New Draft FDA Guidance On Off-label Uses Raises Concerns

On March 3, 2014, FDA made available for comment a revised draft of its "Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices".  The revised guidance seeks to clarify and expand upon FDA's 2009 draft guidance that generated significant controversy. Although the recently released draft guidance addresses some industry concerns, does it address the concerns of those who believed the earlier guidance took a position at variance with the First Amendment?    

An excellent discussion of the revised draft guidance is provided in the Client Alert recently issued by Epstein Becker Green attorneys Amy K. Dow, Ryan R. Benz and Daniel G. Gottlieb.  In summary, the draft guidance expands upon the types of materials that may be distributed (subject to FDA's enforcement discretion) and, for the first time, includes clinical practice guidelines.  In particular, industry had been pushing for more clarity from FDA on this issue. The draft guidance requires that a manufacturer, before disseminating a clinical practice guideline, establish that the clinical practice guideline is "trustworthy" and, as detailed in the Client Alert, meets six tests based on standards developed by the Institute of Medicine.   

Of particular interest, however, is the extent to which FDA may be modifying its position on restrictions on truthful, non-misleading, off-label speech in light of the Second Circuit's important  2012 decision in U.S. v. Caronia.

FDA  has long held the position that, although off-label promotion by pharmaceutical manufacturers and/or their agents is not expressly prohibited by the FDCA or its attendant regulations, such commercial activities are impliedly prohibited as "misbranding."   Thus, when a drug is placed in interstate commerce without adequate directions for use and adequate warnings It is the FDA's view that, by definition, a drug fails to bear adequate directions for an off-label use. Therefore, promotion beyond the scope of the product label may be construed as "misbranding" in violation of the FDCA.

In Caronia, the Second Circuit vacated the conviction of Alfred Caronia, a former pharmaceutical sales representative for Jazz Pharmaceuticals whom a federal district court jury found guilty of conspiring to introduce a "misbranded" drug into interstate commerce in violation of the FDCA.  

The majority held that the FDCA's misbranding provisions cannot be interpreted as a blanket ban on off-label promotion by pharmaceutical manufacturers. However, the court was clear that its holding did not prevent the FDA from regulating the marketing or promotion of prescription drugs and limited its decision to the truthful off-label promotion of prescription drugs for which an off-label use is not prohibited.  The court also stated that more narrowly tailored regulation of speech by the FDA as it concerns off-label use might survive judicial scrutiny.

In analyzing Caronia, it is important to keep in mind that courts, in general, are hesitant to criminalize speech without an articulable public good (such as harm or safety) to be gained from doing so. That is, a desire merely to stop speech is not a sufficient interest (without another countervailing public need) in order to permit the government to regulate or prohibit speech.

In earlier cases, the Supreme Court has disfavored categorical bans on truthful, non-misleading speech because it arises from the "paternalistic assumption" that the public will use truthful, non-misleading commercial information unwisely,  Such paternalism is all the more misguided when the speech is being directed to the medical community over whom  FDA can assert no regulatory authority.  A medical clinician, who has presumably more knowledge than FDA staffers about the diseases and conditions she treats, should not be unnecessarily hamstrung in seeking to become more knowledgeable about a particular drug.

Although Caronia represented a setback for the Agency, it is inaccurate to conclude from this decision that FDA does not retain broad regulatory authority  to regulate promotional speech. The likely battleground in the future will be when the First Amendment is raised as a defense to civil fraud cases, particularly qui tam actions, brought under the federal civil False Claims Act.

The revised draft guidance does not include the same blanket prohibitions included in the earlier pre-Caronia guidance. Under the revised draft guidance, some highlighting and summarizing is permitted as long as it does not promote an off-label use or is misleading. Although FDA clearly still believes that it can regulate non-misleading speech, it has backed off somewhat (perhaps in light of Caronia), and sought to bolster its position by adhering closely to the statutory prohibitions in the FDCA.

A thorough discussion of Caronia and its possible ramifications was the subject of a Client Alert authored by Epstein Becker Green's Stuart M. Gerson, Wendy C. Goldstein, Benjamin S. Martin, Daniel G. Gottlieb, David C. Gibbons, and Natasha F. Thoren issued on the heels of the Second Circuit's publication of its decision.

In the absence of further modification of the draft guidance, to what extent will the risk of noncompliance outweigh the benefit to industry of being able to distribute scientific or medical publications on unapproved new uses?  How will the new guidance affect, if at all, the ability of the medical community to obtain reliable information on off-label uses from drug manufacturers?  It will be interesting to see how the various stakeholders' positions evolve during discussions over the coming months.

Pharmaceutical Failure to Warn.... On Facebook?

The Facebook page of Switzerland-based drug maker, IBSA Institut Biochimique S.A. (“IBSA”), appeared innocent enough: 

If you have just been diagnosed with hypothyroidism or are having difficulty controlling your levothyroxine blood levels, talk to your doctor about prescription Tirosint, a unique liquid gel cap form of levothyroxine.

In an untitled letter to the drug maker on February 28, 2014, FDA advised IBSA that its Facebook webpage was false or misleading because it made representations about the efficacy of Tirosint, but failed to communicate any risk information associated with its use and omitted material facts regarding Tirosint's FDA-approved indications. 

FDA advised IBSA that the webpage misbranded Tirosint within the meaning of the Federal Food, Drug and Cosmetic Act (“FDCA”) and made its distribution violative of federal regulation. Specifically, FDA referenced 21 U.S.C. 352(a), (n); 321(n); 331(a); and 21 CFR 202.1(e)(5). Further, FDA reminded the company that Tirosint is associated with a number of serious risks and includes a Boxed Warning indicating that Tirosint should not be used for the treatment of obesity or for weight loss, among other potential risks associated with the use of this medication.  FDA also alleged that IBSA had failed to disclose important limitations on the approved indications of the product, increasing the risk that the product would be used in patients with conditions that were expressly excluded from the approved indications for use.

FDA and the regulated community has been grappling for some time over what might constitute the improvident use of social media. Unquestionably, a pharmaceutical company will run afoul of FDA if product risks are not disclosed. In this instance, FDA noted that IBSA had failed to disclose any (emphasis FDA’s) of the risks associated with the product’s use. 

FDA directed IBSA to immediately cease activity violative of the Act and to submit a plan for discontinuing the use of all non-compliant promotional materials.

Despite the public attention given to IBSA’s ill-advised social media posting, the pharmaceutical industry and the medical community have made significant strides in recent years to ensure that physicians are receiving full and complete information concerning the medications they are prescribing for their patients. 

One enormous step in the right direction is Sermo, an online community for physicians founded in 2006. Sermo was originally founded by doctors, for doctors. Originally imagined as an adverse effect reporting system without industry influence, Sermo is now a vibrant place where physicians can post observations and questions about clinical issues and hear other doctors’ opinions. 

In just a few short years, Sermo has grown to include 200,000 licensed physicians. Some of the heaviest users of Sermo are older physicians, which is somewhat surprising in that the youngest members of a professional group typically adopt technologies first. 

Increasingly, the major pharmaceutical companies take the view that social media and other on-line resources can provide an important tool in ensuring that its products are used safely, effectively and appropriately. 

At a public hearing conducted by FDA in 2009, Dr. Freda Lewis-Hall, the Chief Medical Officer for Pfizer, reported that the average physician spends about eight hours a week using the internet for professional purposes; that 87% of physicians are interacting with drug and device companies online; and that 60% of physicians are interested in participating in online communities. She opined that the majority of physicians want to engage with health care companies in the social media space to obtain drug information.  These physician participation statistics are probably even more striking today.

Pfizer and other companies now communicate with physicians through social media, particularly through collaboration with Sermo. Dr. Lewis-Hall describes Sermo as the online physician’s lounge where informal but highly valuable consults take place.

On January 13, 2014, FDA issued a portion of its long-awaited social media guidance titled "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics".  Although industry is likely to seek clarification and revision on certain of the rules-of-the-road discussed in the draft, some of the basic concepts expressed are:

1. a company will not be deemed responsible for visitor posts on company-run social media (blogs, chat rooms, message boards, etc) so long as the visitor has no affiliation with the company and the company has no influence over the user-generated content;

2. a company is responsible for content generated by an agent or employee.

3. every advertisement on social media must contain a "fair balance" of the risks and benefits of a drug product and complete disclosure of the product's approved indications for use.  Query. Could a Twitter entry with its 140-character limit ever meet this standard?  FDA is supposed to provide further guidance on this concern down the line.

4. marketing material postmarketing submission requirements must be complied with for any site where the company "exerts influence.......even if the influence is limited in scope. For example, if the firm collaborates on or has editorial, preview, or review privilege over the content provided, then it is responsible for that content."  However, if the company only provides financial support to the site, and its influence is otherwise limited, there is not a reporting requirement. 

The issue of "exerting influence" is problematic and, despite some helpful hypotheticals in the guidance, ambiguous.  Big Pharma has an interest, perhaps even a responsibility, to be involved in e-media forums where the scientific and medical community is seeking interactive information on pharmaceutical products.  However, the draft guidance arguably produces a push-pull reaction.  Do we engage or, by engaging, do we run the risk of having an added regulatory burden by having to file FDA reports concerning participation on the site?  Some clarity for the industry is warranted to avoid over and under-reporting.  

As reflected in this discussion, as all of us – consumers and companies – continue to move forward in a world increasingly dominated by social media, challenges and opportunities abound. On the one hand, there are the missteps, as we see in the case of IBSA. On the other hand, the pharmaceutical industry is moving ahead of the curve to use social media to ensure that its prescribing physicians are well-educated and their patients provided the best possible care. We hope that the final social media guidance facilitates, rather than impedes, this process.

The author acknowledges the important contributions made to this article by Amy K. Dow, a partner at Epstein Becker Green, and Natasha F. Thoren, an associate

Fungal Meningitis Outbreak Spurs FDA Oversight Of Drug Compounders

In 2012, a major outbreak of fungal meningitis was traced to drugs compounded by New England Compounding Centers. The outbreak included approximately 750 confirmed cases and has resulted in 64 deaths to date. Tragedies of this scale have often been the impetus for major changes to federal food and drug laws in the past; the FDCA itself was enacted in 1938 in response to a tragedy in which the use of an improperly manufactured drug (elixir sulfanilamide) led to over 100 patient deaths.

Drug compounding is a process of combining different ingredients to create customized pharmaceutical products for patients.  The practice predates the rise of mass-produced drugs in the United States, and was essentially unregulated by FDA for 50-plus years after passage of the FDCA.

In a Client Alert titled, "Major Changes in Drug Compounding and Drug Distribution Requirements (Part 1 of 2)", Epstein Becker & Green health care practice partners, James A. Boiani (D.C.) and Kim Tyrell-Knott (San Diego), provide an insightful analysis of the Drug Quality and Security Act (H.R. 3204). 

According to Jim and Kim, the bill is compromise legislation crafted by the Senate Health, Education, Labor, and Pension (“HELP”) and House Energy and Commerce Committees, and is expected to pass the Senate soon after it reconvenes today. Once signed into law, H.R. 3204 will fundamentally change the regulation of drug compounding and drug distribution in the United States.

We look forward to the publication of Part 2 of their Alert concerning this important piece of legislation.

Physician's Failure To Read Trumps Drug Company's Failure To Warn

When the prescribing physician in a pharmaceutical product liability case admits that at her deposition that she never reviewed the manufacturer’s label before treating her patient and that the label played no role in her decision to prescribe the drug, plaintiff’s claim that the label should have contained a stronger warning is rendered moot.

Often the physician, a trained clinician, will testify that she was familiar with the risks in question and did not need to be provided a warning. Alternatively, the physician may testify that a stronger warning would not have influenced her decision to prescribe the drug and that she still prescribes the drug. Under either scenario, it may be argued on summary judgment that the learned intermediary did not rely on the allegedly inadequate warning and that, therefore, the plaintiff cannot establish that the alleged failure to warn was a proximate cause of plaintiff’s injury.

In an article on his Drug and Device Law blog on October 17, 2013 titled, “Don’t Forget About a Prescribing Physician’s Failure to Read Warnings,” James M. Beck, Counsel resident in the Philadelphia office of Reed Smith, provides an exhaustive survey of cases dismissing claims where the learned intermediary physician failed to read the warnings. Beck reports on and provides summaries of decisions from 42 jurisdictions.

As Beck observed in another blog post on October 28, 2011, “After all, there is a causation element to every warning claim – the defect (whatever is allegedly wrong with the warning) has to cause the injury. If the prescribing physician never even read the purportedly inadequate warning, none of those inadequacies could have affected his/her treatment of the patient.”
 

Lone Pine's Impact On Pharma Products Litigation

We have written previously about the increasing acceptance by courts to entertain the use of Lone Pine orders as a case management tool. For example, in the Happyland Social Club Fire Litigation, which involved 87 wrongful death claims, the Bronx Supreme Court’s entry in 1992 of a Lone Pine order was instrumental in obtaining dismissals on behalf of defendants whose products plaintiffs could not identify as being in the club at the time of the fire.

More recently, we discussed the use of a Lone Pine order by a Colorado state court in a hydrofracking toxic tort case. In that matter, the court dismissed the claims of plaintiffs who failed to submit sworn expert affidavits establishing a causal relationship between their illnesses and hydrofracking chemicals they claimed to have been exposed to.

Increasingly, Lone Pine orders are being employed as a case management tool in pharmaceutical mass tort cases. Most recently, Judge John F. Keenan, who presides over the Merck Fosamax Products Liability MDL in the SDNY, issued a sweeping Lone Pine order on November 20, 2012.

In its Opinion and Order, the court considered whether to apply the Lone Pine order to all of the plaintiffs’ cases or merely a sub-set. In evaluating this issue, the court observed that was at least some medical or scientific evidence that Fosamax could cause osteonecrosis of the jaw (known as “ONJ”). In light of this purported evidence, the court refused to apply the Lone Pine order to those plaintiffs alleging that they suffered from ONJ.

Why did Judge Keenan enter the Lone Pine order in 2012 when he had rejected earlier efforts by Merck to enter a Lone Pine order in 2010 and 2011? In short, he had become skeptical about the bona fides of plaintiffs’ claims and the candor of Plaintiff’s Steering Committee. “Plaintiffs’ habit of dismissing cases after both parties have expended time and money on case-specific discovery demonstrates that this MDL is ripe for a Lone Pine order.”

Based upon plaintiff’s pattern of behavior, the court said it had “reason to believe that spurious or meritless cases are lurking in the some 1,000 cases on the MDL docket.” The court noted that “more than 50% of the cases set for trial had been dismissed by plaintiffs as had some 31% of cases that had been selected for discovery.

Judge Keenan has been hearing cases in the SDNY since September 1983. Having presided over trials for thirty years, he has developed good instincts in determining when judicial resources are being squandered. Although he did not come right out and state as much, he had clearly become frustrated by Plaintiff’s Steering Committee wasting the court’s time and forcing Merck’s trial counsel to jump through unnecessary hoops. 

Apart from the litany of stringent (and precedential) Lone Pine requirements imposed upon the plaintiffs to whom the order applied, the decision is helpful because it cites with approval the decisions of multiple other courts overseeing complex pharmaceutical MDLs using Lone Pine orders to streamline their dockets. The cited cases include: In re Avandia Mktg., Sales Practices and Prods. Liab. Litig., MDL No. 1871 (E.D. Pa. Nov. 15, 2010); In re Zyprexa Prods. Liab. Litig., MDL No. 1596 (E.D.N.Y. June 2, 2010); In re Bextra and Celebrex Mktg. Sales Practices and Prod. Liab. Litig., MDL No. 1699 (N.D. Cal. Aug. 1, 2008); In re Vioxx Prods. Liab. Litig., MDL No. 1657 (E.D. La. Nov. 9, 2007, July 6, 2009); In re Rezulin Prods. Liab. Litig., MDL No. 1348 (S.D.N.Y. May 9, 2005); In re Baycol Prods. Liab. Litig., MDL No. 1431 (D. Minn. Mar. 18, 2004).

In ruling on the Lone Pine application, the court rejected the Plaintiff's Steering Committee’s suggestion that the MDL had outlived its usefulness and that the court should adopt an “exit plan” and remand all of the cases for trial rather than entertain a Lone Pine order. The court also rejected Plaintiffs’ argument that a Lone Pine order should only be entertained after a global settlement was reached.

The court reasoned that the primary purpose of Lone Pine orders is to eliminate meritless cases, which is at best only tangentially related to the status of settlement negotiations. Whether the MDL culminates in a global or partial settlement, or the remand of cases back to their home districts, the court believed that a Lone Pine order would boost efficiency under either scenario. “In the event the parties reach a settlement, the elimination of spurious claims will ensure that only plaintiffs with meritorious cases are compensated. If the MDL concludes without settlement, and cases are transferred back to their home districts, Lone Pine will ensure that the home districts receive only viable cases.”
 

Ex Parte Communication With Plaintiff's Prescribing Physician

In product liability litigation, a single tactical advantage may determine whether the case is won or lost. Often, being able to anticipate an issue before it arises and addressing it in the Case Management Order may be critical.  This is particularly the case  in pharmaceutical mass tort litigation.

In pharmaceutical product liability cases, the plaintiff’s treating physician is a critically important witness. If one of the parties in the case  is permitted to “woodshed” the treating physician, it gives that party an enormous tactical advantage.  

For example, if only the plaintiff’s’ attorney can interview the treating physician and is able to control what information that the physician is able to see, such as defendants internal documents, plaintiff may have an enormous advantage when the physician’s deposition takes place. The physician's opinion at deposition concerning whether a drug's prescribing information provided an adequate warning may well be influenced by his prior review of internal company documents that she never would have seen but for review of those documents with her patient's lawyer.

The plaintiff bar is very concerned about a defendant’s ability to be in touch with plaintiff’s treating physicians. To them, control of their client’s prescribing physician is sacred ground. 

In an excellent article on this subject titled “Ex Parte Communications with Healthcare Providers in Pharmaceutical  Mass Torts--Highlights of Recent Rulings,” Lela Hollabaugh, a partner in the Nashville office of Bradley Arant Boult Commings LLP, discusses how plaintiffs and defendants lawyers continue to jockey for position with regard to their ability to talk with treating physicians and other healthcare providers outside of the presence of opposing counsel. Increasingly, courts handling pharmaceutical mass tort litigation are entering case management orders that directly address communications with healthcare providers by all parties. Therefore, it is critically important for defense counsel to make the court aware of their concerns as early in the case as possible.

On their side, plaintiff’s counsel seek to prohibit all communications between defense lawyers and healthcare providers regardless of the subject matter. Plaintiffs vehemently argue that such communications are prohibited by the physician-patient privilege.

On the other hand, defense counsel often seek both the opportunity to talk with the doctor about the patient’s care and work to prevent the plaintiff from “woodshedding” the doctor with confidential documents from the defendant company’s internal files.

According to Ms. Hollabaugh, a frequently cited decision on this issue is that of Judge Eldon Fallon in the Vioxx litigation. In re Vioxx Products Liability Litigation, 230 F.R.D. 473 (2005).

Judge Fallon’s decision gave significant deference to the attorney-client privilege and reasoned that defendants had access to the prescribing physician’s information through medical records, depositions and defendant’s sales representative’s records. Judge Fallon’s decision does not place any limitations on plaintiff’s ex parte discussion with these private physicians. Other decisions, particularly in the MDL context, have done more to even the playing field between adversary counsel.

Ms. Hollabaugh’s paper discusses a number of decisions that have placed a limit on the part of the communications with treating physicians. These decisions prohibit plaintiff’s counsel from discussing with their client’s physicians anything other than “the particular plaintiff’s medical condition at issue in the current litigation”. In at least one case cited by Ms. Hollabaugh, plaintiffs agree to this limitation during oral argument over case management issues. 

In another important MDL, In Re Yasmin and Yaz (Drospirenone Marketing, Sales Practices and Products Liability Litigation, plaintiff’s counsel was permitted to provide treating physicians with documents not previously seen by physicians, including confidential and internal documents of the defendant, but plaintiff was required to provide detailed descriptions or copies of all documents shown to the physician to the defendants at least 72 hours before the doctor’s deposition. In addition, the plaintiffs were not permitted to provide notes, highlighting or underlining to the documents provided to the physician. 

This case law cited in the article reflects that courts recognize that the parties before the court are seeking to gain an advantage for their clients by controlling the information provided to a future trial witness. While Ms. Hollabaugh advises that we may expect the courts to continue to protect the physician-patient privilege would exist, that privilege does not and should not be permitted to extend to allow the “woodshedding” of physicians with documents and information that they have never seen, known and that have no bearing on their treatment of the individual plaintiff.  Her article providesa discussion of how several MDL courts have addressed these concerns.

For the practitioner, Ms. Hollabaugh has highlighted an important issue for defense counsel that may not otherwise be picked up during the routine course of defending a pharmaceutical product liability case. This case law should apply not just in mass tort litigation, but in “one off” pharmaceutical product liability cases as well. 

 

First Amendment Bars Pharmaceutical Company Prosecution

The Second Circuit yesterday rendered its much-anticipated decision in United States v. Caronia, the most important Food Drug and Cosmetics Act enforcement case pending in the country. Not only did  the court’s 2-1 holding determine that the First Amendment bars the criminal prosecution of pharmaceutical manufacturers or their sales representatives for truthful, non-misleading speech promoting the lawful, off-label use of an FDA-approved drug affect criminal FDA enforcement cases, it also has great potential impact on False Claims Act cases.

Stuart Gerson, an Epstein Becker & Geen partner in Washington, D.C., who has defended a number of significant  False Claims Act cases (and qui tam cases), opined  this morning that "the Caronia decision is revolutionary, dealing the government a very hard blow in its effort to quash all off-label promotion, and incidentally to try to limit off-label use, irrespective of the fact that such use is a lawful matter to be decided by doctors and patients. And that is the point, since such use is lawful, making truthful statements about such use would infringe allowable speech."

According to Gerson, the Second Circuit "read the FDCA in a hyperliteral way, holding that the misbranding provisions of the Food Drug and Cosmetics Act do not prohibit such truthful promotion of an off-label prescription drug that otherwise is approved, and thus avoided having to make what it also held would have been the constitutional determination that blocking such speech would have violated the First Amendment."  Caronia adopts a view that pharmaceutical companies and trade associations have attempted to advance for years. Gerson believes that the issue  might well reach the Supreme Court.

In any event, Caronia will stand as an important precedent, not only in criminal cases like this one, but in civil fraud cases as well where the government and qui tam relators have argued that off-label promotion is tantamount to false certification and hence a violation of the federal False Claims Act.

Given the importance of the case, it is likely that rehearing en banc will be sought and, perhaps, a petition filed by the government with the Supreme Court. However, it also may be the government’s strategy to follow a policy of non-acquiescence and litigate the point in other circuits, hoping to create a split. In any event, this is a case that pharmaceutical and medical device companies need to watch closely.
 

Texas Adopts Learned Intermediary Doctrine

The Texas Supreme Court rendered judgment in favor of Centocor, Inc., the pharmaceutical manufacturer subsidiary of Johnson & Johnson, in a landmark decision involving the learned intermediary doctrine, Centocor, Inc. v. Patricia Hamilton, Thomas Hamilton and Michael G. Bullen, M.D. (No. 10-0223). The International Association of Defense Counsel (IADC), which often weighs in on signficant jurisprudential issues before appeals courts, filed an amicus brief requesting that the Court reject the direct-to-consumer advertising exception to the learned intermediary doctrine that had been recognized by the intermediate appellate court.  Porter Hedges LLP  filed the brief on IADC's behalf.

The decision is significant because it the first time that the Texas Supreme Court has expressly recognized the learned intermediary doctrine. Texas now joins the vast majority of states that have adopted the learned intermediary rule. In a press release issued yesterday, IADC reported that the Court declined to create a direct-to-consumer advertising exception to the learned intermediary rule, despite the fact that two other states had done so. The Court also recognized that a plaintiff cannot plead around the learned intermediary rule by asserting causes of action such as fraud in what is, at its core, a failure to warn case. Significantly, the Court also recognized that the learned intermediary rule is not an affirmative defense, but a legal doctrine that is part and parcel of the plaintiff's burden of proof. Further, the Court determined that where a prescribing physician is aware of a drug's risks, "any inadequacy of the product's warning, as a matter of law, is not the producing cause of the patient's injuries."

In the opinion, the Court indicated that "Under the learned intermediary doctrine, the manufacturer of a pharmaceutical product satisfies its duty to warn the end user of its product's potential risks by providing an adequate warning to a 'learned intermediary,' who then assumes the duty to pass on the necessary warnings to the end user." The Court held that "the doctrine generally applies within the context of a physician-patient relationship and allows a prescription drug manufacturer to fulfill its duty to warn end users of its product's potential risks by providing an adequate warning to the prescribing physician."

Notably, the Texas Supreme Court was critical of the lower court's opinion, which had attempted to carve out an exception to the learned intermediary doctrine for direct-to-consumer advertising. Although plaintiff Hamilton alleged various common law causes of action, all of her claims pivoted on the issue of whether the Centocor had provided an adequate warning to her physician in its prescribing information.  Therefore, the Court ruled,  the learned intermediary doctrine applied to all of Hamilton's claims. It was incumbent upon plaintiff to demonstrate that an inadequate warning to her prescribing physician was responsible for her injury.  Because plaintiff failed to present any evidence that the purportedly  inadequate warning was at the root of the physician's  decision to prescribe the medication, her claims failed as a matter of law."
 

DRI Seeks To Protect Against "Innovator Liability"

In the case of Wyeth v. Weeks, the Alabama Supreme Court consented to answer the following question from the Middle District of Alabama: “Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by plaintiffs claiming physical injury from a generic drug manufactured and distributed by a different company?" In its brief filed on December 12, 2011—a combined effort with the Alabama Defense Lawyers Association—the Defense Research Institute (DRI)  argues that well-established state tort duty principles prohibit imposing liability on a brand-name manufacturer that did not manufacture the product ingested by plaintiffs. The contrary decision of the Middle District of Alabama is one of but three decisions in the entire country that have allowed failure-to-warn claims to proceed against a brand-name manufacturer where the plaintiff ingested a generic version of the brand-name drug.

The dispute in this case stems from plaintiffs who ingested generic metoclopramide and developed tardive dyskinesia. The plaintiffs claimed that the generic manufacturer failed to warn of the dangers of metoclopramide adequately, and sued the generic defendant on a failure to warn theory. However, the United States Supreme Court recently ruled in PLIVA, Inc. v. Mensing that, because federal regulations prohibit generic manufacturers from unilaterally altering their warning labels, state tort failure-to-warn claims against generic manufacturers are preempted by federal law. Accordingly, the plaintiffs brought suit against the brand-name manufacturers, and the Middle District of Alabama denied in part the brand-name manufacturers’ motion to dismiss. DRI argues against extending common tort principles out of their shape to impose a duty on a defendant who did not manufacture the product and has no control over it. DRI maintains that federal preemption of generic manufacturers does not change this result, even if application of proper tort principles leaves the plaintiff without a remedy.

It would be bad jurisprudence and bad precedent for the Alabama Supreme Court to uphold plaintiffs' position and impose liability on a drug manufacturer, whose  product did not cause the alleged harm.  If that was the result, it is conceivable that a manufacturer with only 10% market share could be held strictly liable for adverse drug reactions caused by generic competitors, who might collectively control 90% of the market.  It would be unfair and unequitable to shift the burden of liability to a manufacturer whose product did not cause the injury merely because the Supreme Court has ruled that preemptioin protects generic manufacturers against state tort failure-to-warn claims. 

Connecticut Reaffirms Learned Intermediary Doctrine

Sunovion Pharmaceuticals obtained summary judgment on October 5, 2011 after oral argument before the Hon. Stefan R. Underhill in federal court in Bridgeport, Connecticut in the case of Swoverland v. GlaxoSmithKline, 2011 U.S.Dist.LEXIS 127753.  Co-Defendant GlaxoSmithKline, represented by King & Spalding, also obtained summary judgment.  William A. Ruskin and Victoria Sloan of Epstein Becker & Green represented Sunovion. 

The plaintiff alleged that his use in combination of Sunovion’s Lunesta, a sleep aid, and GSK’s Paxil, an anti-depressant, caused depression and suicidal ideation, which resulted in an unsuccessful attempt to kill both himself and his daughter.  As a result of the incident, plaintiff was sentenced to prison and forfeited his position as a prison guard.  Sunovion defended the case on the basis that it adequately warned of the drug’s potential risks and that there was no causal connection between any alleged failure to warn and the treating physician’s prescription of the drug. 

In granting summary judgment to Sunovion, the court reaffirmed Connecticut’s adherence to the learned intermediary doctrine on the basis of the Connecticut Supreme Court's 2001 decision in Vitanza v. Upjohn, 257 Conn 365.   Judge Underhill described the learned intermediary doctrine as "essentially hold[ing] that because there is, or when there is a traditional physician/patient relationship, because the physician is the decision-maker as to whether a particular drug will be used by the ultimate consumer, it is the adequacy of the warnings to the physician that matter.  The Court also rejected plaintiff’s assertion that the learned intermediary doctrine should not apply in this case either because Lunesta directly advertised to the patient or over-promoted the product.  The Court held that there was no factual basis in the record to support the application of either of these exceptions to the learned intermediary doctrine and that, as a matter of law, Connecticut did not recognize these exceptions.

Will Wyeth v. Levine Inhibit Pharmaceutical Innovation?

In a provocative thought piece appearing in the Wall Street Journal on March 9, 2009, L. Gordon Crovitz predicts that the United States Supreme Court decision in Wyeth v. Levine will usher in an era of increased prices for drug and create a disincentive for new product innovation. Mr. Crovitz compares the American legal culture behind the Court's decision to the Luddites that smashed mechanized looms in England at the beginning of the Industrial Age in 19th century England.  He also suggests that the decision's logic may lead product manufacturers to "carry 50 different warnings, one for each state, updated by local juries from time to time."  Despite his misgivings about the decision, it is not likely that any product manufacturers, drug makers or otherwise, are likely to start tailoring their warning on a state by state basis.  As a practical matter, products are sold nationally, often through distributors, and it would be virtually impossible to  ensure that product warnings for Texas purchasers ended up in Texas and that product warnings intended for California purchasers ended up in California.  Moreover, from a jury standpoint, nothing would please a plaintiff's lawyer more than to be able to argue that the manufacturer provided a less strict warning for the product in the jurisdiction where his client's accident occurred. 

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Should Brand Name Manufacturers Be Accountable For Side Effects Caused By Generics?

 

How can a brand-name pharmaceutical manufacturer owe a duty to patients who take only a generic version of its product? In a case of first impression in California, a state appellate court held on November 7, 2008 that Wyeth, Inc. owed a duty to plaintiff Elizabeth Conte, who developed a serious and irreversible neurological condition as a result of taking metoclopramide, the generic version of Wyeth’s Reglan, which is used to treat gastroesophageal reflux disease. In so holding, the California appellate court declined to follow the holdings of a majority of courts that have grappled with this issue.

In Elizabeth Ann Conte v. Wyeth, Inc. et al., the Court of Appeal of the State of the California in the First Appellate District in San Francisco, held that a brand-name pharmaceutical manufacturer’s common law duty to use due care when providing product warnings extends not only to consumers of its own product, but also to those patients whose doctors foreseeably rely on the name-brand manufacturer’s product information in prescribing a medication, even if the prescription is filled with the generic version of the drug. In reversing summary judgment granted to Wyeth by the trial court, the appellate court accepted Conte’s argument that Wyeth should be liable for her injuries because a brand-name manufacturer that disseminates information about its product owes a duty of care to ensure the information’s accuracy to all physicians who prescribe the drug in reasonable reliance on that information, even if the patient ends up taking the product’s generic equivalent.

The court agreed with Wyeth that Conte could not pursue a strict products liability claim against Wyeth. Indeed, Conte did not allege that Wyeth was strictly liability due to inadequate warnings. Rather, she claimed that Wyeth failed to exercise due care in disseminating its product information to physicians.  The court rejected Wyeth’s contention that Conte’s case was merely a product liability suit masquerading as a negligence case. The court held that the plaintiff could pursue claims of intentional and/or negligent misrepresentation based upon Wyeth’s labeling information about the safety of metoclopramide, the risks of its long term use, and the likelihood of serious side effects. 

Was the court correct in determining that Wyeth owed the plaintiff a duty in a negligence context where no such duty could be found to exist in a strict liability case? As a matter of public policy, should a brand-name drug manufacturer be subjected to what Wyeth argued might be “permanent and uncontrolled liability” in perpetuity. Even as a brand-name manufacturer’s sales decrease over time, its potential product liability exposure may actually increase because of higher market share won by generic competitors. Ironically, the generic manufacturer takes precious market share from the brand-name manufacturer at the same time that the court shifts the generic’s product liability exposure back to the pioneer. 

We believe that the better reasoned analysis of this issue may be found in Foster v. American Home Products Corp. (4th Cir. 1994) 29 F.3d. 165 (2003), in which the Fourth Circuit held that a manufacturer of a name-brand drug could not be held liable under a theory of negligent representation for an injury arising from the ingestion of a generic version of the drug. Taken to its logical extreme, in the brave new world envisioned by the Conte court, it may not matter that a plaintiff cannot identify the manufacturer of a product that caused an alleged injury so long as the plaintiff can plausibly claim to have relied on some other manufacturer’s operator’s manual.