United States: W.D. Penn. Dismisses Most Claims In Hernia Mesh Case

You've probably heard James Carville's description of Pennsylvania as Pittsburgh on one end, Philadelphia on the other, and Alabama in-between. Let's put aside that last bit, which manages simultaneously to insult both Alabama and middle Pennsylvania, and focus on the rivalry between Pittsburgh and our fair city, Philly. Those two municipalities are separated by a lot more than 305 miles. Pittsburgh invented Big Steel, while we invented, you know, freedom. People in Pittsburgh eat huge sandwiches containing French fries, while we fill ours with meat and cheese-whiz, leaving the fries on the side. Our sports fans are more devoted – think Invincible or Silver Linings Playbook. Lincoln Financial Field had its own Eagles jail. (Granted, Pittsburgh's teams, unlike ours, actually win with some frequency. Congrats to the Penguins, we say through gritted teeth.) A short road trip from Philly gets one to NYC, the Shore, the Poconos, or DC. Not bad, right? If you drive for a couple of hours out of Pittsburgh, you can be in ... West Virginia. (Oh no – time for more Mountaineer hate mail.) Our city's name is on some great movies – e.g., Philadelphia, The Philadelphia Story. Philly was the setting for many essential flicks. There's Witness, Dressed to Kill (that great early scene is in the Philly Art Museum, though you're supposed to think it's the Met), Trading Places, Twelve Monkeys, The Sixth Sense, etc. We could go on and on. (Go ahead, dare us.) Ever heard of Rocky? By contrast, when has cinematic greatness touched Pittsburgh? Wonder Boys? The Fish that Saved Pittsburgh? Groundhog Day? (And that last one is a stretch.) Two of the greatest American painters, Eakins and Cassatt, lived in the Philly area. We'll take either one of them over Warhol. (Yes, yes – it has been pointed out to us that Cassatt was born in Pittsburgh. But she high-tailed it out of there at a young age. She grew up in a nice area near Philly. At least we think it's nice. We live in that area now. Our street is named Cassatt – though named after her father, not her.) Our music is better. We'll take Joan Jett over Christina Aguilera, Teddy Pendergrass over Stephen Foster, Gamble/Huff over Wiz Khalifa, and Pink over Pink Panther (i.e., Henry Mancini, composer of the theme song). In a recent poll, the Philly accent was listed as one of America's ugliest. But guess who 'won' as ugliest of all? Pittsburgh, the heewme of the Yinzers.

But if we had to defend a drug or device client, we'd probably rather be in Pittsburgh. We do not remember anybody ever calling Pittsburgh a judicial heck-hole. Jurors there seem to have a Midwestern-sort of sanity, unlike our jurors, who flip million dollar verdicts around like they were nickels. Moreover, the judges out there seem to get it right. They follow the rules, rather than bend them in an effort to accommodate sympathetic plaintiffs or friendly plaintiff lawyers. Have you ever heard of Pittsburgh litigation tourism? Neither have we. A recent example of Western Pennsylvanian common sense arrived in the form of the decision in Carson v. Atrium Medical Corp., 2016 U.S. Dist. LEXIS 74743 (W.D. Pa June 8, 2016). In Carson, the plaintiff had undergone a hernia repair involving a polypropylene mesh implant. The plaintiff suffered from complications and additional surgical procedures. Her complaint included the usual panoply of claims – strict liability, negligence, and breach of warranties. Pennsylvania law governed, and that turned out to be a bit of a problem for the plaintiff once the defendants filed a motion to dismiss.

As an initial matter, the court held that the plaintiff's strict liability claim was barred by Pennsylvania law – specifically, the Torts Restatement Comment k on "unavoidably unsafe products." To be sure, while the Pennsylvania Supreme Court has invoked Comment k to shut down strict liability claims against prescription drugs, it has not yet decided whether Comment k applies to medical devices. But state lower courts and various federal courts have reasoned that the same rationale for Comment k makes sense for devices. The judge in Carson agreed. The plaintiff argued that if Comment k were to be applied to devices, it should be limited to products that were "accompanied by proper directions and warning." Under that reasoning, a failure to warn claim would get a plaintiff out from under Comment k. But the Pennsylvania Supreme Court has rejected that exception for prescription drugs, so there was no reason to gin it up for devices. Maybe some other states have recognized or made up caveats to Comment k's exclusion of strict liability claims, but the Carson court correctly felt bound by Pennsylvania law, which does not recognize such caveats. Goodbye, strict liability.

The plaintiff conceded that Pennsylvania law prohibited her negligent marketing, negligent testing, and fraud claims. So why were they in the complaint?

The plaintiff also alleged a claim for manufacturing defect. Or perhaps "alleged" is too strong a word. Maybe "wished for"? The plaintiff did not include any actual facts to show anything wrong with the defendant's manufacturing process. Instead, she simply offered general statements that the defendants "were negligent in the manufacturing process." That sort of conclusory statement falls short of the federal pleading standard established in Iqbal and Twombly. Indeed, it falls short of telling us much of anything at all. Deviation from specs? Something else? As we'd say in Philly, whaddya taawkin' bout? Re-dic-liss.

The pesky warranty claims, which so often seem like perfunctory afterthoughts, as if omitting them would get you in dutch with the plaintiff lawyers' union, fared no better. For any defendant in Pennsy staring at a warranty claim, think of the Makripodis case, which held that the "very nature of prescription drugs themselves precludes the imposition of a warranty of fitness for 'ordinary purposes, as each individual for whom they are prescribed is a unique organism." Makripodis by Makripodis v. Merrell-Dow Pharm., Inc., 361 Pa. Super. 589 (Pa. Super. Ct. 1987). Federal courts have embraced Makripodis, and have extended its reasoning to preclude claims for other warranties (e.g., merchantability) as well. Further, think back to Comment k. If medical devices are unavoidably unsafe products, there can be no claim for breach of implied warranty.

It was not an across-the-board win for the defense. The WD Pa. court denied the motion to dismiss the misrepresentation claims. The plaintiff alleged that the defendants marketed the product as "safe, fit and effective for use in hernia repair." She also alleged that the defendants misrepresented and concealed from the plaintiff's physicians the serious risks, damages and defects enumerated in this complaint. At least for now, those causes of action are viable, though whether they will survive discovery remains to be seen.

This article is presented for informational purposes only and is not intended to constitute legal advice.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.