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.

FDA Update on Cereal Recalls

As we recently reported here, this summer the Kellogg Company voluntarily recalled boxes of its Corn Pops, Honey Smacks, Froot Loops, and Apple Jacks due to “an off-flavor and odor” emanating from the cereal. We can’t believe that Toucan Sam, who always seems to be bragging about his nose, missed those foul-smelling boxes.

The FDA recently provided an update on the recall, explaining that the culprit causing the bad smell and taste appeared to be the wax paper liners in the boxes. According to the FDA, only about 50 reports of the foul smell were reported, and no one sustained a serious injury. One of the question-and-answer notes in the update caught our eye:

Are Waxed Papers Legal and Safe to Use in Food Packaging?
Yes, but only when they are manufactured and used in compliance with Federal Food, Drug and Cosmetic Act requirements and FDA regulations.

It comes as a reminder that the FDA does not only regulate the food on our shelves, but also its packaging, known in government-speak as “Food Contact Substances.” Other items with which you may be familiar in terms of the regulation of packaging that comes into contact with food include the debate that rages concerning the level of Bisphenol A, also known as “BPA,” in plastic containers and baby bottles.

More information about the regulation can be found on the FDA website page devoted to the wide world of packaging. In the meantime, we can apparently eat our favorite sugary cereal without first subjecting it to the smell test.

Watch Out, Michael Douglas

Looks like we can all keep our respective iPhones/Blackberries/Droids safely attached to our ears. Our spouses and bosses will be thrilled.

The U.S. Food and Drug Administration recently issued a consumer update [PDF] stating that cell phone use does not increase the risk of developing certain types of brain tumors. Apparently, cell phones emit a type of electromagnetic radiation that four different types of brain tumors just love to absorb (as if one was not enough). However, in the largest study of its kind to date, Interphone, in connection with the World Health Organization, released the findings of a study [PDF] which indicate that using a cell phone did not increase a person’s likelihood of developing such a tumor. The study involved 13 countries and took place over 10 years. Pretty impressive. A National Cancer Institute study also cited by the FDA found no increased frequency of brain tumors between 1987 and 2005, despite increased cell phone usage between those two dates.

This is good news for those of us who use our phones so much that it would be best if we could simply duct tape them to our heads. All the same, we here at Abnormal Use found a few of the points in the FDA’s consumer update to be slightly discouraging. First, what the FDA giveth, the FDA taketh away:

“There are still questions on the effect of long-term exposure to radio frequency energy that are not fully answered by Interphone.”

]Great. So, FDA, you’re saying…you’re still not sure. Second, the FDA suggests that one reason cell phones don’t contribute to brain cancer today is because newer, smaller phones emit fewer emissions. We’re pretty sure Gordon Gekko might be in trouble:
Finally, the consumer update includes tips on how to decrease exposure to radiation while using your phone, including using hands-free devices and limiting the time on the phone.

So, FDA, you’re saying…you’re still not sure. Well, thanks for the update anyway.

The Tylenol Recall

Just in time for the height of the spring allergy season, a voluntary recall was announced on April 30, 2010 for numerous over the counter allergy treatment medications and pain relievers produced by McNeil Consumer Healthcare. This is the second major recall for Tylenol products this year. As you may recall, in January, there was a recall of the adult pain reliever due to concerns about mold. The products recalled were for children and infants which has created somewhat of a panic. McNeil’s most recent press release detailed the reason for the new recall:

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

As can be seen, McNeil has cited quality control standards as being the reason for the recall. The buzz in the blogosphere and in the online news outlets references the presence of bacteria in at least one facility. At this point, it appears that the concerns are not as dire as the buzz would like to portray them. In this report from the Associated Press, Deborah Autor, director of the Food and Drug Administration’s drug compliance office, was quoted as stating that the risk, at this point, to consumers was “remote.” What may eventually come of the recall is too hard to predict at this point. However, with the FDA considering additional steps in the investigation, this is definitely an issue that we will need to continue to monitor. A complete list of the products that were involved in the most recent recall can be found here.

Florida Court Finds Exclusion of FDA Recall Harmless Error

Last week, a Florida appellate court affirmed a defense verdict in a products liability case despite finding that the trial court had erred by excluding evidence. The evidence that was excluded was that the U.S. Food and Drug Administration had later banned the substance at issue, ephedrine, some six years after the Plaintiff took it. In that case, Webster v. Body Dynamics, Inc., the appellate court found the exclusion constituted harmless error, in part because of the Plaintiff’s successful introduction of evidence indicating the risks of ephedrine through an FDA witness. See — So.3d —-, No. 1D08-5114, 2010 WL 624182 (Fla. Ct. App. Feb. 24, 2010) [PDF].

The Plaintiff, a twenty six year old university student at the time of the alleged injury, suffered a stroke in the summer of 1998. For four months prior to the stroke, he had been taking Super Mini/Mini Thin Natural pills, dietary supplements containing ephedrine alkaloids, which were later banned in 2004 by the FDA. The Plaintiff sued the manufacturer and the retail establishment at which he had purchased the pills. The defendants’ theory was, in part, that young men occasionally have strokes for unexplained reasons, and the appellate court noted that “[t]he jury apparently concluded this was one such case.” (Bolstering the defense theory was the fact that no ephedrine was found in the Plaintiff’s system at any time after the stroke.).

Both before and during trial, the judge refused to take judicial notice of the ban or otherwise permit evidence of it to be heard by the jury. The appellate court found that in excluding evidence of the ban the trial court “arguably” erred because such evidence can be introduced to establish that a later-recalled product was defective at the time of the litigated injury, even if that injury occurred before the recall. However, the court found that any error was harmless. In so doing, the court noted that the jury “may well have concluded that there was no convincing proof that ephedrine was in the plaintiff’s system when he suffered the stroke.” It also referenced the detailed testimony of Dr. Parisian, an FDA official who recounted the FDA’s pre-1998 public warnings on ephedrine and the substance’s risks, including the risk of adverse effects, such as strokes, in young people taking the substance. Dr. Parisian also testified that with each pill the Plaintiff had ingested more than three times the amount of ephedrine that she considered “unreasonably dangerous” in such supplements. Nevertheless, the appellate court rejected the the notion that Dr. Parisian should have been able to testify to the ban:

. . . Dr. Parisian’s testimony conveyed in great detail the health and safety concerns that underlay the FDA’s proposal to adulterate dietary supplements containing ephedrine alkaloids in excess of eight milligrams per pill, and ultimately led to the ban of dietary supplements (but not other over-the-counter medications) containing any ephedrine alkaloid at all. Dr. Parisian testified unequivocally that manufacturers continued to market dietary supplements containing ephedrine at levels not recognized as safe and effective by the FDA. She opined in no uncertain terms that the pills Mr. Webster allegedly consumed were “unreasonably dangerous.” The testimony that strokes had been associated with ephedrine use was uncontroverted.

Dr. Parisian’s testimony explained to the jury the reasoning behind the eventual ban of dietary supplements containing ephedrine, and the entire rationale eventually set forth in the text of the rule effecting the ban. The appellant has not demonstrated a reasonable probability that proof of the ban itself would have led to a different result.

See id. at *2 (Footnotes omitted).

The majority’s ruling drew a dissent from Justice Thomas, who argued that “[a] mandatory recall and ban is relevant evidence and demonstrates a product’s design defect, even where the recall and ban is issued after the date of the product’s manufacture.” Presumably, there’s still time for the Plaintiff to appeal this decision, so perhaps the Florida Supreme Court will address the issue.

New News or Not So New News Concerning Avandia?

It appears that the U.S. Food and Drug Administration is taking steps that may end up in removing a popular Type II Diabetes drug, Avandia, from the market. In a safety announcement issued on February 22, 2010, the FDA reported that it is continuing to review data and various studies on the drug rosiglitazone, including the RECORD study. RECORD is the acronym for Rosaglitizone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes. The results of RECORD were released in August of 2009 in a medical journal. The FDA’s safety announcement came on the heels of the recent U.S. Senate Finance Committee report which detailed the committee’s findings, including a possible link between the drug and an increased risk in heart attacks. Specifically, the Finance Committee found:

…the reviewed evidence suggests that GSK [GlaxoSmithKline] knew for several years prior to this study that there were possible cardiac risks associated with Avandia. As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.

Such strong language by the Senate Finance Committee likely has trial lawyers salivating over the sheer number of potential products cases that could be in the pipeline if indeed Avandia is removed from the market. Considering that Avandia sales were approximated at $2.6 billion for the year 2006, there may be potential litigation looming against GlaxoSmithKline.

However, the Senate Committee’s report is NOT news. That is at least the opinion of the American Association of Clinical Endocrinologists (AACE). Dr. Alan Garber, editor of the AACE Patient Safety Exchange, released a statement concerning the “rash of headlines” that resulted after the Senate Committee report was apparently leaked to the New York Times. In his statement, Dr. Garber provided insight on the various studies and then concluded that the “news” about Avandia was in fact “. . . old news, quite old indeed. ” Where does this leave us? Good question. However, it appears that the RECORD study concluded that Avandia did not place its users at an increased risk of death or hospitalization for cardiovascular disease. The more pertinent question may be whether use of the drug places someone at an increased risk for developing cardiovascular disease or a heart attack. As with all studies, there are sometimes more questions or concerns that are raised about the study itself. As such, the FDA is taking a prudent approach in continuing to examine the various studies including the data compiled by the RECORD study before it takes action, if any, this summer.

Caveat Emptor . . . SERIOUSLY!

Average consumers generally trust the notion that the products they purchase “are what they say they are.” But that’s not always the case. Patients at a doctor’s office and home consumers buying medical devices or dietary supplements over the Internet continue to face the issue of misbranding and mislabeling. Recent examples of this disturbing trend abound.

On February 9, 2010, the United States Attorney for the Northern District of New York issued a press release wherein the Department of Justice recounted the sentencing of a group of plastic surgeons using a non-Food and Drug Administration approved TRI-toxin instead of the FDA approved drug, Botox. The sentencing included the following:

THE PLASTIC SURGERY GROUP, LLP (TPSG) of Albany, New York, was sentenced and ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with TPSG’s plea of guilty to one felony count of misbranding drugs, in violation of Title 21,United States Code, Sections 331(k), 352(i)(3), and 333(a)(2) . . . .

Additionally, Doctors WILLIAM F. DE LUCA, Jr., DOUGLAS M. HARGRAVE, JEFFREY L. ROCKMORE, STEVEN M. LYNCH, and JOHN D. NOONAN, were sentenced to probation with community service, and ordered to pay restitution in the amount of $106,686, and a fine of $5,000. TPSG’s practice administrator, PETER M. SLATTERY, and supervisory nurse SUSAN F. KNOTT, were also sentenced and ordered to pay restitution in the amount of $106,686, and fines in the amount of $1,000 and $500, respectively. All individual defendants were sentenced in connection with their guilty pleas to one misdemeanor count of misbranding drugs, in violation of Title 21, United States Code, Sections 331(k), 352(i)(3), and 333(a)(1) . . . .

Just the day before, on February 8, 2010, the United States Attorney for the Southern District of California issued a press release regarding the sentencing of a man who sold thousands of unregistered medical devices that he claimed could treat anything from worms to AIDS. That man, James Folsom, was sentenced to 51 months and ordered to pay a fine of $250,000.

The evidence presented at Folsom’s trial indicated that he marketed the device under the names “NatureTronics,” “AstroPulse,” “BioSolutions,” “Energy Wellness,” and “Global Wellness.” The supposed medical device housed a digital readout that consumers could use to adjust the device to certain settings, as indicated in the accompanying manual, to treat a whole host of maladies including diabetes, strokes, ulcers, AIDS, and worms. The U.S. Attorney’s press release stated:

According to the testimony at trial, during the period from 1997 through August 2008, the defendant purchased over 9,000 units, which he sold to distributors for approximately $1000-1200, and to retail customers for $1995, with sales totaling over $8 million. The devices were manufactured by the defendant and others in a San Diego location, which he failed to register with the Food and Drug Administration (FDA) as a device manufacturing establishment. The defendant used the false name “Jim Anderson,” when selling the device and used post office boxes, self-storage units, and bank accounts opened in the names of others to conduct his business in an effort to avoid detection by the FDA.

The devices were adulterated in that they were marketed without a valid investigational device exemption, without pre-market approval, and in violation of an electrical performance standard set by the FDA, prohibiting lead wires that come into contact with patients from being able to come in contact with potentially hazardous voltages.

Finally, this past January, the FDA updated its earlier warning over an unapproved doppelganger of the FDA’s approved weight loss supplement, Alli. In that update, the FDA provided helpful information, including photos, to assist consumers in identifying the counterfeit drug which contained a non-approved dosage of the active ingredient found in Alli and other weight loss pills, sibutramine. As long as criminals suspect that they can profit from selling unapproved drugs and medical devices, they will continue to do so. As such, it becomes all the more important for consumers to exercise the old Latin adage – caveat emptor! This seems to beg the question: did the Romans have the same problem that we have today?

Doping is Not Worth It

Above: The likely lead exhibit in the litigation predicted below. Click to enlarge.

As Americans, we have a love/hate relationship with food that usually results in hyperlipidemia. So much so that many of you have been driven to the edge of sanity by consuming copious amounts of leafy greens, only to binge on vats of ice cream and trans fats. To you health-conscious readers who recoiled in horror at my fried chicken sandwich post (but secretly enjoy the delicacy that is gas-station fried chicken), we now confront the quagmire of nutritional supplements (read:”steroids”). Perhaps even the health-conscious will admit that some take their “health” too seriously. Having not been to the gym in several years, I can only assume that there are still guys who gel their hair before embarking on 1.8 hour bench press sessions and grunt convincingly about the latest supplements in voices that carry throughout the room. In law school, we called such people “undergrads.” If you know someone fitting this description, let them know of a recent recall.

It all begins with Musclemaster.com, which undertook a voluntary recall of several products that the Food and Drug Administration recently claimed contained, you guessed it, steroids. Rather than take a completely sarcastic spin on this, I’m slightly sympathetic towards Musclemaster. After all, the typical customer wants to push his limits, so, it’s not surprising that the company would push the limits as well. And what better way to indicate that you are pushing the limits than to name your products, for example, “Anabolic Xtreme” or “Monster Caps.” For its part, Musclemaster.com cannot independently confirm whether there were steroids in those products. Nevertheless, Musclemaster.com recalled the products out of “an abundance of caution.”

Perhaps the officers at Musclemaster.com sensed litigation, because a California Appeals Court recently reversed an order denying certification of a class of supplement purchasers. In In re Steroid Hormone Prod.Cases, No. B211968, 2010 WL 196559 (Cal. Ct. App. Jan. 21, 2010) [PDF], Diego Martinez sued for relief under the Unfair Competition Law (UCL) and Consumer Legal Remedies Act (CLRA) because General Nutrition Companies sold supplements containing androstenediol, defined as a controlled substance under California law. The trial court denied class certification on the grounds that individual questions of causation and injury predominated. Martinez failed to establish that he represented the views of the class, in that Martinez testified that he would not have purchased the substances had he known of their illegality under California law. The trial court was not persuaded and gently stated that it could not infer Martinez’s high-mindedness to the rest of the purported class.

The appellate court reasoned that because of the status of California law, a showing of individual deception and reliance wasn’t necessary under the UCL and that the trial court used an incorrect legal assumption under the CLRA. The appellate court left open the question whether there is a “reasonable bodybuilder” standard, and, if so, its application in this matter. As noted above, and as found by the trial court, a reasonable bodybuilder might push the limits more than your ordinary reasonable person. Isn’t it at least plausible that a reasonable bodybuilder would hope against hope that his supplement contained a little something extra. Maybe not in the post-Schwarzenegger era. The court’s legal reasoning is straightforward, but the supplement crowd may have fashioned a workable grand scheme: Buy supplements, see if they work, and if they don’t, seek restitution under consumer protection statutes. Those who disagree may just have sand kicked in their faces.

Renewed Concern Over The Effects of BPA

An old debate is relevant and has new life once again. The issue: does Bisphenol-A pose a health risk to humans? More importantly, does the presence of BPA in products such as baby bottles present a risk to the most susceptible segment of our population, our children? Earlier this month, the Food and Drug Administration issued an updated statement outlining the agency’s stance on the controversial chemical, Bisphenol-A, or BPA. In this statement, the FDA revisited its prior concern over the chemical and the potential adverse effects of BPA on humans. The cause for the renewed concern appears to be the result of recent studies that have employed “novel approaches” in studying the chemical. According to the FDA:

BPA is an industrial chemical used to make a hard, clear plastic known as polycarbonate, which has been used in many consumer products, including reusable water bottles and baby bottles. BPA is also found in epoxy resins, which act as a protective lining on the inside of metal-based food and beverage cans. These uses of BPA are subject to premarket approval by FDA as indirect food additives or food contact substances. The original approvals were issued under FDA’s food additive regulations and date from the 1960s.

In its statement, the FDA acknowledged that the recent studies provided “some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children.” This level of concern was first voiced by The National Toxicology program in its report on BPA.

The history between the FDA and BPA is a long and storied one. The seemingly incomprehensible chemical and its potential effects on the human body is almost as confusing as the FDA’s attempts to communicate its exact position on BPA. As one blogger has pointed out, the communication between the FDA and the public needs to be streamlined, and the issues with BPA need to be better clarified in order to re-institute the public’s trust in the FDA.

The final analysis is this: the FDA intends to leave no stone unturned in order to fully investigate the potential effects of this chemical it will review the regulatory framework, accept public comment, and conduct or support millions of dollars worth of research. In the meantime, the FDA is directing consumers to a new website for interim precautions and more information. The debate has been revived and it appears it will continue until further research, investigation, and regulatory reviews have been completed.

E-Cigarettes: Drug-device combo or mere tobacco product?

Since the fall of 2008, the U.S. Food and Drug Administration has routinely refused to allow the importation of electronic cigarettes, or “e-cigarettes,” into this country. A recent opinion might require a change of that policy. In Smoking Everywhere, Inc. v. U.S. Food & Drug Admin, No. 09-771(RJL), 2010 WL 129667 (D.D.C. Jan. 14, 2010), the U.S. District Court for the District of Columbia granted the Plaintiffs’ request for a preliminary injunction prohibiting the FDA from denying entry of e-cigarettes into the United States and from regulating e-cigarettes as a drug-device combination.

The plaintiffs in this action, Smoking Everywhere, Inc. and Sottera, Inc., are importers and distributors of e-cigarettes. These products are designed “to replicate the adult experience of smoking without combustion or the use of cancerous by-products.”Id. at *1. They import their products from manufacturers located overseas. However, their shipments were denied entry into the United States by the FDA on the basis that the shipments “appear to be adulterated, misbranded or otherwise in violation” of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. Id. at *2.

Due to the action’s procedural posture, the court analyzed the likelihood of the Plaintiffs’ success on the merits, whether the Plaintiffs would suffer irreparable injury were an injunction not to be granted, and whether an injunction would further the public’s interest. Id. at *3. The court’s analysis required it to consider federal tobacco legislation, the FDCA, and the landmark decision of U.S. Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), wherein the Supreme Court held that tobacco products were not subject to FDA regulation as a drug or device.

The Smoking Everywhere court rejected the FDA’s arguments that the term “tobacco product” should be narrowly defined and that e-cigarettes were drug-device combinations. The court stressed that due to the marketing of the e-cigarettes “for customary recreational use, those products (just like traditional cigarettes) are properly excluded from the meaning of drug or device under the FDCA.” Id. at *8. As such, the court determined that the Plaintiffs were “substantially likely to succeed on their claim that the FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA.” Id. The court also determined that the Plaintiffs had suffered irreparable harm due to the FDA’s refusal to allow the importation of their e-cigarette shipments. Id. at *10. In the court’s final analysis, the factors weighed in the Plaintiffs’ favor, and therefore, the court granted the Plaintiffs’ request for an order enjoining the FDA from refusing admission into the U.S. e-cigarettes on the basis that such products are unapproved drugs, devices or drug-device combinations under the FDCA.