Dear Colleagues and Friends,

With email, cell phones, text messages, and social media, writing letters has become a thing of the past. For drug manufacturers (and the lawyers who represent them), however, it is the very act of letter writing that may help avoid liability in a lawsuit regarding an alleged failure to warn. This letter/review highlights the importance of the form and, especially, the timeliness of Dear Doctor letters. So, before you chuck your letter writing skills (i.e., inside address, greeting, body, complimentary close, and signature), note the information below.

Requirements and Guidance for Dear Doctor Letters

According to the U.S. Food and Drug Administration (FDA), Dear Healthcare Professional letters (also known as Dear Doctor letters) are pieces of correspondence mailed from a pharmaceutical product manufacturer or distributor to physicians and other healthcare professionals to convey important product safety information.¹ The federal regulation that governs Dear Doctor letters, in part, provides:

21 C.F.R. § 200.5 – Mailing of important information about drugs.

Manufacturers and distributors of drugs and the Food and Drug Administration occasionally are required to mail important information about drugs to physicians and others responsible for patient care. In the public interest, such mail should be distinctive in appearance so that it will be promptly recognized and read. The Food and Drug Administration will make such mailings in accordance with the specifications set forth in this section. Manufacturers and distributors of drugs are asked to make such mailings as prescribed by this section and not to use the distinctive envelopes for ordinary mail.

The regulation goes on to set forth certain requirements dependent on whether the Dear Doctor letter is intended to convey new information about: 1) a significant hazard to health; 2) important changes in the package labeling; or 3) a correction in product advertising or labeling.² Additionally, the regulation specifies the proper form for Dear Doctor letters to include placement of the drug manufacturer’s name and address, the font type and size, etc.³ The regulation itself is concise, but the FDA also issued a guidance to assist industry and FDA staff to “improv[e] communication of important safety information” in Dear Doctor letters.⁴

Although the FDA’s guidance contains suggestions and “should be viewed only as recommendations” instead of requirements, any pharmaceutical manufacturer that intends to send a Dear Doctor letter should become familiar with the FDA’s guidance on the subject.⁵ Moreover, the pharmaceutical manufacturer should actually work with the FDA to prepare the Dear Doctor letter prior to engaging in any mass mailing.⁶ Indeed, the FDA actually “believes that effective communication of important new information in Dear Healthcare Provider letters can be best accomplished if FDA and the manufacturer work together” on such letters.⁷ The guidance further provides that “FDA encourages manufacturers to consult with the appropriate review division in the development of a Dear Healthcare Provider letter to ensure that the letter clearly and accurately reflects both the manufacturer’s and FDA’s understanding of the issue and the action required to address the issue.”⁸ Working with the FDA on Dear Doctor letters provides an opportunity for the FDA to have input on the content of the letter, and manufacturers who do so may include a statement in the heading or in the body of the letter indicating that the FDA reviewed and agreed with the contents of the letter.⁹ Most pharmaceutical manufacturers and lawyers understand that compliance with the FDA’s guidance and requirements does not necessarily shield one from litigation, but consultation with the FDA is also particularly important to “avoid the need to send a corrective letter in the event that FDA determines […] that the content of the letter was somehow false or misleading.”¹⁰

The Importance of a Timely Dear Doctor Letter

While the form and content of Dear Doctor letters are important, the Tietz v. Abbott Laboratories, Inc., Illinois state court case indicates the importance of timely sending the letters.¹¹ The Tietz plaintiff alleged that Abbott, the manufacturer of a prescription immunosuppressant medication Humira®, failed to warn consumers or physicians that Humira could cause a rare infection known as histoplasmosis.¹² The Tietz plaintiff specifically alleged that his wife suffered from the rare infection as a result of using Humira, and physicians were unable to diagnose the condition for weeks due to Abbott’s failure to warn.¹³ Abbott submitted evidence that it had, in fact, mailed Dear Doctor letters advising of the rare infection in May 2010.¹⁴ The Tietz plaintiff argued, however, that his wife had already been hospitalized for 10 days before Abbott distributed the letters.¹⁵ Further, the Tietz plaintiff argued that the FDA had previously advised Abbott and other manufacturers — in September 2008 — to provide new information about the risks of the rare disease.¹⁶ In other words, the Tietz plaintiff argued that Abbott’s Dear Doctor letter advising of the risk was “too little, too late,” and apparently the jury agreed, as it awarded a $2.2 million verdict.¹⁷

In the Tietz case, the manufacturer had mailed a Dear Doctor letter advising of the risk at issue but to no avail. In fact, the manufacturer submitted evidence that it worked with the FDA to secure approval of the contents of the letter (i.e., the manufacturer had complied with the FDA’s guidance). The manufacturer’s arguments were insufficient to overcome plaintiff ’s failure to warn allegation as the jury found that the Dear Doctor letter had not been sent in a timely manner. A cynical person may read the Tietz case and conclude that working with the FDA to mail a Dear Doctor letter lacks any value and is a complete waste of time. Any such way of thinking, however, seems to miss the point of the Tietz case. So, what is the point? The Tietz case seems to suggest that a Dear Doctor letter must be mailed within a timely period after a manufacturer learns of new safety information that should be shared with prescribing physicians and other healthcare providers. What remains unclear, however, is what period of time makes a Dear Doctor letter timely? Unfortunately, the answer is not in this letter, nor is it in the FDA’s guidance, as the FDA only suggests “it is important to communicate new information promptly to healthcare practitioners involved in prescribing or dispensing a drug, or in care for patients who receive a drug.”¹⁸

Other Cases re Timeliness of Dear Doctor Letters

Although the Tietz case and, more importantly, the FDA’s guidance are silent on the time period that renders a Dear Doctor letter timely and prompt, a review of the case law reveals that the question is one for the jury. For example, in Rutz v. Novartis Pharmaceuticals Corp., the Rutz plaintiff alleged that the defendant manufacturer of a cancer medication failed to warn about the risk of osteonecrosis of the jaw (ONJ) in a timely manner.¹⁹ Specifically, the Rutz plaintiff alleged that the defendant manufacturer waited 10 months after receipt of the first ONJ-related adverse event to notify the FDA of its intent to revise the product labeling to reflect reports of ONJ with the use of its product.²⁰ Further, the Rutz plaintiff alleged that the defendant manufacturer waited 22 months before sending Dear Doctor letters to notify prescribing physicians of the label change.²¹ The defendant manufacturer submitted evidence that it had received the first ONJ-related adverse event nearly six months after the Rutz plaintiff began using its product, and it voluntarily changed the product warnings to reflect the risk of ONJ once it had collected adequate data.²² Plaintiff submitted, however, that the defendant manufacturer “knew about the risk of ONJ long before it amended its warning and sent the letters notifying doctors of the risk.”²³ The court found that the issues of adequacy and timeliness of the defendant manufacturer’s Dear Doctor letter and revised warnings were questions of fact for the jury.²⁴

In Winters and Baldwin v. Novartis Pharmaceuticals Corp., the Baldwin plaintiff also alleged that the defendant manufacturer of a cancer medication failed to warn about the risk of ONJ in a timely manner.²⁵ Specifically, the Baldwin plaintiff presented evidence that the defendant manufacturer “was slow to respond to an obvious problem and arguably tried to conceal or delay information concerning the risk of developing ONJ from the medical community and the public.”²⁶ The Baldwin plaintiff began using the product at issue in July 2003; however, the defendant manufacturer had been notified of the risk of ONJ with the use of its product in June 2003 and instructed members of its sales force not to mention the risk as early as August 2003.²⁷ Although the defendant manufacturer changed the package insert to mention cases of ONJ in December 2003, it failed to send Dear Doctor letters until September 2004.²⁸ Further, by that time, the Baldwin plaintiff had been using the product at issue for 14 months and had lost two teeth.²⁹ The Baldwin plaintiff argued the “warnings were both insufficient and too late,” and the jury agreed by returning a verdict for $225,000 on the failure to warn claim.³⁰

A Medtronic multidistrict litigation (MDL) plaintiff made similar allegations against the manufacturer of implantable defibrillators for failure to warn in a timely manner.³¹ Evidence was presented that the defendant manufacturer learned in early 2003 that its defibrillators had a defective battery that caused the products to lose charge in days instead of years.³² The defendant manufacturer began receiving reports of premature battery depletion around February 2004, and it had received several reports by December 2004.³³ In February 2005, which was two years after first learning of the issue, the manufacturer mailed Dear Doctor letters advising of the risk of battery depletion and product failure.³⁴ The court found the evidence sufficient enough for a jury to determine whether the defendant manufacturer knew of the defect for a substantial period prior to advising of the defect.³⁵

Conclusion

This letter serves as a friendly reminder of the value of Dear Doctor letters. In addition to providing valuable information to prescribers and other healthcare providers, Dear Doctor letters can help shield a manufacturer from failure to warn litigation. If case law is any indication, though, the timeliness of a Dear Doctor letter is as equally important as the contents of the letter. While there is no set amount of time to render a Dear Doctor letter timely, there is no time like the present to brush up on the case law and FDA’s guidance and requirements for such letters to avoid a costly rewrite of the Tietz case.

Warmest regards,

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[i] Manual of Policies and Procedures 6020.10 “NDAs: ‘Dear Health Care Professional’ Letters,” July 2003, at 2. <http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082012.pdf>.

[ii] 21 C.F.R. § 200.5.

[iii] Id.

[iv] FDA’s Guidance for Industry and FDA Staff: Dear Health Care Provider Letters: Improving Communication of Important Safety Information, November 2010. (Referenced in subsequent notes herein as “Guidance.”) <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM233769.pdf>.

[v] Guidance at 1.

[vi] Per the FDA’s Guidance, those intending to distribute Dear Doctor letters electronically should also consult the FDA’s Guidance for Industry on Using Electronic Means to Distribute Certain Product Information. Guidance at 5. See also <http://www.fda.gov/RegulatoryInformation/Guidances/ucm125164.htm>.

[vii] Guidance at 2.

[viii] Id.

[ix] Guidance at 5.

[x] Guidance at 2.

[xi] Milton Tietz et al. v. Abbott Laboratories, et al., No. 12-L-002715, Ill. Cir. Cook Co. (May 2013).

[xii] See <http://www.lexisnexis.com/legalnewsroom/litigation/b/litigation-blog/archive/2013/05/10/illinois-jury-awards-2-2million-to-widower-in-1sthumira-infection-case-to-go-to-trial.aspx>.

[xiii] Id.

[xiv] Id.

[xv] Id.

[xvi] Id.

[xvii] Id.

[xviii] Guidance at 2. Emphasis added.

[xix] Rutz v. Novartis Pharmaceuticals Corp., No. 12-CV-0026-MJR, 2012 U.S. Dist. LEXIS 177779 (S.D. Ill. Dec. 17, 2012).

[xx] Id. at *15.

[xxi] Id.

[xxii] Id. at *12.

[xxiii] Id. at *13.

[xxiv] Id. at *15.

[xxv] Winter and Baldwin v. Novartis Pharmaceuticals Corp., 882 F.Supp.2d 1113 (W.D. Mo. Aug. 3, 2012).

[xxvi] Id. at 1118.

[xxvii] Id.

[xxviii] Id. at 1119.

[xxix] Id. at 1120.

[xxx] Id. at 1116, 1120.

[xxxi] In re Medtronic, Inc., Implantable Defibrillators Litigation, 465 F.Supp.2d 886 (D. Minn. Nov. 28, 2006).

[xxxii] Id. at 889.

[xxxiii] Id. at 890.

[xxxiv] Id.

[xxxv] Id. at 897.

Finis