Supreme Court considers drugmaker’s appeal of $21 million judgment in generic drug case

by John Chapman

In December 2004, Karen Bartlett’s doctor prescribed Sulindac, a generic anti-inflammatory medication, to help treat her shoulder pain. Within months, she began suffering from a severe reaction called Stevens-Johnson syndrome. The condition deteriorated over 60 percent of her skin to the point of causing open wounds. She spent nearly two months in a medically induced coma in a burn unit. She endured more than a dozen eye surgeries and is now legally blind.

Bartlett filed a lawsuit against the Sulindac manufacturer, Mutual Pharmaceutical Company. A jury found that Sulindac was unreasonably dangerous to consumers and therefore was defectively designed. The jury awarded Bartlett more than $20 million in compensatory damages.

The drug company argued that federal law governs generic drug manufacturers’ conduct and therefore Bartlett cannot pursue a state law design defect claim. The trial court disagreed, and the United States Court of Appeals for the First Circuit affirmed the trial court’s judgment. Mutual Pharmaceutical appealed further to the Supreme Court of the United States, which granted certiorari. Mutual Pharmaceutical Co. v. Bartlett, No. 12-142. Oral argument was recently held before the Supreme Court.

The question before the Supreme Court is whether federal law “preempts” a state law design defect claim against a generic drug manufacturer. One type of preemption is known as “conflict” preemption. According to recent Supreme Court decisions, conflict preemption occurs either (1) when it is impossible for someone to comply with both state and federal laws, or (2) when the purposes and objectives of federal law would be thwarted by state law.

Before the Supreme Court, the lawyer for Mutual Pharmaceutical argued:

This is a classic case of impossibility preemption. Federal law required generic sulindac to have the same ingredients, the same warning and the same safety profile as the branded version, but a New Hampshire jury imposed liability because sulindac didn’t have a different safety profile, meaning a different ingredient or a different warning. And as Mensing recognized, that’s an impossibility conflict. And there is no principle basis for treating design defect claims any differently from failure to warn claims.

In Wyeth v. Levine, the Supreme Court ruled that a failure-to-warn claim against a brand name drug manufacturer under state tort law was not preempted by federal law. That case was brought by Diana Levine, a professional musician whose arm had to be amputated after a drug, Phenergan, was injected directly into her blood instead of being administered in a drip solution. The Supreme Court held that Wyeth could have added to its packaging a stronger warning about the risks of injecting the drug. The court held there was no preemption because federal regulation left room for Wyeth to alter its warning labels and because Congress did not specify any intent to preempt state failure-to-warn claims.

However, in the more-recently decided Pliva Inc. v. Mensing, the Court ruled, by a vote of five to four, that with respect to generic drugs, federal law preempts any state laws that would require a manufacturer to make changes in a drug label to provide more warning. The majority found that the case presented an example of “impossibility,” because generic drug manufacturers were not permitted under federal regulation to make label changes.

In the Bartlett case, the generic drug manufacturers argue that the issue is similar to the failure-to-warn case because they are not at liberty to alter the drug to make it safer and therefore have no ability to deal with the design defect. The First Circuit Court of Appeals disagreed, in part because the court indicated that the generic drug manufacturer did have one simple solution: stop selling a product that has a medically dangerous design. A decision from the Supreme Court is expected later this year.

Heygood, Orr & Pearson fighting Big Pharma

The lawyers at Heygood, Orr & Pearson have made it a career priority to hold drug manufacturers accountable and responsible for their actions. As a result, we have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. We have represented hundreds of people regarding dangerous fentanyl pain patches, defective hip and knee implant devices, Yaz, Actos, Avandia and Accutane—to name just some examples.

Heygood, Orr & Pearson is AV-rated, the highest legal and ethical rating available from the leading law firm rating service. Our partners Michael Heygood, Jim Orr, and Eric Pearson are all Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization. Mr. Heygood and Mr. Orr are additionally Board Certified in Civil Trial Advocacy Law by the National Board of Trial Advocacy. Our partners been voted by their peers as “Super Lawyers” in the state of Texas for several years in a row.*

At Heygood, Orr & Pearson, we believe that when a drug company sells a drug or medical device that is dangerous and unsafe, they should be held responsible for the damage. In addition, we have the resources and experience to protect a person’s rights and the rights of their loved ones against irresponsible pharmaceutical companies and medical device manufacturers.

If you have been injured or have lost someone you care about because of defective or dangerous prescription drugs or medical devices, you deserve to have the manufacturer held responsible and to receive proper compensation. Contact us for a free consultation by calling toll-free at 1-877-446-9001 or by filling out the free consultation form on this page to find out more about your legal options.


Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2013.

by John Chapman

John Chapman is a licensed attorney with experience in complex commercial litigation (including securities fraud, RICO, shareholder oppression, and derivative actions) and personal injury litigation.