Parker Waichman LLP

Supreme Court Debates Liability Limit

Low-Priced Drugs Linked To Injuries The pharmaceutical industry’s collective eyes are focused on a Supreme Court case regarding generic drugs that could very well determine the degree to which the public can hold generic drug makers liable for injuries allegedly caused by these lower-priced copies of branded medication. The Supreme Court, which heard arguments from […]

Generic Drug Makers

Low-Priced Drugs Linked To Injuries The pharmaceutical industry’s collective eyes are focused on a Supreme Court case regarding generic drugs that could very well determine the degree to which the public can hold generic drug makers liable for injuries allegedly caused by these lower-priced copies of branded medication.

The Supreme Court, which heard arguments from both sides on Tuesday, is expected to decide if manufacturers of generic drugs can be held accountable for any supposed design defects in their medications. Under current federal law, manufacturers virtually replicate the exact composition of the branded versions of the drugs they mimic.

If the Supreme Court ultimately decides that federal law bars product defect claims under state law, the result would be: It will become practically impossible to hold a generic drug maker accountable for injuries that their own drugs generate.

The specifics of the case in question center on Mutual Pharmaceutical Co., which has asked the Supreme Court to overturn a $21 million jury judgment to Karen Bartlett, who successfully sued the generic drug maker in 2008 for injuries she was alleging had been caused by the company’s drug sulindac, a generic painkiller. She won the trial in 14 days.

rare hypersensitivity reaction associated with the drug

The Boston-based U.S. Court of Appeals for the First Circuit upheld the award; Mutual then brought an appeal to the Supreme Court.

Doctors had diagnosed Bartlett as falling victim to a “rare hypersensitivity reaction associated with the drug,” Reuters reported. Bartlett’s skin peeled off and was replaced by lesions that ruptured across two-thirds of her body, keeping her in a hospital burn unit for months – part of which she spent in an induced coma. Since then, doctors have operated on her eyes 13 times — but she is nearly blind, and also suffers from scarred lungs and a constricted esophagus.

As part of its effort to ask the Supreme Court to overturn the award, Mutual argues that federal law already bars claims such as Bartlett’s because the drug in question had already been approved by the U.S. Food and Drug Administration (FDA), and further, was already subject to federal law requiring generics to sport the same design as the branded drug it is seeking to mimic.

The company cites the 2011 Supreme Court ruling of  PLIVA v. Mensing — which has killed in the crib a large volume of personal injury cases against generic drug manufacturers. In Mensing, the court found that generics were essentially protected by the federal law requiring them to have the same label as their branded counterpart.

incident reports on skin reaction submitted to the FDA

During trial, Bartlett established the claim that sulindac was intrinsically hazardous and the design unreasonably dangerous and defective – a contention supported by the number of incident reports on skin reaction submitted to the FDA.

Mutual’s argument is that generic drug makers don’t control their product’s design, which must imitate its branded opposite number.

About 80 percent of all U.S. prescriptions are filled with generics, according to healthcare information provider IMS Health.

Need Legal Help Regarding Generic Drug Makers?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I understand that process for a case like mine takes time.Parker Wakeman has been working on it for me since my injury in August of 2014.There have been times where frustration has arrived during this period.I can't express my appreciation enough to my paralegal Josephine Burgess-Zephrine .She keeps me updated and aware of everything that goes on.I wish it was over,but I appreciate all that Josephine & Parker Wakeman are doing for me. Sincerely
Bob Schmitt
5 years ago
5 Star Reviews 150
Was very professional and and informative I was very surprised with the outcome. Would have not been able to get this done alone Thanks you again.
Ed Ruvane
6 years ago
5 Star Reviews 150
Denny Tang assisted my family in a major personal injury matter and got us a result we were satisfied with. Denny was a consummate professional and showed great patience and care in our case. We're grateful for his assistance.
Kareen M.
9 months ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038