi’s death resulted directly from miltary decisions, including the use of MRAP vehicles, the timing of the convoy, and, as a prior-decided case articulated, “at the broadest level . . . the military’s decision to utilize civilian contractors in conducting the war in Iraq,” the case involved a non-justiciable political question, “because to evaluate Plaintiff’s complaint would require the court to re-examine military decisions.”  After reaching this conclusion and dismissing the case on those grounds, it did not reach the question regarding the Federal Tort Claims Act.
To us, the most interesting part of the case was the use of a defense found outside the realm of products liability.  The product itself never became the issue in the case, despite the allegations levied against them by the plaintiff on products theories.  We are used to making procedural arguments that operate the same way, but we wonder if there are other long-forgotten classes we are under-utilizing in our products cases.   Who knows?  Maybe that third-year “law in movies” class could provide some novel defenses for cases in the future.

Popcorn and Punitive Damages Caps

Ah, the smell of diacetyl in the morning.  The mere sight of this buttery-flavored chemical makes our mouths water.

As we blogged about previously here and here, the wonderful smell this delectable combination of molecules creates has an unfortunate medical side effect – bronciolitis obliterans – otherwise now known as “popcorn lung.”  According to this piece at AboutLawsuits.com, a Baltimore County, Maryland jury recently awarded Brian Hallock, an employee of a popcorn plant owned by McCormick & Co., $5.4 million in a case he brought against Polarome International Inc. for failing to warn of the dangers of inhaling diacetyl.  That award was reduced to $814,500 pursuant to Maryland’s cap on non-economic damages. (Hat tip: Thanks to Professor Bernabe for alerting us to the verdict.).

Speaking of non-economic damages, several states have undergone debates about caps on damages in various tort reform bills in the last legislative year.  Our beloved South Carolina recently passed a tort reform bill which focused on instituting a cap on punitive damages.  You can read more about the Herculean efforts to get this passed, as well as the results, from our friend Brian Comer of South Carolina Product Liability Blog, both here and here.  Tennessee has also sent a new tort reform bill to its governor for signing.  Read about the ins and outs of that soon-to-be-law here.  Hopefully, these new laws will result in more court-instituted reductions on plaintiff-happy jury awards.  To be continued.

Dear expert witnesses: Please perform testing prior to drafting your report. Thanks. Sincerely, The Plaintiffs.

To be a good expert witness, a person should be extremely knowledgeable about the subject upon which he or she is opining.  The expert should preferably have a nice balance of practical and academic experience in his or her field, be good looking, well spoken, and able to articulate complex theories into easy to understand, layman’s terms. Oh, and one more thing.  The expert should probably wait until after he or she conducts testing on the product at issue in a case to draft his or her expert report.

In Cannioto v. Louisville Ladder, No. 8:09-CV-1892-T-30TBM, 2011 WL 2014260 (M.D. Fla. May 20, 2011), the plaintiff Robert Cannioto was allegedly injured when the 24-foot ladder he was standing on performing roofing work failed, causing him to plummet 16 to 18 feet to the ground.  The ladder was manufactured by LL. Cannioto and Home Depot, and Mr. Cannioto and his wife Bonnie Cannioto sued these two companies on theories of (1) strict liability against Louisville Ladder; (2) negligence of Louisville Ladder; (3) strict liability against Home Depot; (4) negligence of Home Depot; and (5) loss of consortium against Louisville Ladder.  The defendants filed a motion to exclude the testimony of the plaintiffs’ expert, Dr. Charles Benedict, and for summary judgment.

The plaintiffs hired Dr. Bendedict to render an opinion for them about the design and condition of the ladder at issue in the case.  Obviously, the plaintiffs wanted him to say there was something wrong with the ladder.  So, he did, writing a report in which he opined that the ladder was defectively designed.

Unfortunately, Dr. Benedict couldn’t quite get his tests, conducted after he wrote the report, to match his “findings” that the ladder was defectively designed:

In an attempt to prove his theory that the ladder failed as a result of the effect of torsional forces on a defectively designed foot, Benedict had one of his engineers set up a 24–foot extension ladder . . . in a manner similar to the one used by Plaintiff. He then had the engineer stand on the tenth rung of the fly or extended section of the ladder and violently jerk the left rail for almost 10 minutes in an effort to get the ladder to fail. The engineer also set the ladder on uneven ground and placed large weights near one of the feet in an effort to get the rail to fracture. Benedict’s assistants were unable to get the ladder rail to bend or break during the tests.

Don’t you hate when that happens?  So, the expert changed his theory from design defect to manufacturing defect.  In the middle of his deposition.  Without conducting any testing at all on the theory.

During his deposition, Benedict offered a new theory, one about a manufacturing defect rather than a design defect, as to why the subject ladder failed. He testified that the rungs were not properly or adequately attached to the rail and that the rung pulled out. This theory was not in Benedict’s expert report and Benedict admitted that he had not performed any testing to support this theory.
Not surprisingly, defense counsel argued at the hearing that Dr. Benedict should be excluded from testifying about the manufacturing defect because that particular theory had not been included in his expert report as required by Rule 26(a)(2)(B), FRCP.  Once the expert was excluded by the court, the plaintiffs could not support their theory of the case, and the defendants were granted summary judgment.

Wacky Warning Labels Finalists–A Commentary on the State of Affairs in Products Liability Law

Last week, we heard an NPR story about a Wacky Warning Label Contest put on by a man named Bob Dorigo Jones, a Senior Fellow at the Center for America.  According to its website, the Center for America’s mission is “to educate, motivate, and empower Americans to expand skills, entrepreneurship, prosperity and freedom.”

The contest works like this:  People submit entries for the product warning labels which “entertain[] and alarm[] the nation about the lawsuit-happy culture and the lengths to which companies must go to avoid lawsuits.”  People can venture online and vote for their favorites, and there are even cash prizes for the contest winners.  We here at Abnormal Use like the concept of this contest: highlighting the ridiculous lengths to which manufacturers must go to protect themselves from lawsuits, and to protect people from their own lack of common sense.

For instance, here is one of the finalists:

You can view all of this year’s finalists here.  The contest has been going on for fourteen years.  Some information about the 2010 contest can be found here.  The winners of the 2011 contest will be announced in June.  We can’t wait, and we’ll be sure to let you know which warning label wins.  In the meantime, we’d like to hear your thoughts about the most absurd warning labels you’ve encountered, either as a consumer or legal professional.

Manufacturer of Rub Cream Wins Summary Judgment on Allegations of Diabetic Foot Injuries

Earlier this month, the U.S. District Court for the Northern District of Georgia considered the case of Kersey v. Dolgencorp LLC, No. 1:09-CV-898-RWS, 2011 WL 1670886 (N.D. Ga. May 3, 2011). The case involved a tube of Dollar General Maximum Strength Muscle Rub Cream, which was manufactured by defendant Faria and sold under the Dollar General brand. The Plaintiff brought suit against both Dollar General and Faria, alleging that the rub cream caused her to develop multiple diabetic ulcers secondary to chemical burns. Ms. Kersey had been diagnosed with diabetes in 1994, which caused her to have severe diabetic neuropathy in her feet. She had been using the rub cream since 2006 or 2007; these alleged injuries occurred in 2008.

The lawsuit alleged four causes of action against Faria and Dollar General, including (1) negligence, (2) strict liability, (3) breach of express warranty, and (4) breach of implied warranty. Both defendants moved for summary judgment. Plaintiff abandoned all of her claims against Dollar General, as well as the breach of warranty claims against Faria prior to the hearing on Defendants’ motion and, therefore, the court granted the Defendants’ summary judgment motions as to those claims.

The court discussed three claims alleged by Plaintiff in turn: design defect, manufacturing defect, and failure to warn. The court granted Faria’s summary judgment motion as to the design defect. First, it noted that Plaintiff had not even discussed the rub cream’s design, and because she had not presented any evidence of the product’s inherent risks, nor presented an alternative design. The court also noted that the rub cream had been tested by the Food and Drug Administration and determined its composition to be safe and effective.

The court also granted Faria’s motion for summary judgment based on the theory of the manufacturing defect. Plaintiff had not even had the product tested to back up any allegation she may have had that the particular tube of the rub cream was stronger or weaker than the standard formula. No genuine issue of material fact there.

Finally, the court considered the failure to warn claim. The warnings on the box containing the rub cream read as follows:

— For external use only.
— Use only as directed.
— Keep out of reach of children to avoid accidental poisoning.
— Discontinue use if excessive irritation o[f] the skin develops.
— Do not bandage tightly, apply to wounds or damaged skin or use with a
heating pad.
— If condition worsens, of if symptoms persist for more than 7 days or
clear-up and occur again within a few days, discontinue use of this product and
consult a doctor.
— If swallowed, get medical help or contact a Poison Control Center right
away.

The court made a number of findings before granting Faria’s motion for summary judgment on this theory. First, Plaintiff’s doctors stated only that Faria should have known that the rub cream would have been absorbed by the skin, not that this phenomenon would be injurious to diabetics. Second, this was the very first complaint that Faria had ever received about the product  after it had manufactured more than 8 million tubes of the cream. Finally, the court noted that Plaintiff had developed these injuries after using the cream and then putting on socks and shoes, which the court found to violate the warning on the box that advises against bandaging skin after using the product.

The final cautionary note can be found in the case’s only footnote, where the Court indicated without even being asked that Plaintiff’s case had “a strong proximate causation problem.” Indeed, Plaintiff had suffered diabetic-related foot injuries before and after this alleged incident, and had been using the product without incident for years before suffering these particular injuries. Plaintiff’s doctor also testified that he could not testify that, to a reasonable degree of medical certainty, that the complained-of injuries were caused by the rub cream at all.

Federal Hazardous Substances Act Preempts Recovery on Failure to Warn Claim in Fire Death Case

Last month’s Mwesigwa v. DAP, Inc., —F.3d—, 2011 WL 1584760 (8th Cir., April 28, 2011) [PDF] centered around the warnings on a can of DAP Weldwood Gel Formula Contact Cement. The cement is a construction adhesive, and the can looks harmless enough:The warnings on the can, however, tell a different story and were cited extensively by the Court, which described the instructions as follows:

“WARNING! FLAMMABLE! VAPORS HARMFUL AND MAY CAUSE FLASH FIRE” and “BEFORE USE TURN OFF MAIN GAS VALVE.” The lid further instructs the user to keep the product away from heat, electrical sparks, and flame; to shut off pilot lights; to refrain from smoking; to prevent buildup of vapors by opening windows and doors; and to shut off stoves, heaters, and appliances. In addition, the lid depicts an open can with vapors emanating toward a cigarette labeled “smoking,” a gas valve labeled “gas,” a flame labeled “flame/heat,” and electrical volts labeled
“electricity/sparks.” Each of the four pictures contain a bold red line crossed through the black-and-white image.The can further includes “Precautionary measures for use, handling, storage and disposal”:Use in a well ventilated area. Provide fresh air such that chemical odors cannot be detected during use and while drying. Vapors are heavier than air and will collect in low areas. Check all low areas (basements, sumps, etc.) for vapor before entering. Vapor may ignite explosively. Keep away from heat, sparks, and flames. Do not smoke. Extinguish all flames and pilot lights. Turn off stoves, heaters, electric motors and other sources of ignition during use and until all vapor is gone. Keep container closed when not in use. Do not reuse the empty container. Do not use in areas where static electric sparks may be generated. Empty container may contain explosive vapors. Do not weld, cut or torch on or near this container. Store away from oxidizers and caustics. Wear gloves. Avoid skin contact. Wear eye protection with side shields.

The can also included the following warnings: “DANGER! FLAMMABLE LIQUID AND VAPOR HARMFUL OR FATAL IF SWALLOWED,” “VAPOR HARMFUL,” “BEFORE USE TURN OFF MAIN GAS VALVE,” “VAPORS CAN TRAVEL ALONG FLOOR TO ANY SOURCE OF HEAT, SPARK OR FLAME IN NEXT ROOM OR BASEMENT .”

Obviously, when not handled properly, this product can have grave consequences. The plaintiff’s decedent in this case unfortunately learned this fact first-hand. He purchased a can to install new baseboards in his house, and accidentally spilled some of it in his laundry room. When he went to wipe it up, the vapors ignited and caused a flash fire. Mr. Mwesigwa suffered extensive burns and died because of his injuries. His widow and children sued the manufacturer, DAP, for (1) wrongful death on theories of negligence, strict liability, and failure to warn; (2) for negligent misrepresentation; and (3) for violations of the Consumer Product Safety Act. The district court granted summary judgment in favor of DAP. The plaintiffs appealed the summary judgment on the wrongful death failure to warn claims.

DAP’s product is a hazardous substance sold for household use, and therefore, falls under the purview of the Federal hazardous Substances Act (FHSA). The FHSA requires such products to “bear adequate cautionary labels,” but, as the Court pointed out, the statute also preempts any failure to warn claims based on an argument that the label should have included particular warnings not required by the FHSA. Rather, the only claim that the plaintiffs could bring would be an allegation that the label did not comply with the FHSA.

The plaintiffs attempted to assert that the label did not comply with the FHSA because it failed to warn that one of the principal hazards of the cement was the risk of fire from an accidental spill, separate and apart from the general flammability. “Principal hazard” is a defined term under the law, meaning “the principal or primary hazard(s) associated with a hazardous substance.” The Court affirmed the grant of summary judgment as to this argument, since “the risk of fire from an accidental spilling of DAP cement is not a principal hazard that the FHSA requires the label to state affirmatively.”

The plaintiffs also argued that the label failed to state that, in the event of a spill, the product should not be wiped but absorbed with an inert absorbent. The Court also rejected this argument because “the FHSA does not require the DAP cement label to warn consumers against spreading the product after a spill as a precautionary measure.” The term “precautionary measures” is referred to under the statute as steps needing to be followed to avoid or minimize the “principal hazard” of the product.

The Court did a nice job summarizing its findings in this way: “The label complies with the FHSA because the principal hazard to be avoided is flammability, and the way to avoid that hazard is to remove all potential ignition sources.” Because the extensive labeling on the can of DAP complied with those requirements, summary judgment was affirmed as to the failure to warn claims.

Side note: DAP cement apparently also comes in a non-flammable version:

Hydrogen Cars: The Fight Over the Price Tag of Development

Recently, The Washington Post published an online article about the future of the hydrogen car and the effect that the current budget fight will have on this technology. According to the article, President Obama’s administration has continued to cut funding for research and development of cars powered by hydrogen, putting its weight behind electric cars instead. Former President George W. Bush was apparently much more hopeful about the future of hydrogen power and provided more funding to the research. In a related article, the South African weekly newspaper Mail & Guardian discussed the challenges of re-fueling hydrogen powered cars, and how private sector scientists and engineers are working on that problem, too.
The relationship between private and public funding and development of particular technologies is one to watch; it’s interesting to see how one affects the other. For instance, is it an accident that NASA started to think about getting out of the space business, just on the heels of Virgin Galactic’s appearance on the scene? If there is money to be made in the marketplace on hydrogen cars, venture capital and similar sources of private funding will make sure that the federal government’s belt-tightening won’t completely stall development. I, for one, can’t wait for the first Ford Hindenburg to roll off the assembly line.
What does all of this have to do with products liability? Nothing yet, because there isn’t yet a hydrogen car on the market. But my reference to the Hindenburg may not be far off – part of the problem with hydrogen as a fuel source is a perception problem. When the first hydrogen car malfunctions – and as a brand new product, rest assured that there will be bugs to work out – the media and the plaintiffs’ attorneys will use that perception to stir up fear about the technology.
In fact, fear plays a huge role in trying products cases in general – stirring up thoughts of all of those latent defects in our food, cars, and nearly everything else we run across in our lives for the jury to sweat about and decide where best to assign blame for the consequences. So many, in fact, that we here at Abnormal Use can find something in the world of products liability to write about every business day. Thankfully, products liability law has developed in a way that (mostly) takes this fear mongering out of the equation. Well, at least in theory. We’ll see how it all plays out once hydrogen cars hit the roads.

Manufacturer’s Duty to Warn Does Not Include Duty to Train Airline Pilots

In Glorvigen v. Cirrus Design Corp., 2011 WL 1466393 (Ct. App. Minn. April 19, 2011) [PDF], the Minnesota Court of Appeals considered how far a manufacturer’s duty to warn extends in the context of piloting an aircraft. In so doing, the court found that any such duty does not extend so far as to require the manufacturer to provide pilot training.

The facts were these: In 2001, Gary Prokop received his pilot’s license, training mostly on an aircraft manufactured by Cessna and logging most of his hours in that plane, as well. He had a visual-flight-rules certification, which meant that he was not permitted to fly when weather conditions might require the use of instruments. He subsequently completed all of the training he needed to take the test to be instrument-certified, but he had not yet taken the test.
In 2002, Prokop bought a new plane, a Cirrus SR22. He was provided a Pilot’s Operating Handbook and FAA Approved Airplane Flight Manual for that aircraft. Also included in the purchase price of the plane was two days of “transition training.” Not to be confused with classes on how to actually fly a plane, this “transition training” was designed simply to show a pilot how the new aircraft differed from the plane the purchasing pilot had previously flown. In this case, the transition training was supposed to have included training on the autopilot system of the Cirrus plane, a feature Prokop’s original Cessna lacked. In addition to this two days of transition training, Prokop purchased and attended an additional day and a half of training.
Following these training sessions, the instructor was supposed to grade the pilot on specific maneuvers on an evaluation sheet, leaving blank those maneuvers which had not been performed by the pilot. Following his training, Prokop received “S” for “satisfactory” on all maneuvers except one that involved the use of autopilot in switching between flying visually and flying with the use of instruments. That part of the evaluation form remained blank.
On January 18, 2003, after being cleared to fly, Prokop and a friend, Jamed Kosak, took off from Grand Rapids, Michigan on their way to St. Cloud for their sons’ hockey game. A few minutes later, the plane struck the ground and both men were killed in the accident. The trustees for the decedents’ next of kin sued Cirrus; the trustee for Kosak’s next of kin also sued Prokop’s estate. The Kosak complaint alleged that “Cirrus undertook a duty to provide Prokop with flight training, that Cirrus breached an implied warranty of merchantability by omitting a flight lesson [concerning switching from visual to instrument flying using autopilot], and that Prokop was negligent in piloting the aircraft.” The Prokop complaint alleged that Cirrus was negligent in the “designing, testing, manufacturing, sale, distribution, maintenance, warnings, pilot training, and instructions given regarding the aircraft.”
Much of the ensuing trial focused on the “transition training” – what specifically was taught by the instructor, whether or not that one training session in question was actually performed or not, and whether or not the crash would have happened if the training had been performed properly or differently. Following the trial, the jury awarded both trustees damages.
On appeal, however, the appellate court focused not on the adequacy of the transition training, but whether or not the manufacturer, Cirrus, owed a duty to train Prokop at all. The issue, as framed by the appeals court, was, “Does an airplane manufacturer’s duty to warn by providing adequate instructions for the safe use of its aircraft include a duty to provide pilot training?”
The appellate court concluded that it does not, for two reasons. The first focused on the purpose of the transition training, and whether or not it had anything to do with the manufacturer’s duty to warn:

Respondents assert that Cirrus offered transition training as a means of satisfying its duty to warn by providing adequate instructions for safe use. But the record indicates that the purpose of transition training was to assist Prokop to be proficient in the use of an unfamiliar aircraft. Although proficiency training undoubtedly promoted the safe use of the SR22, we find no support in the law for respondents’ proposition that Currus’s duty to warn included an obligation to train Prokop to proficiently pilot the SR22–which is the crux of respondents’ claims.

Second, the court focused on the fact that at the time he purchased the aircraft, Cirrus provided Prokop with two sets of written instructions: the Pilot’s Operating Handbook and FAA Approved Airplane Flight Manual for the Cirrus Design SR22.

Therefore, the court held, “any liability based on appellant’s failure to provide adequate transition training cannot be sustained under a product-liability theory.”

This is the right decision for a few reasons. First, the transition training was not mandatory, nor was it a prerequisite for buying the plane from Cirrus in the first place. If Prokop had never availed himself of the training offered, then the adequacy of the training would never have been put under the microscope. Secondly, there was never any allegation that the training Prokop did receive was performed negligently. And, finally, the liability waves from a finding that Cirrus did owe a duty to train Prokop could have turned into tidal waves, leading to de facto requirements that chainsaw manufacturers provide training to every person who buys their product from a Home Depot, car manufacturers give driving lessons, ad infinitum. But for now, the floodgates remain closed on this issue, thanks to the Minnesota Court of Appeals.

The cost of preventing pre-term births: questions of ethics, public policy, and potential liability

Here’s the good news: a new drug called Makena manufactured by a company called KV Pharmaceutical was recently approved by the FDA for the treatment and prevention of pre-term births. But the approval has not come without controversy, as reported by media outlets all over the country. [For additional coverage, see here and here]. The problem? The drug, which must be administered by a shot once a week for about 20 weeks, was running about $20/dose prior to the approval. After the FDA gave the drug a nod, however, the price shot up to $1,500/dose. We’ll do the calculation for you: that’s $30,000 over the course of one pregnancy. [Note: the FDA has no control over pricing.] Now, the company has since reduced the price of each dose to $690, as reported by NBC, which would reduce the total price tag to $13,800.00. Nevertheless, the March of Dimes decided to end its relationship with the company.

This is not a new issue for drug companies, or for the people who need the drugs they manufacture. As KV Pharmaceutical pointed out to The Washington Post, the company is spending approximately $200 million developing the drug and having it approved by the FDA.

This is not atypical for the pharmaceutical industry; research and development are very expensive. In order for the company to stay in business and keep finding and manufacturing drugs that are of use to the public, the company should be entitled to recoup those costs and make a profit. But what duty do these companies have to the human race in general? This question can be posed not only to KV, but to the manufacturers of drugs used to treat cancer and other life-threatening conditions. What responsibility do these companies have to all people, and not just the people who have insurance that is willing to pay for these drugs, or others who can open their wallets and foot the bill themselves? It’s a chicken-and-egg problem that doesn’t seem to have a clear answer. For now, there are companies like Ther-Rx, a division of KV, which has developed a program for women who cannot afford the cost of Makena. The company also indicated it might be willing to develop a cheaper generic version.

Even more interesting from our point of view is the potential legal liability companies risk. The Washington Post indicated that “outside experts said the FTC could sue KV if it concludes the company is illegally impairing competition.” A Washington Post article on the subject interviewed an antitrust lawyer on the subject:

“It threatens to extract significant competitive harm on extremely vulnerable pregnant women, and it threatens to significantly inflate health-care costs at a time when controlling health-care costs is a critical national priority,” said David Balto, a Washington antitrust lawyer who worked at the FTC.

This is an issue that will continue to force some tough choices. And, cynical though it may seem, we are certain that litigation about this very issue is inevitable, if not with this drug than with the next one down the line.

The Peanut Butter Products Liability Litigation Blues

As a defense lawyer, we are often place in the strange position of having to prove a negative. Sure, it’s supposed to be the plaintiffs’ burden to prove his or her case, and in theory, at least, everyone is innocent, er, not liable unless proven otherwise.

But we all know it doesn’t happen that way sometimes.

Take the recent case of the contaminated and recalled peanut butter. You remember all that, right? In 2007, ConAgra Foods peanut butter, marketed under the national brand Peter Pan and Wal-Mart store brand Great Value, were linked to several hundred cases of salmonella poisoning, and a massive recall was issued for the spreads. [Read more about that recall here.]

What followed this recall, dear readers? You guessed it! Massive amounts of litigation! So much, in fact, that it was all consolidated by the MDL Panel, at least for pretrial proceedings.

Since 2007, the slow wheels of justice have been turning. On March 23, the Northern District of Georgia ruled on ConAgra’s motion for summary judgment in In re ConAgra Peanut Butter Products Liability Litigation, 2011 WL 1060990 (N.D. Ga. March 23, 2011).

Not to get too graphic, but there are only a few ways to prove if a person has in fact contracted salmonella poisoning, or if they just have a nasty case of the stomach bug. You guessed it: they test one’s blood and other bodily fluids. The Court officially noted: “[T]hese samples are important in determining causation.” So, a number of plaintiffs stepped up to the proverbial plate and supplied samples. When some samples came up negative for salmonella poisoning, ConAgra moved for summary judgment based on lack of causation. Slam dunk, right?

Apparently not.

The Court denied the motion for summary judgment without prejudice because “without the plaintiffs’ individual medical records, it is unclear when the sample was taken and whether there is a scientific or medical explanation–other than another illness–for a negative test. Therefore, ConAgra is not entitled to summary judgment before individual discovery on plaintiffs’ medical records is complete.”

We’re not sure exactly what the parties have been doing for the four years since this whole thing started, but apparently, the plaintiffs have not been trying to gather medical records or retain experts to satisfy their burden. Nevertheless, the Court granted them additional time to hold ConAgra hostage – otherwise known as “satisfy their burden” – in these cases.