December 5, 2016

Product Liability Litigation Update—December 2016

A publication of the Product Liability Practice Group


In This Issue:

Recent Developments Affirm Vitality of the Learned Intermediary Defense



Third Circuit Affirms Dismissal of Claim on Failure-To-Warn Grounds

In Bock v. Novartis Pharmaceuticals Corp., Case No. 15-3696, 2016 WL 5799663 (3d Cir. Oct. 5, 2016), the Third Circuit soundly rejected plaintiff's argument that summary judgment on learned intermediary grounds was premature because it preceded introduction of expert testimony on warnings.

The case involved Aredia and Zometa, two bisphosphonates which treat certain cancer complications. Studies in 2003 and 2004 showed a possible link between biophosphonates and osteonecrosis of the jaw (ONJ) in patients who underwent invasive dental procedures while taking the drugs. In light of these studies, in 2004 and 2005, Novartis sent "Dear Doctor" letters to the medical community describing changes to the drugs' package inserts.

Plaintiff Bock claimed to suffer from ONJ and brought negligent failure to warn claims under Pennsylvania law. However, his physicians testified at deposition that they were aware of the risk of ONJ for patients on Aredia and Zometa, but that biophosphonates were the standard of care for patients like Mr. Bock and they would nonetheless still prescribe biophosphonates to Mr. Bock because the benefits of the drugs outweighed the risk. Recognizing the risk of ONJ, Mr. Bock's hematologist testified that he told Mr. Bock to inform him right away if he had issues with his teeth. Despite his physician's instruction, Mr. Bock underwent an invasive tooth extraction without informing his physicians. Mr. Bock developed ONJ, and filed suit.

On appeal from the District Court's grant of summary judgment to the defendant based on this testimony, the Third Circuit rejected Mr. Bock's argument that he should have been permitted to adduce expert testimony on warnings. Plaintiff argued that because summary judgment was granted before expert testimony on the contents of the warnings was taken, there was no way to tell what the doctors would have done had they been presented with a supposedly adequate warning. The Third Circuit disagreed. It reasoned that, because the doctors testified that they would prescribe the same treatment for the plaintiff today, the plaintiff could only prevail if there was some continuing deficiency in the labeling. Yet, under Pennsylvania law, "[a] warning should not be held improper because of subsequent revelations." Id. at *6 (citing cases). Speculation that expert testimony would "reveal that the risks of bisphosphonate treatment are actually greater than they are presently known" was insufficient to defeat summary judgment.

This case reaffirms that defendants may in appropriate cases move for early summary judgment on the basis of prescribing doctor testimony without waiting for full expert discovery to conclude.

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Hundreds of Cases Dismissed in New Jersey Accutane

A New Jersey state judge recently issued two orders dismissing 160 consolidated cases claiming that the acne drug Accutane caused inflammatory bowel disease on the basis of prescriber testimony.

In the first order, the court granted summary judgment for defendants in 86 cases due to the lack of testimony from plaintiffs' prescribing physicians, who were either deceased or could not be located. See Order Granting Motion for Summary Judgment Based on Lack of Proximate Cause Because Plaintiffs' Prescribers are Deceased or Unable to be Located. In Re: Accutane Litig., Civ. No. 271 (MCL), N.J. Super. Ct. Law Div. (entered Oct. 12, 2015). The ruling turned on the "heeding presumption," a rebuttable presumption that instructs the jury that had an adequate warning been given, the recipient of the warning (in the context of a prescription drug case, the prescriber) would have heeded it. Coffman v. Keene Corp., 133 N.J. 581, 601 (N.J. 1993); In re Diet Drug Litigation, 384 N.J. Super. 525, 544-45 (Law. Div. 2006) (extending the presumption to pharmaceutical litigation). Plaintiffs argued that under that presumption, the burden shifted to Defendants to show that the doctors would have still prescribed the drug. The court disagreed. It reasoned that under both New Jersey law and the law of certain of the plaintiffs' residences, the heeding presumption did not apply to cases where the risk was warned against, even if the adequacy of that warning was in dispute. In some states, moreover, the court found that the heeding presumption did not apply at all in pharmaceutical cases. The court further determined that, even if the heeding presumption did apply, Defendants rebutted given statements from the medical community recommending the continued use of Accutane.

The second ruling applied to 74 plaintiffs whose prescribing doctors testified that they still would have prescribed Accutane had the warning been different. See Order Granting Summary Judgment Based on Lack of Proximate Cause, In Re: Accutane Litig., Civ. No. 271 (MCL), N.J. Super. Ct. Law Div. (entered Oct. 12, 2015) (Order II). Analyzing each prescribing doctor's testimony, the court ruled that the learned intermediary doctrine required dismissal because plaintiffs failed to prove that a different warning would have changed their doctors' prescribing decisions. The court further rejected plaintiffs' argument that plaintiffs' own testimony that they would not have taken the drug if adequately warned defeated summary judgment. Order II at 3 (citing Rossitto, Wilkinson v. Hoffma[n] La Roche Inc., Nos. A-1236T1, A-1237-13T1, slip op., 58-62 (July 22, 2016)). The court reasoned that plaintiffs' argument, if accepted, would effectively gut the learned intermediary doctrine.

The Accutane rulings represent an important re-affirmance of the principle that it is squarely plaintiffs' burden to prove causation by showing that a different warning would have changed the prescribing doctor's prescription decision.

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FDA Unveils New Website for Anonymous Reporting of Regulatory Violations

The Food and Drug Administration (FDA) recently introduced a new webpage for reporting allegations of regulatory violations by medical device manufacturers or marketers. The new webpage, launched on October 21, 2016, enables any person—including current or former employees, competitors, or even plaintiffs' attorneys—to submit a report to FDA regarding a broad variety of potential violations. Illustrating the types of allegations it expects to receive, FDA identifies:

  • non-FDA-approved promotion or advertising;
  • failing to submit required safety reports;
  • failing to comply with design or manufacturing responsibilities;
  • marketing a device without proper FDA clearance;
  • importing a device without satisfying the applicable legal requirements;
  • forging or falsifying an export certificate;
  • failing to register and list a device; and
  • knowingly deceiving FDA.

FDA encourages reporters "to include supporting information and contact information in case additional information is needed for FDA to understand the allegation and act on the report." The agency also permits anonymous reporting and guarantees that it will maintain reporters' anonymity unless legally required to do otherwise.

According to the new webpage, all reported allegations will be reviewed by the Center for Devices and Radiological Health (CDRH). CDRH is then charged with prioritizing its review based on the level of potential risks to patients. Following an assessment of the allegation, CDRH has the option of issuing a warning letter, conducting an inspection, or even requesting a recall. CDRH may also request additional information from or simply monitor the medical device manufacturer.

FDA implemented a similar reporting mechanism in 2010, the "Bad Ad Program," which only addresses reports of potentially untruthful or misleading prescription drug advertising and promotion, rather than the broad array of violations addressed by the new website. Also, although anyone may submit a complaint to FDA, the Bad Ad Program "is focused primarily on health care professionals" and is "designed to educate health care professionals about the role they can play in helping FDA ensure that prescription drug advertising and promotion is truthful and not misleading." Despite its comparatively limited scope, reports submitted through the Bad Ad Program led to the issuance of a number of enforcement letters. The new website is broader in scope and may have a similar, if not greater, impact. At any rate, whether or not this new website generates additional FDA actions against medical device manufacturers, records of inquiries and investigations completed by CDRH will potentially be available to plaintiffs' attorneys through requests under the Freedom of Information Act.

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