If You're as Disappointed with the 510(k) Process as Everyone Else Who Manufactures Medical Devices, Here Is Your Chance to Actually Influence the Process

On Tuesday August 31, 2010, CDRH will host a live webinar to discuss the details of both reports and respond to any questions and concerns raised by the medical device Community. Click:


The FDA is now seeking additional public comments and input on the reports, especially on implementation feasibility and on potential alternatives.  

Before You Can Help Yourself, You Must Know the Subject Well

The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, formally established jurisdiction by the FDA over medical devices, requiring premarket review and approval by the FDA by means of a 510(k) submission prior to any marketing of new products. Such review is for the purposes of making available to consumers devices that are safe and effective, and fostering innovation in the medical device industry. “The 510(k) process was originally intended to ensure economic parity between post-enactment and pre-enactment devices.” Riegel v. Medtronic, 451 F.3d 104 (2d Cir. 2006).

Thirty-three years after the Amendments and the birth of the 510(k), in September 2009, CDRH convened an internal 510(k) Working Group that began a comprehensive assessment of the 510(k) process, being charged with evaluating the 510(k) program and exploring actions CDRH could take to strengthen the program and to improve the constancy of its decision making, with a principal focus on actions the Center could take in the short term under its existing statutory authority. Another and independent assessment by the Institute of Medicine is expected to conclude in the summer of 2011. (Another recent CDRH Report is entitled “Volume II: Task Force Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations.”)

Two open meetings earlier in 2010, plus comments entered into the dockets of each group, provided significant input for the Reports.

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Bartlett v. Mutual Pharmaceutical Company, Inc.: Living in a Post-Wyeth v. Levine World.

Ever since the Supreme Court’s decision in Wyeth v. Levine, drug manufacturers have found themselves at increased risk from state tort claims. On July 12, 2010, the United States District Court for the District of New Hampshire issued an opinion in Bartlett v. Mutual Pharmaceutical Company, Inc., 2010 U.S. Dist. LEXIS 69825 (D.N.H. July 12, 2010).  This case arises from an incident where a plaintiff, seeking treatment for pain in her right shoulder, was prescribed a non-steroidal, anti-inflammatory drug (“NSAID”) called Clinoril. The prescription was filled with the generic version of the drug, which was manufactured by the defendant. Weeks later, the plaintiff developed Stevens-Johnson Syndrome ("SJS") progressing to toxic epidermal necrolysis ("TEN"), a potentially fatal condition. The plaintiff sued defendant and alleged, among other things, that the defendant’s drug’s safety risks outweighed its medical benefits, making it an unreasonably dangerous product and that the defendant should have strengthened the drug’s safety warning in light of a certain reports in the medical literature about the connection between the drug and SJS/TEN. Both parties moved for summary judgment on various points.

In his opinion, Judge Lapalante found the following:


  1. Adequacy of the Safety Warning. The court refused to grant summary judgment on whether defendant’s drug label adequately warned doctors of the risk of SJS/TEN. The court reasoned that given the severity of SJS/TEN and a study indicating that the drug had more reported cases than most NSAIDs, the decision should be left to the jury.
  1. Causation. On various issues of causation, the court found as follows:

A.                            Reliance on Warning Labels. The court granted summary judgment in favor of the defendant on the issue of whether the defendant’s alleged failure to issue a stronger warning caused plaintiff’s injuries on the basis that the plaintiff’s doctor never reviewed the label warnings.


B.                             Non-Label Theories. The court granted summary judgment in favor of the defendant on the issue of whether a stronger warning by the defendant could have reached the physician’s attention through some other means apart from the label and found that the plaintiff did not provide enough evidence to establish the presence of a trial-worthy issue as to whether the defendant 's alleged failure to warn caused her injuries.


C.                            Defective Design Claims. On the issue of design defect, the court concluded that the plaintiff presented enough evidence (in the form of expert testimony) to create a trial-worthy issue as to whether defendant’s drug is unreasonably dangerous and whether that defective condition caused her injuries.


  1. Fraud. The court granted summary judgment in favor of the defendant on the issue that the defendant committed fraud, because neither the plaintiff nor the plaintiff’s physicians relied on the drug’s label.
  1. Punitive Damages.  The claim for punitive damages survived summary judgment because a reasonable jury could conclude that the defendant recklessly created a risk of great harm to consumers.


  1. Negligence for Failure to Survey Medical Literature. Although the defendant conceded that it did not survey medical literature, the violation of an FDA regulation requiring surveillance did not amount to negligence per se and the Food Drug and Cosmetic Act did not provide private enforcement of such violations.  Thus, plaintiff’s request for summary judgment was denied.

Federal Court Rules that Generic Drug Manufacturers Cannot Hide Behind FDA Approval

The Legal Intelligencer reported that in a recent interpretation of the Wyeth v. Levine decision, a federal judge ruled that generic drug manufacturers are not immune from suit because the Federal Drug Administration (“FDA”) approved its generic drug product. In the May 26, 2010 In re Budeprion XL Marketing & Sales Litigation decision, U. S. District Court Judge Berle M. Schiller refused to dismiss a class action law suit filed by consumers who experienced side effects after switching brand-name drug Wellbutrin to generic drug Buproprion.

According to FDA regulations, to receive FDA approval for a generic drug, generic drug manufacturers must submit an Abbreviated New Drug Application (“ANDA”) providing scientific proof that the generic drug is the “bioequivalent” of a brand-name drug. This is shown by using data to prove the generic drug is comparable to the brand-name drug in dosage form, strength, route of administration, quality, performance characteristics, and intended use. This approval process was developed in 1984 by the establishment of the Hatch-Waxman Act (the “Act”). The Act is designed to expedite the availability of less costly generic drugs by permitting the FDA to approve applications to market generic versions of brand-name drugs without costly and duplicative clinical trials.


In Wyeth v. Levine, the U. S. Supreme Court found that Federal law does not trump a state law imposing a duty to warn on drug manufacturers. In this case, Levine sued Wyeth for failing to adequately warn the medical staff who treated her about the risks of the anti-nausea drug Phenergan. After a clinician injected Levine with Phenergan directly into her vein, the drug entered Levine's artery, she developed gangrene, and doctors amputated her forearm. A jury determined that Levine's injury would not have occurred if Phenergan's label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a professional musician. Wyeth appealed the verdict all the way to the U. S. Supreme Court, asserting that Levine’s failure to warn law suit was pre-empted by Federal law because Phenergan's labeling had been approved by the FDA. The Supreme Court upheld the jury’s verdict and rejected Wyeth’s argument, stating that entrusting the FDA with drug labeling decisions does not absolve a drug manufacturer of the responsibility to comply with a state law regarding the duty to warn.


Judge Schiller’s decision in Budeprion expanded on the Supreme Court’s decision in Wyeth. In Budeprion, consumers brought a class action suit against Teva Pharmaceuticals (“Teva”) and Impax Laboratories (“Impax”), two manufacturers of Buproprion. The suit alleges that Teva and Impax became aware of the side effects, which stem from a difference in the method of release of the drug into the body, but failed to warn doctors or patients of the differences between the generic and brand name drug. In response to the law suit, Teva and Impax asserted that the suit should be dismissed because Federal law pre-empts claims arising from a state’s law regarding a duty to warn. Judge Schiller rejected Teva and Impax’ argument by finding that “state law causes of action do not frustrate congressional intent with respect to the regulation of generic drugs.” He opined that the Teva and Impax’ logic would remove any incentive for generic drug makers to monitor the safety of their medications and update labels accordingly after receiving FDA approval. Such an interpretation, Judge Schiller further opined, finds no support in the law.


This decision reminds generic drug manufacturers that while their purpose is to provide a low cost alternative to brand-name drugs, it is important to remember that the health and welfare of the consumer should always come first.