National pharmacists' association calls for end of direct to consumer advertising

Back in December I reported that the American Medical Association called for a ban on direct to consumer advertising.  Now comes news that the American Society of Health-System Pharmacists has also joined the call, arguing that much of of the information provided in consumer advertising is misleading and contributes to the overuse of pharmaceutical drugs.  Go here for more information.

I have long held the same position, but I think it is naive to expect the FDA to go back to the day when direct to consumer advertising was banned.  The United States is one of only three countries in the world that allow direct to consumer ads for prescription drugs.  (New Zeland and Brazil are the other two.) 

West Virginia Legislatively Recognizes the Learned Intermediary Doctrine as a Product-Liability Defense

On February 26, West Virginia became the 38th state to adopt the learned intermediary doctrine when Governor Earl Ray Tomblin signed SB 15 into law.  The law effectively overrules a 2007 West Virginia Supreme Court decision that had rejected the defense.  Go here for more details.

American Medical Association calls for an end of direct to consumer advertising -- UPDATED

The American Medical Association, which represents 250,000 doctors, has called for an end to direct-to-consumer advertising for prescription drugs, a $4.5 billion-per-year industry in the United States, AdWeek reports.  The US is one of very few countries in the world that allows such a practice.  Of course, the AMA does not dictate policy for the FDA or Congress but its position may have some influence.

UPDATE (12/7/2015):  Torts Today and AboutLawsuits.com have more on the story.

UPDATE (12/13/15):  The New York Times has a short editorial on the issue here.

Comments on the $9 billion verdict

Yesterday I reported that a jury in Louisiana had awarded what someone called "maybe largest monetary award ever" against a pharmaceutical company for injuries caused by the drug Actos.  

Whatever its place in history, the verdict has generated some debate.  The defendant quickly responded by announcing it would appeal the verdict.  Others have provided additional commentary.  The TortsProf blog opined that "[b]ecause of the presumptive single-digit Due Process ratio, there is a strong possibility the punies will at least be reduced."  An article in Reuters agrees.

On the other hand, although agreeing that the amount of the verdict is likely to be reduced, Eric Turkewitz of the NY Personal Injury Law Blog, thinks an award of much more than a "single-digit ratio" can be justified.  His conclusion:  "So what will happen in the Actos litigation? I think that a punitive damage award of 100x or greater is in the cards if the plaintiffs satisfy the court that the conduct was reprehensible ... And I also think that, given the significant document destruction that led to that whopper of an award, that satisfying that element won’t be too difficult. Assuming that the $1.5M in compensatory damages aren’t touched, I think that ultimately a punitive award of $150M+ is sustainable under current law."

Jury awards $9 billion in punitive damages for side effects of Actos diabetes drug

In what may be the largest award ever against a pharmaceutical company, after more than 12 weeks of trial, it took a Louisiana jury only a few hours to return a verdict in the first federal case involving the development of bladder cancer from side effects of Actos. The jurors found for the plaintiff and awarded $1.5 million in compensatory damages and an additional $9 billion in punitive damages against Takeda Pharmaceuticals and Eli Lilly. The case was based on the allegation that the makers of the diabetes drug Actos withheld information from consumers and the medical community about the risk of users developing bladder cancer. There are still aBout 3,000 other complaints pending involving nearly identical allegations. AboutLawsuits has many more details on the story here.
 

New study concludes direct to consumer ads result in unneeded prescriptions; is anyone surprised by this?

AboutLawsuits is reporting that a new study has concluded that direct to consumer advertising of prescription drugs results in unneeded prescriptions.  And my reaction, just as with that other study that concluded that many direct to consumer ads are misleading, is "Duh! You needed a study for that?"  I could have told you that.  Why do you think pharmaceutical companies spend so much on direct to consumer advertising?

This is why, years ago, some jurisdictions held that manufacturers should not be allowed to rely on doctors to provide warnings to the consumers.  If the product was one that was offered to the public through direct to consumer advertising, there should be a duty to warn the consumer the same way.  Not many jurisdictions have followed the lead of those few cases, though.  Maybe these new reports could some day persuade more courts to adopt this view.

New study finds many direct to consumer advertising of prescription drugs are misleading. Is anyone surprised?

A new study published in the Journal of General Internal Medicine prepared by researchers from the Dartmouth Institute for Health Policy found that six out of every ten direct-to-consumer drug advertisements shown on television provide false or misleading information.  The ads omitted or exaggerated important information, provided opinions or made meaningless associations with lifestyles.  Go here and here for more details.  In my opinion, this is hardly surprising.  Ever since the beginning of DTC advertising it was clear the intent was the same as with all other advertising: to get people to buy something, not to provide public service announcements.

Texas adopts learned intermediary rule

Last month the Texas Supreme Court formally adopted the learned intermediary rule in a case called Centecor v. Hamilton (available here).  For a comment praising the decision go here.  For a comment criticizing the learned intermediary doctrine in general go here.

Quick tought on the learned intermediary doctrine

The Drug and Device law blog has a comment on the recent case Legard v. Ortho-McNeil Pharmaceutical, Inc., 2011 U.S. Dist. LEXIS 67997 (N.D. Ohio June 24, 2011) in which the court dismissed a claim based on the learned intermediary doctrine.  As you would expect, they use the case to support the continued use of the doctrine. I have an entirely different take on it.  In my opinion, the case actually illustrates why we don't need the doctrine. 

I will start by confessing that I have not read the case myself.  I am, thus, commenting based on the information provided in the D&D blog.  So read their full comment here.  To make a long story short, the case involves a plaintiff who sued the manufacturer of a birth control patch claiming inadequate warnings about the risks of blood clots.  The facts show, however, that the defendant did warn the doctor, that the doctor warned the patient and that the patient admitted to understanding the warnings from the doctor and the package insert.  The case was dismissed. 

Given those facts, I agree the case should have been dismissed.  But, here is the thing, we do not need the learned intermediary doctrine to reach that result.  Even if we get rid of the LID entirely, the case should have been dismissed. 

This was a case where the plaintiff's own evidence defeated her claim that there were no warnings.  She simply did not have a claim.  The manufacturer would have won regardless of whether the jurisdiction did away with the LID. 

Thus, the case raises the question...  if the cases that should be dismissed can be dismissed without using the LID, and if there are cases that should not be dismissed that are getting dismissed because of the LID, why do we need the LID to begin with?

Comment on the "learned intermediary doctrine"

I have argued that it may be time to revise the notion of the learned intermediary doctrine (see here); and I am not alone in this (see here). In contrast, the folks at the Drug & Device Law Blog defend the doctrine and make a strong argument (here) that courts should not only adopt it, but that there should be no exceptions to it.

Is Congress going to abolish the learned intermediary doctrine?

In a recent interview, I argued that the time has come to take a careful look at the concept of the so-called "learned intermediary doctrine" in prescription drug cases. I am clearly not alone on this. At least two states have abolished the doctrine and Professor David Owen, author of leading textbooks and hornbooks on Products Liability has argued that "[i]n this day of mass merchandising of prescription drugs in the media, where drug manufacturers have chosen to jump over doctors and market their drugs directly to patients, it seems that manufacturers logically should have a corresponding duty to supply warnings of dangers directly to patients, too." (See here). Not surprisingly, those who favor defendants in these types of cases, disagree. That's why the Drug and Device Blog calls a bill to abolish the learned intermediary doctrine "something completly stupid." For their arguments in favor of the doctrine you can go here and here. Apparently, Rep. Bob Filner (D-CA) has introduced a bill (H.R. 6421) that seeks to abolish the learned intermediary rule. In summary, the bill says that "[i]t shall not be a defense to any tort claim in any court in the United States that a manufacture of a product has fulfilled that manufacturer's duty of care when the manufacturer provides all of the necessary information to a learned intermediary who then interacts with the consumer of the product." Unfortunately, the bill is probably not going anywhere. I would be incredibly surprised if it did - not only because of Congress is in a "lame duck session" but because of the powerful lobbying by the pharmeceutical industry.

Learned intermediary doctrine protects pharmacy from having to alert customer of dangerous drug interaction

While some jurisdictions are adopting the learned intermediary doctrine (here) and others are abandoning it (here), the Illinois Court of Appeals has just issued a short but interesting case on the issue of whether the learned intermediary doctrine relieves a pharmacy from a duty to warn a customer of a potential drug interaction.

As you probably know, the learned intermediary doctrine provides that manufacturers of prescription drugs do not have duty to warn consumers directly of the risks involved in using prescription drugs because they can rely on the physicians who prescribe them to do so. In Illinois, the doctrine has for a long time, and with only one exception, been applied to exempt pharmacies and pharmacists from liability for failing to give warnings to patients. Part of the reasoning for extending the use of the doctrine in this manner is to prevent the pharmacist from second guessing the physician -- who the doctrine assumes is the best qualified and best positioned person to determine what is best for the patient -- and thus to prevent having the pharmacist interfere with the doctor-patient relationship.

The new case decided by the Illinois Court of Appeals is called DiGiovanni v. Albertson's Inc and it is availble here. In it, the court follows the long standing rule in the state that recognizes the protection provided by the learned intermediary doctrine for pharmacists. Given the long standing approach on the issue in the state and given the specific facts of the case, the case is correctly decided, but I have some mixed feelings about it.

As I have commented before (here), it may be time to revisit the whole LID doctrine to begin with. And, I believe it is unnecessary to apply it to pharmacists. I do not see a problem in holding pharmacists to the same standard of care that we hold everyone else. They should act like reasonable people under the circumstances. If they do, there will be no liability. The result in this case would have been the same had we applied that simple rule.

 The facts were clear that the pharmacist acted reasonably. The record indicates that the pharmacist called the physician prior to filling the prescription regarding the potential interaction, and the physician indicated that he would monitor the patient. Under those circumstances, the pharmacist was reasonable in relying on the expertise of the doctor. Perhaps the pharmacist could have told the patient to check with his doctor about the possible drug interaction too, but I am not sure that we can say that - under the circumstances - failing to do so should result in liability.

I guess my point is that the main concern here should be to develop a doctrine that seeks to provide the consumer with more protection. If it requires that pharmacists use their expertise by double checking with the doctor or telling the patient do double check with the doctor before exposing the patient to a known risk, so be it. The burden on the pharmacist to make a phone call or give a word of warning to a customer seems well worth it to me.

Pharma admits it made false statements on label

Teva Pharmaceuticals has admitted that it made false statements on the label of Gianvi, a generic clone of Bayer’s Yaz birth control pill. For more on this story go to AboutLawsuits.com.

FDA issues warning against Pfizer for failure to report side effects

In response to a six week long audit of Pfizer’s New York headquarters last summer, the FDA has recently issued what has been decribed as a "stinging" 12-page letter scolding Pfizer for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including Lipitor, Selzentry, Lyrica, Camptosar and Viagra. Go here for the full story. Go here for a copy of the letter.

More on the FDA's attempts to get doctors to report pharmaceuticals ads

Here is Pharmalot's version of the story on the FDA attempts to get doctors to report bad advertisements by pharmaceutical companies.

FDA wants to get doctors to help identify misleading drug marketing practices

Federal drug regulators are hoping to recruit doctors in the hunt for misleading drug advertisements through a new initiative aimed at marketing materials that provide inaccurate or misleading information, or make statements that downplay or omit the negative side effects of drugs. Go here for the full story. For a comment from the right wing Washington Legal Foundation on this topic go here.

Thoughts on the "learned intermediary doctrine"

In a comment on whether the ban on "off label marketing should be eliminated (available here), the blog Tort Deform makes the case for abolishing the "learned intermediary doctrine:"

 . . . I would . . . end the learned intermediary doctrine. The learned intermediary doctrine traditionally prevents consumers from suing pharmaceutical companies for failing to warn consumers of the dangers of a prescription drug. Instead, a consumer has to sue the pharmaceutical company for failing to warn doctors of the dangers of a specific drug. Because consumers can’t just buy a prescription drug on their own, they have to get a prescription from a doctor[, the] doctor acts as an intermediary between the consumer and the pharmaceutical company. And it is the doctor’s responsibility to ensure that the patient is a proper candidate for the drug. I believe if we abolished the learned intermediary doctrine, pharmaceuticals would be more forthcoming in their disclosures about specific drugs. Warning consumers about the dangers of a drug is different than warning doctors. Pharmaceutical companies would have to do more to educate the public than release a study in a medical journal, for example. More importantly, abolishing the learned intermediary doctrine would take into account how drugs are actually prescribed. In reality, many patients see a drug on TV and then decide they want that drug. They then get an appointment with their doctor, ask the doctor for a prescription, and the doctor writes the prescription with few if any questions. Instead of acting like a “learned intermediary,” many doctors act like nothing more than a middleman, happy to collect an office visit fee in exchange for a prescription for just about any drug a patient wants. Abolishing the learned intermediary doctrine would force pharmaceuticals to actively attempt to warn consumers about the dangers of specific drugs. This can only improve patient safety. 

 I agree.

FDA proposes new rule on direct to consumer ads

The FDA has proposed a new rule to amend its direct-to-consumer regulations covering broadcast ads and would require info about side effects and contraindications to be presented in a “clear, conspicuous and neutral manner.” Go here for the story. UPDATE 4/13: Mass Tort Defense blog has more on the story here.

Colorado Appellate Court Adopts Learned Intermediary Doctrine

See the full story (with links to the case) here.

Is a warning that a drug may cause cancer in dogs adequate notice that it may cause cancer in humans?

The Drug Recall Lawyer Blog is reporting today on an interesting case in which the title of this post is the key issue. Go here for the full story.

In this case, the plaintiff was on hormone therapy, including a drug called Provera for ten years, through three different physicians. Part of this time, she took Provera (a progestin) in combination therapy with Premarin (an estrogen). The label for Provera, inserted in the Physicians’ Desk Reference by Pfizer, included the following: Beagle dogs treated with medroxyprogesterone acetate [the active ingredient in Provera] developed mammary nodules some of which were malignant. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas the nodules in the drug-treated animals were larger, more numerous, persistent, and there were some breast malignancies with metastases. Their significance with respect to humans has not been established.

Based on this warning, Pfizer tried to claim that Plaintiff was on notice that the drug could have caused her breast cancer more than two years before she filed the lawsuit (and, more than two years before a study showed the cancer risks with respect to humans).

The jury decided for the plaintiff, but the court entered a judgment notwithstanding the verdict. However, on December 31, the Superior Court of Pennsylvania (Pennsylvania’s first level appellate court) decided in Simon v. Wyeth Pharmaceuticals, et al. that the trial judge's grant of judgment notwithstanding the verdict was erroneous stating that "It defies logic, contrary to the trial court’s suggestion, that Appellant should have been aware of the risk of taking HRT through her own due diligence. It is entirely unreasonable that a lay person, completely lacking in medical training, would make the logical connection between HRT and breast cancer prior to the release of the WHI study, when three trained medical doctors believed that there was no such connection."

In the alternative, the trial court also justified the JNOV by concluding Pfizer’s failure to warn was not a proximate cause of the plaintiff's injury. This conclusion was apparently based on Pfizer's argument that a different warning would have made no difference. If that was the argument, by the way, the issue was not about proximate cause but about cause in fact. But in any case, the appellate court rejected the argument, noting that the doctors behaved much differently with their patients after the release of the study related to possible side effects in humans. One doctor noted in a deposition that, after the study, he “took every single patient off of the pill” There was sufficient evidence to support an inference that a different warning would have made a difference. There are about 1,000 other hormone therapy cases pending in courts around the country.