In Bartlett v. Mutual Pharmaceutical Co.,Inc., the United States Court of Appeals for the First Circuit held that generic drug manufacturers cannot rely on federal preemption to shield themselves from products liability claims alleging defective design of generic drugs.

I. Facts

Karen Bartlett (Bartlett) suffered burns on two-thirds of her body and permanent near-blindness several months after she started taking a generic version of the prescription drug sulindac, an anti-inflammatory pain reliever. Sulindac has been known on rare occasions to cause a hypersensitivity reaction like Bartlett’s. Mutual Pharmaceutical Company (Mutual) was the maker of generic sulindac.

II. Procedural Posture

Bartlett sued Mutual in New Hampshire state court, asserting design defect and inadequate warning claims. After Mutual removed the case to federal district court on diversity grounds, the court dismissed all of Bartlett’s claims except for her state law claim that sulindac had a design defect. The jury found in favor of Bartlett, awarding her $21.06 million in damages. Mutual appealed.

III. Preemption

On appeal, Mutual argued that federal law impliedly preempted Bartlett’s state law design defect claim because:

1.    The Food and Drug Administration (FDA) closely regulates prescription drugs and their warnings.
2.    The FDA requires generic drugs to have the same design and warning labels as the brand-name bioequivalents.
3.    The FDA had already approved sulindac.
4.    Congress did not intend for juries to have the power under state law to second-guess the FDA’s decision in approving a drug.

Mutual cited to  PLIVA, Inc. v. Mensing in support of its argument.  The Mensing Court held that FDA regulations impliedly preempted state law inadequate warning claims against generic drug manufacturers. The Court found that such claims conflict with federal labeling standards that require generic drugs to carry the same warning labels as the brand-name bioequivalents.

Mutual made a similar argument with respect to Bartlett’s design defect claim.  Mutual contended that just as FDA regulations prohibit it as a generic drug manufacturer from altering the labeling on sulindac, Mutual is prohibited from altering the composition of sulindac pursuant to FDA regulations. Consequently, Mutual argued that FDA regulations barred Bartlett’s design defect claim.

The First Circuit disagreed and declined to extend Mensing to design defect claims. The court did agree with Mutual that it could not have changed the chemical makeup of sulindac.  However, the court found that Mutual could have chosen to not manufacture the drug at all. Noting a developing split in the lower courts, the First Circuit stated that if the Supreme Court wants to expand Mensing to cover state law design defect claims, then it should issue such a ruling. Thus, the court upheld the jury award.

IV. Split in the Lower Courts 

Contrary to the First Circuit’s view, there is no split developing in the lower courts. These courts all agree that state law claims against generic drug makers for design defect and “failure to withdraw drug” are preempted pursuant to Mensing:

A. Design Defect Claims Preempted

•    Second Circuit

In re Pamidronate Prods. Liab. Litig. (E.D.N.Y. Jan. 30, 2012)

•    Third Circuit

In re Fosamax Prods. Liab. Litig. (D.N.J. Nov. 21, 2011)
Lyman v. Pfizer, Inc. (D. Vt. Feb. 3, 2012)

•    Fifth Circuit

Eckhardt v. Qualitest Pharmaceuticals, Inc. (S.D. Tex. April 30, 2012)
Johnson v. Teva Pharmaceuticals (W.D. La. May 21, 2012)
Stevens v. PLIVA, Inc. (W.D. La. Nov. 15, 2011)

•    Sixth Circuit

Fulgenzi v. Pliva, Inc. (N.D. Ohio Mar. 31, 2012)
In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig. (E.D. Ky. Mar. 5, 2012)

•    Eleventh Circuit

Metz v. Wyeth (M.D. Fla. Mar. 28, 2012)

B. “Failure to Withdraw Drug” claims preempted

•    Fourth Circuit

Gross v. Pfizer, Inc. (D. Md. Nov. 22, 2011)</a>

•    Fifth Circuit

Eckhardt v. Qualitest Pharmaceuticals, Inc. (S.D. Tex. April 30, 2012)
Cooper v. Wyeth, Inc. (M.D. La. Mar. 6, 2012)
 Johnson v. Teva Pharmaceuticals (W.D. La. May 21, 2012)

•    Sixth Circuit

*In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig. (E.D. Ky. June 22, 2012) (rejecting Bartlett as unpersuasive)

•    Eighth Circuit

Moretti v. Mutual Pharmaceutical Co. (D. Minn. Feb. 13, 2012)

•    Eleventh Circuit

 Coney v. Mylan Pharmaceuticals, Inc. (S.D. Ga. Jan 19, 2012)
Metz v. Wyeth (M.D. Fla. Mar. 28, 2012)
Moore v. Mylan, Inc. (N.D. Ga. Jan. 5, 2012)

V. Is Bartlett “Certworthy?”

It is has to be.  Two criteria that the Supreme Court evaluates in granting certiorari is:

1. Importance of the case.
2. Egregious error on the part of the lower courts.

The Bartlett decision could have a costly impact on American health care. As far as whether the lower courts committed egregious error:  is it the First Circuit or the fair number of federal district courts who disagree with the First Circuit?

 

Erika Staples is familiar with the medical field, and knows that knows medical malpractice is a serious issue.  There are many legal firms available to help victims.