Philly Court Applies Michigan Law to Dismiss Risperdal Cases

by Reed Smith
Contact

Delve into the crime stories of Elmore Leonard, whether in the form of the books, movies, or television shows, and you are likely to spend considerable time in Michigan and Florida.  True, Justified was set in Kentucky.  But Marshall Givens was forced to leave the Sunshine State after shooting a suspect (“Let’s just keep it simple: he pulled first,  I shot him”), and the big criminal organization he often contended with hailed from Detroit.  Leonard, also known as the Dickens of Detroit, was a native of Michigan and later spent much time in Florida.  Those two locations furnish a nice contrast between city and swamp, both settings being utterly sweaty and corrupt. 

There is nothing especially sweaty about what we do, and we’d like to think that corruption is far, far away, but if you delve into our litigation docket, you are likely to encounter a tug of war between Michigan and Pennsylvania.  We live in Pennsylvania.  Our courts and laws seem inordinately fond of drug and device law plaintiffs.  By contrast, Michigan has just about the best, most pro-defense laws on the books, and, consequently, Michigan plaintiffs look to hightail it out of there and file their cases in a more hospitable jurisdiction – like, say, ours. 

Recently in the Philly mass tort Risperdal litigation, a local judge did the right thing and told Michigan plaintiffs that they were stuck with Michigan law.  In Re Risperdal Litigation, 2015 Phila. Ct. Com. Pl. LEXIS 254 (Phila. CCP October 1, 2015).  The 13 plaintiffs were Michigan residents who claimed that they developed gynecomastia after taking Risperdal during adolescence.  The defendants filed summary judgment motions arguing that Michigan’s Products Liability Act applies and affords the defendants immunity on the plaintiffs’ claim for 1) negligence, 2) negligent design defect, 3) fraud, 4) strict liability – failure to warn, 5) strict liability – design defect, 6) breach of express warranty, 7) breach of implied warranty, 8) conspiracy, and 9) medical expense incurred by parents.  The plaintiffs disagreed.  They needed Pennsylvania law to apply, otherwise they would lose. 

They lost. 

Michigan’s Product Liability Act is a thing of beauty.  Behold its splendor and majesty: "In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller."  Mich. Comp. Laws § 600.2946(5).  Like a supermodel with a mole, the Michigan law possesses an imperfection that almost enhances its beauty.  The Act contains two exceptions to this blanket immunity granted to drug manufacturers.  First, a drug manufacturer will not be immune if it “intentionally withholds from or misrepresents” information from the FDA, whereas the provision of such information would have either prevented FDA approval to begin with or would have prompted the FDA to withdraw approval.  Second, bribery of an FDA official would call off the immunity. 

Pennsylvania law is not quite as good.  Or let’s put that a different way.  If the Michigan law is the Mona Lisa of American product liability law, Pennsylvania’s version is more like an episode of Bowling for Furniture, or a YouTube cat video.  Let’s leave it at this: there is a conflict of laws. 

We know which law we would apply.  And, happily, the Pennsylvania court agreed.  Pennsylvania’s choice of law rule combines the approach of the Restatement (Second) on Conflicts of Law and the interests of the state analysis.  Michigan was the place of alleged injury for each of these cases.  The conduct causing the injury occurred in both Michigan, where the plaintiffs and their prescribing physicians received any misrepresentation regarding Risperdal and where the plaintiffs were prescribed, purchased, ingested and allegedly injured by the drug, and Pennsylvania, where one of the defendants was alleged to have concealed material information regarding the safety of Risperdal.  A review of the legislative history of Michigan Products Liability Act shows that it was passed for the express purpose of limiting the liability of drug manufacturers.  By contrast – and here we confess to being almost amazed that our local court had such a moment of enlightenment, Pennsylvania has no interest in becoming “a repository for cases filed by Michigan residents seeking to avoid application of the Michigan Products Liability Act.”  Even if the Michigan Product Liability Act seems “harsh” (that was the word the Philly court used; we prefer “sound,” “logical,” “lovely,” or “calipygian”) it governs the case of these Michigan plaintiffs.      

So, saddled with the law of the jurisdiction where they live, vote, and root for the hapless Lions, the plaintiffs presented three arguments why the Products Liability Act does not apply.  First, they argued that Risperdal was not, in fact, approved for safety and efficacy by the FDA because its label did not contain an indication for adolescent use.  Second, the plaintiffs argued that they met the first exception to the Products Liability Act because the defendants withheld information from the FDA and a question of fact existed as to whether Risperdal would have been approved, or maintained its approval, if the withheld information had been supplied to the FDA.  Finally, the plaintiffs argued that a prior guilty plea by one of the defendants was tantamount to a federal finding of fraud on the FDA.

Each one of those arguments was a swing and a miss – something seen often this season with the surprisingly crummy American League Detroit baseball franchise.  First, a physician’s decision to use a pharmaceutical for an “off-label” purpose is not only an acceptable practice, but also “an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”  The “off-label” use did not somehow render the label unapproved.  Second, the issue of whether the defendant lied to the FDA in getting its label opens up once more the issue of whether such an exception is preempted by Buckman.  The Michigan state courts have not yet addressed the issue of whether § 600.29(5)(a) is preempted by the FDCA.  As we have mentioned many times before, the federal courts are split on the preemption issue.  The Sixth Circuit, which includes the federal courts in Michigan, decided that § 600.29(5)(a) is implicitly preempted.  Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir., 2004).  Conversely, the Second Circuit went the other -- that is, wrong – way.   Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2nd Cir., 2007), aff’d by an equally divided court sub nom, Warner-Lambert Co., LLC v. Kent, 552 U.S. 440, 128 S.Ct. 1168 (2008) (per curiam)(4-4 decision). 

We wish the Philly court would have come down on the side of Garcia, but it concluded that it did not need to, because (1) there had been no federal finding of fraud, and (2) even if there was a federal finding of fraud, the plaintiffs produced no facts showing that “the drug would not have been approved, or the [FDA] would have withdrawn approval for the drug if the information were accurately submitted.”  Indeed, in response to a citizen’s petition, the FDA recently declined to withdraw Risperdal from the market, stating “based on review of clinical data submitted by the sponsor, published literature, and postmarketing surveillance, there is no evidence … that would warrant revocation of the pediatric indication of [Risperdal]."

That leaves the plaintiffs' argument that a November 2013 guilty plea showed fraud.  And here we must confess, ala a classic Elmore Leonard story, to withholding a fact that registered a bigger impact upon delayed disclosure.  That guilty plea related to promotion of the drug for the treatment of dementia in the elderly.  That guilty plea was, in other words, “wholly irrelevant”  to the question of whether the defendants submitted accurate information to the FDA concerning the frequency of developing gynecomastia after taking Risperdal during adolescence.

There are one or two other rulings in the case.  They are minor characters.  Leonard famously issued his Ten Rules for Writing.  One of them was “Try to leave out the part that readers skip.”  Perhaps we have already violated that rule.  This is the punchline:  the Philly court did a fine job, it chose the right law, any merit to the plaintiffs’ arguments was out of sight, and the summary judgment in favor of the defendants was entirely justified.

Written by:

Reed Smith
Contact
more
less

Reed Smith on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.