Preempting Products Liability Claims Against Generic Drug ManufacturersKelly Savage, Esq.

Pharmaceutical manufacturers all face

the prospect of tort litigation now and in the

future.

Litigation

over pharmaceutical drugs exacts a staggering

cost on the industry.

Most Common Potential Claims:

• Design Defect Claims; • Design Defects Based on A Failure to Warn;• Manufacturing Defect Claims;• Negligence Claims;• Fraud and Deceit Claims;• Breach of Express and Implied Warranty Claims;

and• Deceptive Practice Act Claims.

Drug lawsuits

cost more than money

Today, you’ll learn more about the important defense of preemption and its potential impact on defending product liability claims brought against your company.

• End goal: learn to help your company avoid costly litigation.

• Preemption can insulate some medical device and drug manufacturers from liability.

• Background and fundamentals of preemption as it applies to generic drug manufacturers.

• How this relates to your company.

Preemption Fundamentals – What is Preemption?

• Federal preemption arises under the Supremacy Clause of the United States Constitution, which provides that federal law is the Supreme Law of the Land.

• Simply put, when a plaintiff seeks to force a defendant either to violate federal law or to face civil liability, both the Supremacy Clause of Article VI of the United States Constitution and the doctrine of preemption are implicated.

• Under this doctrine, any federal law—even a regulation by a federal agency—trumps any conflicting state-law claim.

Types of Preemption• Preemption may arise either expressly—where the federal legislation

states that any other claims are preempted—or by implication.

• Implied preemption occurs in one of two situations: (1) through a broad and comprehensive Congressional scheme occupying the entire field (field preemption), or (2) through a conflict between a state remedy and a Congressional enactment (conflict preemption).

• An actual conflict arises in one of two ways: (1) when compliance “with both federal and state regulations is a physical impossibility,” or (2) when state law “stands as an obstacle to the accomplishment and execution of the full purposes of Congress.”

Why Should Preemption Matter to You?

• Preemption is a Powerful Defense

• Preemption is Generic

• Preemption is a Legal Question

• Preemption is Severable

• Preemption Applies to Generic Drug Manufacturers

Recent example: Dennis Quaid and Baxter

• Quaid and his wife sued the makers of Heparin for allegedly giving their twin babies an overdose of the drug.

• The twins were only a few weeks old when they were given 10,000 units of Heparin at Cedars-Sinai Hospital in Los Angeles. They were supposed to receive 10 units of the blood thinner given in an IV to avoid blood clots.

• The Quaids allege that Baxter, which makes the blood thinner Heparin, was negligent by making different doses in similar vials with similar blue labels.

Baxter’s “Dear Doctor Letter”

• IMPORTANT MEDICATION

• SAFETY ALERT

• BAXTER HEPARIN SODIUM INJECTION 10,000 UNITS/ML AND HEP-LOCK U/P 10 UNITS/ML

• February 6, 2007

• Dear Healthcare Provider:

• This important safety information concerns the potential for life threatening medication errors involving two Heparin products:

– • Heparin Sodium Injection 10,000 units/mL

– • HEP-LOCK U/P 10 units/mL

• Baxter is aware of fatal medication errors that have occurred when two Heparin products with shades of blue labeling were mistaken for each other. Three infant deaths resulted when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL.

• The currently marketed 1 mL vials of Heparin Sodium Injection

• 10,000 units/mL and the HEP-LOCK U/P 10 units/mL use shades of blue as the prominent background color on their labels.

• Healthcare professionals should be reminded to:

– • Never rely on color as a sole indicator to differentiate product identity.

– • Always carefully read the product label to verify that the correct product name and strength have been selected.

– • Always carefully review both the drug name and dose on the label before dispensing and administering these products.

– • Double-check your inventory as soon as possible, to ensure that there is no mix-up of the products.

– • Notify all staff of the potential for errors in dispensing and administering these products. It is advised that you provide color photographs (see below) to staff to assist in their understanding of the product similarities.

Baxter’s Motion to Dismiss

• Baxter has filed a motion to dismiss the case, relying on the same preemption argument that is currently pending before the Supreme Court in Levine v. Wyeth, 128 S.Ct. 1118 (2008). (See also 71 Fed. Reg. 3922 (Jan. 24, 2006))

• Baxter argues that the FDA’s approval of its application to market the drug preempts plaintiffs’ lawsuit.

• So, says Baxter, this suit should not be heard by a judge or jury.

• Case pending

Brand Name vs. Generic Drugs

NDA vs. ANDA Review ProcessNDA Requirements

• Labeling

• Pharm/Tox

• Chemistry

• Manufacturing

• Controls

• Inspection

• Testing

• Animal Studies

• Clinical Studies

• Bioavailability

ANDA Requirements

Labeling

Pharm/Tox

Chemistry

Manufacturing

Controls

Inspection

Testing

Bioequivalence

What are the Basic Generic Drug Requirements?

• Same active ingredients

• Same route of administration

• Same dosage form

• Same strength

• Same conditions of use

• Inactive ingredients already approved in a similar NDA

Labeling

• “Same” as brand name labeling

• May delete portions of labeling protected by patent or exclusivity (i.e., an indication)

• May differ in excipients and product description (i.e., colors and shapes)

Preemption and Generic Drugs

Generic Drugs and Preemption

• Generic drug manufacturers cannot unilaterally change their labeling after approval, even to add or strengthen the existing warning.

• If a generic drug manufacturer makes any unilateral change to its label or product insert to add or strengthen a warning so that its marketing ceases to be identical to the innovator drug’s marketing, “the FDA will withdraw approval of a generic maker’s ANDA . . . .” Colacicco v. Apotex Inc., 521 F.3d 253 (3d Cir. 2008)

• Plaintiffs cannot force generic drug manufacturers to choose between avoiding civil liability and complying with federal law through tort litigation.

Preemption: A Case Study

Gaeta v. Perrigo Pharmaceuticals Company

Recent Trends

Using Preemption to Your Advantage