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.

Four Loko: PBJ or Goober Grape?

Manufacturers love to combine two independently successful products and pass the combination off to consumers as a new and original idea. After the surge in popularity of energy drinks and the advent of Red Bull-vodka cocktails, it came as no surprise that the alcoholic energy drink was born. Unfortunately, just like Smucker’s Goober Grape, the results were less than stellar.

Last November, the Food and Drug Administration (“FDA”) warned four manufacturers of alcoholic energy drinks that the caffeine added to their product was an “unsafe food additive.” Citing concerns that caffeine may mask the effects of alcohol, the FDA instructed manufacturers to cease adding caffeine to their product or face the possibility of “further action” under federal law. The FDA made no mention of the after-market mixture of caffeine and alcohol. The FDA’s warning was only the beginning of the bad news for alcoholic energy drink manufacturers.

Recently, a New Jersey man sued Phusion Projects, the manufacturer of the popular Four Loko beverage, in state court, claiming that the product caused heart damage. The plaintiff, 22-year-old Michael Mustica, alleges that he developed a heart arrhythmia after drinking two-and-a-half cans of Four Loko over the course of one evening. Each 23.5 ounce can of Four Loko contains 12 percent alcohol, the equivalent of four beers, and 135 milligrams of caffeine, the equivalent of two cups of coffee. Ironically, the plaintiff claims to have fallen asleep prior to waking with a racing heart and difficulty breathing. Along with his claim of negligence, he also alleges that Phusion Projects failed to warn him of the potential danger of combining caffeine and alcohol. The report was silent as to whether these events took place before or after the November FDA warning.

We may want to withhold judgment until more facts surface. First, the plaintiff claims that his heart condition is the result of one night of Four Loko consumption. However, further investigation could reveal that the plaintiff – like many other 20-somethings – has a significant history of caffeine and/or alcohol consumption. A history of this nature can cause heart arrhythmia even without the consumption of Four Loko. Second, while the FDA’s warning about alcoholic energy drinks did not come until November 2010, concerns over energy drink consumption have been expressed since as early as 2008. Four Loko may have lacked a warning, but certainly, the plaintiff was likely aware of the potential health concerns from drinking 70.5 ounces of an energy drink in the span of one evening.

Furthermore, while we here at Abnormal Use have no medical evidence to refute the FDA study, it would seem illogical to hold Phusion Projects liable under these circumstances. At its essence, Four Loko is nothing more than a manufactured version of a cocktail served in every bar in America. If the combination of caffeine and alcohol is as dangerous as the FDA believes, then why hasn’t it – or some other government agency or official – issued a similar report concerning the safety of after-market mixing? We can only surmise that the FDA, just like the rest of us, likes its peanut butter and jelly sandwiches, but hates its Goober Grape.

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.

FDA Convenes Expert Panel to Consider Food Dye-ADHD Link

Last week, a Food and Drug Administration advisory panel composed of doctors, scientists, and consumer representatives spent two days reviewing evidence that purportedly shows a link between synthetic food colorings and ADHD, or hyperactivity, in kids. Artificial dyes are added to many familiar snack and junk foods – staples of the modern diet. This alleged link has been the subject of ongoing debate for decades, pitting the food industry against parents, public watchdog groups and academics who have demanded a closer look at food additives.

Businessweek reports that the FDA believes there is not enough evidence at this point to definitively conclude whether food dyes contribute to ADHD. The panel’s task thus was not to consider imposition of a ban on the additives, but rather to consider whether foods should require warning labels or whether more research should be done. Well, the panel has spoken. CBS News reports that although the panel recommended that the FDA further study the possible link, it voted 8-6 that warning labels are not necessary. There is not enough evidence at this point, according to the panel, to show any link. As it stands, packages must list the food colorings on its labeling, but no warnings about a potential link to hyperactivity are required.

Interestingly, across the ocean, where this issue is already “old news,” the European Food Safety Authority has already mandated that foods with color additives contain warning labels for consumers. Here at least, additional regulation may be on the horizon, but not soon. One last thought: Perhaps it’s not the color additives that instigate the alleged behavioral problems, but the overall quality of the snack and junk foods, their sugar content, or even the lifestyle choices of the families that purchase said food in order to appease the sweet teeth of their children.

The Regulation of Electronic Cigarettes

If you are a fan of Bravo’sReal Housewives of Beverly Hills” series, you will undoubtedly recall the episode featuring the appearance of psychic Allison DuBois at a dinner party hosted by Camille Grammer. DuBois was quite irksome, but surprisingly, not due to the cigarette she puffed at the dinner table. While DuBois’s cigarette caused little conflict at the party, the product has been at the forefront of some intense litigation and proposed legislation in recent months.

DuBois’s “cigarette” was an electronic cigarette or “e-cigarette.” As such, it was a battery-powered device that allows users to inhale vaporized nicotine, minus the tobacco, tar, and carbon monoxide. E-cigarette advertisements claim that the product is “the smarter and safer alternative to smoking” which looks, tastes, and feels like a real cigarette. If true, the e-cigarette could dramatically impact the nation’s health. Apparently, though, the Food and Drug Administration (“FDA”) has its doubts.

The emergence of the e-cigarette presented the FDA with a new opportunity to extend its regulatory reach. However, over a decade ago, the FDA lost its initial bid to regulate cigarettes and smokeless tobacco under the Federal Food, Drug, and Cosmetic Act (“the Act”) via the U.S. Supreme Court’s decision in FDA v. Brown & Williamson Tobacco Corp., 539 U.S. 120 (2000) (holding that Congress had not vested the FDA with the power to regulate cigarettes and smokeless tobacco products). Despite that loss, the FDA has made other attempts to regulate e-cigarettes, and we’ve created the handy list below to summarize those attempts:

  • In 2009, the FDA warned that e-cigarettes contain carcinogens and toxic chemicals such as diethyline glycol (an ingredient used in antifreeze). According to its statement, the FDA was concerned that e-cigarettes would increase nicotine addiction and tobacco use in young people. The FDA began detaining shipments of e-cigarettes at the border. Following the examination of the seized goods, it determined that the product meets the Act’s definition of a combination drug-device product and, accordingly, was subject to FDA regulation. E-cigarette distributors challenged the FDA’s jurisdiction.
  • In January 2010, the U.S. District Court for the District of Columbia granted a preliminary injunction to allow e-cigarette distributors to continue to import their products into the country. Judge Richard Leon agreed with the distributors that Brown prevented the FDA from regulating e-cigarettes. The FDA appealed the ruling, and the D.C. Circuit Court of Appeals issued a stay on Judge Leon’s injunction. (For a more thorough examination of the Court’s decision, see our earlier discussion of that matter here.)
  • In September 2010, the FDA notified five e-cigarette distributors that it was taking enforcement actions against the companies for violations of the Act. The list of violations included “violations of good manufacturing practices, making unsubstantiated drug claims, and using the devices as delivery mechanisms for active pharmaceutical ingredients like rimonabant and tadalafil.” In addition, the FDA announced its decision to regulate e-cigarettes as combination drug-device products. As a consequence of regulation, e-cigarette manufacturers would be required to comply with the FDA’s drug-approval process.
  • On December 7, 2010, the D.C. Court of Appeals affirmed the district court decision and held that the FDA lacked the authority to regulate e-cigarettes under the Act as drugs or devices. In addition, the D.C. Court of Appeals held that the FDA may only regulate the marketing of e-cigarettes pursuant to the Tobacco Act.

While the FDA may have been unsuccessful in its legal battles thus far (the FDA is considering an appeal), several states are considering regulating, or in some instances banning, e-cigarettes. Recently, New York took the first steps to becoming the first state to ban e-cigarettes, passing a proposed bill through the Health Committee of the New York Assembly. The bill’s sponsor, Assemblywoman Linda Rosenthal, indicated she wanted to proscribe e-cigarettes until they undergo more investigation and regulation. Assembly Health Committee Chairman Richard Gottfried has urged e-cigarette manufacturers to prove to the FDA the legitimacy of their “smoking cessation” claims.

Rosenthal and Gottfried may have a point: e-cigarettes may pose some yet-to-be-determined health hazards. It is interesting that the FDA and state legislatures have become so adamant at this stage about banning a cigarette alternative. While we may not know the ill-effects, if any, of vaporized nicotine, we do know the risks associated with tar, tobacco, and carbon monoxide. There is always a risk that e-cigarettes can lead to hazards more significant than cancer and emphysema. However, it seems counter-intuitive to protect consumers by banning a product which may have risks in favor of one we know poses the threat of serious illness.

We can all relate to the fear of the unknown. On the one hand, we may discover in the future that the conservative approach of the FDA and the various state legislatures was proper. On the other hand, we may discover Allison DuBois knew what was safe all along. After all, she is a psychic.

FDA Proposes New Warning Labels to Alert Smokers that Smoking is Bad

Mmmmmm. Now the cigarette is even closer to my lungs. And I get the added benefit of focusing on lung cancer without worrying about any pesky oral cancer or hairy tongue. Yes, hairy tongue is a real disease, and tobacco use is a contributory factor. (Strangely enough, coffee drinking is also a contributing factor, which is unfortunate for the universe of associates who depend on both coffee and cigarettes to stay awake.) As noted in multiple media, including the New York Times and much of the blogosphere, the FDA is proposing new illustrative warning labels to encourage people to quit smoking. Yum. To see some of the other proposed labels, click here. Here are several different opinions on the impact of this move.

Defense Litigation-oriented opinion: I’ll note that this move is a generation away from paying off for Big Tobacco. It’s hard to imagine that a smoker will succeed in ignoring or not understanding these types of warnings, when the warning is designed to take up 50% of the package area surface. So, certainly, these warnings are favorable to future litigation outcomes for Big Tobacco, which will reduce their anticipated exposure to large jury verdicts. In 20 years, cigarette manufacturers may be more profitable than ever.

Conspiracy-theorist opinion: This is a much easier way to pay lip service to the idea that we want to reduce the overall costs of smoking to the public, than say, banning cigarettes. The federal government doesn’t want to ban cigarettes because according to this website that I know nothing about, the federal government took in $8.5 billion in cigarette taxes in 2009. Way to go progressive tax system! Therefore, these new labels are good for both the government and manufacturers.

College student opinion: Moreover, this is sure to be an effective tool to decrease the existing pool of smokers. Does anyone else think that your typical college student will have a large poster of the above graphic hanging in his room while he smokes, while, at the same time, thinking how smart he is because he appreciates the irony? Meanwhile, because the cost of college will continue to skyrocket, the rest of us will appreciate the irony of the graduate struggling to pay off his student loan debt (because college graduates make all the money) while he looks for money in his budget to buy cigarettes.

Realistic opinion: If you want people to quit smoking, tell them about hairy tongue. Surely, the prospect of hairy tongue is scarier than emphysema.

Defense-litigation perspective resumed: The universe of manufacturing defects in this realm is pretty small. Failure to warn claims will soon be extinct, which will leave design defect claims as the viable strict liability alternative. Surely this labeling program will establish significant comparative negligence. Fraud and civil conspiracy claims will begin to die out as the early generations of smokers die out. What kind of new legal theories will be invented to establish liability over the next generation? This seems like a pretty good time to start a cigarette manufacturing company.

Diabetes Drug Avandia to be Severely Restricted in U.S., Unavailable in Europe

In a highly anticipated decision, the widely used diabetes medication Avandia will be pulled from the market entirely in Europe and will now only be available in the United States under tough new restrictions, according to a recent article in The Washington Post. As we previously reported here, the Avandia debate has been a longstanding, contentious issue regarding the pharmaceutical industry and the U.S. Food and Drug Administration’s ability to police its safety. The issue, for years, has been the drug’s potential to increase users’ risks for cardiovascular problems, as there were conflicting reports and studies on the issue.

In our previous post on this issue, we reported that the FDA had said in a February 2010 safety announcement that it would continue to examine studies and data on Avandia health issues before it would take any action with regard to the drug. Since February, according to The Washington Post, both the FDA and European Medicines Agency have concluded that the risk that Avandia could cause heart attacks and strokes outweighs the drug’s benefits for most patients. This decision will have a significant impact–approximately 600,000 diabetics in the United States currently take Avandia.

Starting within the next few months, the drug will be unavailable in Europe. The European agency did, however, stop short of taking the most drastic measure of completely revoking the drug’s approval. Rather, European officials have recommended only suspending the approval, leaving open the option of reinstating the drug if further data on the issue emerge. In the United States, patients will be allowed to take Avandia only if they are not able to control their blood sugar with other medications. As such, doctors who prescribe Avandia will have to justify their decisions to do so. Additionally, patients who want to continue their use of the drug will be required to sign statements indicating that the understand the associated risks. Use of the drug in the U.S. is expected to decline significantly.

According to The Washington Post, the “unusual” coordinated announcement by the U.S. and European drug agencies is representative of the more collaborative relationship between the agencies that has been in place since the 2003 globalization of the pharmaceutical industry. The two coordinated their announcements to attempt to avoid confusion among patients.

Although this announcement stopped short of a total withdrawal of the drug from the U.S. market, it certainly is not good news for its manufacturer, GlaxoSmithKline. The company reportedly already faced approximately 13,000 lawsuits from plaintiffs who alleged that the maker failed to warn patients of heart attack risks. Although GlaxoSmithKline announced this summer that it had reached settlements in approximately 10,000 of those suits, more are sure to follow on the heels of this announcement.

Sixth Circuit Allows State Law Negligence Claims

Last year, the Supreme Court decided Wyeth v. Levine [PDF], stating that Congress, through the FDCA, did not intend to preempt state law failure to warn claims. The Sixth Circuit extended Levine in Wimbush v. Wyeth, No.09-3380, 2010 WL 3256029 (6th Cir. Aug. 18, 2010) [PDF], and reasoned that a plaintiff could pursue negligence claims relating to a manufacturer’s decision to bring a drug to market, i.e., a pre-labeling, pre-approval claim.

Mary Buchanan, the Plaintiff’s decedent, developed primary pulmonary hypertension, allegedly caused by her ingestion of Redux, a weight-control drug pulled from the market in 1997. The pulmonary hypertension was the alleged cause of death. It’s unlikely, at least in Ohio, that there would be many more claims like the plaintiff’s. Ohio statutory law would now preempt any negligence claims based on products liability, but Buchanan filed her claim before the statute became effective. Therefore, Wimbush brings us into a strange scenario where, although the drug manufacturer can successfully defend the failure to warn claim, there are other state law claims that are not preempted and allowed by state tort law.

After explaining why the state law negligence claim would be allowed under state law, the Sixth Circuit reversed the district court’s grant of summary judgment in favor of Wyeth. The Court, leaning heavily on Levine, noted that Congress had never enacted an express preemption provision throughout the 70-year history of the FDCA. In light of the history of the scheme, there could be no preemption of state law claims, express or implied. Nevertheless, the Sixth Circuit acknowledged that its decision was breaking new ground:

Finally, we are aware of no federal appeals court decision since Levine concluding that FDA regulation preempts any aspect of state tort law, though we admit that, until today, there is also no post-Levine court of appeals authority for the proposition that the Levine rationale extends beyond the realm of failure-to-warn claims to apply to all pre-approval state law claims.

Wimbush may be used to open a door in other jurisdictions to allow other state law negligence claims in jurisdictions where the standards, statutes of limitations, or venire may be plaintiff-oriented. Look for plaintiffs’ attorneys to test the state law waters with inventive tort actions. I’m sure that there are all manner of pre-approval state law claims that are about to be manufactured.

FDA Issues Warning on Frozen Mice

Abnormal Use does not want to be accused of failure to warn, so here’s your warning: you might not want to read this post right after lunch. The FDA has issued a warning on the use of frozen mice sold for reptile food. (You may recall that we mentioned this very briefly in a previous Friday Links post, but you must have thought we were kidding.). Now, before you use your mouse to click directly out of Abnormal Use for the day, you might want to keep reading.

The contaminated mice, sold by Biggers and Callaham LLC, doing business as MiceDirect, may be contaminated with salmonella, a nasty little bacteria that can cause some very unpleasant symptoms. The FDA is warning those with compromised immune systems not only to avoid handling the rodents themselves, but also to avoid handling any reptiles who may have already consumed contaminated rodents. Some people have already reported symptoms.

So, if anyone in your family likes to cuddle with snakes, you might want to stop that practice. We think that might be a good idea generally, but even more so now.

Failure to Survey Medical Literature may be Negligence Per Se

One issue in a recent decision by the District Court of New Hampshire was whether a generic manufacturer’s failure to comply with Food an Drug Administration (“FDA”) regulations constitutes a per se violation of its duty of care under New Hampshire law. Bartlett v. Mutual Pharm. Co., No. 08-CV-358-JL, 2010 WL 2765358 (D.N.H. Jul. 12, 2010). Judge Joseph N. Laplante answered in the negative, holding that the jury could consider the violation as evidence of a breach but it was not a per se breach of duty.

In Bartlett, Karen Bartlett sought medical treatment for right shoulder pain. Her physician prescribed a non-steroidal anti-inflammatory (“NSAID”) drug called Clinoril. Bartlett’s pharmacist filled per prescription with Sulindac, the generic version of Clinoril, manufactured by Mutual Pharmaceutical Company (“Mutual”). Two weeks after taking Sulindac, Bartlett was diagnosed with Stevens-Johnson Syndrome (“SJS”) progressing to toxic epidemal necrolysis (“TEN”), a serious and potentially fatal condition characterized by necrosis of the skin and mucous membranes.

As a result, Bartlett filed suit against Mutual asserting state law claims for strict products liability – failure to warn, strict products liability – defective design, fraud, and negligence. During discovery, it was found that the year prior to Bartlett’s physician prescribing Clinoril to her, an international medical journal found a link between NSAIDs and the conditions that Bartlett suffered from. It found 89 reported cases of SJS/TEN over a 17 year period in patients taking Clinoril, more than any other NSAID on the market. Also during discovery, Mutual admitted not being aware of the study and not monitoring medical literature for information on Sulindac’s safety risks. According to Mutual, the manufacturer of the brand named drug was responsible for monitoring safety risks.

On cross-motions for summary judgement, Bartlett argued that she was entitled to summary judgement on her negligence claim based on Mutual’s failure to survey medical literature for adverse events associated with Sulindac. Bartlett based this argument on the FDA requirement that generic manufacturers “develop written procedures for the surveillance . . . of post-marketing adverse drug experiences to the FDA.” 21 C.F.R. Section 314.80(b).

The Court interpreted this regulation to require generic manufacturers to develop procedures for surveying medical literature for information and studies on safety risks. Therefore, the question became whether Mutual’s admitted violation of this safety regulation versus violation of a statute could be a per se violation of its duty of care. The Court found that courts were split over whether plaintiffs could seek to enforce a FDA violation through a negligence per se action even thought the FDCA does not provide for a private right of action. Judge Laplante found no clear answer in New Hampshire but held that the New Hampshire Supreme Court would likely not treat the violation as negligence per se. Therefore, the court denied Bartlett’s motion for summary judgment and ruled that the jury could consider the violation as evidence of breach.

Drug manufacturers, generic and named-brand, must be aware of these FDA regulations governing surveillance of medical literature. Compliance with these regulations will be especially relevant in states that consider violations as negligence per se and not merely evidence of breach for the jury to consider.