US Supreme Court Rules In Favor of Generic Drug Makers

Generic Drug Manufacturers Have No Liability in Personal Injury, Per Supreme Court

On Monday, June 24, the US Supreme Court ruled in a 5-4 decision that generic drug makers are not liable for personal injury caused by side effects.

The decision reverses the original decision in the case of Karen Bartlett, a New Hampshire woman who took Mutual Pharmaceutical’s generic pain medication, sulindac, for shoulder pain. However, she had an allergic reaction to the drug that was so severe, the Boston court originally ruled in her favor, saying that the drug was too dangerous to be on the market.

Bartlett’s allergic reaction to the generic drug caused her to lose 60% of her outer skin layer. She spent 6 months in a medically-induced coma, had 12 eye surgeries to correct damage, and spent a year being fed through a feeding tube. She is still nearly blind, has lesions over two-thirds of her body, and cannot eat normally.

Because there were no additional warnings on the packaging, Bartlett opened a personal injury lawsuit against Mutual Pharmaceuticals for alleged design defects. If the drug had been the functional equivalent of its name brand counterpart, she would not, in theory, have suffered such horrible injuries from an allergic reaction.

The court in Boston awarded Bartlett $21 million in personal injury damages. However, Mutual appealed the ruling, arguing that the decision conflicted with federal law, and the case went to the Supreme Court.

Now, the Supreme Court has decided that generic drug manufacturers cannot be sued for improper labels, because labels must be the same as those presented on the drugs’ brand name counterparts.

Bartlett’s “situation is tragic and evokes deep sympathy, but a straightforward application of preemption law requires that the judgment [in her favor] be reversed,” Justice Samuel A. Alito Jr. wrote for the court majority. Chief Justice John G. Roberts Jr. and Justices Antonin Scalia, Anthony M. Kennedy and Clarence Thomas agreed.

The oddity in the law relates to generic drugs versus brand name drugs. In 2009, the Supreme Court ruled that pharmaceutical companies that manufacture brand name drugs can be sued for damages.

This is the second ruling in favor of generic manufacturers, and against those that suffer personal injury because of the side effects.

The Strom Law Firm Can Help with Personal Injury Lawsuits Against Dangerous Drugs

At the Strom Law Firm, LLC, our personal injury lawyers understand that your case, your story, is about more than just an accident or physical injury.

It is also about what happened after the accident or injury. It’s about how that accident and those injuries have affected you and your life, and about how they may keep on affecting you in the foreseeable future. It’s about before and after.

As your personal injury attorneys, you can depend not just on our knowledge and understanding of the law, our resources, and our proven ability to secure positive results in personal injury cases. You can depend upon our commitment to telling your story and to securing fair compensation for all the ways you have been affected and will continue to be affected in the future.

If you have been harmed, or a loved one has been harmed or killed, by a defective product or drug, the attorneys at the Strom Law Firm can help. You may be entitled to compensation through a personal injury lawsuit. We offer free, confidential consultations to discuss the facts of your case, so contact us today. 803.252.4800.

About Pete Strom

Defending criminal charges including drug crimes, DUI, CDV, mail fraud, wire fraud, bank fraud, computer crimes, money laundering, and juvenile crimes, Pete also handles Federal and State investigations. Representing individuals in Civil Matters including Class Actions, Personal Injury, Qui Tam Actions, Defective Products, Nursing Home Neglect, and Professional Licensing Defense cases. Joseph Preston “Pete” Strom, Jr., the managing partner at Strom Law Firm, L.L.C., has been fighting for justice since 1984.

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